Inimmune

Inimmune Inimmue is a biotechnology company founded by pharmaceutical industry veterans focused on developing next generation immunotherapeutics.

Inimmue is a promising new biotechnology company founded by pharmaceutical industry veterans, focused on developing the next generation of immunotherapeutics. The group has extensive expertise in synthetic and process chemistry, drug formulation and immunology. Our pipeline currently includes several compounds and formulations thereof that modulate the innate immune system through Toll-like Recept

ors 4 and 7/8. Current preclinical programs are developing these assets for use in areas of critical patient need such as food allergy, allergic rhinitis, autoimmunity, as well as topically in cancer. Additionally, Inimmune applies its collective 50 years expertise in preclinical drug development to offer various contract services. Inimmune was founded in early 2016. It is located in Missoula, MT and works in close collaboration with the Center for Translational Medicine at the University of Montana as well as several industry and several academia and industry partners.

Inimmune is teaming up with SPI Pharma for a webinar spotlighting globally licenseable and scalable adjuvant technologie...
08/24/2026

Inimmune is teaming up with SPI Pharma for a webinar spotlighting globally licenseable and scalable adjuvant technologies for next-generantion vaccine development.

Dr. Juhienah Khalaf (Inimmune) and Peter Tygesen (SPI Pharma) will explore proven adjuvant platforms including QS-21, TLR4 agonist-based liposomal systems and squalene- and alum- based technologies formulated with a synthetic MPL analogue. The conversation will also cover INI-2002 an affordable and stable TLR4 agonist supporting the development of next-generation adjuvant systems and how these platforms can deliver strong immunogenicity and favorable safety profiles at a cost effective price point.

This session is built for anyone working in vaccine R&D, adjuvant research, preclinical and translational development, business development and licensing, or global health accessibility initiatives.

For millions of people living with allergies, everyday moments, from meals to time outdoors, require constant vigilance....
06/29/2026

For millions of people living with allergies, everyday moments, from meals to time outdoors, require constant vigilance.

Innovation in allergy treatment isn’t just about science. It’s about reducing that burden and improving quality of life.

That’s what drives our work at Inimmune.

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Innovation is driven by people.At Inimmune, our team brings together deep expertise in immunology, clinical development,...
06/09/2026

Innovation is driven by people.

At Inimmune, our team brings together deep expertise in immunology, clinical development, and translational science – all focused on advancing new solutions for patients.

Learn more about us: https://inimmune.com/

Inimmune is proud that our very own scientists have been published again.
06/05/2026

Inimmune is proud that our very own scientists have been published again.

Mizuno et al. describe the synthesis of a human-selective STING agonist, INI3069, that activates conventional TBK1-mediated cellular processes such as IRF3 phosphorylation and ISG expression while blocking TBK1-independent phenotypes including TFEB activation, autophagy, and Golgi trafficking. Using...

06/02/2026

is around the corner!

Inimmune will be participating in this year’s meeting, where our CEO, David Burkhart, Ph.D., is scheduled to present on our approach to advancing disease-modifying and progress from our INI-2004 program.

📍 June 24, 4:15-4:30 p.m. PT

Learn more: https://convention.bio.org/speakers/david-burkhart

Innovation Organization

May is  , a month dedicated to helping patients and families educate their communities and advocate for   safety. Food a...
05/04/2026

May is , a month dedicated to helping patients and families educate their communities and advocate for safety.

Food allergies may be unseen, but they should never be unnoticed. At Inimmune, we’re advancing our allergy program with the needs of millions of people worldwide living with in mind.

Our CEO, David Burkhart, Ph.D., will present at the Food Allergy Fund Summit taking place April 29, 2026, in NYC.Dr. Bur...
04/22/2026

Our CEO, David Burkhart, Ph.D., will present at the Food Allergy Fund Summit taking place April 29, 2026, in NYC.

Dr. Burkhart will join leaders advancing new approaches to treatment and prevention to discuss translating science into solutions for patients with food allergies.

We look forward to joining these critical conversations shaping the future of research and innovation.

Check out the agenda here: https://foodallergyfund.org/summit2026

What does it take to develop a disease-modifying therapy for allergic rhinitis?In a recent interview with  Leader’s  Pro...
04/08/2026

What does it take to develop a disease-modifying therapy for allergic rhinitis?

In a recent interview with Leader’s Proch, our CEO Burkhart shares how Inimmune is advancing INI-2004, a novel intranasal designed to reprogram the immune system and deliver durable responses for patients.

The discussion also explores the nuances of clinical trials, from seasonal timing to the role of controlled chamber studies in improving signal detection.

Read more: https://www.clinicalleader.com/doc/considerations-for-allergic-rhinitis-trials-are-nothing-to-sneeze-at-0001

Inimmune CEO David Burkhart explains how a GSK layoff led to the formation of a new company focused on treating allergic rhinitis. Here, he shares success from the companys approach to site selection, trial design, and timing.

03/26/2026

INIMMUNE IS ON THE MOVE AT THE WVC

We’re excited to share some big updates—highlighted by a special co-presentation from our own Dr. Juhienah Khalaf alongside Dr. Peter Tygesen, Business Development Director at SPI Pharma (our valued partner):
🗓 March 30
📍 Room 209AB
🕛 12:20 PM EST
“Innovative Adjuvants for Global Health.”
Join us at WVC in Washington, DC for the presentation and visit us at booth #452 to explore our cutting-edge adjuvant system pipeline and see how we’re helping shape the future of global health. 💉🔬

03/12/2026

INIMMUNE COMPLETES ENROLLMENT AND DOSES FIRST PATIENT IN PHASE 2 CHAMBER TRIAL OF INI-2004 FOR ALLERGIC RHINITIS

INI-2004 advances as a rapid, disease-modifying immunotherapy for allergic rhinitis with platform potential across all allergic diseases; topline data expected June 2026
Missoula, MT — March 11, 2026 — Inimmune Corporation, a clinical-stage biotechnology company developing novel immunotherapies for allergic diseases, today announced the completion of enrollment and dosing of the first patient in its Phase 2 allergen challenge chamber trial evaluating INI-2004 in patients with allergic rhinitis.
“Allergic rhinitis affects hundreds of millions of people worldwide, yet treatment options remain largely limited to symptom control or lengthy allergen-specific immunotherapy programs,” said David Burkhart, Ph.D., CEO of Inimmune Corporation. “Completing enrollment and dosing the first patient in our Phase 2 study is a significant step toward demonstrating that INI-2004 can rapidly and durably modify the immune response driving allergic disease. We look forward to reporting topline data from the study in June.”
The randomized, placebo-controlled Phase 2 trial is designed to evaluate the safety, tolerability, and efficacy of INI-2004 in patients with allergic rhinitis using a validated allergen exposure chamber model. INI-2004 targets innate immune pathways that drive allergic inflammation and is designed to rapidly reprogram immune responses to allergens, potentially delivering a disease-modifying effect independent of the specific allergen trigger.
“We believe INI-2004 represents a true ‘pipeline in a product,’” said Ferdinand Massari, M.D., Chief Medical Officer of Inimmune Corporation. “By targeting core innate immune pathways involved in allergic disease, this program has the potential to extend beyond seasonal and perennial allergic rhinitis into additional indications, such as food allergies, allergic asthma, and other atopic conditions. Our goal is to deliver a disease-modifying immunotherapy that simplifies treatment for patients and clinicians while transforming how allergic diseases are managed.”
Following completion of the Phase 2 allergen chamber study, Inimmune plans to engage with regulatory authorities to determine the path forward for late-stage clinical development and potential expansion into additional allergic and asthma-related indications.
About INI-2004
INI-2004 is an investigational, allergen-agnostic immunotherapy designed to reprogram immune responses to allergens by activating toll-like receptor 4 (TLR4), a key pathway involved in innate immune signaling. By targeting core immune mechanisms underlying allergic disease, INI-2004 is being developed as a rapid, disease-modifying treatment that may be effective across multiple allergens.
Inimmune is advancing INI-2004 into clinical studies designed to further evaluate its safety and efficacy in allergic rhinitis and other allergic diseases.
About Inimmune Corporation
Inimmune is a clinical-stage biotechnology company focused on the discovery and development of next-generation immunotherapies for the treatment of infectious diseases, allergy, and cancer. Leveraging its proprietary technology platforms, Inimmune is dedicated to creating safe and effective treatments that harness the immune system to improve patient outcomes. For more information, follow us on LinkedIn and visit www.inimmune.com/.
For more information about Inimmune Corporation, contact:
Email: [email protected]
Phone: 406-541-5913

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1121 E Broadway
Missoula, MT
59802

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