Covid-19 roundup: Novavax recruits AstraZeneca vet as its new CMO — right after David Mott jumps on the board; Operation Warp Speed will cut to 7 candidates
One of the dark-horse contenders in a race to the finish line with a new vaccine for Covid-19 has just wooed a senior AstraZeneca researcher to the fold as its new chief medical officer.
Novavax reports that it has recruited Filip Dubovsky to the team after a 14-year stretch at MedImmune/AstraZeneca. While at the big AstraZeneca sub, Dubovsky had been area head for infectious diseases and vaccines. Earlier he had been scientific director for PATH, a malaria vaccine initiative.
Dubovsky’s arrival comes 1 day after Novavax announced that David Mott — the ex-CEO at MedImmune recently retired from a top spot at New Enterprise Associates — is joining the board.
Novavax also hired Silvia Taylor, as SVP, investor relations and corporate affairs.
Novavax jumped into the race with a seed grant from the Coalition for Epidemic Preparedness Innovations, which followed up with a grant of up to $384 million. And just yesterday, the company raised $200 million in an equity investment from RA Capital. But the biotech has been noticeably absent from the frontrunners cited by Operation Warp Speed — so far in any case. — John Carroll
Stéphane Bancel predicts Moderna vaccine has 80% to 90% chance of success
It would come as no surprise that Stéphane Bancel is bullish about Moderna’s Covid-19 vaccine candidate, which has garnered plenty of attention as the frontrunning project most steps of the way. But just how bullish may yet turn some heads.
In an interview with CNBC, Bancel went on the record giving it an 80% to 90% chance that mRNA-1273 can reduce the risk of disease by half, or efficacy of above 50% in technical speak.
“At the public health level, a vaccine with 50% [efficacy] will slow down drastically infections,” Bancel said, even if it doesn’t protect everyone who gets exposed to SARS-CoV-2.
He was cautious not to commit to a probability around 90% efficacy, saying he’d need more data to assess. Yet the optimism is still extraordinary: As CNBC noted, new vaccines entering human trials from 2000 to 2015 had about a 1-in-3 chance of getting approval.
Bancel cites several reasons why Moderna, a 10-year-old startup, was able to leapfrog storied biopharma players. The mRNA technology lends itself to rapid turnaround; it’s been tested against nine other pathogens; it had a trial run with partners at the NIH in MERS; and it boasts of its own manufacturing site near its headquarters in Boston.
Having touted — somewhat controversially — an antibody response from eight patients in the Phase I trial and more recently released animal data, Moderna has outlined a 30,000-person Phase III trial to begin in July. The goal is to have a vaccine ready to deploy by the end of the year — a goal NIAID director Anthony Fauci has called “aspirational, but it’s certainly doable.” — Amber Tong
Former Shkreli biotech surges on cytokine storm drug
The stock of one of Martin Shkreli’s former biotechs has been soaring over the last month, from less than a $1 to more than $5 per share.
Humanigen, which for several weeks in 2015 was run by the infamous “Pharma Bro,” makes anti-inflammatories for use in, among other things, the hyperactive immune responses, called cytokine storms, that often afflict patients who receive CAR-T cancer treatments. That made their drug a natural fit for Covid-19 after doctors determined these storms were causing some of the worst symptoms in infected patients.
Still, the data on their drug, a GM-CSF inhibitor called lenzilumab, are still highly limited. In a non-controlled preprint posted on MedRxiv earlier this week, 12 patients with severe pneumonia and at least one co-morbidity associated with poor Covid-19 outcomes, were given the drug. Of those, 11 were discharged within 5 days, with no treatment-emergent adverse effects.
That particular round of data sent their stock from $4.08 to $5.45. The company plans to test their drug in larger trials.
Shkreli and an investor group bought a majority stake in the company, then known as KaloBios, in 2015. But when Shkreli was arrested for security fraud for his dealings at a different company, KaloBios fired him. It filed for bankruptcy soon after and re-emerged in 2016 as Humanigen.
On June 2, Venrock, Citadel, and Valiant invested $72 million into the company, spurring the initial resurgence in value and prepping the company for scaling the drug should it be approved.
CEO Cameron Durrant, in an interview with the Wall Street Journal, called Shkreli’s time at the company an “unfortunate history” that lasted roughly 3 weeks.
Operation Warp Speed will cut to 7 candidates, make vaccine free for ‘vulnerable’
The New York Times reported earlier this month that the Trump administration had whittled Operation Warp Speed from 14 to 5 different vaccine candidates, but HHS said yesterday that there would be 7 candidates that move beyond the initial list.
And for “vulnerable” Americans, any vaccine that comes out of the project will be free.
The number of candidates beyond the initial list, in line with early reporting from Bloomberg, give renewed hope for vaccine developers who were left off the initial reported list. That includes Novavax and Inovio, both of which are in Phase I, and Sanofi, a company long backed by HHS and which expects to put their vaccine into clinical testing by the end of the year.
The list of 7 will then be winnowed to a smaller, unspecified number of finalists. The 7 will receive funding and assistance for early trials, and the final few will receive aid for large-scale testing and manufacture. The first of those large trials are expected to come this summer: from Moderna, AstraZeneca and J&J, in that order. The work of scaling is also underway, most recently with federal contracts of $628 million for Emergent BioSolutions and a $204 million for Corning, who will make vials to store and distribute a vaccine.
Questions of price have been thorny so far for the top vaccine developers. Some, such as J&J and AstraZeneca, have said they will not profit on the vaccine. Moderna and Pfizer have said they will not charge exorbitantly.
Administration officials pledged to make the vaccine available to those who can’t afford it or are “vulnerable” on a conference call yesterday, according to several media reports. The officials also said that they can’t guarantee a vaccine will be available by January, the widely reported aim of the initiative. — Jason Mast
CureVac enters the clinic after several tumultuous months
Two days after the German government poured €300 million into the mRNA biotech CureVac, the company announced it will put their vaccine into human trials.
Although straggling some of the other major players, the date of the announcement is in line with the timeline CureVac laid out over the winter. Still, it comes on the heels of three tumultuous months for a company that previously reached unicorn status while largely avoiding controversial headlines.
Arguably the first biotech built around mRNA, CureVac was one of the first companies to publicly begin work on a Covid-19 vaccine after the outbreak emerged, and they were quickly backed by the Center for Epidemic Preparedness Innovations.
Then a flurry of headlines hit over a single week in March. First CEO Daniel Menichella was replaced by founding CEO Ingmar Hoerr. The company cited the need for leadership with a scientific background during a crisis, but the news of a CEO shift in the middle of an unprecedented vaccine race prompted wide speculation.
Then later that week, Reuters and a prominent German paper reported that the Trump administration had tried to lure CureVac to the US to secure access to their Covid-19 vaccine, alarming German officials and beginning what has since been months of international tussling over vaccine access. (CureVac denied the reports, but the New York Times subsequently reported similarly). The EU subsequently made €80 million available to CureVac to shore up manufacturing on the continent — on the same day Hoerr announced that, after a week-long return, he was stepping down for medical reasons and CCO Franz-Werner Haas would step in as acting CEO.
The concerns over access to CureVac’s vaccine haven’t dissipated. The Financial Times reported that the €300 million German government investment was intended to ward off a planned IPO. FT cited a document from the German Finance Ministry: “The intended acquisition of a federal shareholding in CureVac is intended to ensure that the company is not taken over by a foreign investor and that it does not leave the country … It is feared that in case of takeover and migration abroad, a vaccine against Covid-19 developed by CureVac in the future will not be made available to Germany and Europe.”
Unlike Moderna or the Pfizer-partnered vaccine developer BioNTech, CureVac uses a form of mRNA vaccine that triggers an innate immune response, which they’ve long touted as allowing them to give much smaller doses and thus produce far more vaccines. (Moderna considered the technology early in its history and decided against it.) Their first trial, set to take place in Belgium and Germany, will test between 2 and 8 micrograms in 168 patients. Moderna, by contrast, tested between 10 and 200 micrograms. — Jason Mast
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