On August 27, 2018 CStone Pharmaceuticals (CStone) reported that its IND application for CS1002, an investigational cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) monoclonal antibody, has been approved by the China National Drug Administration (CNDA) (Press release, CStone Pharmaceauticals, AUG 27, 2018, View Source [SID1234529081]).
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"We are very pleased to obtain our third China IND approval of our investigational drugs in 2018. CStone already initiated CS1002’s Phase I clinical trial in Australia and dosed the first patient in May." said Dr. Frank Jiang, Chairman and Chief Executive Officer of CStone. " With today’s IND approval of CS1002, CStone is currently the only biopharmaceutical company in China that has all three immuno-oncology ‘backbone’ products (anti-PD-L1, anti-PD-1, and anti-CTLA-4 mAbs) in the clinical stage."
"CS1002 has demonstrated a high level of selectivity, specificity and high affinity to CTLA-4 in preclinical studies," said Dr. Jingrong Li, Senior Vice President of Product Development and Manufacture at CStone. "Combination therapies of anti-CTLA-4 mAb with anti-PD-1 mAb have demonstrated promising efficacy in multiple tumor types by global clinical trials. CStone will explore combination potentials between CS1002 and other drug candidates in our pipeline to provide better therapies for cancer patients in China and beyond."
As of today, CStone has built a portfolio of 14 oncology products, 8 of which are at clinical development stage, including 3 in registration studies. CS1001, China’s first fully human, full-length anti-PD-L1 mAb developed by CStone, has entered pivotal Phase II clinical studies, and will potentially become one of the first locally-developed anti-PD-L1 cancer drugs launched in China. In June 2018, CStone announced the exclusive collaboration and license agreements with Blueprint Medicine and Agios Pharmaceuticals. With these two deals, CStone in-licensed 4 post proof of concept assets, including ivosidenib, which is recently approved by U.S. FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, and avapritinib, which has entered global Phase III clinical studies.
About the CTLA-4 pathway
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 ligands, B7.1 and B7.2, 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.