Covid-19 roundup: CDER pon­ders a move to vir­tu­al ad­comms; con­ser­v­a­tive group urges eas­i­er ac­cess to hy­drox­y­chloro­quine

It’s all hands on the vir­tu­al deck at the FDA. And the folks at CDER are con­sid­er­ing set­ting up a new on­line ap­proach to hold­ing ad­comm meet­ings go­ing for­ward.

Mark Senak, who writes the Eye on FDA blog, posed a se­ries of ques­tions for CDER, in­clud­ing one on ad­comms, which are be­ing in­ter­rupt­ed as the coro­n­avirus pan­dem­ic spreads in the US and around the globe.

As of now, the FDA is can­cel­ing all non-es­sen­tial meet­ings at the agency, in­clud­ing the ad­comms, through April. But CDER does see a pos­si­ble op­por­tu­ni­ty for go­ing vir­tu­al — a big deal in an in­dus­try that re­lies on these meet­ings to keep its R&D strat­e­gy in­tact.

Here’s the ex­change be­tween Senak and CDER on the ad­comms:

Does FDA plan on at­tempt­ing vir­tu­al ad­vi­so­ry com­mit­tee meet­ings?

As this re­mains a dy­nam­ic sit­u­a­tion, we will con­tin­ue to as­sess and cal­i­brate our ap­proach. Where pos­si­ble the agency will lever­age tech­nol­o­gy to host meet­ings al­low­ing for re­mote par­tic­i­pa­tion. We thank you for your pa­tience. In con­sid­er­ing nec­es­sary steps for pro­tecting pub­lic health, in­clud­ing our spon­sors, our com­mit­tee mem­bers and our work­force, we are can­celling or post­pon­ing all non-es­sen­tial meet­ings through the month of April. We will re­assess on an on-go­ing ba­sis for fu­ture months. Where pos­si­ble the agency will lever­age tech­nol­o­gy to host meet­ings al­low­ing for re­mote par­tic­i­pa­tion.

→ A con­ser­v­a­tive group called the Job Cre­ators Net­work — which in­cludes Home De­pot co-founder Bernard Mar­cus as a key backer — is call­ing on Pres­i­dent Trump to clear away the “red tape” and make hy­drox­y­chloro­quine more eas­i­ly avail­able.

The drug is fre­quent­ly cit­ed by Trump as a pos­si­ble short-term panacea for the Covid-19 out­break. It’s al­so un­cer­tain whether it will help at all or cause more dam­age than good — some­thing that is be­ing test­ed in a clin­i­cal pro­gram now. In the mean­time, it’s be­come one of the most pop­u­lar drugs avail­able, mak­ing sup­plies scarce. And that’s what the group wants Trump to fix.

“We’re not ad­vo­cat­ing that peo­ple should take the drug,” a spokesper­son told the Wall Street Jour­nal. “We’re ad­vo­cat­ing that doc­tors should have the op­por­tu­ni­ty to pre­scribe it if they want to do so. The prob­lem is no one can find it. It’s a sup­ply-side is­sue.”

→ British Prime Min­is­ter Boris John­son has test­ed pos­i­tive for coro­n­avirus — on Wednes­day, he ad­dressed Mem­bers of Par­lia­ment in the House of Com­mons.

→An­oth­er set of drug de­vel­op­ers have thrown their hat in­to the an­ti-Covid-19 ring. In ad­di­tion to pro­grams from Mod­er­na, which is al­lied with the NIH — and BioN­Tech, as well as Cure­VacSanofi is al­so work­ing on an mR­NA vac­cine ap­proach with Trans­late Bio, in ad­di­tion to its pre­vi­ous­ly un­veiled tra­di­tion­al vac­cine pro­gram. (End­points Link)

Hep B vac­cine mak­er Dy­navax is al­so work­ing on a vac­cine, in col­lab­o­ra­tion with the Uni­ver­si­ty of Queens­land as part of a Coali­tion for Epi­dem­ic Pre­pared­ness (CEPI) ini­tia­tive.

→ Ex­ist­ing di­ag­nos­tic tests bank on PCR tech­nol­o­gy, which is en­gi­neered to hone in on the virus’ RNA genome. How­ev­er, if the per­son re­cov­ers from the coro­n­avirus in­fec­tion, that ev­i­dence dis­ap­pears. How­ev­er, an­ti­body tests — which re­ly on blood in­stead of nasal or throat swabs — are ex­pect­ed to re­veal who has had the in­fec­tion but was asymp­to­matic and has re­cov­ered. Once col­lect­ed, this in­for­ma­tion will re­veal the full scope of the pan­dem­ic and in­form con­tain­ment strate­gies across the globe. It will al­so help re­searchers work­ing on plas­ma ther­a­pies, which re­quire blood from sur­vivors.

New York-based Hen­ry Schein on Thurs­day said it was mak­ing avail­able an an­ti­body test (green­lit by the FDA un­der emer­gency guid­ance), which de­liv­ers re­sults with­in 15 min­utes from a pin­prick with no in­stru­men­ta­tion re­quired. The com­pa­ny ex­pects to have at least sev­er­al hun­dred thou­sand tests avail­able by March 30 and sig­nif­i­cant­ly in­creased avail­abil­i­ty be­gin­ning in April, it said.

Mean­while, the Unit­ed King­dom is work­ing on its own an­ti­body tests; sci­en­tists in Sin­ga­pore have used to trace chains of trans­mis­sion, and the CDC re­port­ed­ly has plans for its own.

Iron­wood Phar­ma, which sells the bow­el drug Linzess with part­ner Al­ler­gan, said the pan­dem­ic is im­pact­ing en­roll­ment in its late-stage gas­troe­sophageal re­flux dis­ease tri­al. Near­ly 70% of the en­roll­ment tar­get has been hit, but the com­pa­ny no longer ex­pects to re­port top-line da­ta in the sec­ond half of 2020.

→ A glove short­age is re­port­ed­ly loom­ing, as Malaysia — the coun­try that dom­i­nates pro­duc­tion — reels from staff cuts in plants as a re­sult of a lock­down in the re­gion.

→ The US mil­i­tary, ac­cord­ing to Reuters, plans to stop dis­clos­ing some of the more “gran­u­lar da­ta” about in­fec­tions with­in its ranks, fear­ing the in­for­ma­tion may be used by ad­ver­saries.

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

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.