Bluelake Biotechnology 3/21/24 Bluelake Biotechnology 3/21/24

Blue Lake Biotechnology reports positive interim clinical data in children for its RSV vaccine candidate

Athens, Ga. and San Jose, Calif., March 21, 2024 – Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company developing parainfluenza virus 5 (PIV5)-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, today announced preliminary data from the first two cohorts of a Phase 1/2a clinical trial studying BLB201, the company’s investigational vaccine against severe respiratory syncytial virus (RSV) disease. The data show that BLB201 is immunogenic and well tolerated, with no significant safety events reported to date following a single intranasal dose in RSV seropositive children 18-59 months of age. The ongoing trial is currently enrolling both RSV seropositive and RSV seronegative children as young as eight months of age.

“Given the challenges of developing an RSV vaccine for children, it is highly encouraging that BLB201, our intranasal RSV vaccine candidate, has been well tolerated in this age group so far,” said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology. “It is also very exciting to see RSV-specific immune responses to our vaccine in children who have previously been exposed to RSV. We are eager to generate more data in younger children, including infants who have not had prior exposure to RSV, and to develop a highly effective and safe vaccine to protect this vulnerable population from RSV.”

Among the initial 10 participants ages 18-59 months who received BLB201 study vaccine in this Phase 1/2a study (NCT05655182), there have been no serious vaccine-related safety signals reported to date. In the five participants who received the higher dose of 10⁷ PFU of BLB201, prominent increases in RSV neutralizing antibody (nAb) responses were observed at four weeks post-vaccination, with 80% having a 3.6- to 57-fold rise in nABs over baseline. RSV-specific mucosal IgA antibody and cellular immune responses were also observed.

“For the first time, an RSV vaccine candidate has been shown to generate increases in anti-RSV antibody responses in RSV-seropositive children, suggesting that BLB201 could be effective even in infants who have pre-existing anti-RSV antibodies,” continued Dr. He. “This is particularly encouraging given that the target population of our vaccine includes infants under eight months old who may already have passive immunity to RSV from maternal antibodies or exogenously administered anti-RSV antibodies.”

About RSV

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus and one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people, it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under five years old and up to 160,000 older adults are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year.

While there are approved antibody drugs and a maternal RSV vaccine that can provide passive immunity against RSV to infants, there is no approved vaccine for generating prophylactic immunity against RSV in infants and children. Such a vaccine is needed to fully protect young populations at significant risk from severe RSV disease.

About BLB201

BLB201 is an RSV vaccine candidate that is currently in Phase 1/2a clinical testing in children ages eight to 59 months of age. It has received Fast Track designation from the US Food and Drug Administration for the prevention of RSV-associated acute respiratory disease in adults (>60 years) and pediatric populations (<2 years). BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector, which is not known to cause human disease. PIV5 has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. Blue Lake Biotechnology is developing BLB201 as an intranasal vaccine to prevent acute and severe disease associated with RSV infection. Phase 1 clinical trial results demonstrate BLB201's safety and ability to induce antibody and cell-mediated immune responses, positioning it as a promising candidate in the fight against RSV.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and durability with few vaccine-related side effects.

Learn more at Blue Lake Biotechnology.

CONTACTS:

Carolyn Hawley
Inizio Evoke Comms
carolyn.hawley@inizioevoke.com
619-849-5382

Samuel Wu, Chief Business Officer
Blue Lake Biotechnology, Inc. and CyanVac LLC
swu@bluelakebiotechnology.com
650-609-2231

Bluelake Biotechnology 2/15/24 Bluelake Biotechnology 2/15/24

Preclinical Data on PIV5-based Intranasal Vaccine Against Lyme Disease Demonstrates Durable Immune Response

Research Published in NPJ Vaccines

Athens, GA, San Jose, CA, and Memphis, TN – Feb.15. 2024 -- CyanVac LLC, a clinical-stage intranasal vaccine company developing PIV5-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, and Immuno Technologies, Inc., a research and development company working on vaccines and diagnostics for Lyme disease, today announced the publication in NPJ Vaccines of preclinical data showing that mice inoculated with a PIV5-based intranasal vaccine against Lyme disease demonstrated long-lasting neutralizing antibody responses and long-term protection of up to 15 months against multiple strains of Borrelia burgdorferi, the causative agent of Lyme disease.

“Vaccines developed using our proprietary PIV5-based platform have generated long-term immune responses for a range of pathogens in preclinical models and have demonstrated very encouraging human results in RSV and COVID-19,” said Biao He, Ph.D., founder and CEO of CyanVac and an author on the article. “This peer-reviewed research on a vaccine candidate against Lyme disease demonstrates the ability of the PIV5 platform to stimulate durable immune responses against a vector-borne pathogen, broadening its utility. Importantly, because we can rapidly mobilize our platform for emerging and established pathogens, we can respond quickly as public health needs dictate.”

Lyme disease, which is transmitted after a bite of an infected deer tick, is a major public health issue in the Northeast, Mid-Atlantic and Midwest regions of the US, and is estimated to affect more than 450,000 people annually. The majority of individuals with Lyme disease can be effectively treated with antibiotics. However, in a subset of infected individuals, it can become a progressive and potentially debilitating disease characterized by a wide array of clinical manifestations affecting various organs of the body. It is the most prevalent vector-borne disease in the US and Europe, yet there is no licensed vaccine available.

In the article, entitled “Intranasal vaccine for Lyme disease provides protection against tick transmitted Borrelia burgdorferi beyond one year”, a two-dose course of the PIV5-based intranasal Lyme vaccine was shown to provide superior protection against challenge with ticks carrying up to 19 different B. burgdorferi strains, when compared against a subcutaneous Lyme vaccine control (purified recombinant OspAB31 in alum adjuvant). This superior protection was seen in challenge studies performed at 9 and 15 months after immunization. Also, neutralizing antibody activity against B. burgdorferi was maintained at higher levels in the intranasally vaccinated mice than in the subcutaneously vaccinated mice for up to 18 months post-immunization.

“With the most advanced vaccine candidate for Lyme disease in development requiring three intramuscular injections plus a booster, there is a large gap that a technology like our PIV5-based platform can fill,” continued Dr. He. “These preclinical data showing long lasting protection against infection after a prime-boost immunization are extremely encouraging.”

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., are developing intranasal vaccines that harness a full range of immune responses to prevent serious infectious diseases and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 (PIV5) vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and durability with few vaccine-related side effects. Learn more at www.cyanvacllc.com.

About Immuno Technologies

Immuno Technologies, Inc is a preclinical research and development company working on vaccines and diagnostic assays for infectious diseases. As products evolve from the laboratory to the next stage of early development, the company’s long term goal is to design prototypes and spin off these technologies to new ventures and/or seek strategic alliances with partners with commercialization capabilities. The company’s main area of interest is Lyme disease. For more information visit www.immunotechnologies.com.

Acknowledgements

Research reported in this press release was supported by grants from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award numbers R01AI139267, R43AI155211, and R44AI167605, and by funding from CyanVac LLC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Media contact:
Carolyn Hawley
Inizio Evoke Comms
carolyn.hawley@inizioevoke.com
619-849-5382

CyanVac LLC contact:
Samuel Wu, Chief Business Officer
swu@cyanvacllc.com
650-609-2231

Bluelake Biotechnology 10/25/23 Bluelake Biotechnology 10/25/23

Positive Phase 1 Data for Blue Lake Biotechnology’s Intranasal RSV Vaccine Published in Science Advances

Positive Phase 1 Data for Blue Lake Biotechnology’s Intranasal RSV Vaccine Published in Science Advances

• A Phase 1/2a clinical trial is underway in children ages six to 59 months of age

Athens, GA and Los Gatos, CA, October 25, 2023 – Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company developing PIV5-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, announced the publication of positive Phase 1 clinical trial results of its intranasal RSV vaccine candidate BLB201 in Science Advances. Data generated during the first-in-human study of BLB201 showed that BLB201 was well-tolerated and stimulated RSV-specific antibody and cell mediated immune responses in adults ages 33 to 75 years following a single intranasal dose.

"In the ever-evolving landscape of vaccine development, our Phase 1 study of BLB201 showcases the potential of the PIV5 vector platform,” said Blue Lake’s chief executive officer, Biao He, Ph.D. “The positive results not only position BLB201 well in the race for an effective RSV vaccine but also pave the way for using the PIV5 platform in developing other novel vaccines. We are excited about the future possibilities and the impact this could have on global health."

BLB201 was found to increase RSV-specific serum antibody levels as well as RSV-specific mucosal antibodies following a single dose in adults and elderly, all of whom had evidence of prior exposure to RSV. In addition, administration of BLB201 was associated with increases in RSV F antigen-specific CD8+ cytotoxic T cells as well as Th1 CD4+ T cells (helper T cells), highlighting its potential to provide longer-lasting immunity against RSV. Of all intranasal RSV vaccine candidates that have so far been evaluated in adults, BLB201 has generated the most robust immune responses. The vaccine was well-tolerated. Side effects were generally mild, short-lived and self-limited.

"The findings from this phase 1 study of BLB201 represent a significant leap forward in the quest to provide children with a safe and easy to administer vaccine that can provide durable protection,” said Paul Spearman, MD, Professor of Infectious Diseases at Cincinnati Children’s Hospital Medical Center and principal investigator of the study. “We are especially excited to see strong T cell immune responses after intranasal administration, which are important for maintaining long-lasting immunity.”

RSV causes significant mortality and morbidity in the elderly and in infants. It has been difficult to develop an RSV vaccine that can be used in both populations, one which can overcome reduced immune responsiveness in the elderly while avoiding safety issues in infants. The Phase 1 results show that BLB201 is a promising intranasal vaccine candidate for the elderly. In addition, since live vaccines are believed to be safer for infant RSV vaccine development (i.e., unlikely to trigger a phenomenon called “enhanced RSV disease”), BLB201 may also be a safe and effective RSV vaccine for infants. To explore this potential, Blue Lake is now actively enrolling a Phase 1/2a study in infants and children between the ages of six to 59 months in the U.S.

About BLB201

BLB201 is an RSV vaccine candidate that is currently in Phase 1/2a clinical testing in children ages six to 59 months of age. It has received Fast Track designation from the US Food and Drug Administration for the prevention of RSV-associated acute respiratory disease in adults (>60 years) and pediatric populations (<2 years). BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector, which is not known to cause human disease. PIV5 has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. Blue Lake Biotechnology is developing BLB201 as an intranasal vaccine to prevent acute and severe disease associated with RSV infection. Phase 1 clinical trial results demonstrate BLB201's safety and ability to induce antibody and cell-mediated immune responses, positioning it as a promising candidate in the fight against RSV.

About RSV

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus and one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people, it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under 5 years old and up to 160,000 older adults are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year.

While there are costly antibody drugs approved for use in infants that provide temporary passive immunity against RSV, there is no approved vaccine for generating prophylactic immunity against RSV. Such a vaccine is needed to protect populations at the highest risk from severe RSV disease, including the elderly as well as infants, to reduce the substantial health and economic burdens of RSV infection in the US and worldwide.

About CyanVac and Blue Lake Biotechnology

Learn more at Blue Lake Biotechnology.

CONTACTS:

Carolyn Hawley
Evoke Canale
carolyn.hawley@evokegroup.com
619-849-5382

Samuel Wu, Chief Business Officer
Blue Lake Biotechnology, Inc. and CyanVac LLC
swu@bluelakebiotechnology.com
650-609-2231

Bluelake Biotechnology 9/27/23 Bluelake Biotechnology 9/27/23

Blue Lake Biotechnology Presenting at Upcoming BioFuture and BIO Investor Forum Conferences

Athens, GA and Los Gatos, CA – September 27, 2023 - Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company enlisting the full breadth of the immune system to protect people from serious infectious diseases, today announced that management will be presenting and engaging in 1-1 meetings at the following upcoming investor conferences:

BioFuture
- October 6th, 2023 at 10:00 a.m. ET
- New York City, New York
- 1-1 partnering access: https://biofuture.com/one-to-one-meetings/

BIO Investor Forum
- October 18th, 2023 at 1:30 p.m. PT
- San Francisco, California
- 1-1 partnering access: https://bif.bio.org/bio-one-one-partnering

About Blue Lake Biotechnology

Blue Lake Biotechnology, Inc. and its affiliate, CyanVac LLC, are developing intranasal vaccines that enlist the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and save the lives of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and lasting durability with few vaccine-related side effects.

Learn more at https://www.bluelakebiotechnology.com.

CONTACTS:

Carolyn Hawley
Evoke Canale
carolyn.hawley@evokegroup.com
619-849-5382

Samuel Wu, Chief Business Officer
Blue Lake Biotechnology, Inc. and CyanVac LLC
swu@bluelakebiotechnology.com
650-609-2231

Bluelake Biotechnology 9/21/23 Bluelake Biotechnology 9/21/23

From Setbacks to Solutions: Pioneering Safe RSV Vaccines for Infants, Children

article by founder Biao He in Pharmacy Times

Bluelake Biotechnology 6/29/23 Bluelake Biotechnology 6/29/23

Blue Lake Biotechnology Doses First Child in Clinical Trial of Novel Intranasal Vaccine Against Respiratory Syncytial Virus

Athens, GA and Los Gatos, CA, June 29, 2023 - Blue Lake Biotechnology, Inc., a clinical stage intranasal vaccine company harnessing the full breadth of the immune system to protect against serious infectious disease, announced that the first child has been dosed in its Phase 1/2a trial (NCT05655182) of BLB201, the company’s intranasal vaccine against respiratory syncytial virus (RSV). The study is assessing the safety, tolerability and immunogenicity of the vaccine in children aged six to 59 months old.

“The past year has demonstrated a need for a vaccine against RSV to protect children and particularly infants, as we’ve seen a dramatic increase in the number of infections and hospitalizations in this highly vulnerable population,” said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology. “The pharmaceutical industry has struggled to develop a safe and effective RSV vaccine for the youngest people. Our earlier Phase 1 study in adults showed that BLB201 generates significant cellular, mucosal, and humoral immune responses and was well-tolerated without safety signals. We expect the same will hold true in children and are looking forward to future data readouts.”

The BLB201 vaccine will be administered by nasal spray to children 6-59 months of age who may or may not have had prior RSV infection. It will enroll up to 152 participants and evaluate safety and immunogenicity of one or two administrations of BLB201 at two dose levels, compared against placebo.

Preliminary data presented at the 7th International Conference on Vaccines Research & Development from a Phase 1 clinical trial of BLB201 in RSV-experienced adults (18-75 years) (NCT05281263) demonstrated that the vaccine was well-tolerated, with no significant vaccine-related adverse safety signals reported. Approximately 50% of the participants demonstrated increased serum anti-RSV antibody responses above baseline levels in response to a single intranasal dose of BLB201.

About BLB201

BLB201 is an RSV vaccine candidate that has received Fast Track designation from the US Food and Drug Administration for prevention of RSV-associated acute respiratory disease in adults (>60 years) and pediatric populations (<2 years). BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector which is not known to cause disease in humans. PIV5 has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. Blue Lake Biotechnology is developing BLB201 as an intranasal vaccine to prevent acute and severe disease associated with RSV infection. Preclinical studies have demonstrated that BLB201 is immunogenic and prevents RSV infection in animal challenge studies.

About RSV

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus and one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease and older adults, it can cause severe illness and even be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under 5 years old and up to 120,000 adults 65 years and older are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year.

While there are costly antibody drugs approved for use in infants that provide temporary passive immunity against RSV, there is no approved vaccine for generating active immunity against RSV. Such a vaccine is needed to protect populations at highest risk from severe RSV disease, including the elderly as well as infants, to reduce the substantial health and economic burdens of RSV infection in the US and worldwide.

About Blue Lake Biotechnology

Blue Lake Biotechnology, Inc. and its affiliate, CyanVac LLC, are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and lasting durability with few vaccine-related side effects.

Learn more at https://www.bluelakebiotechnology.com.

CONTACTS:

Carolyn Hawley
Evoke Canale
carolyn.hawley@evokegroup.com
619-849-5382

Samuel Wu, Chief Business Officer
Blue Lake Biotechnology, Inc. and CyanVac LLC
swu@bluelakebiotechnology.com
650-609-2231

Bluelake Biotechnology 5/31/23 Bluelake Biotechnology 5/31/23

Blue Lake Biotechnology to Be Featured at the Biotechnology Innovation Organization (BIO) International Convention

Athens, GA and Los Gatos, CA – May 31, 2023 - Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company harnessing the full breadth of the immune system to protect against serious infectious diseases, announced today that company CEO Biao He, Ph.D., will present and host one-on-one partnering meetings at the 2023 Biotechnology Innovation Organization International Convention being held June 5-8, 2023 at the Boston Convention and Exhibition Center in Boston, Massachusetts.

The company presentation will take place at 2:30 PM Eastern in Room 104B on Monday, June 5. Partnering meetings can be scheduled using BIO’s One-on-One Partnering™ system.

In addition to the company presentation, Dr. He will speak on a panel entitled “New Tools in the Infectious Disease Toolbox: Combatting Future Biological Threats” on Wednesday, June 7 from 4:15 PM to 5:15 PM in Session Room 208. Additional panelists include

Robert Popovian, Founder, Conquest Advisors (moderator)
Dave Hering, CEO, Invivyd
Karen Martins, Chief, Antivirals and Antitoxins, BARDA
Lydia Ogden, Ph.D., MPP, Global Public Health R&D Policy and Engagement Lead, Johnson & Johnson

About Blue Lake Biotechnology

Blue Lake Biotechnology, Inc. and its affiliate, CyanVac LLC, are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and lasting durability with few vaccine-related side effects.

Learn more at https://www.bluelakebiotechnology.com.

CONTACTS:

Carolyn Hawley
Evoke Canale
carolyn.hawley@evokegroup.com
619-849-5382

Samuel Wu, Chief Business Officer
Blue Lake Biotechnology, Inc. and CyanVac LLC
swu@bluelakebiotechnology.com
650-609-2231

Bluelake Biotechnology 3/15/23 Bluelake Biotechnology 3/15/23

How a nasal vaccine could reduce the risk of COVID infections — and new variants

from MarketWatch

https://www.marketwatch.com/story/why-a-nasal-vaccine-could-reduce-the-risk-of-covid-infections-and-new-variants-e68a284b

Bluelake Biotechnology 2/24/23 Bluelake Biotechnology 2/24/23

Nasal Covid vaccine shows promise in early clinical trial

from NBC News

https://www.nbcnews.com/health/health-news/nasal-covid-vaccine-shows-promise-early-clinical-trial-rcna71841

Bluelake Biotechnology 2/6/23 Bluelake Biotechnology 2/6/23

Blue Lake Biotechnology to highlight preliminary COVID Phase 1 data at BIO CEO Conference

Athens, GA and Los Gatos, CA, February 6, 2023 - Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company enlisting the full force of the immune system to prevent serious infectious diseases, announced that the company’s founder and CEO, Biao He, PhD, will be presenting at the 2023 BIO CEO and Investor Conference in New York, today at 4:30pm EST. During the presentation, Dr. He will share preliminary results from the Phase 1 trial (NCT04954287) of the CVXGA1 COVID vaccine, including data showing mucosal immunity and cellular immune responses that are considered critical in protecting against COVID infection and illness.

The Phase 1 clinical trial is an open-label, dose-ranging study of CVXGA1, a PIV5-vectored intranasal vaccine expressing the SARS-CoV-2 S protein. The trial is designed to assess the safety, reactogenicity and immunogenicity of a single dose of CVXGA1 in healthy adults and adolescents who have received at least two doses of COVID mRNA vaccines, as well as in unvaccinated healthy adults.

Participants immunized with CVXGA1 showed a broad spectrum of immune responses, including cellular, mucosal, and humoral responses. In particular, among subjects for which data are available so far, over 80% demonstrated increases in CD8+ T-cell responses, which are essential for eliminating infected cells and clearing infection. Furthermore, the vaccine, when used as a booster in this study, was estimated to reduce the risk of symptomatic SARS-CoV 2 infection by 86% in the first 3 months after vaccination, during a time when omicron strains were the prevalent circulating SARS-CoV-2 strains. The vaccine has been well-tolerated to date by recipients in all age cohorts, with limited or no reactogenicity and no serious adverse events assessed as related to the vaccine.

“We were pleasantly surprised to see indications of a protective effect in this Phase 1 trial” said Dr. Biao He, founder and CEO of Blue Lake Biotechnology. “We are excited and encouraged with this result, and through our affiliate, CyanVac LLC, we have submitted a protocol to FDA for a randomized controlled phase 2 trial in which we look forward to more fully evaluating the immunogenicity of the vaccine and to better understanding its protective efficacy.”

Learn more about the trial at https://clinicaltrials.gov/ct2/show/NCT04954287.

About CVXGA1

CVXGA1 is a clinical-stage COVID-19 vaccine candidate based on Blue Lake Biotechnology’s proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. Blue Lake Biotechnology and its affiliate, CyanVac LLC, are developing CVXGA1 as a single dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA1 is immunogenic, protective, and prevents transmission of SARS-CoV-2.

About Blue Lake Biotechnology

Blue Lake Biotechnology, Inc. and its affiliate, CyanVac LLC, are developing intranasal vaccines that enlist the full force of the immune system to keep people healthy, prevent serious infectious diseases, and save the lives of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and lasting durability with few vaccine-related side effects.

Learn more at https://www.bluelakebiotechnology.com.

CONTACTS:

Carolyn Hawley
Evoke Canale
carolyn.hawley@evokegroup.com
619-849-5382

Samuel Wu, Chief Business Officer
Blue Lake Biotechnology, Inc. and CyanVac LLC
swu@bluelakebiotechnology.com
650-609-2231

Guest User 11/7/22 Guest User 11/7/22

Blue Lake Biotechnology Announces Positive Interim Phase 1 Data for BLB201 Intranasal RSV Vaccine

Athens, GA and Los Gatos, CA, November 7, 2022. Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company developing intranasal vaccines using a proprietary parainfluenza virus 5 (PIV5)-based vector, announced preliminary interim data today from a phase 1 clinical trial of its BLB201 vaccine for prevention of severe respiratory syncytial virus (RSV)-associated disease (NCT05281263). The preliminary data were included in an oral presentation by Dr. Hong Jin, Chief Scientific Officer of Blue Lake Biotechnology, at the 7th International Conference on Vaccines Research & Development (Vaccines R&D-2022) in Boston, MA.

The Phase 1 clinical trial is a multi-center, open-label trial designed to evaluate the safety, reactogenicity and immunogenicity of a single dose of BLB201 administered as a nasal spray to 30 healthy adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Only preliminary data from the first study cohort were presented at the conference; additional data from this cohort as well as data from the second cohort are expected to be available later this year.

Dr. Jin shared data from the first study cohort showing that 64% of subjects had increased serum anti-RSV antibody responses above their baseline levels. All subjects were seropositive for RSV at baseline, as was expected because most adults have had one or more RSV infections, typically starting in childhood. If subjects with the highest baseline levels of anti-RSV antibodies are excluded from the analysis, the proportion of subjects that had increased anti-RSV antibody responses above baseline levels becomes 80%. Temporary shedding of vaccine following vaccination was detected in 21% of subjects, indicative of self-limited vaccine replication. Such self-limited replication is desired as this contributes to stimulation of immune responses and serves as an indicator of successful vaccine uptake.

The vaccine has been well-tolerated to date by recipients in both age cohorts, with limited or no reactogenicity and no significant adverse safety signals reported.

“These initial phase 1 results show that our PIV5 platform has an excellent safety profile so far and can stimulate pathogen-specific immune responses in humans,” said Dr. Biao He, founder and CEO of Blue Lake Biotechnology. “Considering the past experience of other intranasal vaccine platforms, I believe it is remarkable that we detected such a high percentage of antibody responses. In particular, it is exciting that RSV-positive adults responded with just a single intranasal dose of our vaccine.”

The Phase 1 clinical trial is being conducted in Cincinnati OH and Charleston SC, and is led by Dr. Paul Spearman, Director of Infectious Diseases at Cincinnati Children’s Hospital Medical Center. BLB201 is based on a PIV5 vector that expresses the F protein of RSV. In preclinical studies, BLB201, delivered intranasally as a single dose, induces serum antibody and mucosal antibody responses as well as cell-mediated immune responses, and is protective against RSV challenge infection in various animal models. Delivered by nasal spray without needles, Blue Lake’s intranasal vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant individuals.

Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263.

About BLB201

BLB201 is an RSV vaccine candidate that has received Fast Track designation from the Food and Drug Administration for prevention of RSV-associated acute disease in adults (>60 years) and pediatric populations (< 2 years). BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector which is not known to cause disease in humans. PIV5 has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. Blue Lake Biotechnology and CyanVac LLC are developing BLB201 as a single dose, intranasal vaccine to prevent acute and severe disease associated with RSV infection. Preclinical studies have demonstrated that BLB201 is immunogenic and prevents RSV infection in animal challenge studies.

About RSV

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and even be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under 5 years old and up to 120,000 adults 65 years and older are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year[SW1] .

While there are costly antibody drugs approved for use in infants that provide temporary passive immunity against RSV, there is no approved vaccine for generating active immunity against RSV. Such a vaccine is needed to protect populations at highest risk from severe RSV disease, including the elderly as well as infants, in order to reduce the substantial health and economic burdens of RSV infection in the US and worldwide.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing lifesaving intranasal vaccines based on a proprietary PIV5-based vaccine platform licensed from the University of Georgia. Our COVID-19 and RSV vaccine programs are in Phase 1 clinical trials. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Gatos, California.

Learn more at https://www.bluelakebiotechnology.com.

Forward Looking Statements

This press release contains forward-looking statements, including with respect to the clinical development BLB201, a prophylactic vaccine to prevent RSV-associated disease, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing product candidates; the size and growth of the markets and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all, in light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are either made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology’s actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac’s and/or Blue Lake Biotechnology’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac’s and/or Blue Lake Biotechnology’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac’s and/or Blue Lake Biotechnology’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.

CONTACT:

Blue Lake Biotechnology, Inc. and CyanVac LLC
Samuel Wu
Chief Business Officer
swu@bluelakebiotechnology.com
(650) 609-2231

Guest User 10/31/22 Guest User 10/31/22

Another Tool in the Fight Against COVID-19

from UGA Today

https://news.uga.edu/another-tool-in-the-fight-against-covid-19/

Guest User 7/27/22 Guest User 7/27/22

CyanVac CEO Speaks at White House Summit on the Future of COVID-19 Vaccines

Athens, GA and Los Gatos, CA, July 27, 2022. CyanVac LLC, a clinical-stage biotechnology company developing intranasal vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, announced that Dr. Biao He, founder and CEO of CyanVac, participated yesterday as a panelist at the White House Summit on the Future of COVID-19 Vaccines. The event was held on the White House campus in Washington DC on July 26, and featured US scientists from academic institutes, organizations, and companies on the cutting edge of innovative next-generation COVID-19 vaccines. Dr. He spoke on a panel entitled “Innovation in Vaccine Delivery”, moderated by Dr. Francis Collins, Acting Science Advisor to the President and Acting Co-Chair of the President’s council of Advisors on Science and Technology and former director of the National Institutes of Health.

“We were truly honored to be invited by the White House to speak at this summit,” said Dr. He. “COVID-19 is an ongoing challenge for the world, and as Dr. Fauci pointed out in his opening remarks yesterday, there is a need for a vaccine that generates mucosal immunity to help break the cycle of viral transmission. It is encouraging that the Administration and its scientific advisors have recognized that our intranasal COVID vaccine may be part of the solution.”

The panel discussed innovative vaccines that use alternative delivery routes and elicit broad and durable immune responses, and the need for manufacturing infrastructure and funding for clinical trials to support the development of these vaccines. Intranasal vaccines were highlighted as perhaps the best way to generate mucosal immunity which could block transmission of SARS-CoV-2, the virus that causes COVID-19, and thereby help end the pandemic. CyanVac has previously shown that its COVID-19 vaccine candidate, CVXGA1, generates mucosal immunity and reduces SARS-CoV-2 transmission between animals in a ferret cohabitation model (data which were peer-reviewed and published in Science Advances in July 2021).

CyanVac is currently conducting a Phase 1 clinical trial of CVXGA1, its PIV5-based COVID-19 vaccine candidate. Its subsidiary, Blue Lake Biotechnology, Inc., is currently conducting a Phase 1 clinical trial of BLB-201, a PIV5-based RSV (respiratory syncytial virus) vaccine candidate.

About CVXGA1 and BLB-201

CVXGA1 is a clinical-stage COVID-19 vaccine candidate that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and its subsidiary, Blue Lake Biotechnology, Inc., are developing CVXGA1 as a single dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA1 is immunogenic, protective, and prevents transmission of SARS-CoV-2. CVXGA1 is currently being studied in a multi-center Phase 1 clinical trial in adults and adolescents led by Dr. Paul Spearman, Director of Infectious Diseases at Cincinnati Children’s Hospital and Medical Center, with additional clinical trial sites in Rochester NY, Bardstown KY and Plano TX. Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263

BLB-201 is a clinical stage RSV vaccine candidate that has received Fast Track designation from the Food and Drug Administration for prevention of RSV-associated acute disease in adults older than 60 years and children under 2 years. BLB-201 encodes a full-length RSV F protein and uses a proprietary PIV5 vector which is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. Blue Lake Biotechnology and CyanVac LLC are developing BLB-201 as a single dose, intranasal vaccine to prevent acute and severe disease associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents RSV infection in animal challenge studies. BLB-201 is currently being studied in a Phase 1 clinical trial also led by Dr. Spearman at Cincinnati Children’s Hospital and Medical Center, with an additional clinical trial site in Charleston SC. Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263.

About CyanVac and Blue Lake Biotechnology

Learn more at https://www.cyanvacllc.com.

Forward Looking Statements

This press release contains forward-looking statements, including with respect to the clinical development of CVXGA1 and BLB-201, prophylactic vaccines to prevent COVID-19 and RSV-associated disease, respectively, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing product candidates; the size and growth of the markets and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all, in light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are either made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology’s actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac’s and/or Blue Lake Biotechnology’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac’s and/or Blue Lake Biotechnology’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac’s and/or Blue Lake Biotechnology’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.

CONTACT:

CyanVac LLC and Blue Lake Biotechnology, Inc.
Gary Titus
Chief Financial Officer
gtitus@cyanvacllc.com
(650) 862-9757

Guest User 7/21/22 Guest User 7/21/22

Blue Lake Biotechnology Announces First Participant Dosed in a Phase 1 Clinical Trial of Its BLB-201 Intranasal RSV Vaccine

Athens, GA and Los Gatos, CA, July 21, 2022. Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced the enrollment of the first participant in a Phase 1 clinical trial of their intranasal BLB-201 vaccine for RSV (respiratory syncytial virus) in Charleston, South Carolina. BLB-201 is based on an attenuated strain of PIV5 that expresses the F protein of RSV. In preclinical studies, BLB-201, delivered intranasally as a single dose, induces serum antibody and mucosal antibody responses as well as cell-mediated immune responses, and is protective against RSV challenge infection in various animal models. Delivered through the nose without injections, Blue Lake’s intranasal vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant individuals.

“The enrollment of the first participant in this RSV vaccine study is an important milestone for Blue Lake,” said Dr. Biao He, founder and CEO. “We now have two clinical stage programs – a COVID-19 vaccine and an RSV vaccine using our intranasal PIV5-vectored vaccine platform, which we expect will confirm the broad utility of our platform.”

“An intranasal vaccine against RSV would be a valuable tool to combat RSV infection in both young children and older adults who are most at risk for severe disease from RSV infection,” said Dr. Paul Spearman, Director of Infectious Diseases at Cincinnati Children’s Hospital Medical Center and principal investigator of the study.

The study is a multi-center, open-label trial being conducted in Cincinnati OH and Charleston SC. It will evaluate the safety, reactogenicity and immunogenicity of a single dose of BLB-201 administered intranasally as a spray to adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Safety data will be collected and analyzed, as will antibody and cellular immune responses to the RSV F protein.

Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263.

About BLB-201

BLB-201 is an RSV vaccine candidate that has received Fast Track designation from the Food and Drug Administration for prevention of RSV-associated acute disease in adults (>60 years) and pediatric populations (< 2 years). BLB-201 encodes a full-length RSV F protein and uses a proprietary PIV5 vector which is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. Blue Lake Biotechnology and CyanVac LLC are developing BLB-201 as a single dose, intranasal vaccine to prevent acute and severe disease associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents RSV infection in animal challenge studies.

About RSV

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and even be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, approximately 58,000 children under 5 years old and 177,000 adults 65 years and older are hospitalized because of RSV infection in the US with, over 14,000 deaths each year. [SW1]

At present there is no preventive vaccine or antiviral treatment approved for RSV, so there is a need for a vaccine that can reduce the substantial health and economic burdens of RSV infection in the US and worldwide.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing lifesaving vaccines based on a proprietary PIV5 vaccine platform licensed from the University of Georgia. Our COVID-19 and RSV vaccine programs are in Phase 1 clinical trials. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Gatos, California.

Learn more at https://www.bluelakebiotechnology.com.

Forward Looking Statements

This press release contains forward-looking statements, including with respect to the clinical development of BLB-201, a prophylactic vaccine to prevent RSV-associated disease, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate; the size and growth of the market(s) and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are other made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology’s actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac’s and/or Blue Lake Biotechnology’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac’s and/or Blue Lake Biotechnology’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac’s and/or Blue Lake Biotechnology’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.

CONTACT:

Blue Lake Biotechnology, Inc. and CyanVac LLC
Gary Titus
Chief Financial Officer
gtitus@bluelakebiotechnology.com
(650) 862-9757

Guest User 6/13/22 Guest User 6/13/22

Nasal Vaccines Are Commercially High Risk, Perhaps High Reward

from The Scientist

from The Scientist, June 2022 Issue 2

https://www.the-scientist.com/bio-business/nasal-vaccines-are-commercially-high-risk-perhaps-high-reward-70068

Guest User 6/9/22 Guest User 6/9/22

CyanVac Announces Data from Preclinical Studies of Intranasal PIV5-based COVID-19 Vaccine Candidate CVXGA1

Athens, GA and Los Gatos, CA, June 9, 2022. CyanVac LLC, a clinical-stage biopharmaceutical company developing intranasal vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced preclinical data in a hamster model using CVXGA1, a COVID-19 vaccine candidate currently in Phase 1 clinical trials. The data show that CVXGA1, which expresses the Spike protein from the original strain (WA1) of SARS-CoV-2 (the virus that causes COVID-19 disease), provides broad protection against other SARS-CoV-2 strains including alpha, delta and omicron variants. In the hamster model, a single intranasal dose of CVXGA1 induced broad serum neutralizing antibodies against, and protected animals against disease challenge by, the WA1 and other strains. In addition, hamsters that received CVXGA1 as a single intranasal booster dose after two doses of an mRNA-based COVID-19 vaccine had higher levels of neutralizing antibodies against multiple SARS-CoV-2 strains than hamsters who were boosted with a third mRNA-based COVID-19 vaccine dose, and were also better protected against viral challenge.

The manuscript describing these data, entitled “Efficacy of Parainfluenza Virus 5 (PIV5)-vectored Intranasal COVID-19 Vaccine as a Single Dose Vaccine and as a Booster against SARS-CoV-2 Variants,” is available on a preprint server at https://biorxiv.org/cgi/content/short/2022.06.07.495215v1 and has been submitted for potential publication in a peer-reviewed scientific journal.

“We are excited to see that our intranasal vaccine candidate, though based on the ancestral strain, can provide broad protection against different SARS-CoV-2 variants,“ said Dr. Biao He, founder and CEO of CyanVac. “What’s more, it provides robust protection when used as a single dose booster for previously vaccinated hamsters. If similar effects are seen in humans, it could make our PIV5-based intranasal COVID-19 vaccine a compelling alternative to injectable vaccines.”

“This work also highlights the ‘plug and play’ capabilities of our proprietary PIV5 platform,” said Hong Jin, PhD, Chief Scientific Officer of CyanVac. “We have successfully generated and tested additional candidate vaccines encoding the Spike protein from variants like delta and omicron, and also a candidate vaccine that encodes both the COVID Spike and nucleocapsid proteins. This demonstrates that we can rapidly respond to emerging variants.”

In the preclinical studies, hamsters were immunized with a single intranasal dose of CVXGA1, and levels of serum neutralizing antibodies against WA1, delta, and omicron were measured at 36 days and 108 days after immunization. Robust neutralizing antibody responses against all three strains were observed at both time points. Additional hamsters were immunized with CVXGA1 followed by challenge with the WA1, alpha, or delta strain. CVXGA1 protected against disease from all three strains, as assessed by change in body weight during the first 5 days after challenge, and by measurement of viral load in the lungs at day 5 by quantitative PCR and plaque assay for infectious virus. (Note that challenge infection using an omicron strain was not performed because omicron is less virulent than the other strains in hamsters.)

In addition, the ability of CVXGA1 to serve as a booster for mRNA-based COVID-19 vaccines was investigated. Hamsters were immunized with two doses of an mRNA-based COVID-19 vaccine 28 days apart. On day 91 after the initial immunization, the animals received a booster dose of either the same mRNA-based vaccine, a placebo, or an intranasal PIV5-based COVID-19 vaccine (CVXGA1 or other experimental vaccine). Serum neutralizing antibody responses against WA1, delta, and omicron (assessed at day 108) were more than seven-fold greater in the CVXGA1-boosted animals than in those that were boosted with the mRNA-based vaccine. When challenged with a SARS-CoV-2 delta variant on day 116, the CVXGA1-immunized animals were better protected against COVID-19 disease than animals that had been boosted with the mRNA-based vaccine, as assessed by change in body weight over 5 days post-challenge and viral load in lung homogenate by quantitative PCR.

CVXGA1 is currently in a Phase 1 clinical trial evaluating the safety and immunogenicity of a single intranasal dose. The trial is led by principal investigator Paul Spearman, MD, Albert B. Sabin Professor and Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center.

About CVXGA1

CVXGA1 is a clinical-stage COVID-19 vaccine candidate based on CyanVac’s proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and its subsidiary, Blue Lake Biotechnology, Inc., are developing CVXGA1 as a single dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA1 is immunogenic, protective, and prevents contact transmission of SARS-CoV-2.

Learn more about the ongoing Phase 1 clinical trial of CVXGA1 at https://www.clinicaltrials.gov/ct2/show/NCT05281263

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing lifesaving vaccines based on a proprietary PIV5 vaccine platform licensed from the University of Georgia. Our lead COVID-19 vaccine program is in Phase 1 clinical trials. Our second program targeting respiratory syncytial virus (RSV) will soon initiate a first-in-man Phase 1 study and has been granted Fast Track designation by FDA. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Gatos, California.

Learn more at https://www.cyanvacllc.com.

Forward Looking Statements

This press release contains forward-looking statements, including with respect to the clinical development of CVXGA1 for COVID-19, a prophylactic vaccine to prevent COVID-19, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate; the size and growth of the market(s) and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are other made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology’s actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac’s and/or Blue Lake Biotechnology’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac’s and/or Blue Lake Biotechnology’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac’s and/or Blue Lake Biotechnology’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.

CONTACTS:

CyanVac LLC and Blue Lake Biotechnology, Inc.
Gary Titus
Chief Financial Officer
gtitus@cyanvacllc.com
(650) 862-9757

Guest User 5/24/22 Guest User 5/24/22

Blue Lake Biotechnology Announces FDA Fast Track Designation for BLB-201 Intranasal RSV Vaccine

Athens, GA and Los Gatos, CA, May 24, 2022. Blue Lake Biotechnology, Inc., a clinical-stage biopharmaceutical company developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BLB-201, an intranasal vaccine for the prevention of respiratory syncytial virus (RSV) associated disease in adults over 60 and children under 2 years of age. BLB-201 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the RSV-F protein. In preclinical studies, BLB-201, delivered intranasally as a single dose, induces serum antibody and mucosal antibody responses as well as cell-mediated immune responses, and is protective in RSV challenge studies conducted in various animal models. Delivered through the nose without injections, the company's intranasal vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant groups.

BLB-201 is one of the few RSV vaccines to have received Fast Track designation for development for use in children under 2 years old. “FDA’s granting of Fast Track designation for BLB-201 reflects the urgent need for an RSV vaccine,” said Dr. Biao He, founder and CEO of Blue Lake Biotechnology and its parent company, CyanVac LLC. “It is encouraging that FDA recognizes the potential of our vaccine to address this need for children under 2 years old as well as for older adults.” Dr. He added, "This RSV vaccine candidate expands our intranasal vaccine pipeline, and builds on our experience in developing a clinical stage intranasal COVID-19 vaccine."

Blue Lake is preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers. The trial is led by principal investigator Paul Spearman, MD, Albert B. Sabin Professor and Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center.

About BLB-201

BLB-201 is an RSV vaccine candidate based on CyanVac’s proprietary PIV5 vector that encodes the RSV-F protein. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and Blue Lake Biotechnology are developing BLB-201 as a single dose, intranasal vaccine to prevent diseases associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents RSV infection in animal challenge studies. The Phase 1 trial will be an open-label trial to evaluate the safety, reactogenicity and immunogenicity of BLB-201 administered intranasally as a single dose to adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Both cohorts will receive a single dose of vaccine by intranasal spray. Safety data will be collected and analyzed, as will serum and mucosal antibody responses and cellular immune responses to the RSV-F protein.

Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263

About RSV

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is one of the leading causes of acute respiratory illness, infecting more than 64 million people worldwide per year. For most people it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and even be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they are younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, approximately 58,000 children under 5 years old and 177,000 adults 65 years and older are hospitalized because of RSV infection in the US with, over 14,000 deaths each year.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing lifesaving vaccines based on a proprietary PIV5 vaccine platform licensed from the University of Georgia. Our lead COVID-19 vaccine program is in Phase 1 clinical trials,. Our second program targeting respiratory syncytial virus (RSV) will soon initiate a first-in-man Phase 1 study. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Gatos, California.

Learn more at https://www.cyanvacllc.com.

Forward Looking Statements

CONTACTS:

CyanVac LLC and Blue Lake Biotechnology, Inc.
Gary Titus
Chief Financial Officer
gtitus@bluelakebiotechnology.com
(650) 862-9757

Guest User 4/20/22 Guest User 4/20/22

Professor moves closer to possible COVID-19 vaccine

from UGA Today

https://news.uga.edu/biao-he-possible-covid19-vaccine/

Guest User 4/10/22 Guest User 4/10/22

The next leap in coronavirus vaccine development could be a nasal spray

from Washington Post

https://www.washingtonpost.com/health/2022/04/10/nasal-covid-vaccine/

Guest User 3/28/22 Guest User 3/28/22

CyanVac and Blue Lake Biotechnology Announce FDA Clearance of IND Application for BLB-201 Intranasal RSV Vaccine

Athens, GA and Los Altos, CA, March 27, 2022: CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., clinical-stage biopharmaceutical companies developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for BLB-201, an intranasal vaccine for the prevention of respiratory syncytial virus (RSV) infection. BLB-201 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the RSV-F protein. In preclinical studies, BLB-201, delivered intranasally as a single dose in each nostril, induces mucosal antibody responses and cell-mediated immune responses as well as serum antibody responses, and has been effective in protecting multiple animal species from RSV infection in challenge studies. Delivered through the nose without injections, the companies' vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant groups.

“FDA’s clearance of our IND for BLB-201 is great news for us, especially on top of our ongoing single dose intranasal COVID-19 vaccine trial in the US. This IND for our second PIV5-based intranasal vaccine is an exciting development that expands our clinical stage pipeline,” said Dr. Biao He, founder and CEO of CyanVac and Blue Lake Biotechnology. “It is an important milestone toward developing RSV vaccines for young children and older adults, both of which face significant morbidity and mortality risk from RSV infection,” Dr Biao added.

The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers. The trial will be led by principal investigator Paul Spearman, MD, Albert B. Sabin Professor and Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center.

“RSV is a common respiratory virus responsible for the hospitalization of more than 3 million children every year, and also affects older adults worldwide,” said Dr. Spearman. “A vaccine that can be delivered by nasal spray would be a valuable tool for reducing this burden.”

About BLB-201

BLB-201 is an RSV vaccine candidate based on CyanVac’s proprietary PIV5 vector that encodes the RSV-F protein. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and Blue Lake Biotechnology are developing BLB-201 as a single dose, intranasal vaccine to prevent RSV infection and serious complications associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents infection in animal challenge studies. The Phase 1 trial will be an open-label trial to evaluate the safety, reactogenicity and immunogenicity of BLB-201 administered intranasally as a single dose to adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Both cohorts will receive a single dose of vaccine by intranasal spray. Safety data will be collected and analyzed, as will serum and mucosal antibody responses and cellular immune responses to the RSV-F protein.

Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263

About RSV

Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is a leading cause of acute respiratory illness, infecting more than 64 million people worldwide per year. For most people it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and even be life-threatening. According to the Centers for Disease Control, approximately 58,000 children under 5 years old and 177,000 adults 65 years and older are hospitalized, and over 14,000 die each year because of RSV infection in the US.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing products based on a proprietary PIV5 vaccine platform licensed from the University of Georgia. Our lead COVID-19 vaccine program is in Phase 1 clinical trials, and has been selected for future NIH/IDCRC support. Our second program targeting respiratory syncytial virus (RSV) will soon initiate a first-in-man Phase 1 study. RSV is a common respiratory virus that routinely and repeatedly infects people at all ages, and is of particularly high risk to children under 2 years old and elderly patients with underlying lung disease. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Altos, California.

Learn more at https://www.cyanvacllc.com.

Forward Looking Statements

This press release contains forward-looking statements, including with respect to the clinical development of BLB-201 to prevent RSV infection, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate; the size and growth of the market(s) and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are other made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology’s actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac’s and/or Blue Lake Biotechnology’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac’s and/or Blue Lake Biotechnology’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac’s and/or Blue Lake Biotechnology’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.

CONTACTS:

CyanVac LLC and Blue Lake Biotechnology, Inc.

Gary Titus

Chief Financial Officer
gtitus@CyanVacLLC.com
(650) 862-9757