On November 30, 2021 ABM Therapeutics (ABM), a clinical-stage biopharmaceutical company with a focus on treating brain cancers and cancer metastases, reported that its IND application for ABM-1310, a new-generation BRAF inhibitor, has been approved by the National Medical Products Administration (NMPA) to conduct Phase 1 clinical trials in patients of advanced solid tumors with BRAF mutation in China (Press release, ABM Therapeutics, NOV 30, 2021, View Source [SID1234596305]). This is the first clinical candidate and IND approval obtained by ABM Therapeutics in China.
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ABM-1310 is a brain-penetrant BRAF inhibitor. Due to its high selectivity and optimal physicochemical properties, as well as superior efficacies and high margin of safety in preclinical models, it is expected to solve issues, such as brain metastasis, that are associated with marketed drugs.
The Phase 1 trials will be a multi-center, open-label study to assess safety, tolerability, pharmacokinetics, and preliminary efficacy. The primary goal of the study is to determine the optimal dose for Phase 1b/2 studies. The company started an ongoing Phase 1 safety trial in the United States in June of 2020.
"This is excellent progress for ABM. I really appreciate the team, including members from our supporting CRO, for all their highly efficient and superbly executed hard work. This first IND approval in China is another milestone in the development of ABM-1310, which further validates ABM’s capabilities of independent R&D innovation and technological excellence," said Dr. Chen Chen, founder and CEO of ABM Therapeutics. "Due to the blood-brain barrier (BBB), most anti-cancer drugs have poor brain penetration, resulting in limited efficacy on the brain lesion. It is an indisputable fact that many cancer patients are affected by brain metastases, but current treatment options are rare. It is a challenge to develop brain-penetrant anti-cancer drugs, but there is certainly a highly unmet medical need. ABM-1310 is a novel small molecule with high water solubility, cell permeability, and selectivity. We will begin clinical development at full throttle in China with the hope of bringing the potential therapeutic benefits to patients in the near future."
As a leading company with an emphasis on small molecules with good cell/brain permeability to address cancer metastases, particularly brain metastases, ABM has a broad and robust proprietary pipeline based on its brain medicine R&D platform. The company looks forward to further collaboration with investigators, clinical sites, big pharma and biotech companies.