AIM ImmunoTech Announces Positive Data from Phase 2a Study Evaluating Ampligen® as a Component of a Chemokine Modulatory (CKM) Regimen for the Treatment of Colorectal Cancer Metastatic to the Liver
11 April 2022 - 9:05PM
AIM ImmunoTech Announces Positive Data from Phase 2a Study
Evaluating Ampligen® as a Component of a Chemokine Modulatory (CKM)
Regimen for the Treatment of Colorectal Cancer Metastatic to the
Liver
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 the
presentation of data from the ongoing Phase 2a clinical study at
Roswell Park Comprehensive Cancer Center evaluating AIM ImmunoTech
Inc. drug candidate, Ampligen® (also known as rintatolimod) as a
component of treatment for colorectal cancer metastatic to the
liver at the American Association for Cancer Research (AACR) Annual
Meeting 2022, being held April 8-13, 2022, in New Orleans,
Louisiana.
The presented research was led by Roswell Park
medical oncologist Sarbajit Mukherjee, MD, MS, in collaboration
with senior investigator Pawel Kalinski, MD, PhD, Chair of
Immunology at Roswell Park. Title: Initial results
of a phase II study evaluating a chemokine-modulatory (CKM) regimen
in patients with colorectal cancer metastatic to the
liverPresenter: Sarbajit Mukherjee, MD, MS
Based on preclinical data and previous reports
showing the prognostic value of intratumoral CD8+ T cell (CTL) in
colorectal cancer (CRC) outcomes, it was hypothesized that systemic
infusion of the combination of IFNα-2b with Ampligen (selective
TLR3 ligand for i.v. use) could reprogram the local balance between
the CTL- and regulatory T cell (Treg)-attracting chemokines and the
resulting patterns of immune infiltrates in liver tumors.
This early Phase 2a trial studied how well
celecoxib, recombinant interferon alfa-2b, and Ampligen work in
treating patients with colorectal cancer that has spread to the
liver. The study was designed on the basis that 1) celecoxib may
stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth; 2) Recombinant interferon alfa-2b is a
substance that can improve the body's natural response and may
interfere with the growth of tumor cells; and 3) Ampligen may
stimulate the immune system, so that giving celecoxib, recombinant
interferon alfa-2b, and Ampligen together may help reprogram the
tumor microenvironment and make the tumors more responsive to
immune therapy.
For the study, recurrent/metastatic CRC patients
with unresectable liver metastases amenable to biopsy were
eligible. Patients had prior treatment (Rx) with fluoropyrimidine,
irinotecan, oxaliplatin, and an anti-EGFR targeted therapy (if RAS
wt), or contra-indication to such. Patients received IFNα-2b IV (20
million units/m2 IV daily) and Ampligen (200 mg IV daily) plus oral
celecoxib (200 mg twice daily) on days 1, 2, 3, 8, 9, 10, 15, 16,
and 17. Response assessment was done via liver biopsies (pre-Rx and
on day 24 ± 4 days) and CT imaging (RECIST v1.1) on Day 46. The
primary endpoint was the change in CD8+ T-cells before Rx, with
that seen post-Rx (measured by quantitative RT-PCR as a ratio of
CD8α to a housekeeping gene, HPRT). With a sample size of N=12
evaluable pts, the study design had a 90% power to detect a 0.77
standard deviation increase (pre- to post Rx) at a significance
level of 0.1. Nineteen patients with microsatellite stable (MSS)
CRC were enrolled in the study between Apr 2018 and Oct 2020, and
12 were evaluable for the primary endpoint.
“The primary endpoint of this study, a
significant increase in CD8a expression post-treatment, along with
increases in CTL-attracting chemokines coupled with a decrease in a
key Treg/MDSC attractant indicate a positive immune effect on the
tumor microenvironment and suggest this CKM approach has the
potential to increase tumor responses to checkpoint inhibitors”,
commented David R. Strayer, MD.
Summary of Key Findings:
- The study's primary endpoint was
met, evidenced by increased CD8a expression post-treatment
(p=0.046).
- Saw increase in the CD8a/CD4
(p=0.03), CD8a/FOXP3 (p<0.01) and GZMB/FOXP3 (p<0.01)
ratios.
- The expression of CTL-attracting
chemokines CCL5 (p=0.08), CXCL9 (p=0.05), and CXCL10 (p=0.06) were
increased, while expression of the Treg/MDSC attractant CXCL12
(p=0.07) was decreased post-treatment.
- Median OS was 10.5 (90% CI
2.2-15.2) months, and the median PFS was 1.5 (90% CI 1.4, 1.8)
months.
- No tumor responses were seen. The
treatment was well tolerated. Of all enrolled patients (N=19),
adverse events were noted in 74% of patients, with the most common
being fatigue (58%). Grade 3 or higher adverse events were rare
(5%).
For more information about the study, please visit
ClinicalTrials.gov: NCT03403634.
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 disease caused by the SARS-CoV-2 virus. For
more information, please visit www.aimimmuno.com.
Cautionary Statement
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. The Phase 2a
Study discussed above will require further studies. Studies and
trials are subject to many factors including lack of regulatory
approval(s), lack of study drug, or a change in priorities at the
institutions sponsoring other trials. Significant additional
testing and trials will be required to determine whether the use of
Ampligen® as a component of a chemokine modulatory (CKM) regimen
for the treatment of colorectal cancer metastatic to the liver will
be useful and enhance effectiveness of immunotherapies or
otherwise, and no assurance can be given that this will be the
case.
Investor Relations ContactJTC
Team, LLCJenene Thomas 833-475-8247AIM@jtcir.com
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