Blue Lake Biotechnology, Inc.

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. & SAN JOSE, Calif.--(BUSINESS WIRE)-- 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. This press release features multimedia. View the full release here: 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 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. View source version on businesswire.com: 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 Source: Blue Lake Biotechnology, Inc View this news release online at:

ATHENS, Ga. & SAN JOSE, Calif.--(BUSINESS WIRE)-- 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.

Research Published in NPJ Vaccines ATHENS, Ga. & MEMPHIS, Tenn.--(BUSINESS WIRE)-- 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 . 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 . 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. View source version on businesswire.com: Contacts 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 Source: CyanVac LLC View this news release online at: