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.

Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

President Trump (left) and NIAID chief Anthony Fauci in the White House press room, April 22, 2020 (Michael Reynolds/Sipa via AP Images)

White House tries to dis­cred­it An­tho­ny Fau­ci — could he be on his way out?

For two months in late winter and early spring, Anthony Fauci and President Trump stood in uneasy co-existence at White House briefings — an unlikely truce between an infectious disease official who had helped combat AIDS and Ebola and a president who repeatedly denied the danger of a virus that would go on to kill 100,000 Americans, repeatedly rejected masks and certain social distancing efforts, and promoted a drug with little scientific basis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,100+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Steve Arkinstall, Revitope CEO

Mass­a­chu­setts biotech Re­vi­tope scores first col­lab­o­ra­tion thanks to dual-en­gag­ing T cell plat­form

Revitope Oncology began 2020 hopeful that its cancer immunology platform would be finally ready to flourish. On Monday night, that platform nabbed the biotech its first collaboration.

The Massachusetts-based company has agreed to a licensing agreement with Shanghai-based Junshi Biosciences in which Revitope can receive up to $160 million in development and commercial milestones, plus royalties. In addition, Junshi will make a direct equity investment of $10 million, equal to 9.99% of Revitope shares, as the two companies work to develop a dual-antigen targeting cancer therapies.

Albert Bourla, AP

Covid-19 roundup: CanSi­no eyes more over­seas PhI­II sites as Cana­da tri­al re­port­ed­ly stalls; In­di­an drug­mak­er surges on 30-per­son da­ta

Having leveraged connections in Canada for a planned Phase III trial of its Covid-19 vaccine, CanSino is venturing out to a few more others as it plots a global late-stage program.

“We are contacting Russia, Brazil, Chile and Saudi Arabia, and it’s still in discussion,” Dongxu Qiu, executive director and co-founder of CanSino, said at a conference in Suzhou, China, per Reuters.

The trial is likely to start “pretty soon,” he added, with plans to recruit 40,000 participants total.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,100+ biopharma pros reading Endpoints daily — and it's free.

En­gi­neer­ing an on/off switch for CAR-T out of yeast and Juras­sic Park

Almost as soon as CAR-T emerged in the mid-2010s as a near-cure for some cancers, so did a question: How do you give this without risking killing patients?

At the time, James Patterson was wrapping an MD-PhD at a yeast lab at London’s Francis Crick Institute. Yeast may seem an unlikely place to find a fix for cancer therapy, but reading through other researchers’ solutions to CAR-T’s toxicity, Patterson wondered if a method long used by yeast biologists called auxotrophy might be useful. You genetically modify cells to make them dependent on a particular nutrient. Then you can make them live or die — proliferate or deplete — by giving or taking away that nutrient.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,100+ biopharma pros reading Endpoints daily — and it's free.

CEO John Oyler at the Endpoints/PharmCube BIIS18 conference in Shanghai (Photo: Endpoints News)

Chi­na's BeiGene now has $5B+ cash in its cof­fers. How's the Am­gen-part­nered biotech go­ing to spend it?

When Amgen wagered $2.7 billion to grab a 20.5% stake in BeiGene late last year, execs saw themselves buying into a “world-class operation” that would help them tap into the world’s most populous country and a growing biopharma powerhouse.

It turns out they were just getting started.

Over the weekend, BeiGene $BGNE brought in a hefty $2.08 billion — $421 million from Amgen — through a direct offering of its Nasdaq shares exclusively involving existing investors. New York-based hedge fund Baker Bros. Advisors also bought a chunk of new shares.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 85,100+ biopharma pros reading Endpoints daily — and it's free.

Nader Pourhassan, CytoDyn CEO (Jeff Kravitz/FilmMagic for CytoDyn’s Pro, Getty Images)

Cy­to­Dyn shares slammed as BLA fil­ing for leron­limab in HIV hits a wall

In a press release issued in early June announcing a BLA acknowledgment letter from the FDA, CytoDyn CEO Nader Pourhassan said he is hopeful about getting a PDUFA date for its lead drug, leronlimab, on July 10.

Instead, they received a refuse-to-file letter today.

The company said the agency is just looking for “certain information needed to complete a substantive review.” No clinical trials are necessary; all that’s needed is additional analysis and a meeting with the FDA.

Play­ing catch-up, Roche out­lines plans for a PhI­II he­mo­phil­ia A pro­gram — next year

For now, the big focus in the hemophilia A gene therapy race has been centered on frontrunner BioMarin, with an expected OK just weeks away, and the crew from Sangamo/Pfizer, which has been looking to play catch-up with a pivotal study in the works.

But now Roche’s new gene therapy division at Spark has updated its own schedule, saying they’re looking at a Phase III start sometime next year as they optimize the dose and immunomodulatory regimen in order to avoid any future mishaps that could derail the program.