ST. LOUIS – Biotech startup Precision Virologics, which develops adenovirus-based vaccines in St. Louis, and Bharat Biotech, a manufacturing giant of vaccines, jointly obtained rights from Washington University School of Medicine in St. Louis for a novel chimp-adenovirus vaccine for COVID-19. Precision Virologics has optioned rights for USA, Europe, and Japan. Bharat has obtained a license for all other markets.
The licensing agreements for Precision Virologics and Bharat Biotech will lead to rapid clinical development, following the intranasal vaccine candidate having shown unprecedented levels of protection in mouse studies. This technology and data recently was published in scientific journal Cell and in an editorial in Nature.
Excerpt from Nature:
“[Precision Virologics’] adenovirus vaccine, unlike any of the leading candidates, is designed to be administered through the nose. A team led by [viral immunologist Michael] Diamond and Washington University cancer biologist David Curiel [Interim CEO at Precision Virologics] found that mice given a single dose of the intranasal vaccine were fully protected from SARS-CoV-2, with virtually no sign of virus in their upper or lower airways. Mice that received an injection of the same vaccine were only partially protected, echoing animal data from some leading candidates. This was because the intranasal vaccine summoned potent ‘mucosal’ immune responses that can block the virus at the site of infection in the upper airways, the team says.
“On the basis of such results, Diamond feels that his team has “a mission” to push its vaccines into human trials, to “see if they're going to be one of the last ones standing — even if they’re not the first ones out there.””
The Precision Virologics team is led by Interim CEO David T. Curiel, MD, PhD, along with Scientific Advisor, Michael S. Diamond, MD, PhD.
“The ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration,” said Dr. Curiel. “An effective nasal dose not only protects against COVID-19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat. Most other vaccine candidates currently under development can’t do that.”
Based on these exceptional findings, the National Institutes of Health is advancing the studies in non-human primates. Phase I trials – a single nasal dose – will take place at Saint Louis University’s Vaccine and Treatment Evaluation Unit. Bharat Biotech, upon obtaining regulatory approvals, will pursue clinical trials in India and undertake large-scale manufacture of the vaccine at its GMP facility located in Genome Valley, India.
“We are proud to collaborate on this innovative vaccine,” said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech. “We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion individuals vaccinated receiving a single-dose regimen. An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive. Our experience in viral vaccines, manufacturing capabilities, and distribution continue to be our strong suit in ensuring safe, efficacious, and affordable vaccines. It is prudent for Bharat to be involved in diverse but tenable projects to provide a much-needed vaccine against COVID-19 reaches all citizens of the world.”
Precision Virologics has received business development and coaching services from BioGenerator, the accelerator and investment arm of BioSTL. BioGenerator’s Director of Entrepreneur Support, Harry Arader currently oversees Intellectual Property rights and business negotiations for Precision Virologics. BioGenerator also provided extensive support for successful grant applications to the NIH and executive search for senior business talent for the company.
Precision Virologics is a vaccine company developing advanced generation adenoviral vaccines. Precision’s lead agent is a potency enhanced simian adenovirus-based COVID-19 vaccine delivered via the nasal route. Precision also has vaccine development programs for influenza, Zika, and chikungunya. Advanced molecular engineering of adenovirus provides technology platforms to provide key advantages. Precision’s unique capabilities provide ideal positioning for rapid development of effective vaccines for emerging bioweapon and pandemic threats.
Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications. Located in Genome Valley, the hub for the global biotech industry, the company has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. The company is proficient in conducting extensive multi-centre clinical trials, having completed more than 75 trials enrolling more than 300,000 participants globally. Our commitment to global social innovation programs and public-private partnerships resulted in the introduction of path-breaking WHO pre-qualified vaccines BIOPOLIO® ROTAVAC® and Typbar TCV® combatting Polio, Rotavirus and Typhoid infections respectively. Bharat Biotech has successfully partnered with NIV-ICMR having developed JENVAC®, a licensed Japanese Encephalitis vaccine. The recent acquisition of the Rabies vaccine facility, Chiron Behring, Ankleshwar has positioned Bharat Biotech as the largest Rabies vaccine manufacturer in the world. To learn more about Bharat Biotech visit www.bharatbiotech.com.
BioGenerator, the investment arm of BioSTL, produces a sustained pipeline of successful bioscience companies and entrepreneurs in St. Louis by creating, growing and investing in promising new enterprises. Visit biogenerator.org for additional information, and follow us on LinkedIn and Twitter.
St. Louis Business Journal: St. Louis biotech startup Precision Virologics acquires rights for Covid-19 vaccine
KMOX: A St. Louis-discovered COVID vaccine is proving to be "exceptional," because it blocks the virus at the site of infection
St. Louis Post-Dispatch: St. Louis startup licenses ‘underdog’ COVID-19 vaccine from Washington University
KMOV: Local start-up developing possible nasal spray vaccine for COVID-19