• Licensing agree­ment in­cludes equity investment and poten­tial devel­op­ment, clin­i­cal, regu­la­tory and commercial mile­stones and tiered royalties
• Ayala retains world­wide rights to all other indi­ca­tions for AL102

Rehovot, Israel, and Wilmington, DE (Press Release) – Ayala Pharma­ceu­ticals, Inc., a clin­i­cal-stage com­pany devel­op­ing medicines for cancers that are genetically identified, announced today that it entered into an option to license agree­ment with Novartis for its inves­ti­ga­tional agent AL102 in multiple myeloma. Under the terms of the deal, Ayala will receive a $10 million equity investment from Novartis and is eli­gible to receive devel­op­ment, clin­i­cal, regu­la­tory and commercial mile­stones along with tiered royalties on net sales of AL102.

Novartis will conduct certain studies to eval­u­ate AL102 in com­bi­na­tion with its B-cell maturation an­ti­gen (BCMA) ther­a­pies in multiple myeloma. Ayala will provide the drug supply. All devel­op­ment costs asso­ci­ated with the above studies will be fully born by Novartis. Ayala retains world­wide license rights for AL102 for all other indi­ca­tions.

“We are extremely pleased to enter this agree­ment with Novartis on AL102. Novartis has a strong commitment and expertise in on­col­ogy, and a proven record of success in drug devel­op­ment, making them an ideal strategic partner for AL102 in multiple myeloma,” said Roni Mamluk, PhD, chief exec­u­tive officer at Ayala. “This col­lab­o­ration is important to Ayala as it im­medi­ately strengthens our bal­ance sheet, further val­i­dates our tech­nology and accelerates the clin­i­cal devel­op­ment of AL102 as a com­bi­na­tion ther­apy in hema­to­logic cancers.”

AL102 is an oral small-molecule that inhibits gamma secretase, an enzyme which may be targeted to in­­crease levels of BCMA, which is expressed in most multiple myeloma patients. BCMA is actively shed from multiple myeloma cells by gamma secretase, hence its inhibition by AL102 may in­­crease BCMA levels on multiple myeloma cells. Therefore, AL102 is being studied to eval­u­ate its clin­i­cal role in enhancing anti-BCMA ther­a­pies.

Ayala is committed to devel­op­ing new targeted ther­a­pies for genomically-defined cancers in patient pop­u­la­tions with high unmet medical need. In addi­tion to investigating AL102 as an anti-BMCA ther­apy in multiple myeloma, Ayala is eval­u­ating AL102 as an inhibitor of the Notch path­way in other hema­to­logic cancers.

Multiple myeloma is a rare and aggressive blood cancer that accounts for approx­i­mately one per­cent of all cancers. In the U.S., there are nearly 90,000 people living with, or in remission from, multiple myeloma. Approximately, 26,850 Americans are diag­nosed with multiple myeloma each year and 11,240 patient deaths are reported on an annual basis.

About Ayala Pharma­ceu­ticals

Ayala Pharma­ceu­ticals, Inc. is a clin­i­cal-stage bio­pharma­ceu­tical com­pany dedicated to devel­op­ing targeted cancer ther­a­pies for people living with genetically defined cancers. Ayala is broadly devel­op­ing its prod­uct can­di­dates, AL101 and AL102, best-in-class gamma secretase inhibitors, with clin­i­cal and nonclinical studies underway in both solid tumors (AL101) and hema­to­logic malig­nan­cies (AL102). The com­pany’s lead agent, AL101, is cur­rently in Phase 2 for adenoid cystic carcinoma patients with tumor bearing Notch activating mutations.

As a precision on­col­ogy com­pany, Ayala was founded in November 2017 with an ex­peri­enced global man­agement team and a strong in­­vestor base. For more in­for­ma­tion, visit www.ayalapharma.com.

Source: Ayala Pharma­ceu­ticals.