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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Covid-19 roundup: Con­tro­ver­sy around colchicine per­co­lates af­ter study fail­ure; As­traZeneca's meet­ing with EU was 'con­struc­tive,' but did­n't solve much

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

'Bank of BAR­DA': In­ves­ti­ga­tion finds HHS raid­ed pan­dem­ic pre­pared­ness funds for decade be­fore Covid-19

Before 2020, few Americans had ever heard of the Biomedical Advanced Research and Development Authority, BARDA, or its far-flung mission to stave off future pandemics and bio-threats. Allegedly, that made it a pretty good target for others in HHS who needed to scavenge some extra cash.

Over the last decade, other HHS officials raided BARDA’s coffers and misappropriated millions of dollars that Congress had earmarked to fund vaccine research and prepare for public health emergencies like Covid-19, according to a new report from the US Office of Special Counsel, which investigated a whistleblower report.

Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.