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.