AIM ImmunoTech Inc (NYSE:AIM) has announced that data from the ongoing Phase 2 cisplatin-resistant advanced recurrent ovarian cancer clinical study utilizing Ampligen (rintatolimod) has been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held April 8-13, in New Orleans, Louisiana.
In a statement; Thomas Equels, chief executive officer of AIM ImmunoTech commented: "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," he added.
READ: AIM ImmunoTech hails positive data from patient study using Ampligen on advanced and metastatic pancreatic cancer
Details of the abstract presentation are as follows:
- 'Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer', E-Poster presentation by Dr Mackenzy M. Radolec, Clinical Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, UPMC Magee-Womens Hospital on Friday, April 8, 2022, from 12,00pm-1.00pm CDT; Poster Number: 6134; Session: OPO.TB06.01 - Tumor Microenvironment
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 Dr Robert Edwards, 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: two complete responses (15.4%), three partial responses (23.1%), 3 stable disease (23.1%), five 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," saud Dr David Strayer, chief medical officer, chief scientific officer of AIM Immunotech and Board Certified in Medical Oncology.
Roswell Park Comprehensive Cancer Center posters
In a separate statement, AIM ImmunoTech also announced that oncology experts from Roswell Park Comprehensive Cancer Center will present findings from two ongoing clinical studies involving Ampligen (rintatolimod) at the American Association for Cancer Research (AACR) Annual Meeting 2022.
Research led by Roswell Park medical oncologists, Dr Shipra Gandhi and Dr Sarbajit Mukherjee, in collaboration with senior investigator Dr Pawel Kalinski, Chair of Immunology at Roswell Park, has been accepted for presentation as late-breaking poster abstracts at the meeting.
Details of the abstract and late-breaking poster presentations are as follows:
- 'Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to the liver', a late-breaking poster presentation by Sarbajit Mukherjee, on Monday, April 11, 2022, from 9.00am-12.30pm CDT at Poster 2, Section 33
- 'Systemic Rintatolimod and Interferon-alpha2b selectively reprogram local tumor microenvironment in patients with metastatic triple negative breast cancer for enhanced influx of cytotoxic T-lymphocytes but not regulatory T-cells', a late-breaking poster presentation by Shipra Gandhi on Monday, April 11, 2022, from 1.30pm to 5.00pm CDT at Poster 12, Section 35
The late-breaking and clinical trials abstract titles and authors are now available on the AACR Online itinerary planner. The late-breaking and clinical trials abstract text are under embargo until April 8, 2022, at 1.00pm ET.
AIM ImmunoTech 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 coronavirus (COVID-19), the disease caused by the SARS-CoV-2 virus.
Contact the author at jon.hopkins@proactiveinvestors.com