FDA Grants Fast Track Designation to ABM-1310 for Glioblastoma

The Food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of BRAF inhibitor

for the treatment of patients with glioblastoma (GMB) who are carrying the BRAF V600E mutation, according to a news release from biopharmaceutical company ABM Therapeutics.

The Fast Track Designation — which, as ABM Therapeutics explained in the release, is granted “to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need” — follows the FDA’s grant of an Orphan Drug Designation for ABM-1310 to treat malignant gliomas, including glioblastoma, earlier this year, according to the release.

"We are very grateful to the FDA for recognizing the potential of our novel next-generation investigational drug ABM-1310 to help patients with brain tumors," said Dr. Zane Yang, CMO of ABM Therapeutics, in the news release. "This offers ABM an interactive collaboration with the FDA to ensure ABM-1310 clinical development expeditiously with the highest standards of safety and quality."

AMB-1310 is currently being evaluated in China in a phase 1, open-label, multicenter clinical study examining its safety, tolerability, pharmacokinetics and preliminary anti-cancer efficacy in patients with BRAF V600-mutant relapsed and drug-resistant primary malignant brain tumors, according to clinicaltrials.org.

With an estimated enrollment of 52 patients the trial, which is currently recruiting, began in June and is estimated to be completed in May of 2028, clinicaltrials.org reported.

AMB Therapeutics announced in early September that the first patient had been successfully dosed in the trial.

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"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", Dr. Chen Chen, CEO of ABM Therapeutics, said in a Sept. 1 news release. "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."

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The National Cancer Institute reported that that there will be an estimated 24,810 new cases of brain and other nervous system cancers, as well as an estimated 18,990 deaths from these diseases, in 2023.

Additionally, a phase 1, first-in-human, open-label dose escalation and dose expansion study of ABM-1310 with 112 patients that began in 2020 in the United States is also recruiting and is estimated to be completed by early 2025, according to clinicaltrials.gov.

The preliminary findings from the American trial was presented at the ASCO 2023 Annual Meeting and in a study published in the Journal of Clinical Oncology, with study authors writing that AMB-1310 “was generally well tolerated, with no new safety signals. Preliminary efficacy data demonstrate favorable activity of ABM-1310 in pts with BRAFv600-mutated solid tumors, including primary CNS (central nervous system) tumors, and (patients) previously refractory to other BRAF/MEK inhibitors and I/O therapies (immunotherapies).”

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