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 Receptors 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 Adds Key Executives in Advance of Phase 2 Allergic Rhinitis Data to Accelerate Clinical Expansion into Food All...
03/05/2026

Inimmune Adds Key Executives in Advance of Phase 2 Allergic Rhinitis Data to Accelerate Clinical Expansion into Food Allergy and Allergic Asthma

Missoula, MT – February 26, 2026 – Inimmune Corporation, a clinical-stage biotechnology company developing next-generation immunotherapies, today announced the appointments of Dr. Ferdinand Massari as Chief Medical Officer and Ryan McMillian as Head of Financial Strategy. The addition of these two accomplished biotech industry veterans strengthens the company’s leadership team as Inimmune advances the clinical expansion of its lead allergic rhinitis program into allergic asthma and food allergy.
Dr. Massari brings more than two decades of experience in clinical development and translational medicine across immunology and inflammatory diseases. He has a proven track record of building high performing clinical teams to deliver commercial success at both biotech and large pharma companies. As CMO, he will lead Inimmune’s clinical strategy and ex*****on, guiding the continued development of the company’s lead allergy program and its planned expansion into allergic asthma and food allergy, two areas with significant unmet patient need and limited disease-modifying treatment options. Dr. Massari is assuming the role of CMO previously held by Dr. Jon Ruckle, who successfully led Inimmune’s oncology and allergy programs through Phase 1 clinical trials.
Mr. McMillian joins Inimmune as Head of Financial Strategy, bringing extensive expertise in biotech finance, corporate strategy, and capital formation. In this role, he will oversee financial planning and strategic initiatives designed to support the company’s growing clinical portfolio and long-term value creation strategy.
“Inimmune is entering an important phase of growth as we broaden the scope and impact of our allergy program,” said David Burkhart, Chief Executive Officer of Inimmune Corporation. “Our Phase 2 trial in allergic rhinitis is completing enrollment and we expect to report top-line data in June 2026. As we prepare to expand into allergic asthma and food allergy, Dr. Massari’s deep clinical development experience and Mr. McMillian’s financial and strategic leadership will be instrumental in successfully supporting that expansion.” Dr. Massari added, “INI-2004 could revolutionize the treatment of allergic rhinitis and food allergies providing patients with the first truly disease-modifying therapy that is highly safe, effective, rapid and convenient.”
Building on this milestone, the company is preparing to expand development of their rapid, disease modifying immunotherapy to include allergic asthma and food allergy—conditions that affect millions worldwide and impose a substantial health and economic burden.
The appointments of Dr. Massari and Mr. McMillian reflect Inimmune’s commitment to assembling a world-class leadership team capable of advancing innovative immunotherapies through clinical development and toward commercialization.
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.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the clinical development, potential benefits, and future prospects of INI-2004. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Inimmune undertakes no obligation to update any forward-looking statements.

For more information about Immune Corporation, contact:
https://inimmune.com/
Email: Info@inimmune.com

Harnessing the Immune System to Improve Human Health Our Pipeline Our Pipeline Harnessing the Immune System to Improve Human Health Our Pipeline Our Pipeline July 24, 2024 July 16, 2024 May 15, 2024 January 8, 2024 December 1, 2023 November 30, 2023 July 24, 2024 July 16, 2024 May 15, 2024 January 8...

03/03/2026

Inimmune is looking for a Formulations Research Associate. Check out the posting below.

03/03/2026

.......... .
lnimmune
Job Description

JOB TITLE: RESEARCH ASSOCIATE
Work Location: Inimmune - 1121E Broadway, Ste 121, Missoula, MT 59802
Division/Department: □ Chemistry □ Immunology � Formulations □ Admin □ Quality □ Clinical
Supervisor/Manager:
Work Status: � Full-time □ Part-time □ Contract

Duties and Responsibilities:
Contribute to the design, preparation, and characterization of novel vaccine and adjuvant formulations supporting discovery and early development programs.
Perform and support development of analytical methods, including HPLC and physicochemical characterization techniques, to evaluate formulation performance, stability, and quality attributes.
Design and execute experiments with increasing independence while collaborating cross-functionally with immunology and chemistry teams.
Ability to perform limited troubleshooting with formulation methods and analytical instrumentation.
Designs experiments with limited/some supervision.
Maintain accurate and compliant laboratory records and review notebooks of team members for quality.
Ensure compliance with all company policies, SOPs, and safety standards.
Contribute to the preparation of technical presentations and data summaries for departmental and company meetings.
Education, Skills, and Experience Requirements:
Bachelor’s degree with 2 or more years, or master’s degree with 1 or more years, of relevant laboratory experience.
Experience developing, optimizing, and executing HPLC methods for analytical characterization is desirable.
Strong hands-on laboratory skills, including accurate experimental ex*****on, solution preparation, data analysis, and meticulous documentation.
Working knowledge of FDA regulatory expectations and documentation practices related to drug development is preferred.
Strong written and verbal communication skills, with the ability to summarize and present experimental findings to cross-functional teams.
Proficiency in statistical evaluation and graphical presentation of scientific data using appropriate analytical tools.
Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint, for data analysis, documentation, and presentation preparation.
Ability to manage multiple priorities and meet project timelines in a fast-paced research environment.
Physical Requirements:
Able to perform essential duties consistent with ADA, FMLA, and other federal, state, and local standards.
Ability to maintain regular and punctual attendance consistent with ADA, FMLA, and other federal, state, and local standards.
Ability to lift 50 lbs.
Supervisory Responsibilities:
None

02/04/2026

MEDICINAL CHEMISTRY INTERN 2026
Join Inimmune Corp. as a Medicinal Chemistry Intern to gain hands-on experience synthesizing compounds and collaborating on drug discovery and development projects.
Key responsibilities include:
• Synthesizing novel chemical intermediates and final compounds.
• Reviewing chemical literature to guide reaction sequences.
• Setting up, monitoring (TLC and/or LCMS and/or HPLC) and working-up reactions.
• Purifying compounds by automated chromatography or recrystallization.
• Generating and interpreting analytical data.
• Helping develop plans to address medicinal chemistry goals.
• Maintaining a complete laboratory notebook.
• Work closely with experienced chemists to learn process and discovery programs for optimization, synthesis and characterization of small organic compounds.
The company is looking for:
• Enrollment in an undergraduate/graduate degree program in Organic Chemistry or Medicinal Chemistry.
• Practical experience with organic synthesis, methods development, total synthesis, or similar.
• Ability to work in a laboratory environment.
• Minimum of one-year prior laboratory experience.
• Good verbal and written communication skills.
• Creative thinking and teamwork abilities.
• Interest in attending program events including social gatherings and career development workshops.
• Ability to commit to a 12 week, full-time, 40 hours per week, during summer 2026.
• Legal authorization to work in the United Stated without sponsorship, now and in the future.
• Position is fully onsite at the Missoula, Montana location.
Training & Development
• Exposure to medicinal chemistry research and cross-functional collaboration
• Opportunity to learn about adjuvants discovery principles
• Gain professional hands-on experience in a Biotech company setting.
• Social events for interns and company-wide participation

Apply online via Indeed or send resume / CV directly to HR@Inimmune.com

12/05/2025

Generation of a shelf-stable, broadly-reactive influenza vaccine formulated
with TLR4, TLR7/8, or TLR9 stimulating adjuvants

11/24/2025

Inimmune participates in the development of an innovative intranasal influenza vaccine

Inimmune is part of a European consortium, led by the Medical University of Vienna, whose goal is to develop a next-generation vaccine against influenza strains with pandemic potential
The consortium aims to be selected under the European Commission’s EU4Health programme

Girona, XX November 2025 – Inimmune, a leading clinical stage biotech company focused on the development of novel vaccine adjuvants, immunotherapies and delivery systems, announced today they are participating in a pioneering European project that seeks to transform the way we protect ourselves against influenza. The initiative, coordinated by the Medical University of Vienna, aims to develop a next-generation intranasal vaccine capable of providing broader and longer-lasting protection, not only against seasonal influenza strains but also against strains with pandemic potential. The consortium has submitted its proposal to HaDEA (European Health and Digital Executive Agency) and is seeking to be selected under the European Commission’s EU4Health programme.
Inimmune brings over 20 years of vaccine development experience to the program and contributes their proprietary vaccine adjuvant INI-4001 which enhances the vaccine efficacy. Specifically, Inimmune will lead the creation of the optimized mucoadhesive intranasal formulation, support preclinical studies, prepare formulations for GLP toxicology and future clinical manufacturing by providing scalable adjuvant production and formulation expertise, critical components enabling the vaccine’s safety, stability, and immunogenicity.
Influenza remains one of the leading threats to public health worldwide. According to the World Health Organization (WHO), it causes between 290,000 and 650,000 deaths every year due to respiratory complications . In addition, influenza viruses are constantly changing, which requires vaccines to be updated annually and can reduce their effectiveness. These characteristics, combined with vaccination fatigue among the population, highlight the need for more effective, longer-lasting vaccines with less invasive administration routes.
A vaccine designed to increase acceptance and curb transmission
The vaccine candidate proposed by the consortium will use a pioneering strategy based on one of the main surface proteins of the influenza virus, which in turn is one of the most conserved. The vaccine will facilitate the work of healthcare professionals, and it is intended to stimulate a stronger local immune response in the respiratory mucosa
Contributing to Europe’s objective of strategic autonomy in public health
This project contributes to the European Union’s strategic health objectives, particularly in the areas of health security and preparedness for potential pandemics. It will provide an innovative solution that combines advanced scientific design, European industrial production, and a model of exemplary public–private collaboration. The vaccine, which is intended to be stable between 2 and 8 °C, will be designed for rapid and large-scale deployment, reinforcing Europe’s strategic autonomy and reducing dependence on non-EU manufacturers in health emergency situations.
With this project, Inimmune reaffirms its commitment to innovation in human health and its role as a key partner in building a future better prepared to face infectious threats.
Current status and next steps
The consortium is currently awaiting the resolution from HaDEA, to whom the project proposal was submitted under the EU4Health programme. Since the first three specific contracts are planned to be signed in 2025, it is expected that the European Commission will announce the tenderers selected for the first phase of a total length of 98 months by the end of the year. The indicative budget amounts to EUR 147,951,410, which represents the indicative ceiling for each of the framework contracts to be signed.
A European collaboration integrating academia, cutting-edge research, and vaccine manufacturing expertise
Coordinated by the Medical University of Vienna (Austria), the project leverages HIPRA’s industrial leadership and vaccine R&D expertise. The University of Bergen (Norway) leads the phase I clinical trial, while Karolinska Institutet (Sweden) provides mucosal immunology analysis. The University of Boku (Austria) specializes in purification processes, Inimmune

(USA) contributes its proprietary adjuvant (INI-4001) and extensive formulation expertise, and Mount Sinai Hospital (USA) adds expertise in vaccine design.
Together, these complementary strengths make the consortium uniquely equipped to develop innovative intranasal influenza vaccines.
About Inimmune
Inimmune Corp. (Missoula, MT) is a privately held clinical-stage 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.
Contact:
Media Relations
Inimmune Corporation
Phone: (406)-541-5913
Email: info@inimmune.com

08/13/2025
06/02/2025

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.

02/26/2025

Inimmune Welcomes Dr. Heather Madsen of Hatteras Venture Partners to Board of Directors

Missoula, MT – [Date] – Inimmune Corporation, a clinical-stage biotechnology company specializing in next-generation immunotherapies, is pleased to announce the appointment of Dr. Heather Madsen to its Board of Directors. Dr. Madsen, a distinguished life sciences executive and Operating Partner at Hatteras Venture Partners, brings extensive expertise in the creation of high-performing life science teams and strategic growth initiatives.
“We are thrilled to welcome Dr. Madsen to our Board,” said Dr. David Burkhart, CEO and co-founder of Inimmune. “Her diverse experience spanning early R&D to post-marketing including strategic development will be invaluable as we continue to advance our immunotherapy pipeline and expand our impact in the biotech space.”
With a background in genetics and over twenty years of experience across drug discovery and clinical development, Dr. Madsen has a deep understanding of the scientific and business landscapes that drive the success of healthcare companies. She joined Hatteras Venture Partners in 2024 to spearhead new company incubation as well as identify and support innovative biotech companies for the Hatteras portfolio. Prior to joining Hatteras, Dr. Madsen held leadership positions at GSK and ViiV Healthcare contributing to the growth and development of high-potential therapeutics, vaccines, and technologies. She is a co-author of 40 peer-reviewed scientific publications and a co-inventor of 3 patents.
“Inimmune has demonstrated remarkable progress in developing novel immunotherapies to treat allergy and cancer that have the potential to transform patient care,” said Dr. Madsen. “I look forward to working with the leadership team to support the company’s growth and help bring innovative treatments to market.”
Dr. Madsen’s appointment comes at a pivotal time for Inimmune as the company advances its clinical programs and seeks strategic partnerships to accelerate the commercialization of its groundbreaking immunotherapies.
For more information about Inimmune and its leadership team, please visit www.inimmune.com.
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.

02/26/2025

February 26, 2025
Inimmune to present successful Phase I allergy trial results at the American Academy of Allergy Asthma & Immunology meeting in San Diego, February 28-March 3, 2025.

Missoula, MT, February 26, 2025 - Inimmune Corporation, a clinical-stage biotechnology company specializing in next-generation immunotherapies for cancer, allergy, autoimmunity, and vaccines will attend the AAAAI meeting in San Diego from February 28-March 3 where Dr. Jay Evans, Inimmune’s Chief Scientific and Strategy Officer, will provide an update on Inimmune’s clinical stage treatment for seasonal allergic rhinitis (https://annualmeeting.aaaai.org/).
Inimmune’s disease-modifying allergy treatment, INI-2004, is an allergen agnostic immunotherapy that binds and activates toll-like receptor 4 (TLR4). In response to the ragweed challenge, participants in our Phase I study treated with INI-2004 intranasally showed a dose-dependent improvement in nasal congestion as measured by acoustic rhinometry compared to placebo participants. Additionally, all doses of INI-2004 were well tolerated over multiple administrations.
Inimmune CEO, Dr. David Burkhart, noted that Rapid disease-modifying treatment for allergies are urgently needed and we are enthusiastic about positive Phase 1 Clinical Trial results with INI-2004.”
The AAAAI is a leading organization providing resources and education for allergists, immunologists, and patients across the spectrum of allergies, asthma, and related immune deficiency disorders. Their annual meeting beings together global experts in allergy and immunology to discuss the latest clinical advancements.
About Inimmune:
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 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: info@inimmune.com

Address

1121 E Broadway
Missoula, MT
59802

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