AIM ImmunoTech Announces Encouraging Translational Data from Phase 2 Study Evaluating Ampligen® for the Treatment of Advanced Recurrent Ovarian Cancer

Data presented at the Society for Immunotherapy of Cancer (SITC) 38^th Annual Meeting

Longitudinal comparison of biomarkers in tumor microenvironment showed a gradual, durable response over time in T lymphotactic CXCR3 ligands and cytolytic factors

Phase 2 study ongoing; topline interim results expected before year end

OCALA, Fla., Nov. 08, 2023 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, today announced encouraging translational data from an ongoing Phase 2 clinical trial utilizing AIM’s drug Ampligen^® in patients with platinum-sensitive advanced recurrent ovarian cancer.

The abstract with data illustrations, titled “Combination intraperitoneal chemoimmunotherapy triggers a T-cell chemotactic locoregional response in patients with recurrent platinum-sensitive ovarian cancer,” was presented by collaborators from the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine (“UPMC”) — one of the world’s top centers for the treatment of gynecological cancers — at the recent Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, in San Diego, Calif. The data was also made available at the conference in a poster presentation.

Data highlighted in the abstract were collected by UPMC through translational studies focused on the immune tumor microenvironment (TME), using a longitudinal collection of biospecimens, including plasma, PBMC, IP washes and tumor tissue collected from patients treated in a Phase 2, efficacy/safety trial (NCT03734692) combining intraperitoneal (IP) chemotherapy (cisplatin) with dual agent immunotherapy using intravenous (IV) pembrolizumab (anti-PD1, Keytruda^®, provided by Merck) and IP rintatolimod (Ampligen^®, a dsRNA acting as toll-like receptor 3 -TLR-3- agonist, provided by AIM).

Key Highlights:

• Sequential sampling of the IP cavity showed an increase in cellularity immediately after treatment consistent with an “acute” pro-inflammatory reaction.
• Mesoscale Delivery (MSD) measurements in IP washes revealed an acute increase in granzyme B, perforin, TNF alpha, CXCL9, CXCL10, and CXCL11 after treatment (p<0.05). Longitudinal data revealed a progressive increase in some biomarkers (p<0.05).
• RNA sequencing data showed a significant upregulation acutely in STAT1 and downstream targets, CXCL9, 10, 11 and TH1 type response genes (p<0.05).

Robert P. Edwards, MD, Chief Medical Officer of the UPMC Community and Ambulatory Services Division and Co-Director of the Women’s Cancer Research Center at the UPMC Hillman Cancer Center, stated, “The profound local T-cell cytoxicity activation we see with this combination is markedly improved over previous work we have published on this platform with this recurrent disease profile.”

David Strayer, MD, AIM’s Medical Officer, a Board-Certified oncologist and a former Professor of Medicine and Neoplastic Diseases at Hahnemann University, stated, “We continue to be encouraged by the data being demonstrated by Dr. Robert Edwards and his team at UPMC. These data highlight the effectiveness of combinatorial treatments including Ampligen in modulating the cellular make-up of the tumor microenvironment through cytokine profile changes. These data show a similar profile to previously published data from Roswell Park in Stage 4 triple negative breast cancer. The thing that intrigues me most is the persistent upregulation of the T-lymphotactic cytokines over time, and the lack of immune exhaustion as demonstrated in the ability of the treatment to cause a statistically significant upregulation of these cytokines after repeated treatment. As a whole, these data demonstrate an encouraging result in the promotion of increased T cell chemotaxis and cytolytic function for improved clinical outcomes in patients with advanced recurrent ovarian cancer.”

AIM Chief Executive Officer Thomas K. Equels stated, “There is a significant unmet need in advanced recurrent ovarian cancer and these findings continue to bolster our confidence in Ampligen’s potential. Additionally, we hope to announce topline interim survival results from UPMC in the near future.”

For more information about the Phase 2 clinical trial of platinum-sensitive advanced recurrent ovarian cancer utilizing Ampligen^®, visit clinicaltrials.gov and reference identifier: NCT03734692.

About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The company’s lead product is a first-in-class investigational drug called Ampligen^® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

For more information, please visit aimimmuno.com and connect with the company on Twitter, LinkedIn, and Facebook.

CONTACT: Investor Contact:

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Jenene Thomas
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AIM@jtcir.com