On May 26, 2020 Qurient Co. Ltd. (KRX: 115180), a clinical stage biotech company in Korea, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for Q702, orally available immuno-oncology therapeutic small molecule targeting Axl, Mer and CSF1 receptor tyrosine kinases (Press release, Qurient Therapeutics, MAY 26, 2020, View Source [SID1234558487]).
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Under this IND, Qurient plans to initiate a Phase 1 clinical study in patients with advanced solid tumors for whom standard of care therapies are currently ineffective. The Phase 1 study is expected to begin in 3Q2020 and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Q702. The study will be conducted at multiple clinical centers in the United States.
"IND clearance for Q702 is an important milestone presenting a novel drug candidate that not only boosts immune cells in the tumor microenvironment but also makes tumor cells more visible to the immune system," said Kiyean Nam, Ph.D., CEO of Qurient. "We believe Q702 may have an important role in the cancer immunotherapy, improving clinical responses in patients who are unresponsive and/or refractory to currently available immunotherapy."
Q702 is an orally available, selective Axl/Mer/CSF1R triple kinase inhibitor showing significant in vivo activity as monotherapy as well as in combination with anti-PD-1 antibody. Q702 not only modulates innate immune components such as myeloid derived suppressor cell (MDSC), tumor associated macrophage (TAM) in tumor micro-environment (TME), but also increases MHC I expression in tumor cell.
The Axl inhibitor program was licensed from Lead Discovery Center (LDC) and the Max-Planck Society at lead stage and further optimized by Qurient. The research program initially originated from Professor Axel Ullrich’s laboratory from the Max Planck Institute of Biochemistry, Martinsried/Germany.
"We are excited to see the progress in this project and are looking forward to the application in humans in the near future. With Qurient, we have identified an ideal partner for this project and we are more than happy about the results of our strategic partnership with them," said Matthias Stein-Gerlach, Senior Patent and Licensing Manager at Max-Planck Innovation GmbH.
"Reaching a clinical candidate for development is one of the most important milestones in our partnerships," adds Bert Klebl, CEO and CSO of the LDC. "Starting an early-stage collaboration with Ullrich’s lab from Max Planck, leading to a licensing agreement with Qurient, we jointly mastered the pharmaceutical research phase and are now very eager to receive the results from this drug candidate in patients. Starting with this program, we have since built a sustainable and strong partnership with our partner Qurient, focusing on the translation of innovative biology and drug discovery programs from LDC’s academic network."