The study will enrol newly diagnosed patients with isocitrate dehydrogenase wild-type, MGMT-unmethylated glioblastoma. Credit: Gorodenkoff/ Shutterstock.com.

Moleculin Biotech has announced the initiation of an investigator-initiated Phase II NU 21C06 clinical trial, funded by the National Institutes of Health (NIH), of WP1066 plus radiation therapy for adults with glioblastoma.

The trial is being conducted under Northwestern University’s Investigative New Drug application, which references Moleculin’s own US Food and Drug Administration (FDA)-cleared IND in April 2022.

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Apart from NIH, BrainUp, a non-profit organisation focusing on creating awareness on brain cancer, is providing additional funding.

The open-label, multi-arm study is focusing on newly diagnosed patients with isocitrate dehydrogenase (IDH) wild-type, O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated glioblastoma.

The primary goal of the study is to measure progression-free survival, while secondary outcomes include the analysis of the tumour microenvironment.

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WP1066, an immune/transcription modulator, is designed to enhance the immune response to tumours by hindering regulatory T cells’ errant activity and oncogenic transcription factors.

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The asset obtained orphan drug designation for the treatment of brain tumours and rare pediatric disease designation for three other paediatric indications.

Moleculin Biotech chairman and CEO Walter Klemp said: “We are continuing to evaluate WP1066 in additional indications including for the treatment of paediatric brain tumours and look forward to its continued development.”

In November last year, Moleculin reported positive initial efficacy data from the Phase II part of a Phase IB/II clinical trial of Annamycin to treat patients with soft tissue sarcoma (STS) lung metastases.