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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.

There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.

Here’s the rundown:

1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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