Immunome Inc., to acquire AL 102, a phase III asset for the treatment of desmoid tumors, from Ayala Pharmaceuticals.

Based on the terms of the agreement, Immunome will pay Ayala $20 million in cash and $30 million in Immunome common stock (valued at 30-day VWAP as of February 1, 2024) at the closing and will pay up to an additional $37.5 million in development and commercial milestone payments. Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.

AL 102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase III RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy. AL 102 is a potential once-daily oral treatment for desmoid tumors. Data from clinical trials have shown AL 102 may be more effective in treating desmoid tumors than Ogsiveo (nirogacestat), which recently became the first treatment approved for desmoid tumors by the FDA in November 2023.

The Phase II portion of the RINGSIDE study demonstrated clinically meaningful anti-tumor activity across multiple parameters . The data showed high objective response rates, including 75% of evaluable patients (and 64% of intent-to-treat patients) in the 1.2 mg once daily arm, the dose being evaluated in the current Phase III trial. Furthermore, patients receiving the 1.2 mg daily dose experienced a median best reduction in tumor volume of 88% as measured by serial MRI exams, as of the previously reported July 5, 2023 data cut-off, and also demonstrated improvement in other radiographic parameters.

“Immunome is committed to advancing therapies with best-in-class potential. We are especially optimistic about the rapidity and depth of the tumor responses observed in the Phase II portion of RINGSIDE,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. “AL 102 will complement our existing portfolio of targeted cancer agents that are approaching Phase 1 trials. As we complete the work required to advance AL 102 to NDA submission, our goal is to bring clinical benefit to an underserved patient population while generating substantial value for stockholders. We also plan to investigate other populations of cancer patients that could benefit from treatment with AL 102.”

It is estimated that as many as 1,650 people in the U.S. are diagnosed annually with desmoid tumors, also known as aggressive fibromatosis, and the population prevalence is much higher. Desmoid tumors, which occur predominantly in young adults, can cause significant pain and disability. Available non-pharmacologic therapies such as surgery or radiation are often ineffective and can lead to long term complications, and unapproved targeted therapies lack long-term potency. In November 2023, AL 102 was granted Orphan Drug Designation by the FDA.

The Phase III registration segment (Part B) of RINGSIDE continues to enroll patients globally at a good pace with greater than 70% of the 154 patients we aim to enroll already dosed.