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

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

ATHENS, Ga. and LOS GATOS, California, Nov. 7, 2022 /PRNewswire/ — Blue Lake Biotechnology, Inc., a clinical-stage biotechnology company developing intranasal vaccines using a parainfluenza virus 5 (PIV5)-based vector, announced today preliminary interim data from a phase 1 clinical trial of its BLB201 vaccine for the prevention of severe respiratory syncytial virus (RSV)-associated disease (NCT05281263). Preliminary data was included in an oral presentation by Dr. Hong Jin, Chief Scientific Officer of Blue Lake Biotechnology, at the 7th International Conference on Vaccine Research and Development (Vaccines R&D-2022) in Boston, MA.

The Phase 1 clinical trial is an open-label, multicenter 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 (18 to 59 years of age). ). 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 cohort of the study 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 expected because most adults have had one or more RSV infections, usually beginning in childhood. If subjects with the highest baseline anti-RSV antibody levels are excluded from the analysis, the proportion of subjects who had increased anti-RSV antibody responses above baseline reaches 80%. Temporary vaccine shedding after vaccination was detected in 21% of subjects, indicating self-limited vaccine replication. Such self-limited replication is desired as it contributes to the stimulation of immune responses and serves as an indicator of successful vaccine acceptance.

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 thus far and can stimulate pathogen-specific immune responses in humans,” said Dr. Biao He, Founder and CEO of Blue Lake Biotechnology. “Considering past experience with other intranasal vaccine platforms, I think it is remarkable that we detected such a high percentage of antibody responses. In particular, it is exciting that RSV-positive adults responded to a single intranasal dose of our vaccine.”

The Phase 1 clinical trial is taking place 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 RSV F protein. In preclinical studies, BLB201, administered intranasally as a single dose, induced serum and mucosal antibody responses, as well as cell-mediated immune responses, and protected against RSV infection in various animal models. Administered via nasal spray without needles, Blue Lake’s intranasal vaccines have the potential to make it easier to administer vaccines to broad populations, including pediatrics and those who are hesitant to use needles.

Learn more about the test 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 the prevention of acute RSV-associated illness in adults (>60 years) and pediatric (<2 years) populations. BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector that does not cause disease in humans. PIV5 has been commonly administered to dogs as part of combined distemper and 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 illness associated with RSV infection. Preclinical studies have shown that BLB201 is immunogenic and prevents RSV infection in animal challenge studies.

About RSV

Respiratory syncytial virus (RSV) is a common and highly contagious respiratory virus that 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 serious illness and even be life-threatening. Repeated RSV infections are thought to be common, so even people who contracted RSV as young, healthy adults may be at risk of RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under the age of 5 and up to 120,000 adults over the age of 65 are hospitalized each year due to RSV infection in the US, with up to 10,000 deaths each year .

While there are expensive antibody drugs approved for use in infants that provide temporary passive immunity against RSV, there is no approved vaccine to generate active immunity against RSV. Such a vaccine is needed to protect populations most at risk of severe RSV disease, including the elderly and infants, in order to reduce the substantial health and economic burdens of RSV infection in the US and all over the world.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing life-saving 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 of 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 possible complications thereof; the ability to obtain and maintain regulatory approval; the labeling of any approved product; the scope, progress and expansion of the development and commercialization of product candidates; the size and growth of the markets and the rate and degree of market acceptance of the same vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaboration; and the ability to achieve business development transactions on terms favorable to the Company, in any event, in light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or being made by or on behalf of CyanVac and/or o Blue Lake Biotechnology may not occur, and the actual results of CyanVac and/or Blue Lake Biotechnology could differ materially and adversely from those anticipated or thereby implied. Factors that may affect the results of CyanVac and/or Blue Lake Biotechnology include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, timing, costs, and the uncertainty of obtaining approvals. regulatory requirements, changes in the regulatory landscape, uncertainties related to raising additional capital as necessary to meet the needs of CyanVac and/or Blue Lake Biotechnology on acceptable terms, or at all, the absence of any product demand guarantees, market acceptance or competitive advantage for either CyanVac and/or Blue Lake Biotechnology’s needs. or Blue Lake Biotechnology’s product candidates, if approved, and certain commercial, legal, social and economic risks. Any forward-looking statement in this release speaks only as of the date of this press release and is 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

Business director

swu@bluelakebiotechnology.com

(650) 427-0166

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SOURCE Blue Lake Biotechnology, Inc.

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