AIM ImmunoTech Announces Publication of Positive Results from Phase 1/2 Study of Intraperitoneal Chemo-Immunotherapy in Advanced Recurrent Ovarian Cancer
25 January 2022 - 12:00AM
AIM ImmunoTech Announces Publication of Positive Results from Phase
1/2 Study of Intraperitoneal Chemo-Immunotherapy in Advanced
Recurrent Ovarian Cancer
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
publication of positive data from a Phase 1/2 study of
intraperitoneal chemo-immunotherapy in advanced recurrent ovarian
cancer. The manuscript titled, “Phase I trial combining
chemokine-targeting with loco-regional chemo-immunotherapy for
recurrent, platinum-sensitive ovarian cancer shows induction of
CXCR3 ligands and markers of type 1 immunity1” was published in the
American Association for Cancer Research publication, Clinical
Cancer Research.
The Phase 1/2 study being conducted by the
University of Pittsburgh School of Medicine is designed to evaluate
the immunologic and potential clinical effectiveness of intensive
locoregional sequential intraperitoneal (IP) cisplatin (IPC) with
intravenous (iv) paclitaxel followed by peritoneal infusion of a
chemokine modulatory (CKM) regimen composed of a cocktail of IP
rintatolimod and interferon-alpha (IFNα) for patients with advanced
stage ovarian cancer (III-IV) at primary neoadjuvant setting. AIM
ImmunoTech provided rintatolimod (Ampligen®, a dsRNA acting as TLR3
agonist), for the Phase 1/2 study. “These results represent an
important extension of prior studies using human tumor explants
that showed Ampligen’s potentially important role as a TLR3 agonist
acting synergistically with high-dose IFNα and celecoxib to
selectively enhance Teff cell-attractants while suppressing
Treg-attractants in the tumor microenvironment with a concomitant
increase in the Teff/Treg ratio. This current study shows that
similar findings are seen combining Ampligen with
chemokine-targeting and chemo-immunotherapy in patients being
treated for recurrent ovarian cancer. The importance of boosting
the Teff/Treg ratio in the tumor microenvironment is that it is
associated with the conversion of ‘cold’ tumors into ‘hot’ tumors,
which have an increased sensitivity to chemo-immunotherapy and an
improved chance of showing tumor regression. This, of course,
creates the potential for a positive survival advantage,” stated
David Strayer, MD, Chief Medical Officer, Chief Scientific Officer
of the Company and Board Certified in Medical Oncology.
Thomas Equels, Chief Executive Officer of AIM
commented, “We are very pleased with these results. Ampligen® has
demonstrated broad immunological effects and we believe has the
potential to be a key component in the treatment of ovarian cancer.
We are grateful to the University of Pittsburg School of Medicine
and are excited to provide support for a larger Phase 2 study which
we believe has the potential to provide hope for patients and their
families, as well as drive significant shareholder value.”Twelve
patients were enrolled in Phase 1 portion of the trial and were
treated with IP cisplatin, IP Ampligen®, and oral celecoxib (COX-2
blocker). Patients in cohorts 2, 3 and 4 also received IP IFNα at
2, 6 and 18 million units, respectively. The primary objectives of
the study were to evaluate safety, identify Phase 2 recommended
dose and characterize changes in the immune TME. Peritoneal
resident cells and IP wash fluid were profiled via NanoString and
Meso Scale Discovery (MSD) multiplex assay, respectively.Of the 12
patients enrolled in this Phase 1 trial, 9 (75%) were evaluable for
safety, toxicity, and other endpoints. The 3 non-evaluable patients
did not complete at least 3 cycles, due to platinum
hypersensitivity reactions or port complications. Overall, the
regimen was well tolerated, apart from the highest dose of IFNα.
Most common toxicities for all grades were anemia (58%),
hypomagnesemia (50%), hyponatremia (41.7%), arthralgia (41.7%), and
fatigue (41.7%). There was one grade 4 hypomagnesemia (8.3%). Dose
limiting toxicities of abdominal pain of grade 3 or more were noted
in two patients who received 18MU IFNα (cohort 4).
The Phase 2 recommended dose of IFNα was 6
million units every 3 weeks. Median PFS was 8.4 (3-16.4) months.
Median overall survival was 30 (8-66) months. The Company believes
these survival outcome data provide an encouraging early signal.
Overall response rate was 55.6% and the disease control rate (DCR)
was 77.8%, consistent with the expected platinum-sensitive
response. Among responders, median duration of response was 11.7
(6-16.4) months.
Key Results Highlights
- Determination of the safety profile
and identification of Phase 2 recommended dose for the combination
of local cisplatin, Ampligen and IFNα, with oral celecoxib;
- Chemo-immunotherapy combination
triggers robust transcriptomic changes in peritoneal resident cells
obtained in longitudinal sampling via IP washes;
- Protein content of IP wash fluid
captures treatment-induced increases of IFN-induced immune effector
molecules; and
- Tumor immune profile at interval
debulking shows partial overlap with IP wash, and points to
upregulation of genes encoding for perforin and granzyme B.
Longitudinal sampling of the peritoneal cavity
via IP washes demonstrated local upregulation of
interferon-stimulated genes, including CTL-attracting chemokines
(CXCL-9, -10, -11), MHC I/II, perforin and granzymes. These changes
were present two days post chemokine modulation and subsided within
one week.
“Epithelial ovarian cancer, the most common form
of ovarian cancer, is the most aggressive gynecologic cancer and
despite aggressive surgery and chemotherapy treatment options, the
5-year survival rate for patients with advanced high grade serous
ovarian cancer remains low. I am very encouraged by the results
from this study. With our growing body of positive data, I look
forward to further advancing development of this important program
with the hope of addressing the significant unmet medical need,”
added Robert P. Edwards MD, Milton McCall Professor and Chairman,
Department of Obstetrics, Gynecology, and Reproductive Sciences,
University of Pittsburgh School of Medicine, Director of Women’s
Health for UPMC.
Based on these encouraging results, the Company
plans on supporting a follow-up Phase 2 trial that will
specifically define the immunologic and clinical efficacy of tumor
loaded αDC1 vaccine in conjunction with the cisplatin/chemokine
modulatory combination regimen will be conducted.
For more information about the Phase 1/2 study,
please visit clinicaltrials.gov and reference identifier
NCT02432378.
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. While the Company believes that
the results of the Phase 1/2 study of intraperitoneal
chemo-immunotherapy in advanced recurrent ovarian cancer were
positive, significant additional testing will be required. No
assurances can be given as to whether any studies will be
successful or yield favorable data. Additionally, 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. There is also the potential
for delays in clinical trial enrollment and reporting because of
the COVID-19 medical emergency. 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 ContactJTC
Team, LLCJenene Thomas 833-475-8247AIM@jtcir.com
1 Clin Cancer Res January 19 2022 DOI:
10.1158/1078-0432.CCR-21-3659
Aim Immunotech (LSE:0A4Y)
Historical Stock Chart
From Feb 2024 to Mar 2024
Aim Immunotech (LSE:0A4Y)
Historical Stock Chart
From Mar 2023 to Mar 2024