Nimbus’ Phase 1/2 Trial for NDI-101150 Shows Promise in Treating Advanced Solid Tumors

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Results of the trial found that monotherapy led to clinical benefit in 16.7% of patients, including complete and partial responses in renal cell carcinoma (RCC) patients.

Cancer tumor cell mutation. Generative AI technology. Image Credit: Adobe Stock Images/Hero Design

Image Credit: Adobe Stock Images/Hero Design

Nimbus Therapeutics presented promising data from its Phase 1/2 clinical trial of NDI-101150, a novel HPK1 inhibitor, at the American Society of Clinical Oncology (ASCO) Annual Meeting. According to the company, the trial assessed the treatment as a monotherapy and in combination with pembrolizumab in adults with advanced solid tumors. Results taken from 44 patients in dose escalation cohorts and 15 in dose expansion cohorts found that monotherapy offered clinical benefit to 16.7% of patients, with three patients also maintaining a stable disease over six months. Additionally, six out of eight renal cell carcinoma (RCC) patients experienced stable disease or better, and biopsies showed enhanced CD8+ T cells and dendritic cell infiltration.1

“We are encouraged by these results being presented at ASCO and additional observations to date showing monotherapy clinical benefit and an acceptable safety profile of NDI-101150, further validating HPK1 as a differentiated next-generation immunotherapy target for people living with advanced solid tumors in need of new effective treatment options,” said Nathalie Franchimont, MD, PhD, chief medical officer, Nimbus, in a press release. “HPK1 inhibition is a promising therapeutic approach as it is shown to activate T cells, B cells and dendritic cells to mount a robust anti-tumor response, whereas currently approved checkpoint inhibitors activate T cells. NDI-101150 is a potent and highly selective HPK1 inhibitor that has the potential to achieve significant tumor growth inhibition and make a meaningful difference for patients.”

Back in October, Nimbus announced preliminary data from the Phase 1/2 study of NDI-101150. The data, which included 13 patients, showed promise in safety and efficacy. Monotherapy supported clinical benefits in three patients, with a complete response in a renal cell carcinoma patient and prolonged stable disease in the other two. Further, the patient that experienced a complete recovery was previously treated with a formulation of nivolumab, an immune checkpoint inhibitor antibody.2

“We’re pleased to share these first clinical data from our clinical trial of NDI-101150. We are encouraged by the preliminary efficacy we have seen thus far, which supports the potential of NDI-101150 to provide a meaningful therapeutic option for patients with solid tumors,” said Franchimont, in a press release. “HPK1 inhibition is an exciting approach because of its potential to activate not just T cells, as checkpoint inhibitors do, but also B cells and dendritic cells. We look forward to sharing future updates on NDI-101150, including data from ongoing combination cohorts and dose expansion cohorts.”

According to CIRM, solid tumors consist of brain, ovary, breast, colon and cancers of other tissues. They are also believed to divide in order to create the cells that produce the tumor.3

“Stem cell scientists are studying cancer stem cells from solid tumors in the lab to find ways of destroying them. If these cancer stem cells share characteristics that allow them to be destroyed by the same drug, then a single new drug could significantly improve cancer treatment for a range of different cancer types,” reports CIRM.

References

1. Nimbus Therapeutics Presents New Positive Monotherapy Phase 1/2 Clinical Data of HPK1 Inhibitor in Treatment of Advanced Solid Tumors at 2024 ASCO Annual Meeting. Nimbus Therapeutics. May 23, 2024. Accessed May 24, 2024. https://www.nimbustx.com/2024/05/23/nimbus-therapeutics-presents-new-positive-monotherapy-phase-1-2-clinical-data-of-hpk1-inhibitor-in-treatment-of-advanced-solid-tumors-at-2024-asco-annual-meeting/

2. Nimbus Therapeutics Presents Positive Preliminary Data from Clinical Trial of HPK1 Inhibitor in Solid Tumors at SITC Annual Meeting. Nimbus Therapeutics. October 31, 2023. Accessed May 24, 2024. https://www.nimbustx.com/2023/10/31/nimbus-therapeutics-presents-positive-preliminary-data-from-clinical-trial-of-hpk1-inhibitor-in-solid-tumors-at-sitc-annual-meeting/

3. Solid Tumor Fact Sheet. CIRM. Accessed May 24, 2024. https://www.cirm.ca.gov/our-progress/disease-information/solid-tumor-fact-sheet/

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