AIM ImmunoTech Announces the National Cancer Institute’s Award of $14.54M to Study Ampligen as Part of Five Roswell Park-led Chemokine Modulation Clinical Trials in Melanoma, Colorectal and Ovarian Cancers

On April 6, 2020 The National Cancer Institute reported an award of $14.54 million to Roswell Park Comprehensive Cancer Center to test chemokine modulation incorporating AIM ImmunoTech’s Ampligen as an immuno-modulator as part of a strategy to turn ‘cold’ tumors into ‘hot’ tumors (Press release, AIM ImmunoTech, APR 6, 2020, View Source;id=188846&p=2174901&I=1206939-c7Z3G6f3m8 [SID1234556150]). Chemokine modulation is designed to enhance the effectiveness of common immunotherapies and lead to new, life-saving combination therapies for people battling cancer.

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HIGHLIGHTS

Prestigious grant will fund 5 clinical trials in patients with 3 cancer types
Focus is targeting chemokine system to make ‘cold’ tumors ‘hot’
Strategy to be studied in patients with colorectal, ovarian or melanoma tumors
The multi-center team will be led by Pawel Kalinski, MD, PhD of Roswell Park, in collaboration with partners at University of Pittsburgh Medical Center (UPMC) and The Tisch Cancer Institute at Mount Sinai. The planned clinical trials include two studies in patients with metastatic colorectal cancer, two in advanced ovarian cancer and one in patients with checkpoint-resistant advanced melanoma. Three of the five studies will be conducted at Roswell Park, with the two ovarian cancer studies to be led at UPMC’s Hillman Cancer Center, with participation from Roswell Park.

Kalinski plans five Phase II or Phase IIA clinical trials to assess the efficacy of combining the chemokine-modulating effects of Ampligen with common checkpoint blockade inhibitors that are used to treat different cancer types. According to Kalinski, traditionally, only about 20% of cancer patients are good candidates for such checkpoint inhibitors.

Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center, is leading the team conducting the planned five clinical trials studying Ampligen. Photo credit Roswell Park Comprehensive Cancer Center.

"Ampligen is a unique and highly selective immune system modulator that can be an important component of chemokine modulation therapy, one of the available strategies for converting cancers that are traditionally checkpoint-resistant into treatable, ‘hot’ tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies," said Dr. Kalinski, who is Vice Chair for Translational Research, the Rustum Family Professor for Molecular Therapeutics and Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park.

"The work of Professor Kalinski and his team at Roswell Park is charting a path forward for the future of immuno-oncology. Roswell Park, one of our country’s first and foremost cancer research centers, lives up to its tradition of excellence," said David Strayer, MD, AIM’s medical director and noted oncologist.

All five studies are expected to open by year-end 2021.

Six Ampligen clinical trials are currently underway at academic cancer centers – including several at Roswell Park, under the guidance of Dr. Kalinski – testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors. AIM will promptly update stockholders and the market as more information on these studies becomes available. However, with the nation’s health care system increasingly focused on the COVID-19 pandemic – and with cancer patients especially at risk for the disease – AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency.

Read Roswell Park’s full announcement here: View Source