Nimbus Therapeutics has announced significant progress in its oncology therapeutic pipeline, highlighted by the completion of an investigational new drug (IND) application submission for NDI-219216, a novel Werner syndrome helicase (WRN) inhibitor. The company plans to initiate a first-in-human clinical trial of NDI-219216 in the first half of 2025, targeting microsatellite instability high (MSI-H) tumors.
NDI-219216: A Potential Best-in-Class WRN Inhibitor
NDI-219216 is a non-covalent WRN inhibitor designed to target MSI-H tumors, which are characterized by a high mutation rate due to defects in DNA mismatch repair. Preclinical data indicates that NDI-219216 has the potential to be a best-in-class agent, demonstrating significant tumor regression and complete responses at low oral doses across various tumor types.
According to Dr. Anita Scheuber, Senior Vice President, Therapeutic Area Head, Oncology, "NDI-219216 has demonstrated compelling preclinical data, including significant tumor regression and complete responses at low oral doses across tumor types. The preclinical safety studies suggest a promising benefit-risk profile as we prepare to evaluate this compound in patients. We are excited to advance NDI-219216 into a first-in-human clinical trial later this year."
HPK1 Inhibitor NDI-101150: Phase 1/2 Clinical Study
Nimbus Therapeutics has also completed its Phase 1/2 clinical study of NDI-101150, a highly selective and potent hematopoietic progenitor kinase 1 (HPK1) inhibitor, for the treatment of advanced solid tumors. Clinical data presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting in November 2024 demonstrated monotherapy efficacy with a favorable safety profile, supporting potential combination therapy approaches. The company is actively evaluating opportunities to maximize the therapeutic potential of this program.
Appointment of Peter J. Tummino as President of R&D
In addition to the clinical advancements, Nimbus Therapeutics has appointed Peter J. Tummino, Ph.D., as President of Research and Development. Dr. Tummino will be responsible for advancing the company’s product portfolio through all phases of discovery and clinical development. Jeb Keiper, M.S., M.B.A., Chief Executive Officer of Nimbus, stated that Dr. Tummino's expanded role will be instrumental in advancing their innovative pipeline.
Expanding Drug Discovery Efforts
Nimbus Therapeutics continues to progress drug discovery efforts across metabolic and autoimmune targets, including the development of novel therapies that activate AMP-activated protein kinase (AMPK) to treat metabolic disorders, as part of a research collaboration with Eli Lilly and Company. The company has also expanded its pipeline with the addition of new undisclosed therapeutic targets, leveraging its computational and structure-based drug design approach.
