AIM ImmunoTech and Study Collaborator Roswell Park Commence Enrollment in an NCI-funded Phase 2 Clinical Trial Evaluating Ampligen® (rintatolimod) in Primary PD-1/PD-L1 Resistant Melanoma
30 Août 2022 - 1:30PM
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
AIM ImmunoTech (AMEX:AIM)
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