ABM-1310

SAN DIEGO, Calif. and SHANGHAI, Sept. 1, 2023 /PRNewswire/ -- ABM Therapeutics, a clinical-stage biopharmaceutical company, today announced that the first patient has been successfully dosed in its multicenter Phase I study of ABM-1310 in patients with relapsed and drug resistant primary malignant brain tumors in China. This is the second clinical study of ABM-1310 in China. ABM-1310, the company's proprietary clinical candidate developed as a next-generation BRAF inhibitor and demonstrated superior properties in pre-clinical animal models for treating cancer brain metastases, is a selective, highly water-soluble, orally active, and brain-penetrant small molecule BRAF inhibitor. ABM has been carrying out 2 additional studies of ABM-1310 in patients with BRAF V600X mutated advanced solid tumors in several well-known cancer centers in the United States and China. The preliminary observation of the US Phase I trial was presented at ASCO 2023 Annual Meeting (). The newly opened study (NCT05892653) is a phase I, open-label, multicenter clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer efficacy of ABM-1310 in patients with BRAF V600X mutant relapsed and drug resistant primary malignant brain tumors, with the goal to determine the optimal/recommended dose for phase 2 studies. "We are excited to start this new study of ABM-1310. Primary brain tumors represent over 100 different sub-types, and patients whose tumors carry a BRAF V600X mutation are one of the clusters. Although progress has been made in the treatment of patients with primary malignant brain tumors in recent years, there is still a highly unmet medical need for those with recurrent or drug resistant diseases", said Dr. Chen Chen, CEO of ABM Therapeutics, " We have 3 clinical studies of ABM-1310 ongoing in China and the United States. We will work with investigators and clinical sites to push forward the clinical development of ABM-1310, with the passion to bring the potential therapeutic benefits to patients." "Due to unfavorable prognosis associated with most primary malignant brain tumors and the limited treatment options that are currently available, there is an imperative to explore new therapeutic approaches. ", said Dr. Zane Yang, CMO of ABM Therapeutics. "Since ABM-1310 exhibits higher water solubility, cellular and blood-brain barrier penetration capabilities, compared to other BRAF inhibitors in preclinical research, we expect that ABM-1310 will provide special clinical benefits for patients with central nervous system tumors harboring BRAF V600X mutation" As a clinical-stage biotechnology company, ABM has got a broad and robust proprietary pipeline to construct a Brain-Penetrant Kinase Drug Development Platform (BPKddTM）. We look forward to working with international pharmaceutical companies and biotech companies from multiple perspectives and making our drugs to benefit more patients in the world. About ABM Therapeutics A clinical-stage biopharmaceutical company with a mission to focus on small molecule research and development of novel drugs for the treatment of cancer, with an emphasis on blood–brain barrier (BBB) penetration and brain metastases. ABM's pipeline includes several programs in various stages of discovery and development, most of which have improved brain permeability to address the unmet needs of treating cancers and metastases in the brain. SOURCE ABM Therapeutics

GBM is a hard-to-treat and extremely aggressive brain tumour. Credit: create jobs 51 / Shutterstock.com. ABM Therapeutics has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for ABM-1310 to treat patients with glioblastoma (GBM) harbouring the BRAF V600 mutation. A small-molecule BRAF inhibitor, ABM-1310 is an orally administered medicine with high BRAF mutation selectivity, blood-brain barrier permeability and water solubility. Recommended Reports Reports Clostridium difficile Toxin B (toxB or EC 3.4.22.) Drugs in Development by Therapy Areas and Indi... GlobalData Reports LOA and PTSR Model - Drug For Autism And Dementia in Autism Spectrum Disorder (ASD) GlobalData View all Companies Intelligence ABM Corporation GBM SRL ABM Therapeutics Inc View all The inhibitor is currently in Phase I trials at clinical sites in China and the US, targeting advanced solid tumours with the BRAF V600 mutation. Interim results from the US Phase I trial showed that ABM-1310 exhibited promising anti-cancer activity and a good safety profile in patients with advanced solid tumours, including primary brain tumours such as GBM and other gliomas. In China, a new Phase I clinical study focused specifically on GBM has recently commenced. GBM is a hard-to-treat and extremely aggressive brain tumour. Its treatment remains a significant challenge owing to tumorigenesis complexities and resistance to the therapy. Traditional treatments such as surgical resection, radiation therapy and chemotherapy have limitations. ABM Therapeutics, a clinical-stage biopharmaceutical company, focuses on small molecule research and the development of new medicines to treat cancer, specifically brain cancer and brain metastases from solid tumours. ABM has been developing a pipeline for the construction of a brain medicine research and development platform known as BPKdd. The pipeline comprises several programmes at different stages of discovery and development.