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
May 23 2024 - 5:12PM
Business Wire
– 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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Media Contact Cindy Fung, PhD Nimbus Therapeutics
cindy.fung@nimbustx.com