CStone Pharmaceuticals announced an investigational new drug (IND) filing has been submitted to Human Research Ethics Committees of the Ashford Cancer Center in Australia for CS1002, an independently-developed investigational cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) inhibitor. The application represents CStone's third molecule to be submitted for clinical trial approval overseas during 2017.
CS1002 is an immunoglobulin G (IgG) 1 class, fully human monoclonal antibody (mAb) that has demonstrated high levels of specificity and selectivity for CTLA-4 during pre-clinical studies and is expected to provide a new therapeutic option for cancer patients. The molecule will primarily be developed alongside other candidate drugs as part of combination therapies.
"We are very pleased to take another major step forward in terms of our global R&D strategy, and CS1002 represents a new milestone for CStone in the field of cancer immunotherapy. During December 2017, we have now successfully made three IND filings for drug candidates to enter international clinical trials,” Dr. Frank Jiang, Chief Executive Officer (CEO) of CStone said. “This will enrich our clinical research strategy for combination immunotherapies, and help to accelerate these drug candidates towards early registrations as new treatment options addressing the unmet medical needs of a broad patient population."
Cytotoxic T lymphocyte associated antigen 4 (CTLA-4), also known as CD152, is a transmembrane protein encoded by the CTLA-4 gene that can down-regulate the activity of T cells when binding with its ligand, B7, a pathway also used by tumor cells to avoid T lymphocyte attack. Consequently, blockade of the CTLA-4 pathway can stimulate T cell activation and proliferation to induce or enhance anti-tumor immune responses. CTLA-4 provides a new immuno-therapeutic approach to a number of diseases, including tumors.
Presently, Bristol-Myers Squibb's Yervoy (ipilimumab) is the only anti-CTLA-4 antibody to gain a market approval worldwide, although Yervoy has not yet been approved in China. Pre-clinical tests have shown that CS1002 has a relatively strong affinity to CTLA-4 and is expected to match Yervoy in terms of efficacy.