Immunome Secures Phase 3 Desmoid Tumor Drug AL102 from Ayala

Immunome, Inc., a biotechnology firm concentrating on pioneering cancer therapies, has announced a definitive asset purchase agreement with Ayala Pharmaceuticals, Inc., a clinical-stage oncology company. According to the deal, Immunome will acquire AL102 and AL101, two drug candidates from Ayala, for $20 million in cash and $30 million in Immunome common stock, along with up to $37.5 million in potential milestone payments. The transaction, subject to regulatory approvals and Ayala's stockholder consent, is expected to enhance Immunome's pipeline significantly.

AL102 is currently undergoing evaluation in the randomized Phase 3 RINGSIDE international trial, aiming to treat desmoid tumors, a severe soft tissue cancer. Findings from clinical trials suggest that AL102 could surpass existing treatments like OGSIVEO™ (nirogacestat), the first FDA-approved therapy for desmoid tumors as of November 2023.

Phase 2 of the RINGSIDE trial yielded promising results, with a 75% objective response rate among evaluable patients on the 1.2 mg once-daily regimen, the same dose now tested in Phase 3. Patients taking this dosage experienced an 88% median reduction in tumor volume, according to MRI assessments in July 2023, along with improvements in other radiographic indicators.

Dr. Clay B. Siegall, President and CEO of Immunome, expressed enthusiasm about the acquisition, emphasizing the company's dedication to advancing therapies with best-in-class potential. Dr. Siegall highlighted the striking efficacy observed in the Phase 2 trial and underscored Immunome's commitment to addressing the needs of an underserved patient population while delivering value to shareholders. The company also intends to investigate additional cancer patient groups who might benefit from AL102.

Ayala Pharmaceuticals' CEO, Ken Berlin, shared pride in Ayala's contributions to the AL102 project and expressed confidence in Immunome's capacity to finalize the RINGSIDE study and bring AL102 to market. Berlin believes that Immunome's experienced team of drug developers is well-suited to advance AL102 to commercialization.

Approximately 1,650 individuals in the U.S. are diagnosed with desmoid tumors annually, with a higher population prevalence. Predominantly affecting young adults, desmoid tumors can cause significant pain and disability. Non-pharmacologic treatments such as surgery or radiation often prove ineffective and can result in long-term complications. In light of this, AL102 received Orphan Drug Designation from the FDA in November 2023.

Immunome focuses on innovative cancer treatments, using advanced technologies to discover and develop novel antibodies and therapeutic targets. Ayala Pharmaceuticals specializes in developing treatments for rare tumors and aggressive cancers, with a lead focus on AL102 and another candidate, aspacytarabine, aimed at treating acute myeloid leukemia (AML) in unfit first-line patients.