Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is pay­ing out a $25 mil­lion up­front for the rights to sell Turn­ing Point Ther­a­peu­tics’ lead drug re­potrec­tinib in Greater Chi­na. The San Diego-based biotech is al­so in line for up to $151 mil­lion in mile­stones, along with mid-to-high teen roy­al­ties. Zai plans to add sites to the Phase II tri­al of the drug, which is de­signed to treat ROS1-pos­i­tive ad­vanced NSCLC in pa­tients who were not pre­vi­ous­ly treat­ed with a TKI.

Xen­cor and Atre­ca forged a col­lab­o­ra­tion and li­cense deal to re­search, de­vel­op and com­mer­cial­ize T cell en­gag­ing bis­pe­cif­ic an­ti­bod­ies as po­ten­tial ther­a­peu­tics in on­col­o­gy. Atre­ca will pro­vide an­ti­bod­ies against nov­el tu­mor tar­gets while Xen­cor en­gi­neers XmAb bis­pe­cif­ic an­ti­bod­ies that al­so bind to the CD3 re­cep­tor on T cells: “Up to two joint pro­grams will be mu­tu­al­ly se­lect­ed for fur­ther de­vel­op­ment and com­mer­cial­iza­tion, with each part­ner shar­ing 50 per­cent of costs and prof­its. Each com­pa­ny will lead de­vel­op­ment, reg­u­la­to­ry and com­mer­cial­iza­tion ac­tiv­i­ties for one of the joint pro­grams. In ad­di­tion, the agree­ment al­lows for each part­ner to pur­sue up to two pro­grams in­de­pen­dent­ly, with a mid- to high-sin­gle dig­it per­cent roy­al­ty payable on net sales. Atre­ca and Xen­cor be­gan work­ing to­geth­er in 2019 un­der a ma­te­r­i­al trans­fer agree­ment to ac­cel­er­ate this new col­lab­o­ra­tion agree­ment.”

→ Di­al­ing up the ap­pli­ca­tion of AI in its drug dis­cov­ery work, Roche has en­list­ed Cam­bridge, MA-based Rever­ie Labs for a mul­ti-tar­get col­lab­o­ra­tion to screen and op­ti­mize in­hibitors of sev­er­al ki­nas­es. James Sabry, head of phar­ma part­ner­ing, is ap­par­ent­ly in for the long run with Rever­ie Labs’ plat­form, which gen­er­ates mil­lions of chem­i­cal struc­tures to choose from.

Take­da is li­cens­ing a phage dis­play “li­brary of li­braries” from Twist Bio­science to search for, val­i­date and op­ti­mize its an­ti­body pipeline. The deal cov­ers the core ar­eas of on­col­o­gy, rare dis­eases, neu­ro­science and gas­troen­terol­o­gy.

Roche’s Chugai sub­sidiary is team­ing up with Ther­mo Fish­er to de­vel­op a com­pan­ion di­ag­nos­tic for Ro­z­lytrek in Japan, which has been ap­proved in the coun­try for ROS1-pos­i­tive non-small cell lung can­cer.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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