Immunitas Presents Phase 1/2a Data Highlighting Anti-Tumor Activity of Novel Immunotherapy IMT-009 at AACR 2026 Annual Meeting

Translational findings suggest biomarkers associated with tertiary lymphoid structures may help identify patients most likely to benefit from IMT-009 treatment

Apr. 20, 2026 at 6:38am

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An extreme close-up, translucent X-ray image revealing the intricate internal structure of a cancer cell, glowing against a dark background to conceptually represent the innovative approach of the IMT-009 immunotherapy.Cutting-edge X-ray imaging sheds light on the molecular mechanisms behind a promising new cancer immunotherapy.San Diego Today

Immunitas Therapeutics presented Phase 1/2a clinical data for IMT-009, its first-in-class anti-CD161 antibody, at the American Association for Cancer Research (AACR) Annual Meeting 2026. The data highlights IMT-009's potential as a novel immunotherapy with early signs of anti-tumor activity in heavily pretreated patients, as well as a favorable tolerability profile both as a monotherapy and in combination with fruquintinib.

Why it matters

The findings from this study suggest IMT-009 could address significant unmet needs across difficult-to-treat cancers. The emerging biomarker insights may also help guide patient selection and inform future development strategies for IMT-009, both as a monotherapy and in combination with other therapies.

The details

In the dose-escalation portion of the trial, 22 patients were treated with IMT-009 monotherapy, and 26 patients were enrolled in the biomarker cohort expansion across selected tumor types. In the Phase 1b combination arm, 19 patients with second- to fourth-line microsatellite stable (MSS) colorectal cancer received IMT-009 in combination with fruquintinib. Key findings include: 1) Preliminary anti-tumor activity in heavily pretreated patients, with one confirmed partial response observed in the monotherapy arm and one in the combination arm; 2) Favorable tolerability profile, with the highest treatment-related adverse event observed being Grade 2 in the monotherapy study and one Grade 4 treatment-emergent adverse event that was not considered related to IMT-009 in the combination arm; and 3) Translational analyses suggesting the presence and number of CLEC2D-positive/CD161-positive tertiary lymphoid structures, as well as CXCL13 expression, may be associated with clinical benefit and could help inform future patient selection approaches.

  • As of January 30, 2026, the data was presented at the AACR Annual Meeting 2026, which took place from April 17-22, 2026 in San Diego, California.

The players

Immunitas Therapeutics

A clinical stage precision immunotherapy company committed to discovering and developing novel, antibody-based therapeutics for patients with autoimmune diseases and cancer.

Amanda Wagner

Chief Executive Officer at Immunitas Therapeutics.

Susanna V. Ulahannan, M.D.

The presenting author from The University of Oklahoma, Stephenson Cancer Center/SCRI.

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What they’re saying

“These data highlight IMT-009's potential as a novel immunotherapy with a differentiated mechanism designed to address significant unmet needs across difficult-to-treat cancers.”

— Amanda Wagner, Chief Executive Officer

What’s next

The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). The company plans to continue the clinical development of IMT-009 as both a monotherapy and in combination with other therapies.

The takeaway

The early clinical data and translational findings for IMT-009 suggest this novel immunotherapy has the potential to address significant unmet needs in difficult-to-treat cancers. The biomarker insights may help guide patient selection and inform future development strategies, which could ultimately improve outcomes for cancer patients.