Albany Molecular Research, Inc. (AMRI), a global contract research and manufacturing organisation, has signed an exclusive license agreement with Chai Therapeutics, LLC for the development of ALB 109564(a), AMRI’s novel 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 in March 2012 by AMRI to Bessor Pharma, LLC, a translational drug development company. Chai Therapeutics is an affiliate of Bessor Pharma, LLC.

Under the terms of the license 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.

Thomas E D’Ambra, Ph.D, chairman and CEO of AMRI said, “We are very pleased to continue to work with Bessor on the further development of AMRI’s novel tubulin inhibitor.” He further added, “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. Dr Berkowitz and his team have a proven track record of success in drug development and we are confident in their ability to move this programme forward.”

D’Ambra continued, “The tubulin inhibitor programme 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.”

Barry A Berkowitz, Ph.D., president and CEO of Bessor said, “In AMRI’s work to date, ALB 109564(a) has shown significant promise as a next generation tubulin inhibitor for the treatment of cancer. Through our integrated network of drug development and clinical experts and the flexible structure afforded by Chai, we plan to advance the clinical program to further define the compound’s potential.  ALB 109564(a) is one of several translational projects in Bessor’s growing portfolio that it is advancing to key value points.”

AMRI has built a strong initial programme around ALB 109564(a), providing an early indication that it may offer clinically relevant activity distinct from other tubulin inhibitors. This proprietary programme, as well as AMRI’s other available pipeline programmes in the therapeutic areas of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), cognitive impairment and schizophrenia, were each created with business strategies aimed at differentiating them from existing standards of care.

ALB 109564(a) is a novel analogue 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 unique biocatalysis technology platform, natural products chemistry expertise, and high potency development capabilities. ALB 109564(a) has significant benefits compared with existing tubulin inhibitors in the same class. AMRI’s phase I study of ALB 109564(a) involved intravenous administration of ALB 109564(a) to cancer patients with advanced solid tumours. The study was designed to evaluate the compound’s safety, tolerability, and pharmacokinetic profile and document effects on tumour 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.

AMRI is a global contract research and manufacturing organisation offering customers fully integrated drug discovery, development and manufacturing services.