Juno will pay $24M to set­tle the JCAR015 scan­dal — but don’t ex­pect that to change in­dus­try at­ti­tudes on re­port­ing sna­fus

A no­to­ri­ous string of pa­tient deaths caused by Juno Ther­a­peu­tics’ JCAR015 wound up killing the one-time CAR-T star, de­rail­ing their shot at join­ing the break­through race even­tu­al­ly won by No­var­tis and Kite. Through­out the con­tro­ver­sy, though, Juno ex­ecs fierce­ly main­tained that they had done every­thing by the book.

They nev­er budged an inch. Un­til now.

The com­pa­ny, now a sub­sidiary of Cel­gene, as well as for­mer CEO Hans Bish­op, have signed off on a $24 mil­lion pay­ment to the stock­hold­ers who brought a class ac­tion suit against the biotech based on their claims that the com­pa­ny had mis­led in­vestors by con­ceal­ing the death of the first pa­tient. 

Hans Bish­op

In the le­gal ac­tions that in­evitably fol­lowed, Juno’s ex­ecs fought fu­ri­ous­ly against the claims. And in this set­tle­ment, they still aren’t mak­ing any con­ces­sions on li­a­bil­i­ty. Ac­cord­ing to the pact, they sim­ply want to set­tle a lengthy and ex­pen­sive law­suit — avoid­ing a tri­al — with­out mak­ing con­ces­sions on their role.

The Puget Sound Busi­ness Jour­nal was the first to re­port the set­tle­ment sev­er­al days ago.

The time­line on this is im­por­tant. 

The suit not­ed that the first death caused by JCAR015 ini­tial­ly went un­men­tioned at Juno, leav­ing in­vestors vul­ner­a­ble to the stun­ning news a month lat­er that a se­ries of deaths forced in­ves­ti­ga­tors to stop the tri­al, with the FDA drop­ping a clin­i­cal hold on the pro­gram that blast­ed their stock price. Then, af­ter one of the short­est paus­es on record at the FDA, the agency lift­ed the hold days lat­er on Juno’s as­sur­ances that with­draw­ing one of the drugs used to prep the pa­tients would re­solve the safe­ty is­sues.

Once the drug was dosed again, though, more pa­tients died, even­tu­al­ly wreck­ing the ef­fort and leav­ing Juno to go on to fo­cus on its fol­lowup drug, JCAR017, which has im­pressed in clin­i­cal tri­als.

The mon­ey in the set­tle­ment amounts to lit­tle more than a speed­ing tick­et for Juno and its new own­ers at Cel­gene, which paid $9 bil­lion for the com­pa­ny. Twen­ty-four mil­lion dol­lars is a round­ing er­ror for the prin­ci­pals now in­volved.

Biotech com­pa­nies are of­ten loathe to pub­licly ac­knowl­edge pa­tient deaths trig­gered by their drugs. But you can on­ly get away with that large­ly un­scathed if you’re pri­vate. Pub­lic com­pa­nies are re­quired to stick to a more nar­row path. But mak­ing rel­a­tive­ly small con­ces­sions like this will on­ly send the wrong mes­sage to drug de­vel­op­ers with a pen­chant for keep­ing prob­lems un­der wraps as long as pos­si­ble, which al­so brings to mind Clo­vis’ re­cent will­ing­ness to set­tle a probe of its trou­bled ro­ci pro­gram with a $20 mil­lion pay­ment.

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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?

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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.

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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.

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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.

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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.

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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.

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.