Curis said today it has exercised its options under a nine-month-old collaboration with Aurigene to license oral small molecules for immuno-oncology and precision oncology.
The deal will generate $6 million for Aurigene, and expand Curis’ pipeline with two cancer-focused programs. In the first program, the biotech agreed to advance into clinical studies CA-170, a first-in-class oral, small molecule checkpoint antagonist targeting programmed death ligand-1 (PD-L1) and V-domain Ig suppressor of T cell activation (VISTA).
“We believe that this property of targeting two unique checkpoint regulators provides CA-170 with the potential to not only address, but potentially expand beyond tumors with PD-L1 overexpression or those that may have relapsed after PD-1/ PD-L1 targeting therapies,” Ali Fattaey, Ph.D., Curis' president and CEO, said in a statement. “Development of CA-170 is a priority for Curis, and we and Aurigene are working diligently to complete the required IND-enabling studies in the coming months.”
To that end, Dr. Fattaey said, Curis expects to file an IND and begin Phase I clinical testing of CA-170 during the first half of 2016.
CA-170 was selected from a broad PD-L1 antagonist program that Curis and Aurigene have worked on since launching their immune-oncology collaboration in January. Back then, the companies agreed to address immune checkpoint pathways through multiple programs, with Curis having the option to exclusively license compounds once a development candidate was nominated within each program.
In addition, Curis has agreed to license from Aurigene a preclinical program focused on developing inhibitors of Interleukin-1 receptor-associated kinase 4 (IRAK4), a serine/ threonine kinase involved in regulating innate immune responses, and which also plays an important role in certain blood cancers. Targeting IRAK4 holds potential for new treatments against cancer and cytokine-driven inflammatory and autoimmune diseases, according to the company.
Curis also expects to file an IND for development of the IRAK4 inhibitor within the first half of 2016, Dr. Fattaey said.
Curis said it agreed to pay Aurigene a one-time payment of $6 million in return for an exclusive, royalty-bearing license to develop, manufacture, and commercialize compounds from the programs. The programs covered by the agreement include CA-170 and products containing such compounds worldwide—except for India and Russia, where Aurigene will retain rights to commercialize such compounds through an exclusive, royalty-free, fully paid license.
Aurigene scientists are expected to present data from the PD-L1/VISTA immuno-oncology and the IRAK4 programs at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, set for November 5-9 in Boston.
Curis also said it has selected a second preclinical program within the immuno-oncology collaboration with Aurigene. That program centers on evaluating small molecule antagonists with dual PD-L1 and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) targeting properties. TIM-3, an inhibitory checkpoint molecule, is co-expressed with programmed cell death-1 (PD-1) receptors on highly exhausted cytotoxic T cells in tumor tissues as well as expressed on certain regulatory T cells.
“We are also encouraged with the progress in our second immuno-oncology program that is generating small molecules targeting PD-L1 and TIM3, which may provide for additional opportunities to relieve the inhibitory effects of multiple immune checkpoints on exhausted T cells using our small molecule antagonist approach,” Dr. Fattaey added.
Development of Curis’ immuno-oncology programs will be led by David Tuck, M.D., the company’s vp, clinical and translational sciences. He joined Curis from EMD Serono in May 2015, where he served as senior medical director in the Oncology Translational Innovation program.