– NDI-101150 treatment associated with increase in activated CD8+ T cells and dendritic cell infiltration in tumors and an acceptable safety profile –

– Treatment with NDI-101150 monotherapy resulted in preliminary evidence of clinical benefit in five patients, including one complete response, one partial response, and three cases of durable stable disease –

Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced the presentation of new positive data from the company’s ongoing Phase 1/2 clinical trial of NDI-101150, a novel, oral small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor in development for the treatment of advanced solid tumors (NCT05128487). Results are being highlighted in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL.

The Phase 1/2 multicenter, open-label trial is designed to assess NDI-101150 as a monotherapy (50-200 mg dose) and in combination with 200 mg pembrolizumab in the treatment of adults with advanced solid tumors. The results being presented at the ASCO Annual Meeting include updated data from 44 patients in the dose escalation cohorts (n=38 on monotherapy, n=6 on combination therapy) and additional data from 15 patients in the dose expansion cohorts. Results, as of March 18, 2024, showed:

• Treatment with NDI-101150 monotherapy was associated with clinical benefit in five out of 30 (16.7%) response-evaluable patients.
• One patient with renal cell carcinoma (RCC) in the dose escalation cohort exhibited a complete response, and one patient with RCC in the dose expansion cohort exhibited a partial response. Both patients were pre-treated with multiple lines of therapies including checkpoint inhibitors.
• Three patients with RCC, pancreatic cancer and endometrial cancer, respectively, maintained durable stable disease (SD) for more than six months while on treatment (21 months for the patient with RCC).
• In the RCC patient population, six out of eight response-evaluable patients had a best overall response of SD or better.
• NDI-101150 showed an increase in activated CD8+ T cells and dendritic cell infiltration in on-treatment patient biopsies compared to archival biopsies, consistent with nonclinical studies of NDI-101150 showing immune cell infiltration and robust anti-tumor activity in murine syngeneic tumor models.
• NDI-101150 is well-tolerated and the overall safety of NDI-101150 remains acceptable.

“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, M.D., Ph.D., Chief Medical Officer at Nimbus. “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.”

The study abstract is available on the ASCO website here and the details of the poster presentation are as follows:

Title: Phase 1/2 Trial of the HPK1 Inhibitor NDI-101150 as Monotherapy and in Combination with Pembrolizumab: Clinical Update

Lead Author: Marcus Noel, M.D.

Date: Saturday, June 1, 2024

Time: 9:00 a.m. – 12:00 p.m. CT

Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Abstract Number: 3083

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. The company advances promising research based on a unique strategy that combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions, and metabolic diseases. The company is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com.

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