AIM ImmunoTech
Announces Presentation of New Data from Roswell Park Comprehensive
Cancer Center Evaluating Ampligen® as a Component of a
Chemokine-Modulating (CKM) Regimen, with Paclitaxel, for the Treatment
of Early-Stage Triple Negative Breast Cancer
– Data selected for poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting
– Treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR)+ microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC)
–
Planned Phase 2 study in early-stage TNBC to determine if CKM including
Ampligen may be a safe and effective alternative to pembrolizumab or
pembrolizumab/NAC
OCALA, Fla., Nov. 14, 2022 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”
or the “Company”), an immune-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 the presentation of positive data
from research led by Roswell Park Comprehensive Cancer Center medical
oncologist Shipra Gandhi, MD,
evaluating Ampligen® (rintatolimod) as a component of a CKM regimen for
the treatment of early-stage triple negative breast cancer (TNBC). The
data are being presented by Roswell Park Comprehensive Cancer Center in a
poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in Boston, MA, November 8-12, 2022.
The
research was led by Dr. Gandhi, a physician scientist who is Assistant
Professor of Oncology at Roswell Park, in collaboration with senior
investigator Pawel Kalinski, MD, PhD, Chair of Immunology and Senior Vice President for Team Science at Roswell Park.
The poster presentation is available at the following link:
Guided
by the preclinical data Roswell Park proposed this CKM regimen, which
combines AIM ImmunoTech’s Ampligen (rintatolimod) (TLR3 agonist),
interferon (IFN)-α2b and celecoxib (COX-2 inhibitor), as an approach for
selectively inducing cytotoxic T-lymphocytes (CTL)-attractants but
decreasing Treg-attractants.2 The Roswell Park researchers
hypothesized that the combination of CKM with chemotherapy can promote
CTL infiltration and result in higher pathological complete response
(pCR)
In a Phase 1 study, 9 patients with stage I-III TNBC, median age 47 (37-55) years, were treated with paclitaxel 80 mg/m2
IV weekly for 12 weeks and CKM for the first 3 weeks, days 1-3 (IV
Ampligen 200 mg daily and oral celecoxib 200 mg twice daily). IFN-α2b
was administered in an accelerated dose-escalation at 0 or 5 million
units (MU)/m2 [dose levels (DL) 1,2 respectively] in the first 2 patients; 10 MU/m2 [DL 3] in 4 patients and 20 MU/ m2
[DL 4] in 3 patients. CKM/paclitaxel was followed by standard
dose-dense doxorubicin and cyclophosphamide (AC) and surgery.
Dose-limiting toxicity (DLT) was defined as grade 3 or higher toxicities
within the first 3 weeks. The primary endpoint was safety and
tolerability. Secondary endpoints included pCR rate. Tumor and blood
biomarkers were analyzed in exploratory studies.
The
results of the study demonstrated that treatment was well-tolerated
with mostly grade 1 or 2 treatment-related adverse events (TRAEs)
without DLTs or delayed or immune-related toxicities. Grade 3 TRAEs
included neutropenia (3/9) attributed to CKM (1/9) or paclitaxel (3/9),
pneumonia (1/9) and anemia (1/9) attributed to AC. Additional pneumonia
and skin squamous cell carcinoma in situ were observed, unrelated to
study treatment. Paclitaxel- or AC-related toxicities were not higher
than expected. 5/9 (56%) of patients attained pCR and 1 more patient
attained ypTmic. CTL marker CD8α was selectively elevated in post-CKM
tumor biopsies (5 patients at DL3 and 4) but decreased in the post-CKM
blood.
“Building
off of the previously developed chemokine modulatory regimen combining
interferon-α with TLR3 agonist Ampligen®, and the evaluation Roswell
Park presented earlier this year at AACR, we remain encouraged by
Ampligen’s demonstrated potential to enhance the effectiveness of
taxane-based chemotherapy of breast cancer and potentially other
diseases. Ampligen has continued to demonstrate its potential to deliver
promising clinical activity in an area where there remain significant
immune-related permanent toxicities with the current standard of care.
We are pleased with these additional data and look forward to continued
evaluation of Ampligen’s potential,” commented Thomas K. Equels, Chief
Executive Officer of AIM ImmunoTech.
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 [email protected].
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.
This
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. 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.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
Print Page
Email to a Friend
