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AIM ImmunoTech says Ampligen data supports synergistic potential with checkpoint blockade therapies

Published: 10:11 21 Apr 2022 EDT

AIM ImmunoTech Inc - AIM ImmunoTech shares Ampligen data supporting synergistic potential with checkpoint blockade therapies
Based on a growing body of clinical data, AIM said it "believes in the potential to expand Ampligen development into treatment of solid tumors"

AIM ImmunoTech Inc (NYSE:AIM) has provided a summary of positive clinical data supporting the synergistic potential of its flagship drug Ampligen (rintatolimod) with checkpoint blockade therapies.

In a statement, AIM ImmunoTech CEO Thomas Equels said: “We have amassed a growing body of encouraging Ampligen data to date through close collaborations with leading KOLs at preeminent institutions.”

He added: “These data have not only affirmed but significantly evolved our belief that Ampligen as a single agent therapy, as well as in combination with the latest powerful cancer therapies, has the potential to become a breakthrough therapy for some of the most difficult to treat and deadly cancers.”

READ: AIM ImmunoTech reports positive data from Phase 2a study evaluating Ampligen as part of a regimen treating colorectal cancer 

Ampligen is the company’s dsRNA drug being developed to fight cancers. It has shown synergy with checkpoint inhibitors, including increasing survival rates and efficacy, in the treatment of animal tumors when used with checkpoint blockade therapies.

The first detection of Ampligen’s synergistic potential with checkpoint blockade therapeutics was witnessed in pre-clinical mouse models of melanoma and pancreatic cancers. Additionally, the company now has data from two clinical studies—in advanced recurrent ovarian cancer and triple-negative breast cancer—that indicate that the drug may have similar anti-tumor activity in humans.

“Working with AIM, our Pancreatic Cancer R&D team at the Buffett Cancer Center did extensive pre-clinical research demonstrating in animal models that Ampligen had a significant therapeutic benefit in treating pancreatic cancer,” said Michael (Tony) Hollingsworth, Associate Director, Basic Research, at the University of Nebraska Medical Center.

In March, Professor CHJ van Eijck and his team at Erasmus MC published data in the journal Cancers showing Ampligen alone was associated with extended overall survival in late-stage pancreatic cancer of 19 months.

“Last week, at AACR, publication of clinical data by UPMC’s Dr Bob Edwards in advanced recurrent ovarian cancer, and Roswell’s Dr Pawel Kalinski in both stage 4 triple negative breast cancer and stage 4 colorectal cancer, strongly supported the advance of Ampligen into human trials for patients in pancreatic and other cancers where checkpoint drugs are not effective,” added Hollingsworth.

Meanwhile, Robert Edwards from the University of Pittsburgh School of Medicine and University of Pittsburgh Cancer Institute noted that checkpoint drugs are “powerful and important therapies,” but only work on ‘hot’ tumors visible to the immune system, not ‘cold’ tumors that are immune-silent.

“Ampligen appears, from these data, to turn cold tumors into hot tumors and create significant therapeutic potential for a successful second round of Ampligen plus checkpoint therapy for those who do not respond to checkpoint therapy alone,” added Edwards.

“In the two ongoing Roswell Park clinical trials we recently presented findings from represent milestones in our 10-year-long NIH and DoD-funded research program aiming to convert immuno-resistant ‘cold’ tumors into ‘hot’ ones that would be more sensitive to immunotherapy,” noted Pawel Kalinski, Senior Vice President for Team Science at, Roswell Park Comprehensive Cancer Center.

“Seeing both studies successfully meet their predetermined efficacy endpoint — selective increase of cytotoxic T lymphocyte markers in tumor tissues — Roswell Park plans to move forward with critical studies assessing therapeutic efficacy of the combination of a rintatolimod-based chemokine-modulating regimen with PD-1 inhibitors, cancer vaccines and/or adoptive T cell therapies in solid tumors.”

Investors can read a comprehensive account of Ampligen’s Phase 2, single-arm safety trial aimed at Recurrent Ovarian Cancer here.

In addition, investors can learn more about a Phase 1 study conducted at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM’s drug candidate Ampligen, and interferon α-2b and pembrolizumab here.

Based on the pre-clinical and human clinical data seen to-date, AIM said it believes Ampligen has the potential to expand into treatment of solid tumors.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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