By Rajaneesh K. Gopinath, Ph.D.
Germany-based BioNTech SE, joins the growing list of biotech and pharma companies who are scurrying to come up with an effective riposte against the rapidly spreading COVID-19 with strategic collaborations.
BioNTech SE is a biotech company founded in 2008, that develops individualized immunotherapies for Cancer and other diseases. It’s individualized neoantigen, BNT122 is an experimental mRNA cancer vaccine which is currently under independent combination trials with Merck’s Keytruda and Genentech’s Tecentriq evaluating its efficacy against cancers such as melanoma. Besides cancer immunotherapies, BioNTech has several collaborations with global biopharma to co-develop mRNA therapeutics including vaccines for cancer, Influenza, and other infectious diseases.
BioNTech’s Collaboration with Pfizer and Fosun Pharma
Today, BioNTech announced that it has signed a letter of intent with Pfizer to co-develop and distribute a potential mRNA-based coronavirus vaccine against COVID-19. Its vaccine candidate BNT162 is anticipated to enter clinical testing by the end of next month. Both parties will immediately start working together, even as the details of the agreement are still chalked out. This comes after Pfizer issued a five-point plan requesting other biopharma companies to join its efforts to combat COVID-19. It’s not for the first time the companies have joined forces for a common goal. BioNTech has previously collaborated with Pfizer in 2018 to develop mRNA-based vaccines for Influenza.
“This is a global pandemic, which requires a global effort. In joining forces with our partner Pfizer, we believe we can accelerate our effort to bring a COVID-19 vaccine to people around the world who need it,” said Ugur Sahin, the Co-Founder, and CEO of BioNTech.
The collaboration with Pfizer would exclude the Chinese market as BioNTech announced a global strategic alliance with China’s Shanghai Fosun Pharmaceutical (Group) Co., Ltd, (Fosun Pharma) to develop and commercialize BNT162 only yesterday. As per the agreement, clinical trials of BNT162 will be conducted in China and if it gets approved, Fosun will help commercialize the vaccine there. Furthermore, it has agreed to buy 1,580,777 of BioNTech’s ordinary shares for US$ 50 million on approval from Chinese regulatory authorities.
“A potential pandemic requires a collective effort and both companies are passionate about contributing to the fight against the current coronavirus outbreak. We are excited to collaborate with BioNTech, one of the leading companies worldwide in the mRNA field. Our shared objective is to develop a vaccine against the coronavirus and to be able to rapidly manufacture a vaccine to turn the tide of COVID-19 infection” said Wu Yifang, President and CEO of Fosun Pharma in a statement.
Competiton in the mRNA Vaccine Space
BioNTech’s rivals Moderna and CureVac are also currently developing vaccines for COVID-19. Moderna’s mRNA vaccine (mRNA-1273) has entered the phase I evaluation study in Seattle as a potential candidate against COVID-19. Yesterday, the National Institutes of Health dosed the very first patient with mRNA-1273. A total of 45 healthy volunteers will be tested with 3 concentrations (25, 100, 250 μg) and administered on a two-dose vaccination scheduled 28 days apart. After the second dose, the participants will be monitored continuously for a period of 12 months. While the phase I trial has just begun, Moderna will start preparing for a potential phase II follow up under its own IND.
The German company CureVac is one of the eight big startups in Europe in terms of funding. CureVac is in the middle of an eventful month and is rumored to be lured by the Trump administration for its potential COVID-19 vaccine. The news was first published in the German newspaper Welt am Sonntag. On March 2nd, CureVac’s CEO, Daniel Menichella was invited to the White House to discuss COVID-19 action strategies with U.S. President Donald Trump, Vice President Mike Pence, and other members of the Coronavirus Task Force including top brass from biopharma companies. Surprisingly, within days, Menichella abruptly stepped down as CEO and CureVac’s founder Ingmar Hoerr took over the reins. Although the company categorically denies any approach from Trump, German officials have hurried to prevent any attempts of monopoly. Besides, yesterday the Europen Commission has offered financial support of €80 million to CureVac as an incentive to stay and develop the vaccine in Europe. It is worth mentioning that Ingmar Hoerr is an advisory board member of the European Innovation Council.
Although market competition is a hallmark of biopharma businesses, the world now depends on stakeholders to acknowledge the gravity of the current situation and direct their efforts towards the greater good of the people.
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