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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.