ALBANY, N.Y.—Best known as a contract research organization (formerly known asAlbany Molecular), AMRI has signed an exclusive option to enter a licenseagreement with Bessor Pharma LLC, a translational drug development company ledby industry veteran and AMRI adviser Dr. Barry A. Berkowitz, for thedevelopment of ALB 109564(a), AMRI's novel tubulin inhibitor compound intemporarily suspended Phase I testing for the treatment of cancer.
"Due to an internal prioritization of AMRI's R&Dprograms, a decision was made to postpone completion of the Phase I study atthe end of 2010," notes AMRI Chairman and CEO Dr. Thomas E. D'Ambra. "The IND remains open, however, and we expect Bessor tocomplete the dose escalation studies as part of their development strategy."
Under the terms of this agreement, AMRI willreceive an undisclosed option fee and reimbursement for certain costsassociated with the intellectual property related to ALB 109564(a). The optionperiod is approximately eight months, during which time Bessor Pharma willconduct further due diligence, engage in the required fundraising andcoordinate with AMRI a technology transfer and advanced development plan. Uponexercising the option, Bessor Pharma will receive an exclusive license to theALB 109564(a) intellectual property and be solely responsible for all relatedresearch and development and patent costs. AMRI will receive royalties on salesof any ALB 109564(a)-related drug that is commercialized, in addition to thepotential to earn additional revenue as the manufacturer of the drug itself. Inthe event that the option is not exercised, all rights to ALB 109564(a) willrevert to AMRI.
D'Ambra notes that a number of different structuralclasses of oncology drugs on the market are classified as tubulin inhibitors.ALB109564(a) is a novel analog from an established and marketed class oftubulin inhibitors, the vinca alkaloids, which kill cancer cells by preventingcell mitosis and are currently marketed and used extensively in anticancerchemotherapy as single entities and in many combination cocktails. Inpreclinical testing, ALB 109564(a) showed several advantages over existingagents in the class including greater efficacy, activity against a broaderrange of tumor types, indications of reduced side-effect potential andpotential for a greater safety margin, he states.
Data from two separate studies in which human tumor cells were implanted intomice were presented in 2008. In the first experiment, ALB109564(a) was examinedin a panel of xenografts including lung, colon and prostate tumors. In thisexperiment both ALB 109564(a) and the established anticancer drug, vinorelbine,used as a control, were dosed intraperitoneally at equivalent therapeutic dosesbased on their maximum tolerated doses. ALB109564(a) gave statistically significant tumor growthdelays in all of these tumor types, whereas by comparison vinorelbine had nosignificant effect against any of these tumors.
A key reason that AMRI had made a decision topostpone further developing this compound in late 2010 was the realization thatpotential partners would require demonstration of a proof of concept in clinicalstudies.
"This achievement would likely require multiple Phase II studies and financialresources beyond the ability of AMRI to pursue, particularly in view of thehigher prioritization of other programs we were working on at the time,"D'Ambra states. "Bessor's industry professionals and consultants share thisview, but as part of their due diligence and because of their therapeuticexpertise, have charted a pathway to proof of concept that does not rely on ashotgun approach, but is targeted to specific tumor types for which notherapeutic agent has been approved and for which they believe ALB 109564(a)will show efficacy in man. Obviously, we hope they aresuccessful."
Berkowitz says, "AMRI has built a strong initial program around ALB 109564(a),providing an early indication that it may offer clinically relevant activitydistinct from other tubulin inhibitors. AMRI's decision to select Bessor toadvance this compound is an important further endorsement of our developmentteam and approach." He adds, "Bessor is acquiring a portfolio oftranslational-stage compounds and advancing them to key value points through anintegrated pharmaceutical network and a team of top drug development andclinical experts. We look forward to working with AMRI and its strengths indrug discovery and API manufacture on this project and potentially other futureprojects as part of our network."
