Inimmune Corp.

Intranasal administration of a synthetic Toll-Like Receptor 4 (TLR4) agonist INI-2004 significantly reduces allergy symptoms following therapeutic administration in a murine model of allergic sensitization. MISSOULA, Mont., July 30, 2024 /PRNewswire/ -- Inimmune, a leading biotech company focused on the development of novel immunotherapies and vaccine adjuvants announced the publication of pre-clinical efficacy and safety data for INI-2004. "Intranasal administration of a synthetic TLR4 agonist INI-2004 significantly reduces allergy symptoms following therapeutic administration in a murine model of allergic sensitization" was published in Frontiers in Immunology on July 23, 2024 (). This research highlights the significant disease modifying impacts of INI-2004 in allergic disease following intranasal administration and describes the remarkable safety profile of this innovative treatment. INI-2004 is a fully synthetic allergen-agnostic immunotherapy that binds and activates TLR4. In a murine model of allergic rhinitis (AR), the disease modifying effect of intranasally administered INI-2004 was measured by a significant reduction in airway resistance, eosinophil influx, and cytokines involved in the pathogenesis of allergic rhinitis AR. These IND-enabling studies formed the basis for a recently completed Phase 1a/b clinical trial (NCT06038279) demonstrating that INI-2004 is safe and well tolerated over multiple administrations and improves nasal congestion in people suffering with allergic rhinitis. This data demonstrates the utility of the mouse allergy model in evaluating TLR4 agonists as immunomodulatory drugs and proof of principle for the efficacy of INI-2004. Allergic rhinitis impacts over 400 million people globally and is one of the most common chronic diseases in the United States impacting 10-30% of adults and 40% of children. Safe and effective disease modifying treatments are still needed for allergic illness. "Treating the underlying disease is a critical step in stopping progression of atopy, especially for people who are poly-sensitized to multiple allergens. Inimmune is excited about this disease modifying novel treatment option for allergic rhinitis," said Inimmune's Chief Scientific and Strategy Officer, Dr. Jay Evans. About Inimmune Corporation Inimmune Corp. (Missoula, MT) is a privately held biotechnology company focused on the discovery and development of innovative immunotherapeutics, 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, MT (USA). For more information on Inimmune's research and development of novel immunotherapies, vaccine adjuvants, and delivery systems, please visit . Contact: Media Relations Inimmune Corporation Phone: (406)-541-5913 Email: [email protected] SOURCE Inimmune

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

WILMINGTON, Del., July 16, 2024 /PRNewswire/ -- SPI Pharma, Inc. a global leader in biopharmaceutical excipient and adjuvant systems, and Inimmune, Corp., a pioneering biotechnology company specializing in the discovery and development of innate immune modulators, announce an agreement in principle to create a strategic collaboration to develop and commercialize advanced adjuvant systems for vaccine development. This collaboration leverages Inimmune's world-class expertise in adjuvant formulation and immunotherapeutics and SPI Pharma's extensive manufacturing and global commercial capabilities. Adjuvant systems are critical components of vaccines that enhance immune response and efficacy. The partnership will aim to provide reliable supply and open access to advanced adjuvant systems, addressing significant unmet needs in vaccine development and accelerating the availability of these technologies to healthcare providers and patients globally. "Inimmune's dedication to advancing immunological research coupled with SPI Pharma's robust commercial infrastructure creates a powerful synergy," said John McInerney, Vice President of Commercial for SPI Pharma. "Together, we are poised to deliver innovative solutions that can potentially transform vaccine efficacy and patient outcomes worldwide." "We are excited to collaborate with SPI Pharma to bring our vaccine adjuvant technologies to market," said Alan Joslyn, Ph.D., CEO of Inimmune. "This partnership underscores our shared commitment to improving public health through innovation." 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 via novel innate immune modulators 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 . About SPI Pharma: SPI Pharma, headquartered in Wilmington, Delaware, USA, provides innovative products and technical solutions to global pharmaceutical customers. Product lines include Vaccine Adjuvant Systems, Drug Delivery Systems, Antacid Actives, Taste Masking and Excipients. SPI Pharma specializes in drug development services, having participated in over 60 commercially launched and marketed drugs globally. With its sites in the United States, France, and India, the company solves the most challenging formulation problems –– efficiently, cost-effectively, and with a focus on service. For more information, visit . Inimmune contact information: Alan Joslyn CEO Inimmune Corp [email protected] SPI Pharma contact Information: Donald Loveday Global Business Development Manager SPI Pharma [email protected] SOURCE SPI Pharma, Inc.