Christi Shaw, Kite CEO (Jeff Rumans for Endpoints News)

Gilead­'s Kite earns sec­ond-line win for CAR-T Yescar­ta, set­ting up a bat­tle over ear­li­er blood can­cer pa­tients

Bris­tol My­ers Squibb shook the CAR-T field ear­li­er this month with a break­through win in ear­li­er-line blood can­cer pa­tients with the promise of chang­ing the par­a­digm in cell ther­a­py care. Now, old­er com­peti­tor Yescar­ta is un­cork­ing re­sults of its own in that sought-af­ter pop­u­la­tion — and this time it ac­tu­al­ly has some da­ta to show.

Kite’s Yescar­ta boost­ed event free sur­vival over a stan­dard of care reg­i­men of physi­cians’-choice sal­vage ther­a­py fol­lowed by high-dose chemo plus a stem cell trans­plant in sec­ond-line re­lapsed or re­frac­to­ry large B cell lym­phoma pa­tients in a win the drug­mak­er is call­ing a “land­mark” in CAR-T care, Kite said in a re­lease.

At a two-year check in, pa­tients in the Phase III ZU­MA-7 tri­al dosed with Yescar­ta post­ed a 60% rel­a­tive in­crease in EFS over stan­dard of care, good for a p-val­ue of 0.0001. The study al­so hit its sec­ondary ORR end­point but OS da­ta were still too im­ma­ture to judge, Kite said.

The study’s in­ves­ti­ga­tors were un­equiv­o­cal about the re­sults, paint­ing the da­ta as a break­through win for the CAR-T class in ear­li­er-line blood can­cer pa­tients.

“The top-line re­sults of the ran­dom­ized ZU­MA-7 tri­al paint the pic­ture of a po­ten­tial par­a­digm shift in the treat­ment of large B-cell lym­phoma,” study co-leader Fred­er­ick Locke said in a re­lease.

The safe­ty re­sults from the study, which en­rolled 359 pa­tients across 77 treat­ment cen­ters, were con­sis­tent with pri­or tri­als, Kite said, with 6% of pa­tients ex­pe­ri­enc­ing a grade 3 or high­er cy­tokine re­lease syn­drome. Kite plans to sub­mit the da­ta for reg­u­la­to­ry ap­proval in the US and EU lat­er this year and present up­dat­ed da­ta at an up­com­ing med­ical meet­ing.

It’s a big win for Kite and one that will keep pres­sure on Bris­tol My­ers, which ear­li­er this month read out da­ta for its own CAR-T, Breyanzi, in sec­ond-line LB­CL pa­tients.

In that study, dubbed TRANS­FORM, Breyanzi beat out physi­cians’-choice sal­vage ther­a­py fol­lowed by high-dose chemo and a stem cell trans­plant — what the drug­mak­er called a “gold stan­dard treat­ment” — in sec­ond-line LB­CL pa­tients. De­spite be­ing three weeks ahead, Bris­tol My­ers had no da­ta to show at the in­ter­im check-in, giv­ing the ear­ly leg up to Kite in terms of ef­fi­ca­cy.

At the time, Bris­tol My­ers tout­ed the TRANS­FORM re­sults as the first time a CAR-T had shown ben­e­fit in that pop­u­la­tion and the on­ly CD19-tar­get­ed CAR-T to show ben­e­fit in sec­ond-line pa­tients. The study in­clud­ed a wide range of po­ten­tial sal­vage ther­a­pies, in­clud­ing rit­ux­imab plus dex­am­etha­sone, high-dose cy­tara­bine, and cis­platin (R-DHAP); rit­ux­imab plus ifos­famide, car­bo­platin and etopo­side (R-ICE); or rit­ux­imab plus gem­c­itabine, dex­am­etha­sone and cis­platin (RGDP).

But now, Yescar­ta, which al­so tar­gets the CD19 pro­tein, has matched those re­sults and could set up a fran­tic mar­ket bat­tle to se­cure ear­li­er-line pa­tients. In the first quar­ter, Yescar­ta bagged $160 mil­lion in sales with a few years of run­way on the mar­ket while Breyanzi on­ly launched in Q1.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Nader Pourhassan, CytoDyn CEO (Photo by Jeff Kravitz/FilmMagic for CytoDyn’s Pro)

Cy­to­Dyn faces DOJ, SEC sub­poe­nas af­ter pro­mot­ing failed Covid-19 drug

The little, PR-happy drug company publicly called out by the FDA is now getting attention from both the SEC and the Department of Justice.

CytoDyn, a one-time penny stock that has gained both money and notoriety for aggressively pushing an old HIV drug as a treatment for Covid-19, disclosed in a regulatory filing Friday the SEC and DOJ have separately subpoenaed the company and “certain of its executives” as part of investigations into the company’s promotion and marketing practices.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Lan Huang, BeyondSpring CEO

Shares of Be­yond­Spring sky­rock­et on new, pos­i­tive can­cer drug tri­al re­sults

Sometimes results come along that shock even a biotech’s believers.

On Wednesday, BeyondSpring, a small New York biotech with an offbeat approach to immunotherapy, announced its lead drug significantly extended non-small cell lung cancer patients’ lives in a large trial. Although the company did not release the exact survival data, it said that nearly twice as many patients were alive after two years on the drug arm than on the standard-of-care arm.

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Pfiz­er puts the pres­sure on Eli Lil­ly's JAK in­hibitor Olu­mi­ant with new da­ta in alope­cia area­ta

As Eli Lilly looks to secure a win for its blockbuster Olumiant in alopecia areata, going where no JAK inhibitor has gone before, Pfizer is coming up from behind with Phase IIb/III results suggesting its own candidate can help regrow hair lost due to the autoimmune disease.

On Wednesday, Pfizer unveiled topline results from the ALLEGRO trial, which enrolled 718 patients 12 years and older with alopecia areata, a condition that can cause sudden, severe and patchy hair loss. While the patients’ episodes of alopecia areata varied in length, they all had one thing in common: They had lost at least half the hair on their scalps.