Dr. Reddy’s Laboratories Ltd and Curis whole subsidiary Aaurigene Discovery Technologies have announced the plans to initiate a phase 2 trial of CA-170, a PDL1- VISTA inhibitor to be conducted at sites in India.
The announcement was made following the presentation of preliminary data from the 34 cancer patients who were in dose escalation stage of Phase 1 trial of CA-170 at ESMO (European Society for Medical Oncology) 2017 Congress by the Aurigene’s collaborator.
Curis Inc., a biotechnology company that is focused mainly on the development and commercialization of effective therapeutics that is essential for cancer treatment. The clinical trials are conducted in U.S., South Korea and Spain. The Phase 2 clinical trial is mainly from the preliminary evidence results and clinical benefits that are observed in the trial.
An oral small molecule, CA-170 is known to target the immune checkpoints PDL1 and VISTA. The data that is presented at the ESMO 2017 represents the phase 1 trial in 34 patients. 30 patients were naïve to prior immunotherapy treatment whereas, four patients had to experience prior treatment with approved anti-checkpoint antibodies.
During the clinical trial, no dose limiting toxicities were observed in doses ranging from 50mg to 800 mg. CA- 170 is known for good oral bioavailability and plasma drug levels which increase gradually with dosage. There is an increase in the activated CD8+ T cells in patient’s blood and tumor biopsy samples that are examined during the treatment.
Out of the 21 participants evaluated for the disease, 13 participants experienced disease stabilization. However, four immunotherapy treatment naïve patients who were treated with CA-170 experienced shrinkage of the tumor and six patients remained on the drug treatment for three months. In addition to the seven of the 34 patients are continuing the treatment and monitored constantly.
CSN Murthy, CEO of Aurigene said, “These results are consistent with the observations made in the preclinical setting and further affirm CA-170’s mechanism of action as an oral small molecule checkpoint inhibitor. Based on these initial clinical results, we are excited for the opportunity to expand testing of CA-170, possibly in earlier lines of treatment and in a greater number of immunotherapy treatment-naïve cancer patients. Together with Curis, we have designed a Phase 2 trial, treating selected populations of patients of interest in the CA-170 program to be treated at major cancer centers in India. Aurigene’s decision to sponsor and fund this trial is further affirmation of our commitment to CA-170 and a reflection of the successful collaboration we have with Curis in multiple development programs. Aurigene has the commercial rights to the program in India and Russia in addition to milestones, royalties other commercial supply rights globally.”
Ali Fattaey, Ph.D., president and chief executive officer of Curis said, “We are pleased with these early results. Evidence of tumour shrinkage and multiple patients remaining on drug treatment for extended periods, along with signals for biomarkers of immune modulation in patient blood and tumour samples, tells us the program continues to move in the right direction. We plan to continue with the dose escalation and continued analysis of patient biopsy samples in the Phase 1 trial. We expect to provide additional updates at upcoming conferences including the Society for Immunotherapy of Cancer (SITC) annual meeting in November.”
Adil Daud, M.D., an investigator in the CA-170 Phase 1 trial and director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center said, “The ability for cancer patients to administer a potential checkpoint inhibitor on their own as a once daily oral drug is a significant and unique opportunity in our field. These initial clinical results are encouraging and merit continued development.”