Pfizer and BioNTech To Initiate COVID-19 Vaccine Clinical Trials In April
Executive Summary
The two companies announced more details about their COVID-19 vaccine development plan, including a $185m upfront payment and $113m equity investment from Pfizer.
Pfizer Inc. and BioNTech SE are moving forward with the development of a mRNA vaccine candidate for COVID-19, with plans to initiate human testing by the end of April. The companies aim to advance multiple candidates into human trials in the US and Europe, they announced on 9 April. The companies also revealed more details of the financial terms of the collaboration, which includes a $185m upfront payment from Pfizer to BioNTech as well as a $113m equity investment. BioNTech will be eligible to receive future milestone payments of up to $563m.
Pfizer revealed in March that it was extending a collaboration with the messenger RNA specialist BioNTech to include an investigational COVID-19 vaccine. Pfizer and BioNTech had already established a flu vaccine collaboration in 2018. (Also see "Interview: BioNTech And Pfizer Explore mRNA Flu Vaccines In $120m+ Deal" - Scrip, 16 Aug, 2018.) The latest announcement reveals just how rapidly Pfizer is hoping to move forward.
Pfizer and BioNTech said they believe they could rapidly scale up manufacturing capacity to supply millions of doses by the end of 2020 and hundreds of millions of doses in 2021, if the program is successful.
The deal centers on BioNTech's propriety mRNA vaccine platform, while Pfizer will contribute its global vaccine clinical research and development, regulatory, manufacturing and distribution infrastructure. The companies will share development costs equally, though Pfizer will initially fund the full development costs and be repaid by BioNTech.
The deal highlights how aggressively big pharma has pivoted to developing a vaccine for COVID-19 and moved up development timetables. Several big pharmas have focused in on mRNA as a faster way to develop a vaccine for COVID-19, including Sanofi, which has teamed up with Translate Bio. (Also see "Sanofi Joins mRNA COVID-19 Club With Translate Tie-Up" - Scrip, 27 Mar, 2020.)
Moving Forward On Multiple Fronts
The expanded vaccine development deal is just one piece of a multi-pronged strategy announced by Pfizer to combat COVID-19, which involves “collaborating with industry partners and academic institutions to develop potential novel approaches to prevent and treat COVID-19.” The big pharma’s five-point action plan, unveiled in March, includes the development of antivirals, establishing a SWAT team of scientific experts to address the pandemic, and vowing to make access manufacturing capacity available to produce a vaccine.
The company provided an update on some of those other initiatives as well. It has confirmed a lead protease inhibitor that has shown antiviral activity against SARS-CoV-2 and plans to begin preclinical confirmatory studies and suitability for intravenous administration. In parallel, Pfizer will be moving forward with plans to initiate a clinical study of the molecule in the third quarter of 2020 if the preclinical confirmatory studies are positive.
The company is also finalizing a research collaboration agreement with the Liverpool School of Tropical medicine's Respiratory Infection Clinical Research Group to provide funding and laboratory support for two new studies exploring the interaction between S. pneumoniae and SARS-CoV-2. The two studies, SAFER and FASTER, will help to demonstrate whether patients infected with COVID-19 have a higher risk of also developing pneumococcal pneumonia and if having both infections leads to more severe disease and poorer outcomes. The SAFER study will enroll 100 health care workers at the Royal Liverpool Hospital, while the FASTER study will recruit 400 patients from the hospital.
Pfizer is also exploring use of the JAK inhibitor Xeljanz (tofactinib) for treating COVID-19 patients. An independent Phase II investigator-initiated study in Italy will be initiated later this week. The hypothesis is that JAK inhibition could mitigate systemic and alveolar inflammation in patients with COVID-19-related pneumonia by inhibiting essential cytokine signaling involved in immune-mediated inflammatory response, which can lead to damage of the lungs and acute respiratory distress syndrome.