On 15 November 2018, Suzhou Kintor Pharmaceuticals Inc. (“Kintor”) received approval from Taiwan Food and Drug Administration (“Taiwan FDA”) for its ALK-1 and PD-1 joint clinical trial for liver cancer. Currently, it has received approval for Proxalutamide clinical trials for prostate cancer and breast cancer and KX-826 clinical trials in both China and US. The approval demonstrates that Kintor has expanded to the area of new drug development in large molecules from clinical trials of small molecule drugs, further strengthening its global R&D footprint.
Its ALK-1 antibody project has received subsidy from the “Significant New Drugs Development” Program under the 13th Five-year Plan in 2018. Professor Xu Jun from Taiwan University College of Medicine Graduate Institute of Oncology acted as the Principal Investigator of the open multi-center ALK-1 and PD-1 Phase II joint clinical trial which was designed to evaluate the safety, tolerability and efficacy in patients with advanced liver cancer. The key hospital partners of the clinical trial included Taiwan University Hospital, MacKay Memorial Hospital and Cheng Kung University Hospital.
The ALK-1 antibody project marks Pfizer’s first license for development of a new antibody drug in tumor therapy, which is expected to become the world’s first fully human therapeutic monoclonal antibody that targets ALK-1. Pfizer has conducted its preliminary development and completed Phase I clinical trials in US and Asia. As validated in nearly 100 patients with advanced solid tumors, the drug has a good safety and efficacy profile. The combination regimen of ALK-1 and PD-1 drugs for patients with advanced liver cancer is expected to become a more efficacious new option by combining ALK-1 targeted therapy for inhibiting angiogenesis of tumor vessels with the efficacy of immunization of the PD-1 drug.
“We are pleased to announce the ALK-1 and PD-1 joint clinical trial has been officially approved. It aligns with Kintor’s commitment to providing our patients with the optimal therapeutic regimens based on our in-house R&D-focused strategy supplemented with in-licensed drugs. Through the clinical trial, we hope we can develop a more efficacious and safer solution for patients with liver cancer, especially for those with advanced tumors as soon as possible. We will also launch a series of clinical trials for renal cancer, breast cancer, prostate cancer and age-related macular degeneration in future.” said Dr. Tong Youzhi, Chairman and CEO of Kintor.
Kintor is a biotech company engaging in R&D of innovative drugs with a focus on prostate cancer, breast cancer and liver cancer. The Company’s key drug candidate Proxalutamide is a new generation of androgen receptor antagonist currently under the Phase III clinical trial for mCRPC in China, Phase II clinical trial in US and Phase I/Ib clinical trial for metastatic AR positive breast cancer in China. It also has a product pipeline including “first-in-class” ALK-1 antibody, PI3K/mTOR kinase inhibitor, Hedgehog/SMO inhibitor and PARP inhibitor. On 29 October 2018, Kintor established its R&D and manufacturing base in Suzhou, China to lay a solid foundation for its in-house R&D strategy.
About Pfizer licensing
On 24 January 2018, Kintor was granted the exclusive worldwide rights to develop, manufacture and commercialize an ALK-1 antibody drug by Pfizer. The drug is expected to become the world’s first fully human therapeutic monoclonal antibody that targets ALK-1. Pfizer would support Kintor with the preclinical and Phase I clinical trial results and proprietary technologies under the Agreement.