APN-497444

Should AL102 live up to its hype, Ayala Pharmaceuticals is in line for development and commercial milestones totaling $37.5 million. Barely two months after SpringWorks Therapeutics secured the first-ever FDA approval for a drug to treat ultra-rare desmoid tumors, Immunome has bagged the rights to a phase 3 therapy it claims could be more effective. The Pennsylvania-based biotech is paying $20 million in upfront cash and $30 million in common stock to Ayala Pharmaceuticals to secure the phase 3 oral gamma secretase inhibitor AL102. The deal also covers an injectable gamma secretase inhibitor called AL101 that’s in a phase 2 trial for adenoid cystic carcinoma. Should AL102 live up to the hype, Ayala is in line for development and commercial milestones totaling $37.5 million. In this morning’s press release, Immunome claimed that “data from clinical trials have shown AL102 may be more effective in treating desmoid tumors” than SpringWorks’ own gamma secretase inhibitor Ogsiveo, which secured FDA approval at the end of November 2023.  Desmoid tumors, which are diagnosed in around 1,650 people in the U.S. each year, are marked by noncancerous soft tissue growths that often cause severe pain and disfigurement. To secure the approval of Ogsiveo, SpringWorks drew on phase 3 data that showed a confirmed objective response rate of 41% for patients taking the drug compared to 8% for those who received placebo. There have been no head-to-head studies of the two drugs. In today’s release, Immunome claimed that among evaluable patients in a phase 2 trial who received a 1.2-mg dose of AL102, the objective response rate so far has been 75%. This is the same dose being tested in Ayala’s ongoing phase 3 study. “We are especially optimistic about the rapidity and depth of the tumor responses observed in the phase 2 portion of RINGSIDE,” Immunome’s CEO Clay Siegall, Ph.D., said in the release. “AL102 will complement our existing portfolio of targeted cancer agents that are approaching phase 1 trials.” “As we complete the work required to advance AL102 to NDA submission, our goal is to bring clinical benefit to an underserved patient population while generating substantial value for stockholders,” Siegall added. “We also plan to investigate other populations of cancer patients that could benefit from treatment with AL102.” Immunome gave itself a late Christmas present in the form of a slate of antibodies and related assets from Atreca, which it bought for $5.5 million upfront. The December 2023 deal included APN-497444, which was Atreca’s lead antibody-drug conjugate program in early development for gastrointestinal cancers.

Biopharma didn't slow down the dealmaking over Christmas. We recap what companies picked up and put in their stockings over the holiday break. You think Santa can stop the biotech deal making train? Think again. A handful of companies couldn’t wait for the New Year—or next week’s JP Morgan Healthcare conference—to announce their latest wheeling and dealing. We recap the Christmas deal spree below. >> Johnson & Johnson picked up licensing rights to LegoChem Biosciences’ Trop2 directed antibody drug conjugate (ADC) LCB84 for $100 million upfront plus $1.7 billion in potential milestones down the line, according to a December 26 press release. J&J’s Janssen unit will gain exclusive, worldwide rights to develop and commercialize the solid tumor and hematological cancer med LCB84, which is currently in a phase 1/2 trial. The healthcare giant becomes the latest Big Pharma to team up with South Korea’s LegoChem, which signed a $1.25 billion pact with Amgen for up to five ADC options in December 2022. The deal follows a frenzy in ADCs among Big Pharmas and an exciting array of data presented in the field at the European Society for Medical Oncology meeting in Madrid in October 2023. >> Roche also couldn’t stay away from the ADC excitement, inking a deal with China’s MediLink—known as Suzhou Yilian Biopharmaceutical Co. in that country. According to a Jan. 2 release, Roche is putting down an unspecified upfront payment plus near-term milestones of $50 million and a potential $1 billion in other milestones down the line. The deal also includes royalties on future sales.   The Swiss pharma will snag exclusive rights to YL211, a mesenchymal epidermal transforming factor (c-MET) ADC under development for solid tumors. >> Astellas Pharma is dishing out up to $37 million in upfront and license option fees to Elpiscience Biopharma in a research and license agreement for novel bi-specific macrophage engagers, the anti-PD-L1/SIRPα bispecific antibody ES019 and another program, according to a Dec. 28 announcement. The small Shanghai-based biotech could receive as much as $1.7 billion in future development, regulatory and commercial milestones. Astellas could also opt in for a further two programs. >> Codexis is offloading exocrine pancreatic insufficiency treatment CDX-7108 to Nestlé Health Science for $45 million total, including a $5 million upfront fee, according to a December 27 release. The deal also includes royalties and could bring an additional $5 million for the biotech if Nestlé decides to opt in on two additional early-stage enzymes in development for the condition. The enzyme engineering biotech cut 18% of staff and reprioritized in November 2022. The decision to hand CDX-7108 over to Nestlé will remove cash burn from development and commercialization costs, according to the latest release. >> Atreca, also reeling from a slate of layoffs last year, has found a buyer for a collection of antibody-related assets and materials. Immunome has offered to pick up the assets for $12.5 million, including $5.5 million upfront and up to $7 million in clinical milestones, according to a Dec. 26 press release. The deal includes APN-497444, which was Atreca’s lead ADC program in early development for gastrointestinal cancers. At the time of the most recent layoffs in November, Atreca CEO John Orwin said the company remained focused on getting APN-497444 through preclinical testing, but cash was running very low. Now, he says the company is “encouraged that Immunome also recognizes” the potential of its tumor-targeting antibodies. Atreca’s shareholders will need to approve the sale, with a plan of dissolution calling for the liquidation of any remaining assets included in the vote, according to the release.   Other Christmas deals: AstraZeneca pays $1B to take the wheel of Gracell’s CAR-T ‘fast car’ While you could forgive some Big Pharmas for backing away from CAR-Ts in the wake of the FDA’s decision to investigate the risk of secondary cancers, AstraZeneca has decided that a cell therapy company would make the perfect Christmas present. Story here BMS enters radiopharma race with $4.1B acquisition of RayzeBio just 3 months after biotech went public There’s been no festive respite for Bristol Myers Squibb’s M&A team as the Big Pharma follows up its acquisition of Karuna Therapeutics with the announcement straight after Christmas that it is also buying radiopharmaceuticals-focused RayzeBio for cash. Story here