James Li (JW)

Teamed up with Lyell, Juno/WuXi joint ven­ture files IPO bet­ting on Chi­na's CAR-T fu­ture

JW Ther­a­peu­tics got its start on the back of CAR-T tech from Juno Ther­a­peu­tics, a joint ven­ture bank­ing on the promise of mar­ry­ing cut­ting-edge Amer­i­can tech­nol­o­gy with WuXi AppTec’s state-of-the-art process de­vel­op­ment and late-stage clin­i­cal in­fra­struc­ture in Chi­na. Four years lat­er, a col­lab­o­ra­tion with a Juno co-founder’s new start­up is ce­ment­ing a bridge to the pub­lic mar­ket.

Lyell has grant­ed JW ex­clu­sive Chi­na rights to two CAR-T pro­grams tar­get­ing AFP and GPC3, anti­gens ap­plic­a­ble broad­ly across sol­id tu­mors, the com­pa­nies an­nounced last week. JW not­ed in its IPO fil­ing on the Hong Kong stock ex­change that it’s al­so nabbed rights to the T-cell an­ti-ex­haus­tion func­tion­al­i­ty.

“Sub­stan­tial” mile­stones and roy­al­ty pay­ments aren’t due un­til the first Lyell ther­a­py is ap­proved in JW ter­ri­to­ry.

Cheng Liu

The col­lab­o­ra­tion fol­lows a deal with Eu­re­ka Ther­a­peu­tics, a Cal­i­for­nia-based part­ner of both Juno and Lyell, through which JW ac­quired Syra­cuse — Eu­re­ka’s Chi­nese sub­sidiary — and its un­der­ly­ing tech plat­form. Eu­re­ka CEO Cheng Liu joined the JW board in hopes of join­ing forces to build the lead­ing cell ther­a­py com­pa­ny in Chi­na.

“Eu­re­ka still keep their in­de­pen­dence out­side Chi­na, they will do their own things,” JW chief James Li said at the time. “But in Chi­na we com­bine their ear­ly dis­cov­ery pow­er with our late-stage de­vel­op­ment and, even­tu­al­ly we are launch­ing our prod­uct next year, com­mer­cial ca­pa­bil­i­ties.”

While the terms went undis­closed, JW now re­veals that the ac­qui­si­tion was val­ued at $105 mil­lion.

Both the Lyell and Eu­re­ka pacts are ex­plic­it­ly fo­cused on sol­id tu­mors, ini­tial­ly start­ing out in he­pa­to­cel­lu­lar car­ci­no­ma.

“One thing we’ve been think­ing hard in the past cou­ple years is how we can get in­to the sol­id tu­mor space, which is ab­solute­ly — to me, it’s the fu­ture of cell ther­a­py,” Li told End­points News.

Be­ing one of the pi­o­neers along­side Fo­s­un Kite and Leg­end, he said, has al­lowed JW to think ahead of new­er ri­vals both in terms of es­tab­lish­ing the best prac­tices and think­ing ahead of the com­pe­ti­tion.

It’s not done with the deal spree. JW not­ed that it’s plan­ning to use parts of the IPO pro­ceds to ex­e­cute its op­tions on a cou­ple of  off-the-shelf nat­ur­al killer cell ther­a­py can­di­dates from Tai­wan’s Ace­po­dia, tar­get­ing HER2 and an­oth­er undis­closed tar­get.

Reg­u­la­tors at the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion have ac­cept­ed its NDA for rel­ma-cel, the lead CD19-tar­get­ing CAR-T ther­a­py de­vel­oped from Juno’s pro­gram. The ini­tial in­di­ca­tion is third-line dif­fuse large B cell lym­phoma — with mul­ti­ple oth­er blood can­cers lined up be­hind it.

Be­hind that there’s a BC­MA pro­gram for which JW plans to file an IND in the first half of 2021, JW wrote in its IPO ap­pli­ca­tion.

Over the years it’s raised $190 mil­lion in ven­ture fund­ing, and pre­vi­ous me­dia re­ports has sug­gest­ed it’s seek­ing to raise $200 mil­lion to $300 mil­lion in the pub­lic de­but. As is stan­dard on HKEX, JW hasn’t pen­cilled in any es­ti­mates.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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