December 10, 2019 – SAN DIEGO, California
ABM Therapeutics Inc. announced on Friday, November 29, that the U.S. Food and Drug Administration (FDA) granted the clearance of the Investigational New Drug (IND) application to proceed with the first-in-human, phase I trial of ABM-1310, a novel BRAF inhibitor with high solubility and brain permeability. The trial will be conducted in adult patients with advanced solid tumors.
Dr. Qinhua Cindy Ru, managing director of CRC Oncology stated, “the submission and subsequent approval of the IND application of ABM-1310 marks our first regulatory milestone with ABM Therapeutics. We look forward to continuing our collaboration with ABM on the clinical development of ABM-1310.”
Dr. Chen Chen, founder and CEO of ABM Therapeutics, “We are pleased that ABM-1310 has been approved to conduct clinical trials in the United States. Many cancer patients are affected by brain metastases, but current treatment options are limited and an effective anticancer drug with brain permeability is urgently needed. We look forward to evaluating ABM-1310 further in clinical trials and hope to bring the potential therapeutic benefits to patients as soon as possible.”
ABM-1310 is a novel BRAF inhibitor, developed by ABM Therapeutics. A multicenter, phase I, first-in-human, trial to evaluate the safety and tolerability of ABM-1310 will be conducted in patients with advanced solid tumors. Clinical trial information: NCT04190628.
About ABM Therapeutics
ABM Therapeutics was founded in 2015 with a mission to focus on the research and development of novel drugs for the treatment of cancer, with an emphasis on treating brain cancer and metastasis. ABM Therapeutics is comprised of a team of experts with over 20 years of experience in the drug development of neurological and oncology drugs. For more information, please contact firstname.lastname@example.org.
About CRC Oncology
CRC Oncology is a contract research organization (CRO) focused on reshaping the global landscape of innovative drugs and therapies for cancer treatment. CRC Oncology provides high quality development and research services by strategically driving global regulatory submissions, authoring quality eCTD dossiers, leading US clinical development, advancing quality management expertise, building and maintaining a 24/7 audit trail, providing full GxP compliance master quality management systems, and bridging global business development needs. For more information, visit www.crconc.com.