Inimmune Presents Late-Breaking Phase 1 INI-4001 Results Demonstrating On-Target Immune Activation in Advanced Solid Tumors at SITC 2026

Study demonstrated no dose-limiting toxicities and dose-responsive cytokine production consistent with TLR7/8 engagement

Results support continued clinical development of INI-4001 as a potential monotherapy and in combination with other cancer treatments

MISSOULA, Mont., Nov. 6, 2026 — Inimmune, a clinical-stage biotechnology company developing novel immunotherapies, vaccine adjuvants and other immune-modulating technologies, today announced Phase 1 results for INI-4001, an investigational small-molecule TLR7/8 agonist, in heavily pretreated patients with advanced solid tumors (NCT06302426). The study demonstrated no dose-limiting toxicities (DLTs) and dose-responsive cytokine production consistent with on-target immune activation. The data are being presented today by Shannon Miller, Ph.D., Vice President at Inimmune, in a late-breaking poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting.

"The Phase 1 data provide encouraging evidence that INI-4001 can activate the TLR7/8 pathway as intended, supporting its potential as a novel approach to cancer immunotherapy," said David Burkhart, Ph.D., Chief Executive Officer of Inimmune. "Despite advances in cancer treatments, many patients do not respond to existing therapies. We believe INI-4001 may help address this challenge by stimulating innate immune activity and making tumors more responsive to immunotherapy. These findings support continued clinical development of INI-4001 as a potential monotherapy, while we also look to explore its use in combination with other cancer treatments."

The Phase 1 study evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of INI-4001 in 10 heavily pretreated patients with advanced solid tumors. INI-4001 was administered intravenously once weekly across five escalating dose levels and was tolerated at doses up to 7.2 µg/kg, with no dose-limiting toxicities reported. Adverse events were primarily transient and consistent with innate immune activation, generally resolving within 24 hours. No concerning pharmacokinetic findings were observed.

Pharmacodynamic analyses demonstrated dose-responsive cytokine production consistent with TLR7/8 activation. At the proposed Phase 2 dose, maximum increases from pre-dose levels included 13.5-fold in IFNγ and 4.15-fold in IP-10, supporting evidence of on-target immune activation. Transient, dose-dependent decreases in circulating lymphocytes were also observed, with levels rebounding within 24 hours, consistent with potential lymphocyte trafficking to tissues and tumors.

Although the study was not designed to evaluate efficacy, two of the 10 patients continue to receive INI-4001 under compassionate use, with no reported disease progression. One patient with a small bowel neuroendocrine tumor has received INI-4001 for 19 months, while a second patient with chondrosarcoma has received treatment for nine months.

Based on these findings, Inimmune is evaluating plans to advance INI-4001 into a Phase 2a clinical study as early as 2027 to further assess its potential as a cancer immunotherapy, subject to securing funding or partnership support.

The late-breaking abstract is published in the Journal for ImmunoTherapy of Cancer and can be accessed through the SITC 2026 abstract database.

Contact Information:

Investor Relations
Inimmune Corporation
(406) 541-5913
[email protected]

Media Relations
Sarah Hall
6 Degrees PR
(215) 313-5638
[email protected]

SOURCE Inimmune Corporation