AMRI signed an exclusive license agreement with Chai Therapeutics for the development of ALB 109564(a), AMRI’s tubulin inhibitor compound in late Phase I testing for the treatment of cancer. This agreement follows the exercise of an option to license the intellectual property, which was granted last March by AMRI to Bessor Pharma, a translational drug development company. Chai Therapeutics is an affiliate of Bessor Pharma.

Under the terms of the current agreement, AMRI received an undisclosed license fee and reimbursement for certain costs associated with the intellectual property related to ALB 109564(a). Chai Therapeutics received an exclusive license to the ALB 109564(a) intellectual property, and will be solely responsible for all related research and development and patent costs going forward; AMRI will receive a share of future consideration from the further development and sales, if any, of any ALB 109564(a)-related drug that may be developed, licensed, and/or commercialized.

“The recent formation of Chai Therapeutics to focus on the development of our compound is a strong statement by our partners of the potential benefit that this technology could ultimately deliver to cancer patients,” said chairman and CEO of AMRI, Thomas E. D’Ambra, Ph.D.

“The tubulin inhibitor program is an asset developed from our past R&D investments. As we have stated previously, we will continue to pursue strategic opportunities to enable AMRI to advance the clinical development of our other compounds and programs to create near- and long-term value for the company.”

ALB 109564(a) is a novel analog from an established and marketed class of tubulin inhibitors, which is designed to kill cancer cells by preventing cell mitosis. The discovery of ALB 109564(a) leveraged AMRI’s biocatalysis technology platform, natural products chemistry expertise, and high-potency development capabilities, added Dr. D’Ambra.

ALB 109564(a) has significant benefits compared with existing tubulin inhibitors in the same class, according Dr. D’Ambra. AMRI’s Phase I study of ALB 109564(a) involved intravenous administration of ALB 109564(a) to cancer patients with advanced solid tumors. The study was designed to evaluate the compound’s safety, tolerability, and pharmacokinetic profile and document effects on tumor growth. Previously announced results from the Phase I clinical dose-escalation study indicate that ALB 109564(a) is well tolerated at the doses tested and shows preliminary evidence of clinical activity in disease types not typically treated with approved vinca alkaloids, continued Dr. D’Ambra.

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