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November 15, 2021

Nimbus Therapeutics begins dosing in Phase I/II solid tumours therapy trial

The study will assess the tolerability, safety, pharmacokinetics, and preliminary anti-tumour activity of NDI-101150.

Nimbus Therapeutics has dosed the first subject in its Phase I/II trial of hematopoietic progenitor kinase 1 (HPK1) inhibitor, NDI-101150, in patients with solid tumours.

A high-priority target in immuno-oncology, HPK1 serves as a key regulator of B cell, T cell and dendritic cell-mediated immune responses.

In an immunosuppressive tumour environment, HPK1 kinase-dead knockin mice showed increased cytokine secretion, CD8+ T cell function, and robust anti-tumour immune responses, according to the company.

Nimbus Therapeutics chief scientific officer Peter Tummino said: “Development of this agent was made possible by Nimbus’ computational drug discovery approach, which continues to provide opportunities to develop new medicines in diseases with high unmet medical need.”

The multicentre, open-label Phase I/II trial will evaluate the tolerability, safety, pharmacokinetics, and the preliminary anti-tumour activity of the small-molecule HPK1 inhibitor.

Approximately 106 subjects are planned to be recruited for the study, which claims to be the first-in-human trial.

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In this trial, NDI-101150 will be given alone or in combination with pembrolizumab to adult patients suffering with advanced solid tumours.

Nimbus Therapeutics CEO Jeb Keiper said: “The preclinical evidence we’ve seen for our HPK1 inhibitors to date, including in vivo data shared at the 2021 AACR Annual Meeting, has shown significant tumour growth inhibition, both as a single agent and in combination with anti-PD1, and robust and durable effects on immune memory.

“New approaches to expand the promise of immuno-oncology to solid tumours are greatly needed and we’re eager to explore the potential of NDI-101150 to help address this unmet need.”

In July 2021, the company raised $105m through a private financing round to support HPK1 inhibitor’s first-in-human trial and advance preclinical programmes against multiple targets in immunology and oncology.

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