Apollomics, Inc. Receives China Investigational New Drug Approval for APL-102 to Initiate a Phase 1 Study

中美药企冠科美博APL-102一期临床试验获批
Published on: November 13, 2020
Author: Amy Liu

Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of new tumor-targeting agents and immuno-oncology agents and their combination therapies, today announced that APL-102 has received China Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study of APL-102 in patients with advanced solid tumors.

Dr. Guoliang Yu, the company’s Co-Founder, Chairman and CEO said that: “APL-102 is a small molecule multi-kinase inhibitor developed by us. It has demonstrated broad and potent antitumor activity in patient derived xenograft mouse models of liver cancer, breast cancer, colorectal cancer, gastric cancer, esophageal cancer and non-small cell lung cancer, demonstrated excellent oral bioavailability and relatively low toxicity in pre-clinical studies. APL-102 may not only be used as a single agent to treat patients, but also has a potential of being co-administered with immunotherapy and other treatments as a combination therapy.”

About APL-102

APL-102 is an oral, multi kinase inhibitor (mKi) targeting several key oncogenic drivers. APL-102 inhibits both receptor tyrosine kinase (RTKs) and serine/threonine-kinases, including: angiogenesis via vascular endothelial growth factor receptors (VEGFRs) and platelet-derived growth factor receptors (PDGFRs); mitogen-activated protein kinase (MAPK) pathway via B-RAF and C-RAF; RET, CSF1R, DDR1 and c-KIT.

Apollomics owns the global clinical development, production and commercial sales rights of APL-102.

About Apollomics, Inc.

Apollomics, Inc., incubated by OrbiMed Asia at inception, is an innovative biopharmaceutical company committed to the discovery and development of oncology mono- and combination- therapies that harness the immune system and target specific molecular pathways to eradicate cancer. The company’s existing pipeline consists of several development-stage assets including novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

Source: Biospace

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