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, today announced 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. 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.

“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.”

For more information about the Phase 2 study, visit ClinicalTrials.gov: NCT04093323

About Roswell Park Comprehensive Cancer Center

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancer's grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or ASKRoswell@RoswellPark.org.

About Ampligen

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies.

Ampligen is currently 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. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

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, immune disorders, and viral diseases, including COVID-19. The Company’s lead product, Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity being developed for globally important cancers, viral diseases and disorders of the immune system.

For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook.

Cautionary StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. The Phase 2 Clinical Trial discussed above is subject to a number of unknowns including, but not limited to, whether the trial will yield favorable results, and that significant additional testing and trials will be required to determine whether Ampligen, as part of a CKM when combined with a type-1 polarized dendritic Cell (αDC1) vaccine, will be effective in treating melanoma patients with Primary PD-1/PD-L1 Resistance. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

 

Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
AIM@jtcir.com
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