On March Bio Ray Lab's self-developed new-generation EP4 receptor small molecule antagonist YY001 clinical trial application was officially approved by the National Medical Products Administration (NMPA), agreeing to conduct Phase 1 clinical trials for advanced solid tumors.
Shanghai Medicilon Inc. (Medicilon) provided
GLP-compliant toxicology DRF tests and application materials for the research and development of YY001, which accelerating the project to get into Phase 1 clinical trials.
Fill in the Gap
China's First Original Research New Drug Targeting EP4 is Approved for Clinical Use
YY001 is a new generation of EP4 receptor small molecule antagonist independently developed by Bio Ray Lab, and it is also the first self-developed highly selective EP4 receptor antagonist in China. There is no similar drug in the world for this target at this moment. Compared with competing products in various stages of clinical trials, its preclinical research data shows that the target activity is increased by 5-10 times, the oral bioavailability is increased by 2 times, the blood drug concentration in the body increased by 4 times. It is a full range of global best-in-class products.
The preclinical efficacy study of Bio Ray Lab's YY001 showed that it exhibited significant anti-tumor effects in advanced solid tumors such as colorectal cancer, gastric cancer and prostate cancer. In addition, when used in combination with PD-1 antibody, the therapeutic effect is significantly enhanced, which is expected to transform cold tumors that are insensitive to PD-1 antibody treatment into hot tumors, providing a new strategy for the treatment of advanced solid tumors and benefiting more cancer patients.
Medicilon Preclinical Research Toxicology Research Department
High Quality and Efficiency Helps Global New Drug Toxicology Research
Medicilon, as a professional biopharmaceutical preclinical comprehensive R&D CRO, was fortunate to undertake some of the toxicological tests of Bio Ray Lab's YY001. The Medicilon toxicology research team has adequate strategies to deal with various difficulties in the experimental design and process. Finally, with the collaboration of both parties, the trial was successfully completed, and the key toxicological test data were obtained, which provided strong support for the drug to successfully obtain NMPA approval for clinical trials.
Medicilon originated in the field of toxicology and has been working hard for 18 years, accumulating profound technical experience in preclinical toxicology. Medicilon Toxicology Research Department can provide research services for small molecule chemical drugs and biologics drugs (including ADCs, antibodies, proteins and peptides). In addition to the common administration routes such as PO and IV, special evaluation platforms have also been established, such as inhalation route, dermal route, ophthalmic route, and sublingual route. Moreover, Medicilon's preclinical research services have passed AAALAC certification, NMPA's GLP certification, FDA's GLP laboratory verification, and complies with TGA and OECD GLP standards, which support mixed declaration projects in multiple countries.
Medicilon congratulates Bio Ray Lab on the clinical approval of YY001, wishing Bio Ray Lab a milestone progress, and hopes that YY001 can open up a new treatment for advanced solid tumors. Innovation-driven, quality first, Medicilon will continue to forge ahead for the unfinished business of human health!
References
1.Peng S, Hu P, Xiao YT, Lu W, Guo D, Hu S, Xie J, Wang M, Yu W, Yang J, Chen H, Zhang X, Zhu Y, Wang Y, Yang Y, Zhu G, Chen S, Wang J, Zhang B, Chen W, Wu H, Sun Z, Ding T, Zhang H, Yi Z, Liu M, Ren S. Single-Cell Analysis Reveals EP4 as a Target for Restoring T-Cell Infiltration and Sensitizing Prostate Cancer to Immunotherapy. Clin Cancer Res. 2022 Feb 1;28(3):552-567. doi: 10.1158/1078-0432.CCR-21-0299. Epub 2021 Nov 5. PMID: 34740924.
2.Lu W, Yu W, He J, Liu W, Yang J, Lin X, Zhang Y, Wang X, Jiang W, Luo J, Zhang Q, Yang H, Peng S, Yi Z, Ren S, Chen J, Siwko S, Nussinov R, Cheng F, Zhang H, Liu M. Reprogramming immunosuppressive myeloid cells facilitates immunotherapy for colorectal cancer. EMBO Mol Med. 2021 Jan 11;13(1):e12798. doi: 10.15252/emmm.202012798. Epub 2020 Dec 7. PMID: 33283987; PMCID: PMC7799360.
About Bio Ray Lab
Bio Ray Lab was founded by top scientists from China and the United States. At present, it has more than 30 employees with doctoral and master degrees. It has more than 5,000 square meters of office and R&D laboratories in Huanpu Yun Chuang International Science and Technology Park, Minhang District, Shanghai.
The company has 3 major drug discovery platforms and 8 product pipelines under development targeting lung cancer, prostate cancer, pancreatic cancer and gastrointestinal tumors. The product, YY001, is a PD-1-insensitive advanced solid tumor treated by tumor immunotherapy. It is about to start a clinical phase 1 trial and is the best immune checkpoint antagonist worldwide. The product, YY002, is the first transcription factor inhibitor in the world. YY002 has been preparing for IND application in both China and the United States. The product pipelines will soon enter the clinic in the future. The company has applied for more than 13 invention patents and 4 PCT patents, and has successfully entered the market of Europe, America, Japan and other countries and regions.
The company has successively won the Gold Award of the 7th "Creating Youth" China Youth Innovation and Entrepreneurship Competition (the only one in Shanghai), the Gold Award of the 6th "Internet +" College Students' Innovation and Entrepreneurship Competition, and the Gold Award of the First National Postdoctoral Innovation and Entrepreneurship Competition. The company's team and products have also been recognized by professional investment institutions. At present, the company has received about RMB 30 millions of angel investment from 5 institutions. The rich product pipeline and the world's top new drug R&D team are expected to enable the company to land in the capital market in the next 3-5 years and become a globally competitive innovative drug company.
About Medicilon
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. Medicilon grows together with the clients and delivers the new drug research and development services to more than 900 clients globally. Medicilon is proud to contribute to human health in the globe.
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