AIM ImmunoTech Inc. Announces the U.S. Department of Defense’s Award of $6.42M to Roswell Park Comprehensive Cancer Center to Study Ampligen as Part of a New Treatment of Brain-Metastatic Breast Cancer
New Ampligen-Related Strategy for Treating Advanced Breast Cancer Earns 'Breakthrough Award'
OCALA, FL / ACCESSWIRE / September 19, 2019 / AIM ImmunoTech Inc. (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers and immune-deficiency diseases - such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) - today announced that the U.S. Department of Defense (DOD) has granted a four-year, $6.42 million "Breakthrough Award" to Roswell Park Comprehensive Cancer Center (Roswell Park) for a clinical study of a combination of therapies, including the company's drug Ampligen, in patients with brain-metastatic breast cancer (BMBC).
Drs. Shipra Gandhi and Pawel Kalinski of Roswell Park Comprehensive Cancer Center will lead a Department of Defense-funded clinical trial assessing a three-pronged immunotherapy strategy for brain-metastatic breast cancer. Image courtesy of Roswell Park
The funding is through the DOD's Breast Cancer Research Program, which started the Breakthrough Awards to support research that has the potential for a major impact and to accelerate progress toward ending breast cancer. The phase II trial, slated to open in 2020, would be the first clinical study to assess the effectiveness of a three-pronged strategy combining distinct immunotherapy approaches:
A new dendritic-cell treatment vaccine developed by Pawel Kalinski, MD, PhD, and colleagues in collaboration with Brian Czerniecki, MD, PhD, Chair of the Breast Oncology Department at Moffitt Cancer Center in Tampa, Florida
Chemokine modulation using a combination proposed and validated by Dr. Kalinski as an optimized adjuvant for dendritic-cell vaccines, incorporating Ampligen and interferon alfa-2b
Immune checkpoint inhibition
The team will study this approach first in patients with localized BMBC, or breast cancer that has begun to spread to the brain but is not yet widely disseminated.
"A major limitation of cancer immunotherapy is that tumors adapt to naturally occurring effector cells by shutting down production of the relevant chemokines in the tumor microenvironment," said Dr. Kalinski, overall Principal Investigator for the project, in a release. "Our strategy uses a unique combination of biologic agents to make tumors visible to the immune system by making them look like tissue that's been infected by a virus. We've never tested them all together before in patients, but the findings from earlier clinical and preclinical studies lend strong support for assessing this combination even in the most aggressive and hard-to-treat cancer types."
"We believe that this is an important milestone for AIM ImmunoTech, as Ampligen being a part of this Breakthrough Award presents an opportunity for establishing the proposition that these combinational therapies may help to turn 'cold' tumors that don't respond to existing therapies into 'hot' ones that the immune system can be trained to recognize and attack," said AIM ImmunoTech CEO Thomas K. Equels.
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. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For example, no assurance can be given as to whether the current or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data. Among other things, for forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
