The US Food and Drug Administration (FDA) has approved investigational new drug (IND) application for Applied Pharmaceutical Science’s next generation RET original new drug, APS03118, to treat unlimited cancer types.
APS03118 is a second generation selective rearranged during transfection (RET) inhibitor that targets patients suffering with non-small cell lung cancer, breast cancer, ovarian cancer, thyroid cancer, colorectal cancer, pancreatic cancer, as well as other advanced solid tumours caused by alterations in RET gene.
The drug has demonstrated highly selective for RET kinases and a significant potency against various RET fusion and mutations at the nanomolar level in the preclinical studies, compared to first-generation selective RET inhibitors.
In mouse models, the RET inhibitor showed potent antitumour activity with a good safety profile. APS03118 also eliminated brain tumours with all animals surviving after dosing in a brain tumour model.
The FDA has already granted breakthrough therapy, accelerated approval, priority review, orphan drug status, and other review incentives to the first-generation selective RET inhibitors currently marketed by the company.
Applied Pharmaceutical is in the process of submitting clinical application to the National Medical Products Administration (NMPA) in China for the new drug APS03118.
Applied Pharmaceutical R&D vice president Dr. Jun Zhong said: “We are delighted that APS03118 has been clinically approved in the U.S. for a global unmet clinical need and that our self-developed innovative drug has been recognized by the FDA.
“APS has always adhered to its international development strategy to provide a new generation of precision therapeutic solutions for cancer patients worldwide.”
The company also stated that a global multi-centre clinical study on the drug will begin in the second quarter of this year in Australia, China, the US and other countries.