INIMMUNE ANNOUNCES FIRST CANCER PATIENT DOSED IN PHASE 1 CLINICAL STUDY USING THE IMMUNOTHERAPEUTIC INI-4001, A NOVEL TLR7/8 AGONIST

MISSOULA, Mont., July 24, 2024 /PRNewswire/ -- Inimmune, a clinical stage biotech company focused on the development of novel immunotherapies, vaccines, and vaccine adjuvants announced today the dosing of the first patient in its Phase 1 single ascending dose study of INI-4001 in patients with advanced solid tumors.

This is an open-label, multiple-ascending dose, two-part dose ranging and cohort expansion study of INI-4001 in patients with advanced solid tumors. This first-in-human trial of INI-4001, Inimmune's proprietary TLR7/8 agonist in a nanoparticle delivery system, will consist of two parts. In Phase 1a, single dose escalation cohorts receiving monotherapy INI-4001 will determine PK, safety, and tolerability. This is followed by Phase 1b where patients who have progressed or have stable disease after 3 cycles of INI-4001 will be allowed to receive concurrent administration of an anti-PD-1 or anti-PD-L1 immunotherapy plus INI-4001.

In pre-clinical studies, INI-4001 was efficacious both as a monotherapy and in combination with anti-PD-1 checkpoint therapy in syngeneic murine tumors (LLC, MC38 and B16F10). Additionally, INI-4001 has been shown to induce production of the cytokine IFNα and activation of antigen presenting cells, leading to downstream T cell activation in vivo. INI-4001 may prove to be an ideal combination agent with checkpoint inhibitors given that a minority of patients currently benefit from checkpoint inhibitor monotherapy.

Inimmune's CEO, Alan Joslyn, said "We are very excited that INI-4001 clinical trials have commenced, as this marks an important milestone for our company and oncology patients. INI-4001 either as monotherapy or in combination with checkpoint therapy can potentially provide physicians a new therapeutic option in their treatment toolbox."

Inimmune's trial of INI-4001 is being conducted in Australia and is expected to be complete by the end of 2025. Additional information can be found at clinicaltrials.gov (NCT06302426).

About Inimmune:
Inimmune Corp. (Missoula, MT) is a privately held clinical stage biotechnology company focused on the discovery and development of novel immunotherapies, vaccines, and vaccine adjuvants. 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 and delivery systems, please visit www.inimmune.com.

Contact:
Media Relations
Inimmune Corporation
Phone: (406)-541-5913
Email: [email protected]

SOURCE Inimmune Corporation