AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immune-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 disease caused by the SARS-CoV-2 virus, today announced the presentation of positive data from research led by Roswell Park Comprehensive Cancer Center medical oncologist Shipra Gandhi, MD, evaluating Ampligen® (rintatolimod) as a component of a CKM regimen for the treatment of early-stage triple negative breast cancer (TNBC). The data are being presented by Roswell Park Comprehensive Cancer Center in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in Boston, MA, November 8-12, 2022.

The research was led by Dr. Gandhi, a physician scientist who is Assistant Professor of Oncology at Roswell Park, in collaboration with senior investigator Pawel Kalinski, MD, PhD, Chair of Immunology and Senior Vice President for Team Science at Roswell Park.

The poster presentation is available at the following link:        Title: Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib)1Presenting Author: Shipra Gandhi, MDAbstract Number: 547

Guided by the preclinical data Roswell Park proposed this CKM regimen, which combines AIM ImmunoTech’s Ampligen (rintatolimod) (TLR3 agonist), interferon (IFN)-α2b and celecoxib (COX-2 inhibitor), as an approach for selectively inducing cytotoxic T-lymphocytes (CTL)-attractants but decreasing Treg-attractants.2 The Roswell Park researchers hypothesized that the combination of CKM with chemotherapy can promote CTL infiltration and result in higher pathological complete response (pCR)

In a Phase 1 study, 9 patients with stage I-III TNBC, median age 47 (37-55) years, were treated with paclitaxel 80 mg/m2 IV weekly for 12 weeks and CKM for the first 3 weeks, days 1-3 (IV Ampligen 200 mg daily and oral celecoxib 200 mg twice daily). IFN-α2b was administered in an accelerated dose-escalation at 0 or 5 million units (MU)/m2 [dose levels (DL) 1,2 respectively] in the first 2 patients; 10 MU/m2 [DL 3] in 4 patients and 20 MU/ m2 [DL 4] in 3 patients. CKM/paclitaxel was followed by standard dose-dense doxorubicin and cyclophosphamide (AC) and surgery. Dose-limiting toxicity (DLT) was defined as grade 3 or higher toxicities within the first 3 weeks. The primary endpoint was safety and tolerability. Secondary endpoints included pCR rate. Tumor and blood biomarkers were analyzed in exploratory studies.

The results of the study demonstrated that treatment was well-tolerated with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without DLTs or delayed or immune-related toxicities. Grade 3 TRAEs included neutropenia (3/9) attributed to CKM (1/9) or paclitaxel (3/9), pneumonia (1/9) and anemia (1/9) attributed to AC. Additional pneumonia and skin squamous cell carcinoma in situ were observed, unrelated to study treatment. Paclitaxel- or AC-related toxicities were not higher than expected. 5/9 (56%) of patients attained pCR and 1 more patient attained ypTmic. CTL marker CD8α was selectively elevated in post-CKM tumor biopsies (5 patients at DL3 and 4) but decreased in the post-CKM blood.

For more information about the Phase 1 study, visit ClinicalTrials.gov: NCT04081389.

“Building off of the previously developed chemokine modulatory regimen combining interferon-α with TLR3 agonist Ampligen®, and the evaluation Roswell Park presented earlier this year at AACR, we remain encouraged by Ampligen’s demonstrated potential to enhance the effectiveness of taxane-based chemotherapy of breast cancer and potentially other diseases. Ampligen has continued to demonstrate its potential to deliver promising clinical activity in an area where there remain significant immune-related permanent toxicities with the current standard of care. We are pleased with these additional data and look forward to continued evaluation of Ampligen’s potential,” commented Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech.

About Roswell Park Comprehensive Cancer Center

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer’s grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

About Ampligen

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies.

Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

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, Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity being developed 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.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

1 dx.doi.org/10.1136/jitc-2022-SITC2022.0547

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