Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surg­ing again off da­ta that sug­gest its an­tivi­ral remde­sivir might im­prove sur­vival.

The new da­ta come from an analy­sis Gilead con­duct­ed com­par­ing the death rate and re­cov­ery time of pa­tients in one of its remde­sivir tri­als to a group of 800 pa­tients “with sim­i­lar base­line char­ac­ter­is­tics and dis­ease sever­i­ty” who re­ceived on­ly stan­dard-of-care around the same time. The re­sult, they said, sug­gest­ed that pa­tients who re­ceived remde­sivir had a 62% bet­ter chance at sur­viv­ing than those who did not.

Ret­ro­spec­tive looks are more sus­pect than place­bo-con­trolled tri­als, so the da­ta are far from con­clu­sive. But it does add new ev­i­dence to the ques­tion of whether remde­sivir can im­prove mor­tal­i­ty. The NIH tri­al that led the FDA to au­tho­rize remde­sivir for use in Covid-19 pa­tients on­ly showed that remde­sivir could help pa­tients re­cov­er faster. Few­er pa­tients on remde­sivir died in that tri­al than on stan­dard-of-care — 8% vs 11% — but the re­sults were not sig­nif­i­cant.

For­mer FDA chief sci­en­tist Lu­ciana Bo­rio said that da­ta from ob­ser­va­tion­al stud­ies are dif­fi­cult to in­ter­pret, but that the bulk of ev­i­dence points to remde­sivir help­ing pa­tients sur­vive Covid-19. “It is very like­ly that Remde­sivir does in­deed af­ford pa­tients a mor­tal­i­ty ben­e­fit,” she said in an email. “The gold stan­dard RCT con­duct­ed by the NIH demon­strat­ing the clin­i­cal ben­e­fit of Remde­sivir in im­prov­ing time to re­cov­er wasn’t pow­ered to de­tect a dif­fer­ence in mor­tal­i­ty. It doesn’t mean that there wasn’t one”

In a tweet, for­mer FDA chief Scott Got­tlieb called the re­sults “en­cour­ag­ing” but urged that it need­ed to be con­firmed. The com­pa­ny ac­knowl­edged in their press re­lease that a prospec­tive study was need­ed.

Gilead was up 2% pre-mar­ket on the news, from $74.71 to $76.18.

Oth­er an­a­lysts and ex­perts, though, were more skep­ti­cal and in some cas­es en­tire­ly dis­mis­sive. Pe­ter Bach, the di­rec­tor for the cen­ter for health pol­i­cy and out­comes at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, said on Twit­ter that com­par­ing tri­al par­tic­i­pants to re­al-world pa­tients on­ly works when doc­tors have a good un­der­stand­ing of the dis­ease, some­thing that isn’t the case with Covid-19.

Baird an­a­lyst Bri­an Sko­r­ney com­pared the study to work from Di­di­er Raoult, the French physi­cian who pub­lished in Feb­ru­ary one of the first tri­als on hy­drox­y­chloro­quine in Covid-19. That study, de­spite gin­ning up sig­nif­i­cant in­ter­est in the drug, was seen as rife with is­sues, in­clud­ing in “los­ing” 6 of the tri­al’s 26 pa­tients “in fol­low-up,” 4 of whom died.

In the study, 312 pa­tients from Gilead’s open-la­bel SIM­PLE tri­al were com­pared to 818 re­al-world pa­tients who had sim­i­lar char­ac­ter­is­tics. Pa­tients who re­ceived remde­sivir had a 7.6% chance of dy­ing, com­pared to 12.6% for those who re­ceived stan­dard-of-care. That trans­lates to 62% im­proved odds of sur­vival — or slight­ly more than dou­ble the 30% im­proved odds the NIH tri­al’s raw num­bers sug­gest­ed.

Sun­Trust an­a­lyst Robyn Kar­nauskas said the sur­vival rates in each tri­al were “com­pa­ra­ble,” while ac­knowl­edg­ing the study was “not an ap­ples-to-ap­ples com­par­i­son.”

The remde­sivir pa­tients in the analy­sis al­so had a 74.4% chance of re­cov­er­ing by day 14, ver­sus 59.9% for stan­dard-of-care.

Not every tri­al, though, has found remde­sivir has a ben­e­fit. On the same day as the NIH read­out, The Lancet pub­lished a study from Chi­na that found remde­sivir im­proved nei­ther mor­tal­i­ty nor oth­er pa­tient met­rics. That study, though, was end­ed ear­ly af­ter the first out­break in Chi­na end­ed.

For hos­pi­tals that can get their hands on it, remde­sivir so far has been one of on­ly two proven treat­ments for Covid-19, along with a gener­ic steroid called dex­am­etha­sone. More an­tivi­rals and neu­tral­iz­ing an­ti­bod­ies, though, are now be­ing stud­ied, hav­ing be­come a grow­ing fo­cus of the Trump ad­min­is­tra­tion. If more ther­a­pies prove ef­fec­tive, the new Gilead da­ta could help physi­cians choose the best op­tion.

“While not as vig­or­ous as a ran­dom­ized con­trolled tri­al, this analy­sis im­por­tant­ly draws from a re­al-world set­ting and serves as an im­por­tant ad­junct to clin­i­cal tri­al da­ta, adding to our col­lec­tive un­der­stand­ing of this virus and re­flect­ing the ex­tra­or­di­nary pace of the on­go­ing pan­dem­ic,” in­ves­ti­ga­tor Su­san Olen­der of Co­lum­bia Uni­ver­si­ty Irv­ing Med­ical Cen­ter said in a state­ment.

So­cial: AP Im­ages

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.