AIM ImmunoTech Announces Abstract Entitled, Negative Impact of Paclitaxel on Human Breast Tumor Microenvironment and Its Reversal by the Combination of Interferon-α with TLR3 Agonist Rintatolimod, (Ampligen®), Accepted for Poster Presentation by Roswell Park Comprehensive Cancer Center at the AACR 2022 Annual Meeting

OCALA, Fla., March 24, 2022 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), 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 disease caused by the SARS-CoV-2 virus, announced today that research led by Roswell Park Comprehensive Cancer Center medical oncologist Shipra Gandhi, MD, has been accepted for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held April 8-13, 2022, in New Orleans, Louisiana.

Details of the poster presentation are as follows:

Title: Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod
Presenting Author: Shipra Gandhi, MD
Poster Number: 3127
Session: PO.TB06.05 – Secreted Soluble Factors and Exosomes in the Microenvironment
Presentation Type: E-Poster presentation
Session Date and Time: Tuesday, April 12, 2022, from 1:30 to 5:00 p.m. CDT

“Paclitaxel is known to have both immunostimulatory and immunosuppressive effects, but its impact on the chemokine system within the tumor microenvironment remains unclear,” commented Dr. Gandhi, who is undertaking these studies in collaboration with senior author Pawel Kalinski, MD, PhD, Chair of Immunology at Roswell Park. “High levels of the cytotoxic T cell attractants CXCL9, CXCL10 and their common receptor CXCR3 in the breast tumor microenvironment predict higher probability of pathological complete response and improved long-term outcomes in patients treated with neoadjuvant taxanes, but are seen only in a limited portion of patients. Our current data highlight the potential for the chemokine modulatory regimen to enhance the effectiveness of taxane-based chemotherapy of breast cancer and potentially other diseases.”

The accepted abstract detailed data gathered from evaluating paclitaxel’s impact on chemokine production in the human breast tumor microenvironment (TME) and the ability of a chemokine modulatory regimen (CKM) of Ampligen and Interferon-α to mitigate potentially undesirable aspects of taxane chemotherapy.

For the study, fresh breast cancer tissues obtained during routine surgeries, breast cancer cell lines BT-549 and MDA-MD-231 and peripheral blood monocyte-derived macrophages were analyzed immediately or cultured ex vivo for 24 hours in the absence or presence of paclitaxel and/or CKM components. The expression of chemokine genes and secretion of chemokines by freshly harvested and ex vivo-treated tumor explants, cancer cell lines and macrophages were analyzed by quantitative PCR (Taqman) and ELISA. Paired Student t-test was used for statistical analyses.

Breast cancer explants spontaneously expressed high levels of MDSC/Treg-attractants CXCL12 and CCL22, but only marginal levels of cytotoxic T cell (CTL) and natural killer (NK) cell attractants CXCL9, CXCL10, CXCL11 and CCL5. Unexpectedly, paclitaxel treatment resulted in further elevation of granulocyte/MDSC-attractant CXCL8 and CCL22, which was reversed by the combination of paclitaxel with the CKM including Ampligen. At the same time, while paclitaxel alone did not induce any of the CTL attractants tested, its combination with a CKM regimen of Ampligen and Interferon-α was highly effective in inducing CXCL9, CXCL10, CXCL11 and CCL5.

“Building off of a previously developed chemokine modulatory regimen combining interferon-α with TLR3 agonist Ampligen®, Roswell Park set out to further evaluate paclitaxel’s impact on chemokine production. Based on the results, we believe that the combination chemokine modulatory regimen including Ampligen has the potential to mitigate undesirable aspects of taxane chemotherapy. We look forward to further evaluation,” added Thomas Equels, Chief Executive Officer of AIM.

The results of the study identify an undesirable aspect of paclitaxel’s impact on breast cancer. The ability of CKM to enhance the expression of CTL/NK cell attractants and suppress the production of Treg/MDSC attractants produced by paclitaxel provides a strong rationale for further study of the combined use of CKM in taxane-based chemo-immunotherapy of breast cancer and potentially other diseases.

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 disease caused by the SARS-CoV-2 virus.

For more information, please visit www.aimimmuno.com.

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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.

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