AnHeart Therapeutics has dosed the first patient in the Phase II G203 clinical trial of safusidenib to treat Grades 2 or 3 recurrent or progressive mutant isocitrate dehydrogenase 1 (mIDH1) glioma.

The two-part, open-label, multicentre study is designed to assess the safety and efficacy of the mIDH1 inhibitor safusidenib as a single agent in patients with WHO Grade 2 or Grade 3 IDH1-mutant glioma.

Part 1 of the study will determine the optimal dose of safusidenib while Part 2 will assess the safety and efficacy.

Approximately 95 patients will be enrolled in the study. The company is currently enrolling patients from the US with plans to expand enrolment to other countries.

Favourable anti-tumour activity was demonstrated in a Phase I clinical trial in glioma patients.

Objective response rate of 33% (4/12) and 17% (6/35) was observed in patients with contrast non-enhancing and enhancing tumours, respectively.

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Safusidenib also showed a tolerable safety profile. 43% of patients treated showed at least one Grade 3 treatment emergent AE. No Grade 4 or 5 AEs or serious treatment-related AEs were observed in the trial.

AnHeart CEO Jerry Wang said: “This marks an important milestone for AnHeart, as we now have two investigational precision therapies in late-stage clinical trials.

“Our mission is to improve the lives of people with cancer. Our strategy is to target known genetic drivers of cancer with the goal of bringing next-generation medicines that raise the bar for what patients should expect from cancer treatment.

“We look forward to sharing additional updates as we continue to progress our clinical programmes.”

In 2020, AnHeart licensed safusidenib from Daiichi Sankyo and owns its worldwide rights, excluding Japan where the latter retains development and commercial rights.