Multi cancer "immune + targeted" treatment! Cornerstone pharmaceutical cs1001 combined with Bayer regofinib global clinical research completed the first patient medication!

January 26, 2020 / BIOON / -- Cornerstone pharmaceutical recently announced that it is in the process of research on the combination of PD-L1 inhibitor cs1001 and Bayer oral multi kinase inhibitor regorafenib (bavango ®) and has completed the first patient administration in Australia This is the first global proof of concept clinical study to explore the recommended dose of cs1001 combined with regofinib, as well as to evaluate the safety, tolerance, pharmacokinetics and antitumor efficacy of various cancer treatments including gastric cancer Cs1001 is an anti-PD-L1 monoclonal antibody independently developed by cornerstone pharmaceutical At present, cs1001 is carrying out a number of clinical trials In addition to a US bridging phase I trial, in China, cs1001 is carrying out a multi arm phase IB trial, two registered phase II trials and four phase III trials for multiple cancer species According to the research data published at the annual meeting of Chinese society of Clinical Oncology (CSCO) in 2019, cs1001 has shown good antitumor activity and tolerance in a number of cancer species in phase IA and phase IB studies Regofinib is an oral drug developed by Bayer company, which takes VEGFR, FGFR, csf1r and other small molecular inhibitors of multiple kinases as targets At present, regofinib has been approved by more than 90 countries including China for the treatment of second-line and above advanced colorectal cancer, advanced gastrointestinal stromal tumor and advanced liver cell cancer In May 2019, cornerstone pharmaceutical and Bayer company reached a global clinical cooperative research As the initiator of cs1001 combined with regofinib clinical research, Bayer company will provide regofinib for the test A number of studies have shown that single kinase inhibitor or single anti-PD-1 / PD-L1 antibody has curative effect in multiple tumor treatments At the same time, preclinical studies have shown that targeted drugs such as regofinib can enhance the efficacy of immunosuppressive checkpoint inhibitors by changing the immune microenvironment of some solid tumors Therefore, the combination of the two mechanisms may play a synergistic role in tumor regression Dr Jiang Ningjun, chairman and CEO of cornerstone pharmaceutical, said, "the clinical trial jointly conducted by cornerstone pharmaceutical and Bayer is an important step in the company's global strategy It's nice to see that the combination of cs1001 and regofinib achieved the first patient administration We hope that this joint exploration will not only supplement the company's product pipeline, but also benefit more cancer patients who lack effective treatment programs "Research conducted on preclinical animal disease models shows that cs1001 and regofinib can enhance the anti-tumor effect, which provides data support for us to carry out this clinical study," said Dr Xie Yizhao, chief transformation medical officer of cornerstone pharmaceutical At the same time, a number of such combined therapies are being carried out for advanced or metastatic solid tumors in the world, and some good data have been obtained We are full of expectation for the clinical trial results of cs1001 and regofinib " About baivango ® (regofinib): This is an oral multi kinase inhibitor, which can block a variety of protein kinases related to tumor angiogenesis (VEGFR1, - 2, - 3, Tie2), tumor proliferation (kit, RET, Raf-1, BRAF), tumor metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (csf1r) Regofinib is a compound developed by Bayer In 2011, Bayer reached an agreement with Onyx, a biotech pharmaceutical company Under the agreement, Onyx will receive royalties based on regofinib's global net sales in the field of cancer At present, regofinib has been approved in more than 90 countries for the treatment of metastatic colorectal cancer (mCRC), metastatic gastrointestinal stromal tumor (GIST) and second-line advanced liver cell carcinoma (HCC) The approved trade name of the drug is baivango ® (stivarga ®), and the approved countries include the United States, European Union countries, China and Japan About cs1001: This is a monoclonal antibody against PD-L1 developed by cornerstone pharmaceutical Cs1001 is produced by OMT transgenic animal platform authorized by ligand company of the United States, which can realize one-stop production of all human antibody As a full-length human anti-PD-L1 monoclonal antibody, cs1001 is a natural immunoglobulin-4 (IgG4) monoclonal antibody that is closest to human body Compared with similar drugs, cs1001 has a lower risk of immunogenicity and related toxicity in patients, which makes cs1001 have a potential unique advantage in safety Cs1001 has completed phase I clinical study dose escalation in China In the study of IA and IB, cs1001 showed good antitumor activity and tolerance in multiple indications At present, cs1001 is carrying out a number of clinical trials In addition to a US bridging phase I trial, in China, cs1001 is carrying out a multi arm phase IB trial, two registered phase II trials and four phase III trials for multiple cancer species Cstone announcements first patient dosed in the global proof of concept study of cs1001 in combination with Bayer's regorafenib