On October 31, 2023 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, reported initial data from the company’s ongoing Phase 1/2 study of NDI-101150, a small-molecule inhibitor of HPK1, which are being presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting in San Diego, CA (Press release, Nimbus Therapeutics, OCT 31, 2023, View Source [SID1234636594]).
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The data presented at SITC (Free SITC Whitepaper) include initial safety and efficacy results from single agent therapy (n=13) in the dose escalation portion of the trial. Monotherapy treatment with NDI-101150 resulted in clinical benefit in 3 patients: One patient with renal cell carcinoma exhibited a complete response (CR) — the absence of all detectable cancer following treatment — while two patients with pancreatic cancer and renal cell carcinoma, respectively, exhibited prolonged (> 6 months) stable disease. Notably, the renal cell carcinoma patient who experienced a CR and clinical benefit with monotherapy NDI-101150 had been previously treated with and progressed on a regimen of nivolumab, an immune checkpoint inhibitor antibody. Furthermore, NDI-101150 demonstrated an acceptable safety profile below 200 mg/day, the identified non-tolerated dose.
"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 Nathalie Franchimont, M.D., Ph.D., Chief Medical Officer of Nimbus. "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."
The Phase 1/2 trial (NCT05128487) is a multicenter, open-label study to 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 or metastatic solid tumors.
In a second poster at SITC (Free SITC Whitepaper), Nimbus is presenting new preclinical data which support the potential for both broad immunotherapeutic potential and best-in-class selectivity of NDI-101150 among publicly disclosed HPK1 inhibitor programs to date. NDI-101150 was found to be over 300 times more selective for HPK1 than related proteins in the MAP4K family — potentially reducing off-target effects.
"Our driving purpose at Nimbus is to leverage our expertise and technology to design breakthrough medicines for patients," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "The data presented at SITC (Free SITC Whitepaper) reinforce the potential first-in-class and best-in-class profile of our HPK1 inhibitor, and we will continue to work to realize its possible benefits to patients with cancer."