BioNTech testing separate mRNA vaccine variant in Chinese trial, closes supply deal with Canada
Plus data for Relief’s peptide, EUA for a saliva test and clinical plans for ImmunityBio’s vaccine
BioNTech started a Chinese COVID-19 vaccine trial Wednesday that will test a different mRNA candidate than the pivotal, global study the biotech is running with Pfizer. Separately, the partners announced a vaccine procurement agreement with Canada.
COVID-19 countermeasure updates also came this week for Relief’s anti-inflammatory peptide and ImmunityBio’s vaccine, plus Clinical Reference Laboratory scored an Emergency Use Authorization (EUA) for its saliva diagnostic.
BioNTech SE (NASDAQ:BNTX) and Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKEX:2196) said 72 volunteers have been dosed with one of the German biotech’s mRNA vaccines in a Phase I trial -- a different variant than what was selected for the global Phase IIb/III trial.
BioNTech and Pfizer Inc. (NYSE:PFE) had been testing four mRNA vaccine variants in parallel. The biotech and Fosun will test in the Chinese trial BNT162b1, a nucleoside-modified RNA subunit vaccine encoding trimerized spike receptor-binding domain. BioNTech and Pfizer are evaluating in a pivotal trial BNT162b2, which encodes a mutated full-length spike.
The partners said when the Phase IIb/III trial launched last week that BNT162b2 elicited similar neutralizing geometric mean titers to BNT162b1, and had a more favorable tolerability profile and potentially broader T cell responses (see “Two Lead mRNA Vaccines Enter Pivotal Testing”).
The randomized, placebo-controlled study will enroll 144 adults in two age groups: volunteers ages 18-55, and 55 and older.
Fosun has exclusive commercialization rights to the vaccine in China, Hong Kong, Macau and Taiwan.
BioNTech and Pfizer also agreed on Wednesday to supply doses of their mRNA vaccine to Canada, the fourth country to close a procurement deal with the partners.
While the number of doses and financial terms are undisclosed, Pfizer has said the price a country pays for the vaccine would depend on the volume of doses purchased (see “Pfizer Lays out Two Phases of Vaccine Pricing”).
The vaccine doses are scheduled to be delivered over 2021.
BioNTech and Pfizer has also agreed to provide Japan with 120 million doses starting 1H21; the U.K. with 30 million doses; and supply the U.S. with $100 million doses, for which it will pay $2 billion (see “U.S. Shows its Willing to Pay More Per Dose”).
The partners expect FDA approval or Emergency Use Authorization of a vaccine as early as October. They’re projecting to manufacture up to 100 million doses by year-end, and up to 1.3 billion additional doses by the end of 2021.
Data for Relief, NeuroRx
Relief Therapeutics Holding AG (SIX:RLF) and NeuroRx Inc. reported Sunday that aviptadil led to rapid recovery from respiratory failure in critically ill COVID-19 patients who had been treated under an emergency use IND or expanded use protocol. The patients had been too sick for enrollment in a Phase II/III study.
One of the critically ill patients treated under the emergency use IND with the synthetic peptide-based vasoactive intestinal polypeptide (VIP) under an emergency use IND came off a ventilator within four days. Aviptadil, which has Fast-Track designation, led to similar results in over 15 additional patients treated under an emergency IND or expanded use protocol.
The companies also highlighted an independent study described in bioRxiv showing that the anti-inflammatory peptide could block SARS-CoV-2 replication in human lung cells and monocytes.
ImmunityBio trial, at-home Dx
ImmunityBio Inc. has submitted an IND to FDA to begin Phase I testing of a COVID-19 vaccine it’s developing with NantKwest Inc. (NASDAQ:NK); and on Tuesday, the partners revealed in a bioRxiv publication that prime-boost administration of the candidate induced all five vaccinated mice to generate both CD8+ and CD4+ T cells against the SARS-CoV-2 spike and nucleocapsid proteins.
The companies, which joined in May to co-develop COVID-19 therapeutics and a vaccine, also showed that four mice had spike-specific antibody responses and two mice produced potent neutralizing responses against SARS-CoV-2.
The vaccine candidate, which ImmunityBio created, is a human adenovirus serotype 5 (hAd5) vector engineered to prevent triggering pre-existing immunity against the adenovirus; as well as to express the SARS-CoV-2 spike and nucleocapsid.
Separately, FDA has granted an EUA to a saliva-based real-time reverse transcriptase PCR-based COVID-19 test, CRL Rapid Reponse, from Clinical Reference Laboratory Inc. Individuals can collect saliva samples for the diagnostic at home. The company said that in studies of paired samples, which FDA required for the EUA, the CRL Rapid Reponse test had 100% sensitivity and specificity.