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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

Roche and Genen­tech re­searchers plot $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Covid-19 roundup: US se­cures 100,000 dos­es of Eli Lil­ly's an­ti­body cock­tail; Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta

A couple weeks after racking up its third EUA for a Covid-19 treatment — this one for its antibody cocktail — Eli Lilly has struck a deal with the US government for at least 100,000 doses.

The US will pay $210 million for doses of bamlanivimab and etesevimab, which will be delivered through March 31, Lilly said in a statement. The deal builds on 1.45 million doses of bamlanivimab alone that the US has already purchased, more than 1 million of which have been delivered. Another 450,000 doses of the single antibody are also expected to arrive by March 31.

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