The trial will assess ABM-1310’s preliminary anti-cancer efficacy in patients with BRAF V600X-mutant relapsed and drug-resistant primary malignant brain tumours. Credit: Elif Bayraktar / Shutterstock.

Biotechnology company ABM Therapeutics has dosed the first patient in its Phase I study to evaluate ABM-1310 in patients with relapsed and drug-resistant primary malignant brain tumours in China.

ABM-1310 is a selective, orally active small-molecule BRAF inhibitor that has shown superior properties in pre-clinical animal models in the treatment of cancer brain metastases.

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The open-label, multi-centre clinical study will assess the tolerability, safety, pharmacokinetics and preliminary anti-cancer efficacy of ABM-1310 in subjects with BRAF V600X-mutant relapsed and drug-resistant primary malignant brain tumours.

Its main aim is to determine the optimal/recommended dose for Phase II studies.

ABM Therapeutics is conducting two additional studies of ABM-1310 in patients with BRAF V600X-mutated advanced solid tumours in various cancer centres in China and the US.

ABM Therapeutics CEO Dr Chen Chen said: “Although progress has been made in the treatment of patients with primary malignant brain tumours in recent years, there is still a highly unmet medical need for those with recurrent or drug resistant diseases.

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“We have three clinical studies of ABM-1310 ongoing in China and the US.

“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.”

ABM Therapeutics chief marketing officer Dr Zane Yang said: “Due to unfavourable prognosis associated with most primary malignant brain tumours and the limited treatment options that are currently available, there is an imperative to explore new therapeutic approaches.

“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 tumours harbouring BRAF V600X mutation.”

Earlier this year, ABM Therapeutics dosed the first US patient in a Phase I trial of ABM-168 for solid tumours.

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