Harnessing the Immune System to Improve Human Health

Harnessing the Immune System to Improve Human Health

Pipeline

The Inimmune team is passionate about developing disease-modifying immunotherapies for indications with major unmet medical needs. Two of our assets, INI-4001 (a TLR7/8 agonist) and INI-2004 (a TLR4 agonist) have advanced into clinical trials. INI-4001 has demonstrated safety, tolerability and on-target immune activation in a Phase 1 clinical trial for all solid tumors. Our dedicated team has also advanced INI-2004, a next generation TLR4 agonist, into the clinic via intranasal administration, where it demonstrated an exemplary safety profile. We are now developing sublingual formulations for clinical use in food allergy therapy. Our adjuvants are in late-stage development, with clinical trials currently being initiated for an INI-4001 adjuvanted opioid vaccine and additional adjuvanted vaccine clinical trials planned for 2027. At the discovery and pre-clinical stage, Inimmune has a deep pipeline of innate agonists and antagonists that are being developed as disease-modifying immunotherapies for other inflammatory diseases.  

Changing The Landscape

Inimmune is a clinical-stage, fast-moving innovative biotech company focused on the discovery and development of novel immunotherapeutics to treat inflammatory conditions. Inimmune has a deep pipeline of innate immune modulating clinical and pre-clinical assets to treat inflammatory diseases, such as cancer, food allergy, and autoimmune conditions, and for use as vaccine adjuvants. Anchoring these seemingly disparate disease indications is the innate immune system, where all immune responses begin. Altering the immune response from the first step creates a deep ripple effect, driving sustained and durable change to treat and prevent disease.

Pipeline

The Inimmune team is passionate about developing disease-modifying immunotherapies for indications with major unmet medical needs. Two of our assets, INI-4001 (a TLR7/8 agonist) and INI-2004 (a TLR4 agonist) have advanced into clinical trials. INI-4001 has demonstrated safety, tolerability and on-target immune activation in a Phase 1 clinical trial for all solid tumors. Our dedicated team has also advanced INI-2004, a next generation TLR4 agonist, into the clinic via intranasal administration, where it demonstrated an exemplary safety profile. We are now developing sublingual formulations for clinical use in food allergy therapy. Our adjuvants are in late-stage development, with clinical trials currently being initiated for an INI-4001 adjuvanted opioid vaccine and additional adjuvanted vaccine clinical trials planned for 2027. At the discovery and pre-clinical stage, Inimmune has a deep pipeline of innate agonists and antagonists that are being developed as disease-modifying immunotherapies for other inflammatory diseases.  

Our Clinical Trials

Inimmune will complete a Phase I clinical trial in oncology using INI-4001, a TLR7/8 agonist, in Q4 of 2026. INI-4001 monotherapy has demonstrated safety, tolerability and on-target immune activation in a Phase 1 clinical trial for all solid tumors. We are currently seeking partners to advance INI-4001 to the next stage of clinical development as a combination immunotherapy.

INI-2004 has also successfully completed clinical trials in allergy when used as an intranasal therapy, demonstrating an exemplary safety profile. Inimmune is currently developing sublingual formulations for use in food allergy therapy and preparing for clinical trials that use intranasal INI-2004 as a mucosal adjuvant for respiratory pathogen vaccines.

Partnerships & Collaborations

We partner with some of the best universities and biotech companies. Want to co-create and develop novel immunotherapeutics to improve human health?

SPI Pharma_171x50 (2)
We have partnered with SPI Pharma, Inc. to develop and commercialize innovative vaccine adjuvant systems. SPI Pharma specializes in drug development services, having participated in over 60 commercially launched and marketed drugs globally.
Boston Childrens Hospital_99x40
Inimmune collaborates on multiple adjuvant discovery and development projects with the labs of Drs. Ofer Levy and David Dowling. Current projects are focused on the development of adjuvanted opioid and pertussis vaccines.
Cleveland Clinic_158x40
We have a long-standing collaboration with Dr. Ted Ross at Cleveland Clinic working on developing an adjuvanted universal influenza vaccine.
Columbia University_230x35
As part of our opioid vaccine development efforts, we are collaborating with Dr. Sandra Comer at Columbia University. Dr. Comer is a leader in the field of opioid vaccine clinical trials.
Duke University_103x45
For our work developing a sublingual food allergy treatment, we are collaborating with Drs. Herman Staats and Brandi Johnson-Weaver.
Icahn School_220x40
We collaborate with Drs. Florian Krammer and Adolfo Garcia-Sastre on multiple projects focused on developing new adjuvanted influenza vaccines.
Intrommune_200x31
We are collaborating with Intrommune to co-develop an adjuvanted food allergy treatment. We are exploring the combination of our clinical-stage TLR4 agonist, INI-2004, with Intrommune’s clinical-stage oral mucosal immunotherapy, INT301.
Oregon Health Science University_200x50
At OHSU, we collaborate with Dr Victor DeFilippis on our STING adjuvant discovery project.
University of Chicago_159x40
We are collaborating with Dr. Aaron Esser-Kahn on discovering novel combination adjuvants.
University of Montana_212x40
Inimmune collaborates with the Center for Translational Medicine Adjuvant Research Team on multiple projects past and present, including our opioid vaccine, TRAC478 vaccine adjuvant, and INI-1098 vaccine adjuvant development projects.
University of North Carolina_164x45
We collaborate with Drs. Mike Kulis and Johanna Smeekens at UNC on the development of a sublingual food allergy therapy.
University of Washington_158x40
At UW, we collaborate with Dr. Marco Pravetoni on our opioid vaccine development project and Dr. Michael Gale on an early-stage adjuvant discovery project.

Careers

We are a biotech company founded by pharmaceutical industry veterans, focused on developing the next generation of vaccines and immunotherapeutics. We have extensive expertise in synthetic and process chemistry, drug formulation, immunology, and clinical translation. Our goal at Inimmune is to recruit, hire, and maintain a diverse workforce. Equal employment opportunity is good business. Equal opportunity applies to all aspects of our employment, including recruitment, selection, hiring, training, transfer, promotion, termination, compensation, and benefits.