APS03118 is a new drug that targets patients with various advanced cancer types, caused by rearranged during transfection (RET) gene alterations
Applied Pharmaceutical Science (APS) has received the US Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application for APS03118.
APS03118 is a new drug that targets patients with various advanced cancer types, caused by rearranged during transfection (RET) gene alterations.
The cancer types include non-small cell lung cancer, thyroid cancer, pancreatic cancer, breast cancer, ovarian cancer, colorectal cancer and other advanced solid tumours.
Also, APS03118 would target patients with resistance to first-generation selective RET inhibitors, said the cancer therapy developer.
APS R&D vice president Jun Zhong said: “We are delighted that APS03118 has been clinically approved in the US 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.”
APS claimed that its APS03118 showed high selectivity for RET kinases in the preclinical studies, compared to currently available first-generation selective RET inhibitors.
The currently available first-generation selective RET inhibitors have received priority review, breakthrough therapy, orphan drug status, and accelerated approval from the FDA, based on their superior efficacy, said the company.
The drug has shown significant antitumor activity against various RET fusion and mutations including V804M/L/E and G810R/S/C mutations, which lead to selective resistance.
APS03118 also demonstrated potential antitumor activity with a superior safety profile in mouse models, and particularly in a brain tumour model, said APS.
The drug eliminated brain tumours, proving its therapeutic advantages in patients with brain metastases, and all animals survived after dosing.
APS is in the process of submitting a clinical application to the National Medical Products Administration (NMPA) in China.
The biopharmaceutical company is also planning to initiate a multi-centre clinical trial in the second quarter of 2022 in the US, China, Australia and other countries.
APS is focused on cancer precision therapy and tumour-driven gene drug development, powered by an in-depth exploration of cancer-causing driver genes, protein structure and function, and synthetic medicinal chemistry.