In August, TrialSite reported on the promising, preclinical stage vaccine for COVID-19 under development at Washington University School of Medicine (WUSM), St. Louis. That investigational product received attention from around the globe, TrialSite can attest based on the traffic to that particular article, including India. And it’s an Indian biotech that just inked a global license deal with the prestigious university located in the ‘Gateway to the West.’ Now Hyderabad-based Bharat Biotech has secured the rights for the vaccine in all territories except for the U.S., Japan and Europe. WUSM St. Louis spinoff Precision Virologics owns the U.S., Europe and Japan markets. The partnership will help fund a Phase 1 clinical trial, located at the university’s health facility in St. Louis. The pair will investigate the safety profile of the investigational product in humans.
WUSM, St. Louis actually licensed the vaccine to both a local St. Louis-based spinoff startup known as Precision Virologics, which develops adenovirus-based vaccines in St. Louis as well as Bharat Biotech. The most lucrative of geographic territories (USA, Europe and Japan) go to the spinoff (Precision Virologics) while again Bharat Biotech has rest of world rights. Now with licensing out of the way and with the recent mouse studies highlighted in both Cell and Nature, rapid clinical development now ensues.
Indian Regulatory Greenlight
Bharat Biotech must now also seek regulatory approval to pursue clinical trials in India. Their ultimate goal of course is first proving that this innovative vaccine candidate is safe, efficacious, while preparing for manufacturing at its GMP facility in the Genome Valley, Hyderabad.
Bharat Biotech chairman and managing director Krishna Ella expressed his enthusiasm about the prospects for the Washington University School of Medicine St. Louis vaccine candidate emphasizing that simplicity and ease of administration involving the intranasal vaccine—eliminating the need for much medical consumable including needles, syringes, etc. and, hence lowering cost.
The vaccine evidences unprecedented levels of protection in mice studies leading to recent attention in prominent journals, such as Cell and Nature. For example, in a recent editorial in Nature, the company shares in its press release that Dr. David T. Curiel, MD, PhD, Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis and Precision Virologics Interim CEO, commented, “The ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration. 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.”
Precision Virologics is a spinoff startup associated with WUSM in St. Louis. A vaccine company developing advanced generation adenovirus vaccines, Precision Virologics lead agent is a potency enhanced simian adenovirus-based COVID-19 vaccine delivered via the nasal route. The startup is also working on other vaccines such as influenzas, Zika and chikungunya. A WUSM St. Louis spinoff, Dr. David T. Curiel, MD, PhD, Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis is the interim CEO.
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.