Curis and Aurigene Discovery Technologies agreed on a collaboration focused on immune-oncology and selected precision oncology targets. The collaboration provides for inclusion of multiple programs, with Curis having the option to exclusively license compounds once a development candidate is nominated within each respective program.
The partnership draws from each company's respective areas of expertise, with Aurigene having the responsibility for conducting all discovery and preclinical activities, including IND-enabling studies and providing Phase I clinical trial supply. Curis will handle all clinical development, regulatory, and commercialization efforts worldwide, excluding India and Russia, for each program for which it exercises an option to obtain a license.
The first two programs under the collaboration are an orally available small molecule antagonist of programmed death ligand-1 (PD-L1) in the immuno-oncology field and an orally available small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4) in the precision oncology field. Curis expects to exercise its option to obtain exclusive licenses to both programs and file IND applications for a development candidate from each in 2015.
“Addressing immune checkpoint pathways is now a well validated strategy to treat human cancers and the ability to target PD-1/PD-L1 and other immune checkpoints with orally available small molecule drugs has the potential to be a distinct and major advancement for patients,” said Ali Fattaey, Ph.D., president and CEO Curis. Recent studies have also shown that alterations of the MYD88 gene lead to dysregulation of its downstream target IRAK4 in a number of hematologic malignancies, including Waldenström's Macroglobulinemia and a subset of diffuse large B-cell lymphomas, making IRAK4 an attractive target for the treatment of these cancers. We look forward to advancing these programs into clinical development later this year.”
“Our scientists at Aurigene have established a novel strategy to address immune checkpoint targets using small molecule chemical approaches, and have discovered a number of candidates that modulate these checkpoint pathways, including PD-1/PD-L1,” noted CNS Murthy, CEO of Aurigene. “We have established a large panel of preclinical tumor models in immunocompetent mice and can show significant in vivo anti-tumor activity using our small molecule PD-L1 antagonists. We are also in the late stages of selecting a candidate that is a potent and selective inhibitor of the IRAK4 kinase, demonstrating excellent in vivo activity in preclinical tumor models.”
For the first two programs, Curis will pay Aurigene up to $52.5 million per program, including $42.5 million per program for approval and commercial milestones, plus specified approval milestone payments for any additional indications. For the third and fourth programs, up to $50 million per program will be paid, including $42.5 million per program for approval and commercial milestones, plus specified approval milestone payments for any additional indications. Curis will pay Aurigene up to $140.5 million per program thereafter, including $87.5 million per program in approval and commercial milestones, plus specified approval milestone payments for any additional indications.
In addition, Curis has issued to Aurigene approximately 17.1 million shares of its common stock, or 19.9% of its outstanding common stock immediately prior to the transaction, in partial consideration for the rights granted to Curis under the collaboration agreement.