OCALA, Fla., March 09, 2022 — 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 data from the ongoing Phase 2 cisplatin-resistant advanced recurrent ovarian cancer clinical study utilizing Ampligen® (rintatolimod) was accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held April 8-13, 2022, in New Orleans, Louisiana.
The clinical trials abstract titles and text are now available on the AACR Online itinerary planner. Details of the abstract presentation are as follows:
Title: Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer
Presenting Author: Mackenzy M. Radolec, MD, Clinical Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, UPMC Magee-Womens Hospital
Poster Number: 6134
Session: OPO.TB06.01 – Tumor Microenvironment
Presentation Type: E-Poster presentation
Session Date and Time: Friday, April 8, 2022, from 12:00 pm – 1:00 p.m. CDT
The investigator initiated, Phase 2, single arm, efficacy/safety trial to evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP Ampligen (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab (IVP) for patients with recurrent platinum-sensitive ovarian cancer is being conducted by the University of Pittsburgh Medical Center.
“These findings suggest induction of T cell activation together with clinical responses may indicate prognostic evidence of tumor environment reprogramming we do not see with chemotherapy alone and may extend survival,” commented Robert Edwards, MD, University of Pittsburgh School of Medicine and University of Pittsburgh Cancer Institute.
A total of 17 patients were enrolled and 13 were evaluable for response in the ongoing Phase 2 trial. Peritoneal fluid aspiration (IP wash) was performed in 13 patients at multiple time points during each cycle of treatment. Washes were collected on Days 1-3 of each cycle, before and after each treatment. Washes from cycle 1, 4 and 6, were included in this analysis. The MesoScale Delivery (MSD) platform was used to profile different biomarkers in the peritoneal samples throughout treatment.
The observed clinical responses were: 2 complete responses (15.4%), 3 partial responses (23.1%), 3 stable disease (23.1%), 5 progressions (38.4%) for a clinical benefit rate (CR+PR+SD) of 61.6%. From 13 patients, 77 IP wash samples were collected at serial time points. MSD measurements in IP washes revealed an acute increase in granzyme B, perforin, TNF alpha, CXCL9, CXCL10, CXCL11 after treatment (p<0.05). Longitudinal data revealed a progressive increase in some biomarkers in the locoregional environment; CXCL9, CXCL10, CXCL11, perforin and TNF alpha were all increased from baseline levels at cycle 1 to baseline of cycle 6 (p<0.05). CXCL12 was also increased acutely after treatment (p<0.05).
“The anti-cancer approach being applied by Dr. Edwards and his team appears to be working, and hopefully will pay large clinical dividends. By combining three drugs – Ampligen and pembrolizumab, which are both immune therapies, with cisplatin, a chemotherapy – evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function has been seen. Importantly, increases of these biomarkers in the tumor microenvironment have been correlated with favorable tumor responses,” stated David Strayer, MD, Chief Medical Officer, Chief Scientific Officer of the Company and Board Certified in Medical Oncology.
“The interim results from this ongoing Phase 2 study are very encouraging. The observed clinical response rate of 61% includes two complete and three partial tumor responses, plus three patients with stable disease among the 13 evaluable patients. An important priority will be to confirm these findings through continuing to enroll patients onto this important study. Further, these data in Advanced Recurrent Ovarian Cancer and the recently published positive data in Advanced Pancreatic Cancer reaffirm our commitment to go full speed ahead in developing Ampligen for these lethal unmet medical needs. There are lives in the balance and our team is determined to make a difference,” concluded Thomas Equels, Chief Executive Officer of AIM.
For more information about the Phase 2 clinical trial of cisplatin-resistant 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 disease caused by the SARS-CoV-2 virus.
For more information, please visit www.aimimmuno.com.
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. This is an ongoing study and we believe the interim results are generally positive, however no conclusions can be drawn until the full study is completed. 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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