AIM ImmunoTech Reports Third Quarter 2022 Financial Results and Provides Corporate Update
15 Novembre 2022 - 01:00PM
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 reported its
financial results for the third quarter 2022 and provided a
business update.
“Over the course of 2022 and throughout this
past quarter, we have remained focused on successfully executing on
our clinical development programs. I am incredibly pleased with the
progress we’ve made and am excited for what remains ahead of us.
Not only have we delivered on our commitments by initiating
studies, but we have also commenced enrollment and are on track to
reach targeted milestones that lay on the horizon. As we enter the
final stretch for 2022, I believe we are well-positioned to reach
the value-driving catalysts across our pipeline. We have been, and
will continue to be, committed to generating near- and long-term
value for all stakeholders,” commented Thomas K. Equels, Chief
Executive Officer of AIM.
Recent Highlights
- Presented 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) at the Society for
Immunotherapy of Cancer (SITC) 37th Annual Meeting.
- Received Orphan Drug Designation
for Ampligen® (rintatolimod) for the treatment of Ebola Virus
Disease.
- Announced FDA clearance of IND
application to evaluate Ampligen in Phase 2 clinical study for the
treatment of post-COVID conditions.
- Commenced enrollment with study
collaborator, Roswell Park, in an NCI-funded Phase 2 clinical trial
evaluating Ampligen in primary PD-1/PD-L1 Resistant Melanoma.
- Announced commencement of Phase 2
study of Ampligen for the treatment of Pancreatic Cancer.
Clinical Program Update
Ampligen® (rintatolimod): dsRNA 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 therapeutic synergy with
checkpoint inhibitors, including increasing survival rates and
efficacy, in the treatment of animal tumors when used in
combination with checkpoint blockade therapies. The first detection
of Ampligen’s synergistic potential with checkpoint blockade
therapeutics was witnessed in pre-clinical mouse models of melanoma
and pancreatic cancers. Additionally, the Company now has data from
two clinical studies — in advanced recurrent ovarian cancer and
triple negative breast cancer — that indicate that the drug may
have similar anti-tumor activity in humans.
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 U.S. Ampligen is also being used
to treat pancreatic cancer patients in an Early Access Program
(EAP) approved by the Inspectorate of Healthcare in the Netherlands
at Erasmus Medical Center.
Immuno-Therapy Targeting Multiple Cancers with High Unmet
Need
- Locally Advanced Pancreatic Cancer
(“LAPC”) – The Company recently commenced its Phase 2 study of
Ampligen as a therapy for LAPC (AMP-270) following receipt of
Institutional Review Board (“IRB”) approval for the trial protocol.
The AMP-270 clinical trial is a randomized, open-label, controlled,
parallel-arm study with the primary objective of comparing the
efficacy of Ampligen versus a no treatment control group following
FOLFIRINOX for subjects with locally advanced pancreatic
adenocarcinoma. Secondary objectives include comparing safety and
tolerability. AMP-270 is expected to enroll approximately 90
subjects in up to 30 centers across the United States and Europe.
The Buffett Cancer Center at the University of Nebraska Medical
Center and Erasmus MC in the Netherlands are expected to be the
primary study sites. ClinicalTrials.gov: NCT05494697.
- Advanced
Recurrent Ovarian Cancer – Phase 1/2 study of intraperitoneal
chemo-immunotherapy in advanced recurrent ovarian cancer. Phase 1
portion was completed and published in the American Association for
Cancer Research publication, Clinical Cancer Research (Clin Cancer
Res January 19, 2022 DOI: 10.1158/1078-0432.CCR-21-3659). The Phase
2 portion of the study is planned to be conducted in the future.
ClinicalTrials.gov: NCT02432378
- Advanced
Recurrent Ovarian Cancer – A follow-up Phase 2 study of advanced
recurrent ovarian cancer using cisplatin and pembrolizumab, plus
Ampligen; up to 45 patients to be enrolled; numerous patients have
commenced treatment. We announced interim data from the study
demonstrating that evidence of increased biomarkers associated with
T cell chemotaxis and cytolytic function was seen when combining
Ampligen, pembrolizumab and cisplatin. Increases of these
biomarkers in the tumor microenvironment have been correlated with
favorable tumor responses. Interim results announced March 2022
detailed an observed clinical response rate of 61% includes two
complete and three partial tumor responses, plus three patients
with stable disease among the 13 evaluable patients. An important
priority will be to confirm these findings through continuing to
enroll patients onto this study. ClinicalTrials.gov:
NCT03734692
- Stage 4
Colorectal Cancer Metastatic to the Liver – Phase 2a study of
Ampligen as a component of a chemokine modulatory regimen on
colorectal cancer metastatic to liver was completed and met primary
endpoint, evidenced by increased CD8a expression post-treatment
(p=0.046).; 15 patients were treated and 12 patients were evaluable
for the primary endpoint. Data suggest that chemokine modulatory
(CKM) regimen with Ampligen may be useful to enhance effectiveness
of immunotherapies. The data from the Phase 2a study was presented
in April 2022 at the American Association for Cancer Research
(AACR) Annual Meeting 2022. ClinicalTrials.gov: NCT03403634
- Stage 4
Metastatic Triple Negative Breast Cancer – Phase 1 study of
metastatic triple-negative breast cancer using CKM therapy,
including Ampligen and pembrolizumab, successfully met primary
endpoint. Positive data from this proof-of-concept study
demonstrate that short-term systemic CKM followed by pembrolizumab
is well-tolerated and selectively enhances local cytotoxic
T-lymphocyte (CTL) infiltration in the tumor microenvironment
(TME). The data from the Phase 1 study was presented at the
American Association for Cancer Research (AACR) Annual Meeting 2022
in April 2022. ClinicalTrials.gov: NCT03599453
-
Early-Stage Prostate Cancer – Phase 2 study investigating the
effectiveness and safety of aspirin and Ampligen with or without
interferon-alpha 2b (Intron A) compared to no drug treatments in a
randomized three-arm study of patients with prostate cancer before
undergoing radical prostatectomy. Patient enrollment has been
initiated in this study designed for up to 45 patients.
ClinicalTrials.gov: NCT03899987
-
Early-Stage Triple Negative Breast Cancer – Phase 1 study of
chemokine modulation plus neoadjuvant chemotherapy in patients with
early-stage triple negative breast cancer has received FDA
authorization. The objective of this study is to evaluate the
safety and tolerability of a combination of Ampligen and celecoxib
with or without Intron A, when given along with chemotherapy. The
goal of this approach is to increase survival. Positive data was
recently presented at the SITC 37th Annual Meeting demonstrating
the Chemokine-Modulating (CKM) Regimen including Ampligen was well
tolerated, with promising clinical activity of pathologic complete
response (pCR) + microinvasive residual disease (ypTmic). Planning
is underway for a Phase 2 study in early-stage TNBC to determine if
CKM including Ampligen may be a safe and effective alternative to
pembrolizumab or pembrolizumab/neoadjuvant chemotherapy.
ClinicalTrials.gov: NCT04081389
-
Refractory Melanoma – Phase 2 study that will evaluate polarized
dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib
for the treatment of HLA-A2+ refractory melanoma at Roswell Park.
Up to 24 patients to be enrolled. ClinicalTrials.gov:
NCT04093323
- Advanced Ovarian
Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant
Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen
at the University of Pittsburgh.
Broad-Spectrum Immune System Response Against SARS-CoV-2
(COVID-19)
Previous animal studies yielded positive results
utilizing Ampligen in Western Equine Encephalitis Virus, Ebola,
Vaccinia Virus (which is used in the manufacture of smallpox
vaccine) and SARS-CoV-1. The Company has conducted experiments in
SARS-CoV-2 showing Ampligen has a powerful impact on viral
replication. The prior studies of Ampligen in SARS-CoV-1 animal
experimentation may predict similar protective effects against
SARS-CoV-2. AIM is currently evaluating the safety and
effectiveness of intravenous Ampligen to reduce replication of
SARS-CoV-2 virus from upper airway in patients in an ongoing Phase
1/2 study for the treatment of COVID-19 cancer patients. The
Company plans to conduct an intranasal study of Ampligen to
potentially enhance and expand natural immunity.
The FDA has authorized Ampligen in a clinical
trial of patients with COVID-19 who have a pre-existing cancer.
That Phase 1/2a study utilizing Ampligen is underway in the
investigator-sponsored Phase 2 trial at the Roswell Park
Comprehensive Cancer Center. ClinicalTrials.gov: NCT04379518
Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic
fatigue syndrome (ME/CFS) / COVID-19 Long Hauler
The Company is currently sponsoring an ongoing,
FDA-authorized AMP-511 (See: ClinicalTrials.gov: NCT00215813)
expanded access program (EAP) for ME/CFS patients in the United
States. AIM has enrolled five post-COVID patients with new onset
ME/CFS following acute COVID-19. Preliminary results based on data
from the first 4 patients, following at least 12 weeks of Ampligen
treatment indicated they had experienced a reduction in fatigue, as
measured via Patient-Reported Outcomes questionnaires. A
statistical analysis of these data indicated that the decrease in
fatigue compared to baseline was statistically significant
(p<0.002), despite the small number of patients. Based in part
on these early positive data, the FDA recently provided their
clearance of the Company’s IND application for a Phase 2 study of
Ampligen for the treatment of Post-COVID Conditions.
The planned Phase 2 study (“AMP-518”) is a
two-arm, randomized, double-blind, placebo-controlled, multicenter
study to evaluate efficacy and safety of Ampligen in patients
experiencing the post-COVID condition of fatigue. The primary
outcome measure of the study is change from baseline to week 13 in
PROMIS® Fatigue Score. Other study outcomes include: change from
baseline to week 6 in PROMIS® Fatigue Score; change from baseline
to week 6 and 13 in distance traveled during a 6-minute walk test;
proportion of subjects with minimal clinically important
difference, defined as at least 54 meters, in the Six-Minute Walk
Test at the end of 12-week treatment phase; change from baseline to
week 6 and 13 in PROMIS® Cognitive Function Score; change from
baseline to week 6 and 13 in PROMIS® Sleep Disturbance Score; and
change from baseline to week 6 and 13 in 36-Item Short Form
Survey.
Approximately 80 subjects between the ages of 18
to 60 years old are expected to be enrolled across up to 10 centers
in the United States. Patients will be randomized 1:1 to receive
twice weekly IV infusions of Ampligen or placebo for 12 weeks with
a follow up phase of 2 weeks. The Company expects to commence
patient enrollment and dosing in the AMP-518 study in Q1 2023.
Recent Ampligen Data Publications
-
Presented Safety and efficacy of de-escalated neoadjuvant
chemoimmunotherapy of triple negative breast cancer (TNBC) using
chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib)1 at
the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting;
and
-
Presented Rintatolimod (Ampligen®): An Investigational
Immunomodulatory Agent Targeted at Cancers of High Unmet Need and
The Mechanism of PAMP Restricted Rintatolimod in Limiting Systemic
Inflammatory Responses at the 2nd Annual Marie Sklodowska-Curie
Symposium on Cancer Research and Care.
Summary of Financial Highlights for
Third Quarter 2022
- As of September 30, 2022, AIM
reported cash and cash equivalents of $36.7 million, compared to
$48.3 million as of December 31, 2021.
- Research and development expenses
for the three months ended September 30, 2022 were $1.4 million,
compared to $2.0 million for the same period in 2021.
- General and administrative expenses
were $5.2 million for the three months ended September 30, 2022,
compared to $1.8 million for the same period in 2021.
- The net loss from operations for
the three months September 30, 2022 was $6.4 million, or $0.13 per
share, compared to $3.8 million, or $0.08 per share, for the three
months ended September 31, 2021.
Please refer to the full 10-Q for complete
details.
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.
Ampligen is currently being used as a
monotherapy to treat pancreatic cancer patients in an Early Access
Program (EAP) approved by the Inspectorate of Healthcare in the
Netherlands at Erasmus Medical Center and AIM has commenced a Phase
2 clinical study in 2022. The Company also has multiple ongoing
clinical trials to evaluate Ampligen as a combinational therapy for
the treatment of a variety of solid tumor types both underway and
planned at major cancer research centers. Additionally, Ampligen is
approved in Argentina for the treatment of severe chronic fatigue
syndrome (CFS) and is currently being evaluated in many aspects of
SARS-CoV-2/COVID-19 myalgic encephalomyelitis/chronic fatigue
syndrome (ME/CFS) and Post COVID Conditions.For more information,
please visit aimimmuno.com and connect with the Company on Twitter,
LinkedIn, and Facebook.
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.
1 dx.doi.org/10.1136/jitc-2022-SITC2022.0547
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
AIM@jtcir.com
AIM ImmunoTech (AMEX:AIM)
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