Inimmune to Present Trial-in-Progress Poster on First-in-Human Study of INI-4001, a Novel TLR7/8 Agonist, at ASCO 2025

Missoula, MT, May 29, 2025 – Inimmune Corporation, a clinical-stage biotechnology company focused on developing next-generation immunotherapies, today announced that it will present a Trial-in-Progress poster at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 30–June 3, 2025, in Chicago, IL.

The poster, titled “A first-in-human phase 1 clinical trial of INI-4001, a novel TLR7/8 agonist, in patients with advanced solid tumors,” outlines the design and objectives of Inimmune’s ongoing Phase 1 study of INI-4001. INI-4001 is a systemically administered, synthetic TLR7/8 dual agonist formulated in a proprietary clinical nanoparticle designed to activate innate immunity and enhance antitumor responses.

Poster Presentation Highlights:

  • Study Design: Phase 1, first-in-human, open-label, dose-escalation trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of INI-4001 in patients with advanced or metastatic solid tumors.
  • Therapeutic Approach: INI-4001 is engineered to stimulate innate immune pathways, with potential application as both monotherapy and in combination with checkpoint inhibitors.
  • Development Goals: The trial will inform dose selection and biomarker-driven strategies for future studies in oncology.

“This presentation at ASCO marks an important milestone for Inimmune as we advance INI-4001 into the clinic,” said Shannon Miller, PhD, VP of Operations at Inimmune. “Our goal is to harness the power of innate immunity to deliver more effective immunotherapies for patients with advanced cancers. We recently completed dose cohort 4 out of 6 and are excited about the progress of the trial.”

No clinical efficacy or safety data will be presented, as the study is ongoing.

For more information about INI-4001 or Inimmune’s pipeline, please visit www.inimmune.com.

About Inimmune Corporation

Inimmune Corp. (Missoula, MT) is a privately held biotechnology company focused on the discovery and development of innovative immunotherapeutics, vaccine adjuvants, and vaccines. Inimmune is harnessing the human immune system to create safe and effective treatments for allergy, infectious disease, autoimmunity, and cancer. Their laboratories and offices are housed in the Montana Technology Enterprise Center (MonTEC) in Missoula. For more information on Inimmune’s research and development of novel vaccine adjuvants, immunotherapeutics and delivery systems, please visit www.inimmune.com.

Media Contact:
Inimmune Corporation
Phone: (406)-541-5913
Email: info@inimmune.com