CyanVac Announces Data from Preclinical Studies of Intranasal PIV5-based COVID-19 Vaccine Candidate CVXGA1
Athens, GA and Los Gatos, CA, June 9, 2022. CyanVac LLC, a clinical-stage biopharmaceutical company developing intranasal vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced preclinical data in a hamster model using CVXGA1, a COVID-19 vaccine candidate currently in Phase 1 clinical trials. The data show that CVXGA1, which expresses the Spike protein from the original strain (WA1) of SARS-CoV-2 (the virus that causes COVID-19 disease), provides broad protection against other SARS-CoV-2 strains including alpha, delta and omicron variants. In the hamster model, a single intranasal dose of CVXGA1 induced broad serum neutralizing antibodies against, and protected animals against disease challenge by, the WA1 and other strains. In addition, hamsters that received CVXGA1 as a single intranasal booster dose after two doses of an mRNA-based COVID-19 vaccine had higher levels of neutralizing antibodies against multiple SARS-CoV-2 strains than hamsters who were boosted with a third mRNA-based COVID-19 vaccine dose, and were also better protected against viral challenge.
The manuscript describing these data, entitled “Efficacy of Parainfluenza Virus 5 (PIV5)-vectored Intranasal COVID-19 Vaccine as a Single Dose Vaccine and as a Booster against SARS-CoV-2 Variants,” is available on a preprint server at https://biorxiv.org/cgi/content/short/2022.06.07.495215v1 and has been submitted for potential publication in a peer-reviewed scientific journal.
“We are excited to see that our intranasal vaccine candidate, though based on the ancestral strain, can provide broad protection against different SARS-CoV-2 variants,“ said Dr. Biao He, founder and CEO of CyanVac. “What’s more, it provides robust protection when used as a single dose booster for previously vaccinated hamsters. If similar effects are seen in humans, it could make our PIV5-based intranasal COVID-19 vaccine a compelling alternative to injectable vaccines.”
“This work also highlights the ‘plug and play’ capabilities of our proprietary PIV5 platform,” said Hong Jin, PhD, Chief Scientific Officer of CyanVac. “We have successfully generated and tested additional candidate vaccines encoding the Spike protein from variants like delta and omicron, and also a candidate vaccine that encodes both the COVID Spike and nucleocapsid proteins. This demonstrates that we can rapidly respond to emerging variants.”
In the preclinical studies, hamsters were immunized with a single intranasal dose of CVXGA1, and levels of serum neutralizing antibodies against WA1, delta, and omicron were measured at 36 days and 108 days after immunization. Robust neutralizing antibody responses against all three strains were observed at both time points. Additional hamsters were immunized with CVXGA1 followed by challenge with the WA1, alpha, or delta strain. CVXGA1 protected against disease from all three strains, as assessed by change in body weight during the first 5 days after challenge, and by measurement of viral load in the lungs at day 5 by quantitative PCR and plaque assay for infectious virus. (Note that challenge infection using an omicron strain was not performed because omicron is less virulent than the other strains in hamsters.)
In addition, the ability of CVXGA1 to serve as a booster for mRNA-based COVID-19 vaccines was investigated. Hamsters were immunized with two doses of an mRNA-based COVID-19 vaccine 28 days apart. On day 91 after the initial immunization, the animals received a booster dose of either the same mRNA-based vaccine, a placebo, or an intranasal PIV5-based COVID-19 vaccine (CVXGA1 or other experimental vaccine). Serum neutralizing antibody responses against WA1, delta, and omicron (assessed at day 108) were more than seven-fold greater in the CVXGA1-boosted animals than in those that were boosted with the mRNA-based vaccine. When challenged with a SARS-CoV-2 delta variant on day 116, the CVXGA1-immunized animals were better protected against COVID-19 disease than animals that had been boosted with the mRNA-based vaccine, as assessed by change in body weight over 5 days post-challenge and viral load in lung homogenate by quantitative PCR.
CVXGA1 is currently in a Phase 1 clinical trial evaluating the safety and immunogenicity of a single intranasal dose. The trial is led by principal investigator Paul Spearman, MD, Albert B. Sabin Professor and Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center.
About CVXGA1
CVXGA1 is a clinical-stage COVID-19 vaccine candidate based on CyanVac’s proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and its subsidiary, Blue Lake Biotechnology, Inc., are developing CVXGA1 as a single dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA1 is immunogenic, protective, and prevents contact transmission of SARS-CoV-2.
Learn more about the ongoing Phase 1 clinical trial of CVXGA1 at https://www.clinicaltrials.gov/ct2/show/NCT05281263
About CyanVac and Blue Lake Biotechnology
CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing lifesaving vaccines based on a proprietary PIV5 vaccine platform licensed from the University of Georgia. Our lead COVID-19 vaccine program is in Phase 1 clinical trials. Our second program targeting respiratory syncytial virus (RSV) will soon initiate a first-in-man Phase 1 study and has been granted Fast Track designation by FDA. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Gatos, California.
Learn more at https://www.cyanvacllc.com.
Forward Looking Statements
This press release contains forward-looking statements, including with respect to the clinical development of CVXGA1 for COVID-19, a prophylactic vaccine to prevent COVID-19, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate; the size and growth of the market(s) and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are other made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology’s actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac’s and/or Blue Lake Biotechnology’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac’s and/or Blue Lake Biotechnology’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac’s and/or Blue Lake Biotechnology’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.
CONTACTS:
CyanVac LLC and Blue Lake Biotechnology, Inc.
Gary Titus
Chief Financial Officer
gtitus@cyanvacllc.com
(650) 862-9757
Blue Lake Biotechnology Announces FDA Fast Track Designation for BLB-201 Intranasal RSV Vaccine
Athens, GA and Los Gatos, CA, May 24, 2022. Blue Lake Biotechnology, Inc., a clinical-stage biopharmaceutical company developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BLB-201, an intranasal vaccine for the prevention of respiratory syncytial virus (RSV) associated disease in adults over 60 and children under 2 years of age. BLB-201 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the RSV-F protein. In preclinical studies, BLB-201, delivered intranasally as a single dose, induces serum antibody and mucosal antibody responses as well as cell-mediated immune responses, and is protective in RSV challenge studies conducted in various animal models. Delivered through the nose without injections, the company's intranasal vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant groups.
BLB-201 is one of the few RSV vaccines to have received Fast Track designation for development for use in children under 2 years old. “FDA’s granting of Fast Track designation for BLB-201 reflects the urgent need for an RSV vaccine,” said Dr. Biao He, founder and CEO of Blue Lake Biotechnology and its parent company, CyanVac LLC. “It is encouraging that FDA recognizes the potential of our vaccine to address this need for children under 2 years old as well as for older adults.” Dr. He added, "This RSV vaccine candidate expands our intranasal vaccine pipeline, and builds on our experience in developing a clinical stage intranasal COVID-19 vaccine."
Blue Lake is preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers. The trial is led by principal investigator Paul Spearman, MD, Albert B. Sabin Professor and Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center.
About BLB-201
BLB-201 is an RSV vaccine candidate based on CyanVac’s proprietary PIV5 vector that encodes the RSV-F protein. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and Blue Lake Biotechnology are developing BLB-201 as a single dose, intranasal vaccine to prevent diseases associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents RSV infection in animal challenge studies. The Phase 1 trial will be an open-label trial to evaluate the safety, reactogenicity and immunogenicity of BLB-201 administered intranasally as a single dose to adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Both cohorts will receive a single dose of vaccine by intranasal spray. Safety data will be collected and analyzed, as will serum and mucosal antibody responses and cellular immune responses to the RSV-F protein.
Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263
About RSV
Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is one of the leading causes of acute respiratory illness, infecting more than 64 million people worldwide per year. For most people it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and even be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they are younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, approximately 58,000 children under 5 years old and 177,000 adults 65 years and older are hospitalized because of RSV infection in the US with, over 14,000 deaths each year.
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 lead COVID-19 vaccine program is in Phase 1 clinical trials,. Our second program targeting respiratory syncytial virus (RSV) will soon initiate a first-in-man Phase 1 study. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Gatos, California.
Learn more at https://www.cyanvacllc.com.
Forward Looking Statements
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.
CONTACTS:
CyanVac LLC and Blue Lake Biotechnology, Inc.
Gary Titus
Chief Financial Officer
gtitus@bluelakebiotechnology.com
(650) 862-9757
Professor moves closer to possible COVID-19 vaccine
from UGA Today
https://news.uga.edu/biao-he-possible-covid19-vaccine/
CyanVac and Blue Lake Biotechnology Announce FDA Clearance of IND Application for BLB-201 Intranasal RSV Vaccine
Athens, GA and Los Altos, CA, March 27, 2022: CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., clinical-stage biopharmaceutical companies developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for BLB-201, an intranasal vaccine for the prevention of respiratory syncytial virus (RSV) infection. BLB-201 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the RSV-F protein. In preclinical studies, BLB-201, delivered intranasally as a single dose in each nostril, induces mucosal antibody responses and cell-mediated immune responses as well as serum antibody responses, and has been effective in protecting multiple animal species from RSV infection in challenge studies. Delivered through the nose without injections, the companies' vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant groups.
“FDA’s clearance of our IND for BLB-201 is great news for us, especially on top of our ongoing single dose intranasal COVID-19 vaccine trial in the US. This IND for our second PIV5-based intranasal vaccine is an exciting development that expands our clinical stage pipeline,” said Dr. Biao He, founder and CEO of CyanVac and Blue Lake Biotechnology. “It is an important milestone toward developing RSV vaccines for young children and older adults, both of which face significant morbidity and mortality risk from RSV infection,” Dr Biao added.
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers. The trial will be led by principal investigator Paul Spearman, MD, Albert B. Sabin Professor and Director of Infectious Diseases at Cincinnati Children's Hospital Medical Center.
“RSV is a common respiratory virus responsible for the hospitalization of more than 3 million children every year, and also affects older adults worldwide,” said Dr. Spearman. “A vaccine that can be delivered by nasal spray would be a valuable tool for reducing this burden.”
About BLB-201
BLB-201 is an RSV vaccine candidate based on CyanVac’s proprietary PIV5 vector that encodes the RSV-F protein. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and Blue Lake Biotechnology are developing BLB-201 as a single dose, intranasal vaccine to prevent RSV infection and serious complications associated with RSV infection. Preclinical studies have demonstrated that BLB-201 is immunogenic and prevents infection in animal challenge studies. The Phase 1 trial will be an open-label trial to evaluate the safety, reactogenicity and immunogenicity of BLB-201 administered intranasally as a single dose to adults in two sequential age cohorts (age 18-59 years and age 60-75 years). Both cohorts will receive a single dose of vaccine by intranasal spray. Safety data will be collected and analyzed, as will serum and mucosal antibody responses and cellular immune responses to the RSV-F protein.
Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT05281263
About RSV
Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus which is a leading cause of acute respiratory illness, infecting more than 64 million people worldwide per year. For most people it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and even be life-threatening. According to the Centers for Disease Control, approximately 58,000 children under 5 years old and 177,000 adults 65 years and older are hospitalized, and over 14,000 die each year because of RSV infection in the US.
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 products based on a proprietary PIV5 vaccine platform licensed from the University of Georgia. Our lead COVID-19 vaccine program is in Phase 1 clinical trials, and has been selected for future NIH/IDCRC support. Our second program targeting respiratory syncytial virus (RSV) will soon initiate a first-in-man Phase 1 study. RSV is a common respiratory virus that routinely and repeatedly infects people at all ages, and is of particularly high risk to children under 2 years old and elderly patients with underlying lung disease. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Altos, California.
Learn more at https://www.cyanvacllc.com.
Forward Looking Statements
This press release contains forward-looking statements, including with respect to the clinical development of BLB-201 to prevent RSV infection, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate; the size and growth of the market(s) and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are other made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology’s actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac’s and/or Blue Lake Biotechnology’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac’s and/or Blue Lake Biotechnology’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac’s and/or Blue Lake Biotechnology’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.
CONTACTS:
CyanVac LLC and Blue Lake Biotechnology, Inc.
Gary Titus
Chief Financial Officer
gtitus@CyanVacLLC.com
(650) 862-9757
CyanVac and Blue Lake Biotechnology Announce First Participant Dosed in a Phase 1 Clinical Trial to Evaluate its CVXGA1 Intranasal COVID-19 Vaccine
Athens, GA and Los Altos, CA, September 27, 2021: CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., clinical-stage biopharmaceutical companies developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced the enrollment of the first participant in a Phase 1 clinical trial of their CVXGA1 intranasal COVID-19 vaccine in Rochester, NY. CVXGA1 is based on an attenuated strain of PIV5 (also known as canine parainfluenza virus) and expresses the S protein of SARS-CoV-2. In preclinical studies, CVXGA1, delivered intranasally as a single dose in each nostril, induces mucosal antibody responses and cell-mediated immune responses as well as serum antibody responses, and has been effective in protecting multiple animal species from SARS-CoV-2 viral infection and in blocking SARS-CoV-2 viral transmission. Delivered through the nose without injections, the companies' vaccines have the potential to facilitate delivery of vaccines to broad populations, including pediatric and needle-hesitant groups.
“The enrollment of the first participant in our first-in-human Phase 1 clinical trial marks another important milestone in our rapid growth as a vaccine company,” said Dr. Biao He, founder and President of CyanVac and Blue Lake Biotechnology. “Our aim is to have a single-dose intranasal vaccine that can be used as a booster for existing vaccines, as well as a vaccine that can serve as a primary vaccine to countries that are struggling to acquire enough vaccine doses for their populations.”
“CyanVac's investigational vaccine has the potential to be both a needle-free vaccine and one that could block disease transmission,” said Dr. Paul Spearman of the Cincinnati Children’s Hospital Medical Center. “For some individuals this may help overcome vaccine hesitancy, and even more importantly it could halt the virus at its point of entry and prevent further spread of COVID-19."
About the Phase 1 Clinical Trial
The trial is a multi-center, open-label trial to evaluate the safety, reactogenicity and immunogenicity of CVXGA1 administered intranasally as a single dose to adults in two sequential age cohorts. In the first cohort, 40 participants aged 18 to 55 years will receive a single dose of vaccine by intranasal spray, escalating from low dose (106 PFU) to high dose (107 PFU). In the second cohort, 40 participants aged 56 to 75 years will receive a single dose of vaccine, escalating from low dose to high dose. Safety data will be collected and analyzed, as will serum and mucosal antibody responses, and cellular immune responses to the SARS-CoV-2 S protein.
Learn more about the trial at https://www.clinicaltrials.gov/ct2/show/NCT04954287 .
About CVXGA1
CVXGA1 is a COVID-19 vaccine candidate based on CyanVac’s proprietary PIV5 vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector itself is a respiratory virus that is not known to cause disease in humans, although it has been commonly administered to dogs as part of combination distemper / kennel cough vaccines for decades. CyanVac and Blue Lake Biotechnology 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 and prevents infection and transmission by SARS-CoV-2.
About CyanVac and Blue Lake Biotechnology
CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., are technology-driven companies developing products based on a proprietary PIV5 vaccine platform licensed from the University of Georgia. Our pipeline features one vaccine in clinical trials, a second vaccine nearing Phase 1 studies, and additional vaccines in preclinical development. Our lead COVID-19 vaccine program has been selected for future NIH/IDCRC support, while our second program is targeting respiratory syncytial virus (RSV). RSV is a common respiratory virus that routinely and repeatedly infects people at all ages, and is of particularly high risk to children under 2 years old and elderly patients with underlying lung disease. In addition, the companies have early-stage proof of concept vaccine programs targeting norovirus and Lyme disease. CyanVac and Blue Lake Biotechnology are headquartered in Athens, Georgia, with a second site in Los Altos, California.
Learn more at https://www.cyanvacllc.com.
Forward Looking Statements
This press release contains forward-looking statements, including with respect to the clinical development of CVXGA1 for COVID-19, which are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential complications thereof; the ability to obtain and maintain regulatory approval; the labeling for any approved product; the scope, progress and expansion of developing and commercializing a product candidate; the size and growth of the market(s) and the rate and degree of market acceptance thereof vis-à-vis alternative therapies; the establishment and maintenance of any applicable collaborations; and the ability to achieve business development transactions on favorable terms to the Company, if at all. In light of these risks and uncertainties, the events and circumstances discussed in such forward-looking statements or which are other made by or on behalf of CyanVac and/or Blue Lake Biotechnology may not occur, and CyanVac's and/or Blue Lake Biotechnology’s actual results could differ materially and adversely from those anticipated or implied thereby. Factors which may affect CyanVac’s and/or Blue Lake Biotechnology’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet CyanVac’s and/or Blue Lake Biotechnology’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of CyanVac’s and/or Blue Lake Biotechnology’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statements in this release speak only as of the date of this press release and are based on information available to CyanVac as of the date of this release, and neither CyanVac nor Blue Lake Biotechnology has any obligation to update or revise any such forward-looking statement.
CONTACTS:
CyanVac LLC and Blue Lake Biotechnology, Inc.
Gary Titus
Chief Financial Officer
gtitus@CyanVacLLC.com
(650) 862-9757