Pfizer, BioNTech, Arcturus Share Timelines For Human Testing As COVID-19 Vaccine Development Intensifies

The enormity of the coronavirus pandemic has forced biopharma companies to step up efforts to expeditiously develop vaccines and treatments for COVID-19. 

The Frontrunners

Moderna Inc MRNA, which was the first company to move its coronavirus vaccine candidate to the clinics, said in mid-March that the first participant has been dosed in an NIH-led, Phase 1 study of its mRNA vaccine in the U.S.

Inovio Pharmaceuticals Inc INO announced earlier this week that it is initiating a Phase 1 study to test its DNA vaccine for the coronavirus following the FDA's acceptance of Inovio's IND application.

Apart from these companies, CanSino Biologics and the Academy of Military Sciences are running Phase 1 trials of their non-replicating vaccine candidate in China.

The University of Oxford is testing a chimpanzee adeno vector vaccine candidate in a Phase 1/2 trial in the U.K.

Novavax, Inc. NVAX said Wednesday it has identified a vaccine candidate and is planning to initiate human trials in mid-May.

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See also: How The COVID-19 Outbreak Is Benefiting Biotech Investors

Pfizer, BioNTech Make Progress

Pfizer Inc. PFE and BioNTech SE – ADR BNTX, which initially announced a collaboration to develop a COVID-19 vaccine on March 17, released further details on the partnership Thursday. 

The companies said they are looking to rapidly advance multiple candidates into human clinical testing based on BioNTech's proprietary mRNA vaccine platforms and leveraging Pfizer's expertise in vaccine R&D, regulatory capabilities and a global manufacturing and distribution network.

The clinical trials are planned to be conducted across multiple sites in the U.S. and Europe. Pfizer and BioNTech said they expect to start the first clinical trial as early as the end of April, contingent upon the receipt of regulatory clearance. 

The collaboration agreement calls for Pfizer to pay BioNTech $185 million in upfront payments, including a cash payment of $72 million and an equity investment of $113 million.

BioNTech also stands to receive future milestone payments of up to $563 million for a potential total consideration of $748 million.

Arcturus Targets Summer Start For Human Trials

Arcturus Therapeutics Ltd ARCT, an mRNA medicines company, said Thursday it plans to initiate human trials of its COVID-19 vaccine candidate — LUNAR-COV19 — this summer.

The company said under the guidance of the Health Sciences Authority of Singapore, it plans to start the trial, enrolling 76 healthy volunteer adults, with follow-up over several months to evaluate the extent and duration of immune response.

LUNAR-COV19 is a potential single-shot, self-replicating mRNA vaccine devoid of any viral material or co-adjuvants, according to Arcturus. 

The company said the vaccine candidate is being manufactured, with the initial GMP batch to be delivered in June.

PFE, ARCT, BNTX Price Action

Pfizer shares were up 2.69% at $35.54 at the time of publication Thursday, while BioNTech shares were up 2.58% at $46.11. Arcturus shares were rising 8.28% to $14.90. 

Related Link: Akers Says It's Halfway Through Plan To Develop COVID-19 Vaccine Candidate