On August 30, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported its clinical development collaborator, Roswell Park Comprehensive Cancer Center ("Roswell Park"), in a clinical trial fully funded by the National Cancer Institute (NCI), has commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant melanoma (Press release, AIM ImmunoTech, AUG 30, 2022, View Source [SID1234618763]). The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination with tumor-selective chemokine modulation ("CKM") comprised of Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib.
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"The start of this NCI-funded clinical trial marks an important milestone for our Melanoma R&D program. Despite recent successes of immune checkpoint inhibitors in advanced-stage disease, only a minority of treated melanoma patients have a durable benefit, reinforcing the need to develop second-line therapies that are effective against checkpoint-refractory disease. Based on the data seen to-date, we believe Ampligen, in combination with Roswell’s polarized dendritic cell vaccine plus interferon, has an opportunity to fill this gap and potentially provide clinical benefit to melanoma patients in need," commented AIM Chief Executive Officer Thomas K. Equels.
Ampligen (rintatolimod) is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country.
The single-arm Phase 2 study plans to enroll up to 24 subjects. Subjects will be on active experimental treatment for 12 weeks. In the absence of disease progression, patients will be followed for progression-free survival (PFS) and overall survival (OS) within routine care. Patients with progressive disease at 12 months can, at the physician’s discretion, begin CTLA-4± PD-1/PDL1 inhibitor treatment and will be followed as per standard of care for this disease group. Patients will continue to be monitored for PFS and OS within standard care visits (every 3 months for up to 2 years). The primary endpoint of the study is objective response rate (ORR) at 12 weeks (only in participants who have completed the first 3 treatment cycles), which will be evaluated using RECIST 1.1 criteria.
The trial will be conducted at Roswell Park under the clinical leadership of Igor Puzanov, MD, MSCI, FACP, Chief of Melanoma at Roswell Park, and the overall scientific leadership of Pawel Kalinski, MD, PhD, Roswell Park Chair of Immunology. Enrollment of patients is underway.
"We are interested in further exploring the potential of rintatolimod for the treatment of refractory melanoma and appreciate AIM’s participation and collaboration in this study," said Dr. Kalinski. "Based on the pre-clinical data demonstrated, we believe that combining our vaccine approach with the rintatolimod-based modulation of the tumor microenvironment in a first-in-human trial has potential for converting checkpoint (PD1)-resistant ‘cold’ melanomas into PD1-sensitive ones. We look forward to getting this study underway and remain dedicated to evaluating the potential effectiveness of rintatolimod for this application."