Tuesday, September 24, 2019
Anchiano Therapeutics Ltd., a pivotal-stage biopharmaceutical company focused on the discovery and development of targeted therapies to treat cancer, today reported that Anchiano Therapeutics, Inc., the Company’s U.S. subsidiary, has entered into an exclusive worldwide collaboration and option to license agreement with ADT Pharmaceuticals, LLC (“ADT”) to develop novel small-molecule inhibitors of RAS and PDE10/β-catenin. This collaboration reflects Anchiano’s ongoing strategy to grow a pipeline beyond its pivotal-stage asset, inodiftagene vixteplasmid, with programs that have the potential to address significant clinical needs, while leveraging Anchiano’s expertise in small-molecule oncology development.
“We are excited to bring both of these important programs aimed at difficult-to-treat genetically-defined cancers into our portfolio. They complement our pivotal program and Codex trial and underscore our commitment to develop therapies with targeted approaches,” said Frank Haluska M.D., Ph.D., President and Chief Executive Officer of Anchiano. “Mutations in RAS are found in approximately one-third of all cancers. Recent exciting advances have been made in treating a subset of these cancers, but the successful development of a RAS-targeted therapy with broad inhibitory activity, irrespective of RAS isoform or mutation, has the potential for great clinical impact. Likewise, APC or β-catenin alterations are found almost uniformly in colorectal cancer and polyposis syndromes, and are observed in other tumor types as well, but effective targeted approaches to these lesions have been lacking. We are enthusiastic about the opportunity to develop PDE10 inhibition to target the Wnt/APC/β-catenin pathway where it is an oncogenic driver.”
Michael Boyd M.D., Ph.D., President and Chief Executive Officer of ADT, added, “We are thrilled to partner with Anchiano, a company with a well-respected management team with a track record of success in development of targeted cancer therapies in their prior experience. We have confidence that this team has the knowledge, capability, and commitment to fully develop these two programs, and a shared vision of bringing new therapies to patients in need.”
Under the terms of the collaboration and license agreement, Anchiano will be granted an exclusive option to license the RAS and PDE10/β-catenin inhibitors in exchange for a $3 million upfront payment to ADT and will fund certain research activities. At any time through obtaining an Investigational New Drug (IND) designation, Anchiano will have the option to exclusively license the compounds worldwide and will be responsible for all aspects of pre-clinical and clinical development and global commercialization. If Anchiano exercises its option, it will be responsible for development and commercialization and will incur additional payment obligations, including milestone and royalty payments to ADT.
LifeSci Advisors, LLC acted as exclusive transaction advisor to Anchiano.
Dr. Haluska added, “In addition to the news of our option to license agreement, we are also providing an enrollment update on our pivotal Phase 2 Codex trial of inodiftagene vixteplasmid in BCG-unresponsive non-muscle invasive bladder cancer patients. We currently have 31 patients enrolled or in active screening, of which 23 have been dosed. We had previously estimated that enrollment for the 35-patient interim analysis would be complete by the end of September, allowing for the 12-week readout to take place in the fourth quarter of this year. While at this time we are close to that projection, our conservative estimate is that data collection and interim analysis will be completed by the first quarter of 2020.”
