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.”

Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A P val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a P value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Konstantin Poukalov

Per­cep­tive re­cruits A-list in­vestors to back its in-house Chi­na start­up with a mam­moth $310M raise

It took two years for Perceptive Advisors to conceive and boot up LianBio, its big bet on a new kind of in-licensing model for China, seeding it with enough cash to set up two anchoring deals with MyoKardia and BridgeBio. The result was a startup that was all ready to go, reaping $310 million just a little over two months after official launch.

Homegrown Chinese biotechs — many of them boasting of US ties and execs with overseas credentials — have been raking in mega-venture rounds in 2020, both from influential local backers and overseas VC firms that have been loading up new cash. As with IPOs, the deal flow might be slower but the amounts are often more staggering. LianBio’s latest round, unusually, is branded both a Series A and crossover.

No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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Sanofi teams up with Mer­ck to pair Keytru­da with a next-gen IL-2 can­di­date from the Syn­thorx buy­out

Nearly a year after snapping up a next-gen immuno-oncology candidate in its $2.5 billion Synthorx buyout, Sanofi is joining forces with Merck to pair the drug with blockbuster Keytruda.

The pharmas are planning a Phase II trial of Sanofi’s non-alpha IL-2 candidate THOR-707 in combination or sequenced administration with Keytruda for various cancers. While the companies are keeping mum about the financial terms and targets, they said the trials will be Sanofi-sponsored.