Curis Expands Oncology Pipeline with an Oral Small Molecule PD-L1/TIM-3 Immune Checkpoint Antagonist

On October 11, 2016 Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of cancer, reported the expansion of its pipeline with CA-327, an oral, small molecule immune checkpoint antagonist targeting programmed death ligand-1 (PD-L1) and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) (Press release, Curis, OCT 11, 2016, View Source [SID:SID1234515734]).

Curis licensed the PD-1/ TIM-3 antagonist program, and designated CA-327 as the development candidate, by exercising its option under the collaboration, license and option agreement established with Aurigene in January 2015. The collaboration is focused on the discovery, development and commercialization of small molecule drug candidates in the fields of immuno-oncology and selected precision oncology targets. The previous licensed programs within the collaboration include CA-170, a first-in-class oral, small molecule antagonist targeting PD-L1 and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints that is currently being studied in a Phase 1 trial in patients with solid tumors and lymphomas, and CA-4948, an oral small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4) that is completing IND-enabling studies.

In addition to targeting PD-L1, a negative regulator of immune activation, CA-327 also targets TIM-3, an inhibitory checkpoint molecule that plays an important role in immune suppression and is co-expressed with programmed cell death-1 (PD-1) receptors on exhausted cytotoxic T cells in tumor tissues as well as expressed on certain regulatory T cells.

The in-license of CA-327 comes three months after the collaboration’s first oral immuno-oncology program entered the clinic and less than a month after a $24.5M investment in Curis by Aurigene.

“We are pleased with the progress of our collaboration,” said Dr. Ali Fattaey, Curis’s CEO, “and look forward to working with our partner, Aurigene, to complete IND-enabling studies for CA-327 in the coming months and expect to file an IND in 2017.”

“We are delighted that our collaboration is advancing its third small molecule program in less than two years,” said CSN Murthy, Aurigene’s CEO. “We continue to work closely with Curis to focus our collective resources, creating and developing innovative drug candidates in the field of oncology, including multiple first-in-class oral small molecule checkpoint antagonists within immuno-oncology.”