Ayala Pharmaceuticals, Inc., a clinical-stage oncology company, and BioSight Ltd., a pharmaceutical company developing therapeutics for hematological malignancies and disorders, entered into a definitive merger agreement pursuant to which Ayala will combine with Biosight in an all-stock transaction. The combined company will operate under the name Ayala Pharmaceuticals, Inc.

The company will work to advance a portfolio of oncology assets, with a primary focus on Ayala’s AL102, a once-daily, potent, selective, oral gamma-secretase inhibitor (GSI) and Biosight’s Aspacytarabine (BST-236). AL102 is currently being evaluated in the registrational RINGSIDE study in desmoid tumors.

There are currently no FDA-approved therapies for the treatment of unresectable, recurrent, or progressive desmoid tumors. Data from the Phase 2 portion of RINGSIDE showed 50% partial response and 100% disease control rates in evaluable desmoid tumor patients treated with AL102. The majority of the patients from Phase 2 have continued on study and are now in the open label extension of the Phase 3 portion of RINGSIDE. Ayala expects to present updated data on these patients later this year.

“The addition of Biosight’s lead asset aspacytarabine (BST-236) fits with our strategic vision and core competencies and provides us with additional avenues towards key clinical catalysts,” said Ken Berlin, President, and CEO of Ayala. “Along with the merger, we have plans to strengthen our balance sheet and execute our clinical plans, with the goal of creating sustainable value for patients and shareholders.”

Pini Orbach, Chairman of Biosight, said, “The Ayala team shares our commitment to bringing innovative treatments to cancer patients in need and we are excited to enter into this merger. Leveraging the combined capabilities and resources of both organizations will provide a truly unique opportunity to build a leading, publicly traded oncology company with advanced and diverse clinical stage assets. I would like to express my deepest appreciation to the entire Biosight team, and I am proud of their excellent work and dedication in advancing aspacytarabine and our pipeline.”