Covid-19 roundup: Moderna sticks to July for its Phase III as rumors swirl; Following US lead, EU buys up Covid-19 treatments
The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.
A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.
Although Moderna did not confirm the two-week setback to Reuters, the company acknowledged it had delayed delivering the trial protocol to regulators and claimed that it decided to delay the launch. According to the sources cited by Reuters, the company differed with regulators and other experts on the level of patient monitoring needed and what the bar for efficacy should be.
The 30,000-person Phase III trial will be the first of several conducted with government assistance to test whether a Covid-19 vaccine is effective. AstraZeneca is also expected to start their own large study this summer, with J&J following thereafter.
Moderna said they have already made enough doses of the vaccine for their Phase III and are on track to expand capacity enough to make 500 million to 1 billion doses per year starting in 2021. — Jason Mast
Europe secures Actemra, MS drug as fight over treatment access heats up
An international fight to secure first access to experimental Covid-19 vaccines has been brewing for months. Now, a similar tug-of-war is unfolding over treatments.
The US has been the most aggressive, receiving the first major supply of remdesivir through donations and then buying up the entirety of Gilead’s production for July, and 90% for August and September. Yesterday, they also snared the first 70,000 to 300,000 treatment doses of Regeneron’s experimental antibody treatment.
Now Europe is trying to do the same with the drug developers in its borders, even if those treatments remain unproven. The European Commission has inked deals with Roche for its IL-6 antibody Actemra and Merck KGaA for its interferon-beta antibody, making them available for however many doses a member country wants to buy, a source told Reuters Wednesday.
The drugs are meant to tamp down the hyperactive immune response that causes some of Covid-19’s worst symptoms, but they are far from proven. Actemra failed to help patients with early-stage pneumonia last month, though some retrospective analyses suggest it could be of use in later-stages. Rebif, a multiple-sclerosis drug, is being tested in several studies for its Covid-19 effects. — Jason Mast
CEPI gives third major grant in exchange for access to doses of vaccine
The Coalition for Epidemic Preparedness has handed out its third largest round of funding yet for a Covid-19 vaccine effort, pouring $66 million into the Chinese biotech Clover Biopharmaceuticals and their protein-based vaccine.
The new funding will help push Clover’s vaccine through the Phase I trial it began last month in Australia while also helping it scale up manufacturing and prepare for a larger study to test whether it can actually prevent Covid-19. It’s the second round of funding CEPI has provided to Clover. They also made a $3.5 million investment in April.
Like CEPI’s other recent large grants, the new funding calls for Clover to provide doses of its vaccine to Covax, the program CEPI, WHO, and Gavi, the Vaccine Alliance set up to help equitably distribute vaccines around the globe. Neither CEPI nor Clover said how many doses the company would provide, but in June, CEPI gave AstraZeneca nearly $400 million in a deal that provided for 300 million doses. Novavax also agreed to provide doses in exchange for a nearly $400 million but did not specify how many.
Clover’s program is one of several vaccine candidates that use GlaxoSmithKline’s adjuvant technology to boost immune responses. — Jason Mast
EU backs Osivax’s pursuit of a universal vaccine
The race to find a vaccine for the novel coronavirus continues to heat up, as the European Commission’s pilot R&D arm taps French biotech Osivax to head up its unique approach to the research.
Aiming to develop a universal jab for the flu and Covid-19, Osivax secured around $20 million in “blended financing” from the European Innovation Council. About $3 million comes from a Covid-19 “accelerator grant” and will go toward completing Osivax’s signature flu vaccine, dubbed OVX836 and currently in Phase IIa. The rest will be included as part of Osivax’s Series B funding, which aims to launch the Phase IIb portion of the study.
“Similar to influenza, which leads to regular global outbreaks, Covid-19 has the potential to mutate,” Osivax CEO Alexandre Le Vert said in a statement. “The ability to protect people from the current and future coronavirus strains is a tremendous opportunity for us and we are particularly thankful for this funding and the validation that it provides our science and technology moving forward.”
Osivax was one of only 28 applicants out of 1,400 to receive an accelerator grant.
Critics of the European Commission — which include Sanofi CEO Paul Hudson — say they have dragged their feet in funding Covid-19 research, at least compared to the response of the US government. A “European Strategy,” unveiled June 17, outlined the methodology the EU would choose to select vaccine candidates, and announced more than $11 billion in funds raised from member countries to commit to vaccine research.
The French biotech sets itself apart as a T cell vaccine. By focusing its technology on attacking a flu virus’ nucleoprotein, which, unlike the rest of the virus, is much less likely to mutate, Osivax hopes to not only inoculate against current strains of the flu but also against future variants.
Part of the OVX836 program will apply this technology against SARS-CoV-2, the strain of coronavirus that causes Covid-19. Osivax’s Series B funding is expected to finance a way to prove the efficacy of its vaccine.
Investment bank Bpifrance also chipped in about $17 million as part of its program to fund private companies seeking to find a COVID-19 vaccine. — Max Gelman
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