Bluelake Biotechnology 12/12/24 Bluelake Biotechnology 12/12/24

Blue Lake Biotechnology Reports Additional Promising Clinical Data from Ongoing Pediatric Clinical Study of Intranasal RSV Vaccine BLB201

Company leaders to speak today during the open public hearing session of US FDA Vaccines and Related Biological Products Advisory Committee meeting

Athens, Ga. and San Jose, Calif., December 12, 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 positive data from a preliminary analysis of the first 63 infants and young children enrolled in the company’s Phase 1/2a clinical study of BLB201, an intranasal vaccine candidate against RSV.

BLB201 has been well-tolerated by the participants in this double-blind placebo-controlled study, with no vaccine-related medically-attended adverse events or serious adverse events reported. Eight symptomatic RSV infections have been reported, all of which have been mild or moderate, with no severe cases or cases requiring hospitalization. Among the 63 children enrolled so far in the study (of which over one third were seronegative for RSV at baseline), a preliminary analysis of partially unblinded data showed that participants who received BLB201 have been more than 80% less likely to contract symptomatic RSV infections than participants who received placebo (p<0.05). Consistent with the immune responses seen in Blue Lake Biotechnology’s prior clinical studies, BLB201 has elicited moderate serum antibody responses and stimulated mucosal and cellular immune responses which are believed to be responsible for the vaccine’s protective activity.

“Historically, the biggest challenge that has stymied the development of infant RSV vaccines for decades is the risk of vaccine-associated enhanced respiratory disease, or VAERD,” said Henry Radziewicz, M.D., chief medical officer of Blue Lake Biotechnology. “In addition to the overall excellent tolerability and safety of BLB201 in infants and young children so far, it is reassuring that we have not detected any safety signals of VAERD.”

“The preliminary analysis showing a greater than 80% reduction in the risk of symptomatic RSV infection underscores the promise of BLB201 as a safe and effective vaccine in preventing symptomatic RSV disease in infants and young children,” added Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology. “We believe these data strongly suggest that our intranasal BLB201 vaccine has a distinct mechanism of protection which is different from the immunity generated by injectable formalin-inactivated and mRNA-based RSV vaccines which have been associated with VAERD. Such vaccines elicit very high levels of serum antibody responses but have not conferred protection against symptomatic RSV infection in infants.”

The Phase 1/2a study (NCT05655182) is a double-blind, placebo-controlled study that is to enroll up to 137 RSV seropositive and seronegative infants and young children between eight and 59 months old in an adaptive design. To date, a total of 38 children have received either a single low dose or a single high dose of BLB201, and another 25 children have received placebo. Primary and secondary endpoints include assessments of safety, tolerability, and immunogenicity, and exploratory endpoints include assessment of the proportion of participants diagnosed with symptomatic RSV infection. The trial is ongoing, and some participants are still within the 12-month follow-up period of the trial.

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 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 efficacy following a single intranasal dose 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 12/9/24 Bluelake Biotechnology 12/9/24

First Subject Dosed in Initial Cohort of Phase 2b Clinical Study of CyanVac’s Intranasal COVID-19 Vaccine Candidate

Clinical study supported by BARDA under Project NextGen to compare CVXGA to mRNA vaccine

Athens, Ga. and San Jose, Calif., December 9, 2024 – CyanVac LLC, a clinical-stage biotechnology company developing intranasal vaccines using a transformational parainfluenza virus 5 (PIV5)-based vector, announced today that the first participant has been dosed in a Phase 2b clinical study of CVXGA, its intranasal COVID-19 vaccine candidate. The study, supported by the U.S. Government’s (USG) Project NextGen, is designed to evaluate CVXGA against a U.S. Food and Drug Administration (FDA)-approved injectable mRNA-based COVID-19 vaccine, with both CVXGA and the comparator mRNA-based vaccine targeting the omicron variant KP.2 strain of SARS-CoV-2. Approximately 400 participants initially will be enrolled in sentinel and safety lead-in cohorts. Once an independent Data and Safety Monitoring Board (DSMB) reviews the safety data of the participants, and the Center for the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) provides approval, enrollment of approximately 9,600 additional participants for the second part of the trial will proceed.

“This phase 2b trial represents a major milestone for our proprietary PIV5-based vaccine platform,” said Biao He, Ph.D., founder and CEO of CyanVac. “Recently we reported positive results from an earlier Phase 2a trial of CVXGA involving 227 adult volunteers. We expect this new Phase 2b trial to play a key role in confirming these results and validating the potential of our PIV5-based vaccine platform.”

The Phase 2b study is being conducted through BARDA’s Clinical Studies Network and is expected to enroll approximately 10,000 adults representative of the U.S. population including people at high risk for severe COVID-19. Participants will be followed for evidence of SARS-CoV-2 infection for 12 months after vaccination. The study is designed to assess the relative efficacy of CVXGA versus mRNA vaccine in the prevention of symptomatic COVID-19. The study also will evaluate CVXGA’s ability to prevent asymptomatic infections, which could be an indicator of the vaccine's ability to prevent the transmission or spread of this respiratory pathogen.

This project is being funded with federal funds from HHS, ASPR, BARDA, under Other Transaction (OT) number 75A50123D00005.

About CVXGA

CVXGA is a clinical-stage COVID-19 vaccine candidate based on a proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector was developed at the University of Georgia and is based on a respiratory virus that is not known to cause disease in humans which has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. CyanVac and its affiliate, Blue Lake Biotechnology, are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA is immunogenic and protective and prevents transmission of SARS-CoV-2. Phase 1 and Phase 2a clinical studies have shown that subjects dosed with CVXGA showed robust mucosal, cellular and humoral immune responses with limited or no reactogenicity and no serious events assessed as related to the vaccine.

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 CyanVac and Blue Lake Biotechnology.

CONTACTS:

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

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

Bluelake Biotechnology 11/25/24 Bluelake Biotechnology 11/25/24

Blue Lake and CyanVac Report Positive Phase 2a Data for Intranasal COVID-19 Vaccine Candidate

Athens, Ga. and San Jose, Calif., November 25, 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, and its affiliate CyanVac LLC, today reported data from a 227-participant Phase 2a clinical trial demonstrating the safety, tolerability, immunogenicity, and efficacy of CVXGA, the company’s intranasal vaccine candidate against COVID-19.

In this study, which was the first double-blind, placebo-controlled trial of a PIV5-vectored vaccine, there was no significant difference in the number of adverse reactions observed in CVXGA-vaccinated versus placebo-vaccinated participants, providing evidence that PIV5-vectored intranasal vaccines can be safe and well-tolerated. Clinical trial participants vaccinated with CVXGA had S-protein specific serum antibody titers at 29 days after vaccination which were 1.9-fold greater than titers in participants who received placebo, a level greater than has been previously reported for other intranasal vaccines in adults. CVXGA induced S-protein specific serum antibody responses in both younger adults (18-64 years old, p=0.002) and older adults (65 years and older, p=0.032), an important consideration given the latter group’s greater risk for severe illness after infection. Participants who received a single dose of CVXGA had a 78% lower risk of developing symptomatic COVID-19 infection compared to the placebo group in the first month after vaccine administration.

“The 78% protection compares quite favorably with the efficacy of approved COVID vaccines, which has been reported to be 52% at four weeks after vaccination,” said Biao He, Ph.D., CEO of Blue Lake and CyanVac. “Most reassuring are the results showing how well tolerated our intranasal COVID vaccine is, in contrast to currently approved COVID vaccines which are commonly associated with injection site reactions, fever, fatigue, and headache. The safety and efficacy data from this trial are highly encouraging, and we look forward to the dosing of more volunteers in the next clinical study of CVXGA.”

The Phase 2a study was a double-blind, placebo-controlled study that enrolled 227 participants who were randomized 1:1 to receive either CVXGA (targeting the S-protein of the omicron XBB.1.5 variant strain of SARS-CoV-2) or placebo. Primary endpoints included assessments of safety, tolerability, and immunogenicity, and exploratory endpoints included assessment of the proportion of participants diagnosed with symptomatic SARS-CoV-2 infection.

“COVID-19 continues to be a public health threat. A more effective, better tolerated, and easily administered vaccine should increase the vaccination rate and reduce the hospitalizations and deaths that continue to occur with COVID-19,” added Dr. He.

About CVXGA

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 efficacy following a single intranasal dose with few vaccine-related side effects.

Learn more at CyanVac and 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 10/21/24 Bluelake Biotechnology 10/21/24

Blue Lake Biotechnology and CyanVac Announce Presentation on Intranasal Vaccine Candidates at the International Society for Vaccines Annual Congress

Athens, Ga. and San Jose, Calif., October 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, and its affiliate CyanVac LLC, today announced the presentation of positive interim pediatric clinical data on BLB201, Blue Lake’s vaccine candidate against respiratory syncytial virus (RSV), at the 2024 ISV Annual Congress in Seoul, South Korea. The oral presentation also included discussion of Phase 1 clinical data on CVXGA, the companies’ clinical stage vaccine candidate against COVID-19.

Hong Jin, Ph.D., Chief Scientific Officer of Blue Lake and CyanVac, presented a talk entitled “PIV5-Vectored RSV and COVID-19 Intranasal Vaccines Show Great Promise in Clinical Studies” which included results from an interim analysis of RSV-seropositive children who are participating in the company’s ongoing Phase 1/2a pediatric study. The data demonstrated the safety and immunogenicity of BLB201 in this population, including RSV F-specific systemic and mucosal antibody responses and cell-mediated immune responses in CD4+ and CD8+ T cells. Similarly, COVID S-specific systemic and mucosal antibody responses and T cell-mediated responses were detected in the Phase 1 clinical trial of CVXGA.

“Our vaccine approach is designed to stimulate potent immune responses from the humoral, cellular, and mucosal pillars of the immune system,” said Biao He, Ph.D., CEO of Blue Lake and CyanVac. “Many currently available vaccine technologies such as mRNA vaccines and protein-based vaccines are not effective in inducing mucosal immunity because they are given intramuscularly. By robustly stimulating all three pillars of immunity, our intranasal vaccine may prevent disease transmission and generate longer lasting immunity than other types of vaccines.”

In addition to the clinical data presented by Dr. Jin at the Congress, Cristina Gingerich, PhD, a CyanVac scientist, will present preclinical data on a PIV5-based vaccine for Lyme disease in a poster entitled “An intranasal parainfluenza virus 5 (PIV5)-based vaccine for Lyme Disease induces protection against multi-strain Borrelia burgdorferi tick challenge in mice.”

The Lyme disease project was a collaboration between CyanVac and Immuno Technologies, Inc. and was supported by the National Institute of Allergy and Infectious Disease of the National Institutes of Health under award number R44AI167605.

About CyanVac and Blue Lake Biotechnology

Learn more at Blue Lake Biotechnology and CyanVac.

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 6/13/24 Bluelake Biotechnology 6/13/24

CyanVac Receives BARDA-Funded Project NextGen Award to Evaluate its Intranasal COVID-19 Vaccine Candidate in a Phase 2b Study

Award will support a 10,000-participant study comparing CyanVac’s PIV5-based intranasal vaccine candidate CVXGA with a commercial COVID-19 vaccine under BARDA’s Clinical Studies Network

Athens, Ga. and San Jose, Calif., June 13, 2024 – CyanVac LLC, a clinical-stage biotechnology company developing intranasal vaccines using a transformational parainfluenza virus 5 (PIV5)-based vector, announced today that it received federal Project NextGen funding to support a comparative Phase 2b study of CVXGA, the company’s PIV5-based vaccine candidate designed to protect against COVID-19.

Project NextGen is an initiative of the U.S. Department of Health and Human Services (HHS) to advance new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19. The award is one of the first made through the Rapid Response Partnership Vehicle, a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response (ASPR) within HHS, to accelerate product and technology development.

The Phase 2b study of PIV-5-based CVXGA intranasal COVID-19 vaccine will be conducted through BARDA’s clinical studies network.

"This award will accelerate the development of our PIV5-based intranasal COVID-19 vaccine, building on our very promising Phase 1 and preliminary Phase 2a clinical trial results,” said Biao He, Ph.D., founder and CEO of CyanVac. “PIV5 is a novel intranasal vaccine vector that has been shown to replicate safely in humans in clinical trials and stimulates all three pillars of immunity – cellular, mucosal, and humoral – with minimal uncomfortable side effects. The successful development of an intranasal COVID-19 vaccine using this new vector will demonstrate the capabilities of our PIV5 platform and benefit the development of PIV5-based vaccines for other emerging infectious diseases.”

Under the award, CyanVac will be the sponsor for a 10,000 participant, randomized double-blinded Phase 2b study that will compare the efficacy, safety and immunogenicity of CyanVac’s next-generation intranasal COVID-19 vaccine candidate to a U.S. Food and Drug Administration (FDA)-approved mRNA-based COVID-19 vaccine. The study will be conducted through BARDA's Clinical Studies Network and will evaluate the vaccine in a subset of participants at higher risk of severe disease. The study is expected to start in the fall of 2024 and will evaluate the efficacy of CVXGA in preventing not only severe COVID-19 infections, but also asymptomatic infections.

"Many vaccines including COVID-19 vaccines are quite effective at preventing serious illness and death, but there is a need for vaccines that can also block transmission of a pathogen to other people,” said Dr. Henry Radziewicz, Chief Medical Officer of CyanVac. “Our intranasal vaccine is delivered to mucosal surfaces, a key focus area for Project NextGen by BARDA because such vaccines have the potential to reduce the spread of disease.”

“We are excited to work with BARDA on this large-scale trial and are grateful for their support,” added Dr. He.

The project is being funded with federal funds from HHS, ASPR, BARDA, under Other Transaction (OT) number 75A50123D00005.

About CVXGA

CVXGA is a clinical-stage COVID-19 vaccine candidate based on a proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector was developed at the University of Georgia and is based on a respiratory virus that is not known to cause disease in humans which has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. CyanVac and its affiliate, Blue Lake Biotechnology, are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA is immunogenic and protective and prevents transmission of SARS-CoV-2. Phase 1 data has shown that subjects dosed with CVXGA showed robust mucosal, cellular and humoral immune responses with limited or no reactogenicity and no serious events assessed as related to the vaccine.

About CyanVac and Blue Lake Biotechnology

Learn more at CyanVac and Blue Lake Biotechnology.

CONTACTS:

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

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

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

About BLB201

About CyanVac and Blue Lake Biotechnology

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