CStone announces first patient dosed with anti-CTLA-4 antibody CS1002 of a Phase I study in Australia

SUZHOU, China, May 4, 2018 /PRNewswire/ -- CStone Pharmaceuticals (Suzhou) Co., Ltd., (CStone) today announced dosing of the first patient of a Phase I clinical trial in Australia for CS1002, an investigational drug targeting cytotoxic T-lymphocyte-associated protein-4 (CTLA-4). CS1002 is CStone’s first drug candidate that has entered clinical trials outside of China.

“The successful initiation of this study is an important milestone for CStone. We have several immunotherapy drug candidates set to enter clinical-stage development in Australia along with CS1002,” CStone’s Chief Executive Officer (CEO) Dr. Frank Jiang commented. “Meanwhile, we are also progressing CS1002 into clinical trials in China, where our IND filing was accepted by the China Food and Drug Administration (CFDA) in March 2018. We plan to assess CS1002 as both monotherapy and an important part of combination therapy in the near future.”

The Phase I study is being led by Professor Dusan Kotasek of the Ashford Cancer Centre Research and will assess CS1002’s safety, tolerability, pharmacokinetics, and initial efficacy in patients with advanced solid tumors.

“CS1002 has produced highly promising results in pre-clinical studies, and this clinical trial will help us determine the appropriate dose for the molecule in preparation for later-stage development,” commented Dr. Jason Yang, Chief Medical Officer (CMO) of CStone.

CS1002 is an immunoglobulin G1 (IgG1), fully-human monoclonal antibody against CTLA-4. CStone owns all global rights to CS1002 and intends to develop it for the treatment of melanoma, non-small cell lung cancer, renal carcinoma and other solid tumors.

About the CTLA-4 pathway

CTLA-4 is a transmembrane surface protein found on the surface of T cells that under normal conditions helps to maintain homeostasis in the immune system by down-regulating the activity of T cells. The CTLA-4 pathway takes effect during the early stage of immune response prior to the PD-1 checkpoint, occurring principally in the lymph nodes when CTLA-4 on activated T cells binds to its ligands B7-1 (CD80) or B7-2 (CD86) on antigen presenting cells or tumor cells. CTLA-4/B7 interaction out-competes the stimulatory receptor CD28 on T cells and leads to attenuated T cell activity. A blockade of immune checkpoints using antibody drugs has been shown to promote T cell activation and proliferation, as well as stimulate the generation of memory T cells leading to durable anti-tumor response.

Presently, Bristol-Myers Squibb’s Yervoy® (ipilimumab) is the only anti-CTLA-4 antibody on the market, but it has not yet been approved in China. Pre-clinical tests have shown that CS1002 has high affinity to CTLA-4 and is expected to match Yervoy® clinical activity and safety in cancer patients.

About CStone Pharmaceuticals Co., Ltd

CStone Pharmaceuticals is a biopharmaceutical company devoted to the development of next-generation innovative drugs. With its broad immuno-oncology pipeline, the firm is pursuing a development strategy focused on combination therapy. In July 2016, CStone announced the completion of its $150 million Series A financing, led by three prestigious VC/PE funds: Oriza Seed Venture Capital, Boyu Capital, and WuXi Healthcare Ventures. All members of the management team are seasoned executives from top multinational pharmaceutical companies. CStone has successfully built up an industry leading team with clinical development and translational medicine as its core competence. With funding and pipeline, CStone is well positioned as the partner of choice for multinational pharmaceutical / biotech companies to develop drugs in China and the Asia-Pacific region.

For more information about CStone Pharmaceuticals, please visit: http://www.cstonepharma.com/

CONTACT: Xiaolin Lu, +86 21 6109 7678, luxl@cstonepharma.com