On September 24, 2019 AIM ImmunoTech (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, reported the U.S. Department of Defense (DoD) has granted $8.32 million in funding in another "Breakthrough Award (Press release, AIM ImmunoTech, SEP 24, 2019, View Source [SID1234539736])". This award is to Moffitt Cancer Center for a Phase 2 clinical study of a combination of therapies, including the Company’s drug Ampligen, in patients with brain-metastatic breast cancer (BMBC).
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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. As recently announced, Roswell Park Comprehensive Cancer Center (Roswell Park) reported receipt of its own DoD-funded Breakthrough Award of $6.42 million to study Ampligen in the treatment of BMBC. Together, these separate but parallel proposed clinical trials are receiving approximately $15 million in DoD funding to study Ampligen as a tumor microenvironment modulating agent component of a dendritic cell vaccine approach in the treatment of brain-metastatic breast cancer, which include both brain parenchyma and leptomeningeal sites of metastasis.
The grant to Moffitt Cancer Center was made possible by the unique complementary preclinical and clinical expertise of the teams of Dr. Brian Czerniecki of Moffitt Cancer Center and Dr. Pawel Kalinski of Roswell Park. The researchers hypothesize that vaccination with HER2/HER3-loaded dendritic cells (alpha-DC1s) combined with tumor-selective chemokine modulation (CKM) will be clinically effective and may enhance antitumor efficacy of PD-1 blockade when treating BMBC. Ampligen is a component of CKM therapy.
"Treatment of brain metastasis to the central nervous system is a large need for women with metastatic breast cancer and this novel immunotherapy offers promise to this group of patients," said Dr. Czerniecki, chair of the Department of Breast Oncology at Moffitt Cancer Center.
The researchers’ submitted impact statement highlights this need: "The current treatments, such as surgery or radiotherapy (whole-brain radiation or stereotactic radio-surgery), or intrathecal (I.T.) chemotherapy, constitute a significant burden for patients and do not prevent recurrence and death. The proposed immune therapy will provide new treatment options for these patients who currently face a very grim prognosis."
"These combination therapies are designed to convert ‘cold’ tumors that don’t respond well to existing immune therapies into ‘hot’ tumors that are more susceptible to targeting by immune therapies," said Equels. "We are honored to have Ampligen evaluated as part of a combination therapy in brain-metastatic breast cancer in this DoD-funded comprehensive clinical trial at Central Florida-based Moffitt Cancer Center, one of the world’s premier breast cancer research centers. Brain-metastatic breast cancer is a devastating illness with very poor prognosis, and we are hopeful that Ampligen will play a major role in providing hope to these patients."