AMRI licenses anticancer tubulin inhibitor program to Bessor Pharma
ALBANY, N.Y.óBest known as a contract research organization (formerly known as Albany Molecular), AMRI has signed an exclusive option to enter a license agreement with Bessor Pharma LLC, a translational drug development company led by industry veteran and AMRI adviser Dr. Barry A. Berkowitz, for the development of ALB 109564(a), AMRI's novel tubulin inhibitor compound in temporarily suspended Phase I testing for the treatment of cancer.
"Due to an internal prioritization of AMRI's R&D programs, a decision was made to postpone completion of the Phase I study at the end of 2010," notes AMRI Chairman and CEO Dr. Thomas E. D'Ambra. "The IND remains open, however, and we expect Bessor to complete the dose escalation studies as part of their development strategy."
Under the terms of this agreement, AMRI will receive an undisclosed option fee and reimbursement for certain costs associated with the intellectual property related to ALB 109564(a). The option period is approximately eight months, during which time Bessor Pharma will conduct further due diligence, engage in the required fundraising and coordinate with AMRI a technology transfer and advanced development plan. Upon exercising the option, Bessor Pharma will receive an exclusive license to the ALB 109564(a) intellectual property and be solely responsible for all related research and development and patent costs. AMRI will receive royalties on sales of any ALB 109564(a)-related drug that is commercialized, in addition to the potential to earn additional revenue as the manufacturer of the drug itself. In the event that the option is not exercised, all rights to ALB 109564(a) will revert to AMRI.
D'Ambra notes that a number of different structural classes of oncology drugs on the market are classified as tubulin inhibitors. ALB109564(a) is a novel analog from an established and marketed class of tubulin inhibitors, the vinca alkaloids, which kill cancer cells by preventing cell mitosis and are currently marketed and used extensively in anticancer chemotherapy as single entities and in many combination cocktails. In preclinical testing, ALB 109564(a) showed several advantages over existing agents in the class including greater efficacy, activity against a broader range of tumor types, indications of reduced side-effect potential and potential for a greater safety margin, he states.
Data from two separate studies in which human tumor cells were implanted into mice were presented in 2008. In the first experiment, ALB109564(a) was examined in a panel of xenografts including lung, colon and prostate tumors. In this experiment both ALB 109564(a) and the established anticancer drug, vinorelbine, used as a control, were dosed intraperitoneally at equivalent therapeutic doses based on their maximum tolerated doses. ALB109564(a) gave statistically significant tumor growth delays in all of these tumor types, whereas by comparison vinorelbine had no significant effect against any of these tumors.
A key reason that AMRI had made a decision to postpone further developing this compound in late 2010 was the realization that potential partners would require demonstration of a proof of concept in clinical studies.
"This achievement would likely require multiple Phase II studies and financial resources beyond the ability of AMRI to pursue, particularly in view of the higher prioritization of other programs we were working on at the time," D'Ambra states. "Bessor's industry professionals and consultants share this view, but as part of their due diligence and because of their therapeutic expertise, have charted a pathway to proof of concept that does not rely on a shotgun approach, but is targeted to specific tumor types for which no therapeutic agent has been approved and for which they believe ALB 109564(a) will show efficacy in man. Obviously, we hope they are successful."
Berkowitz says, "AMRI has built a strong initial program around ALB 109564(a), providing an early indication that it may offer clinically relevant activity distinct from other tubulin inhibitors. AMRI's decision to select Bessor to advance this compound is an important further endorsement of our development team and approach." He adds, "Bessor is acquiring a portfolio of translational-stage compounds and advancing them to key value points through an integrated pharmaceutical network and a team of top drug development and clinical experts. We look forward to working with AMRI and its strengths in drug discovery and API manufacture on this project and potentially other future projects as part of our network."