Bayer and China’s CStone Pharmaceuticals Team Up on Cancer Program

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China-based CStone Pharmaceuticals and Bayer have teamed up to evaluate the safety and efficacy of a checkpoint inhibitor with a multi-kinase inhibitor for the treatment of multiple cancers, including gastric cancer.

The two companies will pair CStone’s CS1001 with Bayer’s regorafenib, an oral multi-kinase inhibitor that targets VEGFR, FGFR, CSF1R and other receptors. This is the first global proof of concept study carried out as a collaboration between the two companies. CStone will be the study sponsor and Bayer will provide regorafenib throughout the clinical trial program. Financial terms of the collaboration were not disclosed.

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CStone has been on a collaboration roll over the past several months. Last week, CStone received approval to initiate clinical development in China of CS1001 in combination with Blueprint Medicine’s BLU-554 (CS3008) in patients with locally advanced or metastatic hepatocellular carcinoma. In 2015, there were approximately 326,000 deaths caused by liver cancer in China, making it the second leading cause of cancer death. In May, CStone and Switzerland-based Numab Therapeutics AG announced a licensing agreement for the development and commercialization of ND021, a potential best-in-class monovalent, tri-specific antibody-based molecule targeting PD-L1, 4-1BB, and human serum albumin.

CS1001 is one of CStone's backbone immuno-oncology pipeline candidates. The drug has demonstrated that it is well-tolerated and has promising anti-tumor activities across a variety of tumor types in clinical studies. CStone is evaluating CS1001 in seven clinical trials. CS1001 completed a Phase I dose-escalation study in China and has demonstrated promising anticancer activity and good tolerance, the company said. CS1001 is currently being evaluated in multiple clinical trials including a bridging Phase I trial in the United States, a multi-arm Phase Ib study, two pivotal Phase II studies and three Phase III studies in China in various cancer types, respectively. It has not yet been approved by any regulatory health authority.

Bayer’s Regorafenib, known as Stivarga in the United States, is approved in more than 90 countries for the treatment of metastatic colorectal cancer and metastatic gastrointestinal stromal tumors. It is also approved in more than 80 countries for the second-line treatment of advanced hepatocellular.

Scott Z. Fields, head of oncology development at Bayer's Pharmaceutical Division noted that there is a rising trend in cancer therapy of combining checkpoint inhibitors with multi-kinase inhibitors. Fields said the goal is to find new solutions for the many treatment gaps that remain for cancer patients. Fields said Bayer looks forward to the collaboration with CStone and exploring the potential of its multi-kinase inhibitor, regorafenib.

Gastric cancer was chosen as one of the targets for this collaboration due to the lack of safe and effective therapies. Lin Shen, vice president at the Peking University Cancer Hospital, said a combination of PD-1/PD-L1 antibodies with multi-kinase inhibitors that target VEGFR can induce significant synergistic anti-tumor effects. Shen said the hope is that a combination of CS1001 and Regorafenib will provide a new treatment option for gastric cancer patients.

Frank Jiang, CStone’s chief executive officer and chairman of the board, said they are pleased that Bayer agreed to partner with the company as the decision is a recognition of the potential of CS1001.

“We hope, by complementing our two companies' pipelines via this combination therapy, that we can develop better cancer treatments for patients. In addition, this collaboration will be a big step forward for CStone's global strategy when we generate positive data,” Jiang said in a statement.

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