Clinical Progress and Business Updates in Oncology Pipeline Reported by Nimbus Therapeutics
Nimbus Therapeutics, a biotechnology company leveraging its advanced computational drug discovery engine to develop breakthrough medicines, today announced significant progress in its clinical oncology pipeline. Additionally, the company appointed Peter J. Tummino, Ph.D., as President of Research and Development. In his new role, Dr. Tummino will oversee the advancement of Nimbus’s product portfolio from discovery through all stages of clinical development.
Nimbus Therapeutics, a clinical-stage biotechnology company specializing in structure-based drug discovery, announced significant updates to its oncology and broader therapeutic pipeline. The company has completed the submission of an Investigational New Drug (IND) application for NDI-219216, a novel Werner syndrome helicase (WRN) inhibitor. This compound is being developed for the treatment of microsatellite instability high (MSI-H) tumors, a type of cancer characterized by genetic instability that can lead to poor treatment outcomes. Nimbus plans to initiate the first clinical trial of NDI-219216 in the first half of 2025 under the leadership of Dr. Anita Scheuber, Senior Vice President and Therapeutic Area Head for Oncology.
“We are encouraged by the momentum building in our oncology portfolio, including advancements in our non-covalent WRN inhibitor program. Data from preclinical studies suggest that NDI-219216 has the potential to be a best-in-class agent,” said Peter J. Tummino, Ph.D., President of Research and Development at Nimbus.
NDI-219216 has shown promising results in preclinical trials, including significant tumor regression and complete responses at low oral doses across various tumor types. The preclinical safety studies have also indicated a favorable benefit-risk profile, which provides optimism as the company prepares to evaluate the compound in patients. Dr. Scheuber expressed excitement about advancing NDI-219216 into a first-in-human clinical trial later in 2025, marking a key milestone in the company’s oncology pipeline.
In addition to the progress with NDI-219216, Nimbus has recently completed a Phase 1/2 clinical study of NDI-101150, a highly selective and potent hematopoietic progenitor kinase 1 (HPK1) inhibitor. This compound is being evaluated for the treatment of advanced solid tumors. Data presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting in November 2024 showed promising monotherapy efficacy, with a favorable safety profile that suggests potential for combination therapy approaches. Nimbus is actively exploring ways to maximize the therapeutic potential of this promising program.
Nimbus has also made significant strides in drug discovery efforts across metabolic and autoimmune diseases. The company is focused on developing novel therapies that activate AMP-activated protein kinase (AMPK), a key target in metabolic disorders. This work is part of an ongoing research collaboration and exclusive worldwide license agreement with Eli Lilly and Company. The company has expanded its pipeline by adding new, undisclosed therapeutic targets, leveraging its unique computational and structure-based drug design platform.
“Nimbus made significant progress in 2024 in our discovery and development programs across oncology, immunology, and metabolism, bringing us closer to our ultimate goal of delivering transformative medicines to patients,” said Jeb Keiper, M.S., M.B.A., Chief Executive Officer of Nimbus Therapeutics. “Peter’s appointment to President of R&D reflects his exceptional leadership and expertise in drug discovery and development. His expanded role will be instrumental in advancing our innovative pipeline. We continue to broaden our drug discovery engine to unlock new, difficult-to-drug targets with compelling biology through our computational expertise, internal drug discovery capabilities, and strategic partnerships.”
Looking ahead, Nimbus is excited to continue making progress in 2025, with several key milestones on the horizon. Mr. Keiper will provide an overview of the company’s progress, pipeline, and anticipated milestones at the upcoming 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025.
About Nimbus Therapeutics
Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company focused on developing novel small-molecule medicines targeting well-validated but difficult-to-drug targets implicated in various human diseases. The company employs a unique strategy combining cutting-edge computational technologies with machine learning-based predictive modeling approaches. Nimbus’ pipeline includes NDI-219216, a WRN inhibitor in development for MSI-H tumors, along with a diverse portfolio of preclinical programs targeting cancer, autoimmune diseases, and metabolic disorders. Nimbus Therapeutics is headquartered in Boston, Massachusetts.
