AIM ImmunoTech Announces Encouraging Translational Data from Phase 2 Study Evaluating Ampligen® for the Treatment of Advanced Recurrent Ovarian Cancer
08 Novembre 2023 - 2:45PM
AIM ImmunoTech Inc. (NYSE American:
AIM) (“AIM”), an immuno-pharma company focused on the
research and development of therapeutics to treat multiple types of
cancers, immune disorders and viral diseases, today announced
encouraging translational data from an ongoing Phase 2 clinical
trial utilizing AIM’s drug Ampligen® in patients with
platinum-sensitive advanced recurrent ovarian cancer.
The abstract with data illustrations, titled
“Combination intraperitoneal chemoimmunotherapy triggers a T-cell
chemotactic locoregional response in patients with recurrent
platinum-sensitive ovarian cancer,” was presented by collaborators
from the Magee-Womens Research Institute at the University of
Pittsburgh School of Medicine (“UPMC") — one of the world’s top
centers for the treatment of gynecological cancers — at the recent
Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, in
San Diego, Calif. The data was also made available at the
conference in a poster presentation.
Data highlighted in the abstract were collected
by UPMC through translational studies focused on the immune tumor
microenvironment (TME), using a longitudinal collection of
biospecimens, including plasma, PBMC, IP washes and tumor tissue
collected from patients treated in a Phase 2, efficacy/safety trial
(NCT03734692) combining intraperitoneal (IP) chemotherapy
(cisplatin) with dual agent immunotherapy using intravenous (IV)
pembrolizumab (anti-PD1, Keytruda®, provided by Merck) and IP
rintatolimod (Ampligen®, a dsRNA acting as toll-like receptor 3
-TLR-3- agonist, provided by AIM).
Key Highlights:
- Sequential sampling of the IP
cavity showed an increase in cellularity immediately after
treatment consistent with an “acute” pro-inflammatory
reaction.
- Mesoscale Delivery (MSD)
measurements in IP washes revealed an acute increase in granzyme B,
perforin, TNF alpha, CXCL9, CXCL10, and CXCL11 after treatment
(p<0.05). Longitudinal data revealed a progressive increase in
some biomarkers (p<0.05).
- RNA sequencing data showed a
significant upregulation acutely in STAT1 and downstream targets,
CXCL9, 10, 11 and TH1 type response genes (p<0.05).
Robert P. Edwards, MD, Chief Medical Officer of
the UPMC Community and Ambulatory Services Division and Co-Director
of the Women’s Cancer Research Center at the UPMC Hillman Cancer
Center, stated, “The profound local T-cell cytoxicity activation we
see with this combination is markedly improved over previous work
we have published on this platform with this recurrent disease
profile.”
David Strayer, MD, AIM’s Medical Officer, a
Board-Certified oncologist and a former Professor of Medicine and
Neoplastic Diseases at Hahnemann University, stated, “We continue
to be encouraged by the data being demonstrated by Dr. Robert
Edwards and his team at UPMC. These data highlight the
effectiveness of combinatorial treatments including Ampligen in
modulating the cellular make-up of the tumor microenvironment
through cytokine profile changes. These data show a similar profile
to previously published data from Roswell Park in Stage 4 triple
negative breast cancer. The thing that intrigues me most is the
persistent upregulation of the T-lymphotactic cytokines over time,
and the lack of immune exhaustion as demonstrated in the ability of
the treatment to cause a statistically significant upregulation of
these cytokines after repeated treatment. As a whole, these data
demonstrate an encouraging result in the promotion of increased T
cell chemotaxis and cytolytic function for improved clinical
outcomes in patients with advanced recurrent ovarian cancer.”
AIM Chief Executive Officer Thomas K. Equels
stated, “There is a significant unmet need in advanced recurrent
ovarian cancer and these findings continue to bolster our
confidence in Ampligen’s potential. Additionally, we hope to
announce topline interim survival results from UPMC in the near
future.”
For more information about the Phase 2 clinical
trial of platinum-sensitive advanced recurrent ovarian cancer
utilizing Ampligen®, visit clinicaltrials.gov and reference
identifier: NCT03734692.
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 is a first-in-class investigational drug
called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3
agonist immuno-modulator with broad spectrum activity in clinical
trials 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.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
AIM@jtcir.com
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