On November 12, 2021 Nimbus Therapeutics, a biotechnology company designing and developing breakthrough medicines through structure-based drug discovery, reported the first patient dosed in the first-in-human Phase 1/2 study of their small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, NDI-101150 (Press release, Nimbus Therapeutics, NOV 12, 2021, View Source [SID1234595402]). HPK1 is a key regulator of T cell, B cell and dendritic cell-mediated immune responses, making it a high-priority target in immuno-oncology.
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"We are proud to expand our clinical development program with the initiation of this first-in-human trial. The preclinical evidence we’ve seen for our HPK1 inhibitors to date, including in vivo data shared at the 2021 AACR (Free AACR Whitepaper) Annual Meeting, has shown significant tumor growth inhibition, both as a single agent and in combination with anti-PD1, and robust and durable effects on immune memory," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "New approaches to expand the promise of immuno-oncology to solid tumors are greatly needed and we’re eager to explore the potential of NDI-101150 to help address this unmet need."
The Phase 1/2 trial is a multicenter, open-label study that will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adults with advanced solid tumors. It is planned to enroll approximately 106 subjects.
"HPK1 is an important therapeutic target in immuno-oncology because of its role in multiple adaptive immune system components, including T cell, B cell and dendritic cell-mediated immune responses. We are pleased to have progressed a highly-selective HPK1 inhibitor into the clinic," said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. "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."