Janet Woodcock, CDER chief (AP Images)

More Warp Speed con­tracts com­ing, vac­cine pro­duc­tion to be­gin in 4-6 weeks — of­fi­cials

Op­er­a­tion Warp Speed has al­ready hand­ed out 4 of what they once said would be 3-5 ma­jor con­tracts to de­vel­op Covid-19 vac­cines, but ad­min­is­tra­tion of­fi­cials in­di­cat­ed Mon­day that more would be on their way.

“The slate is not closed,”  a se­nior HHS of­fi­cial said on a call with re­porters. “We’ve in­vest­ed in four … but the slate is not closed.”

At the same time, the of­fi­cial in­di­cat­ed that Warp Speed would con­tin­ue to fo­cus on three tech­nolo­gies: mR­NA, vi­ral vec­tors and pro­tein sub­units. That leaves the door open for a wide range of plat­forms, no­tably in­clud­ing both of Mer­ck’s vac­cine can­di­dates — one of which has al­ready re­ceived BAR­DA fund­ing — and one of Sanofi’s can­di­dates. It ap­pears to pre­clude, though, the po­ten­tial for In­ovio and Vaxart, among cer­tain oth­er small de­vel­op­ers that have hyped their ties to the Trump ad­min­is­tra­tion, to be in­clud­ed.

The se­lect­ed vac­cines will move in­to large-scale man­u­fac­tur­ing with­in 4-6 weeks, the of­fi­cial said. Right now, HHS and drug­mak­ers are prepar­ing for scale-up — set­ting up fa­cil­i­ties, ac­quir­ing raw ma­te­ri­als and spe­cial­i­ty equip­ment and set­ting up project teams to vis­it every man­u­fac­tur­ing site. The ad­min­is­tra­tion’s goal is to have 300 mil­lion dos­es by ear­ly 2021, with the first batch­es com­ing in the fall.

So far, Mod­er­na, As­traZeneca, J&J and most re­cent­ly No­vavax have been se­lect­ed for Warp Speed. Large-scale tri­als to prove whether the vac­cines work are ex­pect­ed to be­gin with­in weeks for Mod­er­na and As­traZeneca, with J&J and No­vavax launch­ing soon af­ter. With case counts ris­ing through­out the US, in­ves­ti­ga­tors could have an an­swer faster than if the virus was un­der con­trol.

“We need to con­duct a clin­i­cal tri­al in ar­eas where there are out­breaks,” the of­fi­cial said. “So some­what para­dox­i­cal­ly, the cur­rent out­breaks might ac­tu­al­ly help us get a vac­cine to pro­tect peo­ple faster than if we had no out­breaks.”

On the same call, the of­fi­cial and long­time CDER chief Janet Wood­cock gave the fullest pic­ture yet on how the White House plans to ac­cel­er­ate ther­a­peu­tics. Wood­cock re­cused her­self from CDER in May to lead the ther­a­peu­tic ini­tia­tive, but un­til last week, when the ad­min­is­tra­tion an­nounced a $450 mil­lion con­tract for Re­gen­eron’s mon­clon­al an­ti­bod­ies, de­tails on the ini­tia­tive were scant.

Wood­cock said the key cri­te­ria for in­clu­sion in the pro­gram was whether a com­pa­ny could de­liv­er a drug be­fore the end of the year, a dif­fi­cult hur­dle. “This means re­pur­posed drugs or drugs that have un­der­gone rapid clin­i­cal de­vel­op­ment,” Wood­cock told re­porters.

The first goal was drugs that re­duced vi­ral load. That meant an­tivi­rals such as remde­sivir and pas­sive im­mu­ni­ty — a broad term that en­com­pass­es both mon­o­clon­al an­ti­bod­ies that have been rushed through labs at Re­gen­eron, Eli Lil­ly, Vir and oth­er com­pa­nies and con­va­les­cent sera, where some­one who sur­vives the virus do­nates their an­ti­body-en­riched plas­ma.

So far, Wood­cock said, about 40,000 peo­ple have re­ceived sera through BAR­DA and the Mayo Clin­ic. There are no ran­dom­ized con­trolled da­ta yet, but Wood­cock said there’s a “strong pos­si­bil­i­ty” it helps. More than 50 dif­fer­ent mon­o­clon­al an­ti­body pro­grams are now in de­vel­op­ment, she said, but the ad­min­is­tra­tion will fo­cus on those that can reach mar­ket be­fore 2021. Eli Lil­ly has said they could have 100,000 an­ti­bod­ies by the fall, and the BAR­DA-Re­gen­eron deal cov­ers the de­liv­ery of be­tween 70,000 and 300,000 dos­es around the same time.

Both com­pa­nies have start­ed their own tri­als for their drugs, but Wood­cock said this sum­mer the NIH will start tri­als that fol­low a mas­ter pro­to­col to quick­ly test an­ti­bod­ies and an­tivi­rals. She did not in­di­cate which an­tivi­rals, but J&J re­ceived a $152 mil­lion BAR­DA con­tract in Feb­ru­ary to screen for new small mol­e­cules. And Mer­ck’s EI­DD-2801, now in Phase II tri­als for Covid-19, has re­ceived gov­ern­ment fund­ing in the past. Ac­cord­ing to whistle­blow­er tes­ti­mo­ny from oust­ed BAR­DA chief Rick Bright, it is al­so a fa­vorite among some of­fi­cials with­in HHS.

The goal is to know by the fall which drugs can both treat and pre­vent Covid-19. But un­like with vac­cines, where the FDA has set a 50% bench­mark for au­tho­riza­tion, Wood­cock said there would be no pre-set bar for suc­cess. Be­tween pre­ven­tion, ear­ly-stage and late-stage treat­ment, she said, it would be im­pos­si­ble to set one.

“Un­like a vac­cine, we’re talk­ing about maybe a dozen dif­fer­ent sce­nar­ios. We have small mol­e­cules an­tivi­rals, we have mon­o­clon­al an­ti­bod­ies and pro­phy­lax­is and ear­ly pa­tient and out­pa­tient and in­pa­tient and so forth,” Wood­cock said. “It’s pret­ty com­pli­cat­ed.”

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

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.

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.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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