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.

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.