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Applied Pharma : FDA Oks IND Application For APS03118, RET New Drug For Unlimited Cancers

Applied Pharmaceutical Science Inc. said that the U.S. Food and Drug Administration approved the Investigational New Drug or IND application for its self-developed breakthrough new drug APS03118, a next generation selective RET inhibitor.

The clinical application is also in the process of being submitted to the National Medical Products Administration (NMPA) in China, and a global multi-center clinical trial is in the pipeline for initiation in the second quarter of 2022 in the U.S., China and Australia etc, the company said in a statement.

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types, targeting patients with non-small cell lung cancer, thyroid cancer, pancreatic cancer, breast cancer, ovarian cancer, colorectal cancer and other advanced solid tumors caused by rearranged during transfection (RET) gene alterations, as well as patients with resistance to first-generation selective RET inhibitors.

According to the company, preclinical studies have shown that APS03118 is highly selective for RET kinases, and compared to the currently marketed first-generation selective RET inhibitors APS03118 showed significant nanomolar level potent antitumor activity in inhibition to various RET fusion and mutations including RET gatekeeper V804M/L/E and solvent frontier G810R/S/C mutations which lead to resistance to selective RET inhibitors.

APS03118 also exhibited potent antitumor activity with a good safety profile in mouse models, and more significantly, in a brain tumor model, APS03118 completely eliminated brain tumors and all animals survived after dosing, demonstrating the therapeutic advantages of APS03118 for patients with brain metastases.

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