AIM ImmunoTech Inc (NYSE:AIM) said its clinical development collaborator Roswell Park Comprehensive Cancer Center has commenced patient enrollment in its phase 2 study evaluating Ampligen (rintatolimod) in subjects with primary PD-1/PD-L1 resistant melanoma.
The company said the study, which is funded by the National Cancer Institute (NCI), will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination with tumor-selective chemokine modulation comprised of Interferon alpha 2b, Ampligen, and Celecoxib.
Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system.
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AIM said this single-arm phase 2 study plans to enroll up to 24 patients, with first patient dosing expected in the fourth quarter of 2022.
In a statement, AIM CEO Thomas Equels said the start of this NCI-funded clinical trial marked an important milestone for the company’s 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,” he said.
“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.”
The trial will be conducted at Roswell Park under the clinical leadership of Igor Puzanov, chief of melanoma, and Pawel Kalinski, chair of immunology.
“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,” Kalinski said.
“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.”
AIM is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases.
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