Covid-19 roundup: Fau­ci, Collins in­ter­vene to stop FDA plas­ma au­tho­riza­tion, cit­ing weak da­ta; Roche, Re­gen­eron try to take an­ti­bod­ies glob­al

The FDA has placed on hold an emer­gency au­tho­riza­tion for the use of plas­ma as a Covid-19 treat­ment fol­low­ing the in­ter­ven­tion of top fed­er­al health of­fi­cials who claimed the avail­able da­ta were too weak, ac­cord­ing to a re­port in the New York Times.

NI­AID clin­i­cal di­rec­tor H. Clif­ford Lane con­firmed the hold to the Times, adding plas­ma may still be au­tho­rized some­time in the fu­ture.

Much has been made about the prospect of uti­liz­ing do­nat­ed plas­ma from re­cov­ered Covid-19 pa­tients to treat those cur­rent­ly in­fect­ed with the dis­ease. The the­o­ry goes that an­ti­bod­ies in the plas­ma can help re­duce the time pa­tients spend in hos­pi­tals as well as mor­tal­i­ty rates if the treat­ment is ad­min­is­tered quick­ly.

The use of plas­ma to treat dis­ease has been around since the ear­ly 20th cen­tu­ry and doc­tors used sim­i­lar ther­a­pies dur­ing the in­fluen­za pan­dem­ic of 1918. One of the biggest stud­ies in­to adapt­ing the tech­nique for Covid-19 came from the Mayo Clin­ic last week, which showed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in mor­tal­i­ty rates among the most se­vere cas­es. In­di­vid­u­als re­ceiv­ing plas­ma treat­ment with­in three days of di­ag­no­sis had a sev­en-day death rate of 8.7% while those who got plas­ma four days or lat­er had an 11.9% rate.

How­ev­er, that study was lim­it­ed by the lack of a place­bo group, a draw­back the Mayo Clin­ic it­self ad­dressed at the time. Sev­er­al top health of­fi­cials, such as Lane, An­tho­ny Fau­ci and Fran­cis Collins, urged the FDA to hold off on plas­ma au­tho­riza­tion based on the da­ta from that study, the Times wrote.

Wednes­day’s hold fol­lows a cadre of for­mer FDA com­mis­sion­ers ac­knowl­edg­ing the po­ten­tial ben­e­fits of plas­ma treat­ments in an op-ed to the Wash­ing­ton Post two weeks ago. They cau­tioned, though, that more re­search in­to the ther­a­py’s safe­ty and ef­fi­ca­cy is need­ed. — Max Gel­man

UP­DAT­ED: Roche part­ners with Re­gen­eron on a Covid-19 an­ti­body cock­tail, adding glob­al man­u­fac­tur­ing/mar­ket­ing mus­cle

It’s one of those un­like­ly al­liances you’d on­ly see in a pan­dem­ic: Roche is sign­ing on to be a man­u­fac­tur­ing and dis­tri­b­u­tion part­ner for Re­gen­eron’s tai­lor-made Covid-19 an­ti­body cock­tail.

There’s no up­front or mile­stones, but the com­pa­nies say they’ve al­ready be­gun the tech trans­fer process for Roche, with an agree­ment in place since late Ju­ly. The Swiss phar­ma gi­ant will be tasked with dis­tri­b­u­tion — plus all the clin­i­cal and reg­u­la­to­ry work need­ed — out­side of the US, while the Tar­ry­town, NY-based biotech fo­cused on the home turf.

By team­ing up with Roche, Re­gen­eron ex­pects to in­crease sup­ply of REGN-COV2 by at least three and a half times. Roche will hold the rights for at least sev­en years af­ter the first com­mer­cial sales in the Eu­ro­pean Union, as­sum­ing all goes smooth­ly.

In Ge­of­frey Porges’ view, the col­lab­o­ra­tion adds cred­i­bil­i­ty to a pro­gram that still doesn’t have clin­i­cal val­i­da­tion and could have been re­strict­ed by man­u­fac­tur­ing ca­pac­i­ty, crowd­ed out by US or­ders.

“While the Roche col­lab­o­ra­tion will re­duce REGN’s prof­its from REGN-COV2, it should sub­stan­tial­ly re­duce the de­vel­op­ment cost, which would have bur­dened Re­gen­eron for the next few years (est. half-bil­lion dol­lar cost for REGN-COV2 in 2020E based on Re­gen­eron’s Q2 guid­ance re­vi­sion),” he wrote.

While Re­gen­eron CEO Len Schleifer has pre­vi­ous­ly pre­dict­ed it could have emer­gency dos­es ready by the end of sum­mer, clin­i­cal tri­als ap­pear to be tak­ing longer than ex­pect­ed as in­ves­ti­ga­tors strug­gle to en­roll pa­tients in over­whelmed hos­pi­tals. In the most re­cent an­a­lyst call, Schleifer said they’re now hop­ing to gen­er­ate ini­tial da­ta by ear­ly Sep­tem­ber.

Porges es­ti­mates the bench­mark for ef­fi­ca­cy in the treat­ment set­ting to be 50% to 60% re­duc­tion in dis­ease mor­tal­i­ty, and that for pro­phy­lax­is to be 60% or greater re­duc­tion in clin­i­cal­ly sig­ni­cant, symp­to­matic Covid-19 dis­ease — both like­ly achiev­able judg­ing from pri­mate da­ta.

A spokesper­son told End­points News that the ini­tial da­ta in Sep­tem­ber will in­clude vi­rol­o­gy and bio­mark­ers.

In ad­di­tion to hav­ing Roche joint­ly fund the on­go­ing Phase III pre­ven­tion study, a Phase I mul­ti-dose safe­ty tri­al and any new glob­al stud­ies, Re­gen­eron is al­so keep­ing its hand on a sig­nif­i­cant por­tion of the prof­its.

From the 8-K:

Any world­wide gross prof­its from the An­ti­body Prod­uct will be ag­gre­gat­ed and shared based on a pre-spec­i­fied for­mu­la, which is es­ti­mat­ed to re­sult in Re­gen­eron re­ceiv­ing ap­prox­i­mate­ly 50% – 60% of the world­wide gross prof­its, de­pend­ing on the amount of man­u­fac­tured An­ti­body Prod­uct de­liv­ered by each par­ty.

Bill An­der­son

Bill An­der­son, the CEO of Roche Phar­ma, high­light­ed the po­ten­tial for REGN-COV2 both as a treat­ment and pro­tec­tion for peo­ple ex­posed to the coro­n­avirus, mak­ing it a “crit­i­cal line of de­fense.” De­signed specif­i­cal­ly to com­bat SARS-CoV-2, the ther­a­py com­pris­es two dif­fer­ent virus-neu­tral­iz­ing an­ti­bod­ies that bind to the re­cep­tor bind­ing do­main of the virus’ spike pro­tein.

“We’re com­mit­ting our man­u­fac­tur­ing ex­per­tise and ca­pac­i­ty, and our glob­al dis­tri­b­u­tion net­work to bring Re­gen­eron’s po­ten­tial an­ti­body com­bi­na­tion to as many peo­ple around the world as we pos­si­bly can,” he said.

That trans­lates to at least 100,000 liters of “an­nu­al­ized biore­ac­tor ca­pac­i­ty on a full-time cam­paign ba­sis” to man­u­fac­ture the prod­uct, ac­cord­ing to an SEC fil­ing from Re­gen­eron. On its part, Re­gen­eron will ded­i­cate 40,000 liters of its in-house ca­pac­i­ty to the Covid-19 pro­gram.

His­toric ri­vals in eye dis­eases and in­flam­ma­to­ry con­di­tions, Roche and Re­gen­eron (part­nered with Sanofi) took their re­spec­tive IL-6 an­ti­bod­ies to tri­als in hopes of damp­en­ing the dam­ag­ing im­mune re­sponse that plague pa­tients with se­vere Covid-19 — on­ly to be slapped by fail­ures. That left Roche with lit­tle to of­fer in the ther­a­peu­tic fight against the coro­n­avirus, even as its di­ag­nos­tics unit con­tin­ues to sell much-need­ed anti­gen and an­ti­body tests.

Schleifer sees the deal as val­i­da­tion for his team’s record speed and tire­less work as the phar­ma part­ner pro­vides “im­por­tant scale” to the en­deav­or.

He has struck a $450 mil­lion deal with Op­er­a­tion Warp Speed to sup­ply up to 1.6 mil­lion dos­es in the US, both for ther­a­peu­tic and pro­phy­lac­tic use. Back in March he not­ed the com­pa­ny could be­gin mak­ing 200,000 clin­i­cal dos­es a month be­gin­ning in Au­gust, and it’s been look­ing to max­i­mize ca­pac­i­ty on com­mer­cial scale ma­te­r­i­al. — Am­ber Tong

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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