Month: May 2024

– 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 –

BOSTON, Mass. – May 23, 2024 – 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.

Media Contact

Cindy Fung, PhD

Nimbus Therapeutics

cindy.fung@nimbustx.com

BOSTON–(BUSINESS WIRE)–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 appointment of Anita Scheuber, M.D., Ph.D., as Senior Vice President, Therapeutic Area Head, Oncology. In this role, Dr. Scheuber will lead the company’s clinical development strategy in oncology, including advancing its ongoing clinical program targeting hematopoietic progenitor kinase 1 (HPK1) and preclinical program targeting Werner syndrome helicase (WRN), as well as guiding early discovery efforts in oncology.

“We are delighted to welcome Anita to the executive team as we enter a new stage of growth at Nimbus with plans to further expand our focus in oncology,” said Nathalie Franchimont, M.D., Ph.D, Chief Medical Officer at Nimbus. “Her deep expertise and leadership in global clinical development will be a significant advantage for us as we build our pipeline of promising, highly potent and selective small molecules including our WRN program, which is expected to enter the clinic next year.”

Dr. Scheuber joins Nimbus with more than 15 years of experience in the pharmaceutical industry leading oncology clinical development strategy and execution on more than a dozen programs. She has extensive experience in small molecule and immuno-oncology drug development, ranging from early discovery and pre-candidate selection to late-stage development across different tumor types at both small biotechnology and large pharmaceutical companies. Most recently, she provided strategic consulting to biotechnology companies, developing clinical development strategies for multiple early-stage oncology assets. Previously, she served as Vice President and Head of Clinical Development, Oncology at Trillium Therapeutics (acquired by Pfizer in 2021). She also previously served as Vice President of Clinical Development, Oncology at Boston Pharmaceuticals. Before that, she held leadership roles of increasing responsibility at Pfizer and GSK. Dr. Scheuber earned her M.D. from the University of Zurich and her Ph.D. in Neurosciences from Pierre and Marie Curie (now Sorbonne) University in Paris. She completed a post-doctoral fellowship at Harvard Medical School and residencies at Cantonal Hospital in Lucerne and University Hospital Zurich in Switzerland.

“Nimbus has a proven track record of success in setting new standards in precision drug targeting and molecule engineering, bringing a new generation of potentially transformative medicines to patients in need of better treatment options. I am particularly impressed by the compelling data emerging from the company’s HPK1 Phase 1/2 clinical study showing preliminary monotherapy efficacy in patients with advanced solid tumors, and best-in-class potential of the WRN program,” said Dr. Scheuber. “With several important milestones ahead including new data from the HPK1 trial and initiation of the first-in-human WRN trial, I look forward to working closely with the team to build new levels of momentum in our oncology programs moving forward.”

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.