James Li, Cheng Liu (JW, Eureka)

Juno/WuX­i's cell ther­a­py ven­ture buys out sol­id tu­mor play­er in Chi­na, gain­ing a dis­cov­ery en­gine and por­tend­ing more M&A to come

If the cell ther­a­py field in the US is just get­ting start­ed with two com­mer­cial CAR-T play­ers, Chi­na rep­re­sents an even big­ger un­tapped mar­ket for James Li, the CEO of JW Ther­a­peu­tics.

“The whole space is wide open,” he said.

His com­pa­ny, a joint ven­ture cre­at­ed by Juno and WuXi AppTec, has been at the heels of its US coun­ter­parts. It has a BLA at Chi­na’s drug reg­u­la­tors for the lead pro­gram tar­get­ing CD19, a re­vised ver­sion of Juno’s JCAR017; is de­vel­op­ing a BC­MA ther­a­py to fol­low; and more re­cent­ly got in­to NK cells. The team, con­sist­ing of 200-plus em­ploy­ees, cov­ers every­thing from process de­vel­op­ment and man­u­fac­tur­ing to reg­u­la­to­ry af­fairs and qual­i­ty con­trol.

But there are some things it’s lack­ing: JW want­ed to get in­to the sol­id tu­mor space, and it has lit­tle ex­per­tise in ear­ly-stage de­vel­op­ment, where it’s been re­ly­ing ex­ten­sive­ly on Juno (lat­er Cel­gene, now Bris­tol My­ers Squibb).

It’s now filled both those gaps by buy­ing out Syra­cuse Bio­phar­ma, the Chi­nese sub­sidiary of Bay Area-based Eu­re­ka Ther­a­peu­tics.

“We want to build the lead­ing T cell ther­a­py com­pa­ny in Chi­na; it has to have a dis­cov­ery ca­pa­bil­i­ty,” Eu­re­ka founder and pres­i­dent Cheng Liu told End­points News.

Liu not­ed that Eu­re­ka’s con­nec­tion with Juno dates back to 2016, when it li­censed three Memo­r­i­al Sloan Ket­ter­ing-part­nered bind­ing do­mains to the CAR-T play­er to de­vel­op treat­ments for mul­ti­ple myelo­ma, in­clud­ing one for BC­MA.

Since then his staff has been sole­ly fo­cused on sol­id tu­mors, lever­ag­ing TCR mim­ic an­ti­bod­ies and an­oth­er se­cre­tive tech­nol­o­gy that helps T cells in­fil­trate tu­mors to hone in on liv­er can­cer. The an­ti­bod­ies promise to rec­og­nize tar­gets in­side tu­mor cells and bind to them with high­er affin­i­ty than gen­er­al re­cep­tors. A clin­i­cal proof-of-con­cept study con­duct­ed in Chi­na two years ago sug­gest­ed a “sur­pris­ing” im­pact; the biotech is now con­duct­ing an of­fi­cial Phase I/II study in liv­er can­cer in the US.

The deal with JW — which Liu views as a merg­er — will put them on a path to file an IND in Chi­na. The con­struct used in the 2018 tri­al “was two gen­er­a­tions ago in terms of tech­nol­o­gy,” Li said, so they will be tak­ing the new can­di­date in­to tri­als.

Don’t look for them to rush it. Hav­ing watched the drug in­dus­try evolve as Am­gen’s found­ing gen­er­al man­ag­er in Chi­na, Li doesn’t see cell ther­a­py get­ting crowd­ed like PD-1 did, with over a dozen com­pa­nies all clam­or­ing to make the same drug. Not on­ly do you need dif­fer­en­ti­a­tion — some biotechs are get­ting cre­ative try­ing to stand out — you al­so need to be con­sis­tent with cre­at­ing the prod­ucts.

“What peo­ple don’t re­al­ize is it takes a much longer time ac­tu­al­ly if you want to have a com­mer­cial­ly vi­able process, to have some­thing mean­ing­ful you can com­mer­cial­ize,” he said.

The costs as­so­ci­at­ed with build­ing out the in­fra­struc­ture means col­lab­o­ra­tion and M&A will be the way to go.

“We just start­ed a trend,” he said, “but I think more will be com­ing.”

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.