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ABM Therapeutics Announces First Patient Dosed in Phase I Study of ABM-1310 in patients with BRAF V600 in Relapsed and Drug Resistant Primary Malignant Brain Tumors

ABM Therapeutics Announces First Patient Dosed in Phase I Study of ABM-1310 in patients with BRAF V600 in Relapsed and Drug Resistant Primary Malignant Brain Tumors

SAN DIEGO, Calif. and SHANGHAI, Sept. 2, 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 (https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.3098).

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.

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