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.”

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Gallia Levy, Spark CMO (Roche)

Spark Ther­a­peu­tics nabs new CMO from Genen­tech, fill­ing a ma­jor post-merg­er de­par­ture

Spark Therapeutics is getting a new CMO from their new owners.

The gene therapy company-turned-subsidiary has named Gallia Levy, who had been running rare blood disorders — including clinical development for their blockbuster-potential hemophilia antibody Hemlibra for Roche’s big biotech sub Genentech — to run medical affairs.

The appointment is a fitting one. Roche spent $4.8 billion to acquire Spark last year in large part to get their hands on their hemophilia gene therapy, SPK-8011, and expand the toe-hold Hemlibra gave them in an crowded hemophilia space.  It’s also a somewhat ironic appointment: The FTC held up the Spark acquistions for nearly a year, reportedly over concerns about the anti-trust implications of Roche owning both a top chronic treatment in Hemlibra and a top one-time treatment in Spark’s gene therapy.

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DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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