Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage
biopharmaceutical company focused on Artificial Intelligence
(“AI”)-driven therapeutic drug development for the treatment of
non-alcoholic steatohepatitis (“NASH”) and other liver diseases,
today announced the results of a nonclinical research study showing
that CRV431 significantly decreased the growth of liver tumors in a
mouse model of liver cancer. Additionally, CRV431 was as effective
at decreasing tumor burden as an anti-PD1 antibody immune
checkpoint inhibitor, PD1 antibody, and produced more beneficial
changes in tumor infiltrating cells compared to anti-PD1 antibody
treatment.
The study was conducted by FibroFind Ltd.
(Newcastle, UK) in collaboration with Professor Derek Mann, Dean of
Research and Innovation at Newcastle University. In this study,
mouse hepatocellular cancer (“HCC”) cells (hep53.4 cells) were
surgically implanted into livers of recipient mice. In the absence
of drug treatment, large tumors developed over a period of 28
days.
Drug treatments began in the treatment groups on
Day 14 after HCC hep53.4 cell implantation, when the tumors had
reached approximately 15% of their final size. Mice received either
once-daily CRV431, administered orally, or a single dose anti-PD1
antibody, administered intraperitoneally. An additional treatment
arm examined a CRV431/anti-PD1 antibody combination treatment. Drug
dosing continued for a total of two weeks (Days 14 to 28 post-HCC
implant) and the changes in tumor volumes were measured from the
initiation of drug treatment to the end of the experiment.
Treatment with CRV431 or an anti-PD1 antibody each decreased tumor
size by 76%, while the CRV431/anti-PDI antibody combination
treatment decreased tumor size by 83%, compared to the vehicle
treatment (no drug).
Microscopic examination of the tumors showed
that CRV431 beneficially doubled the number of tumor-infiltrating
CD4 and CD8 lymphocytes. This same finding was observed with
anti-PD1 treatment, suggesting that both treatments stimulated
immunity against the tumors. Furthermore, CRV431 decreased the
number of neutrophils in the tumors by 55%, which was not observed
with anti-PD1 antibody treatment. Because neutrophil-mediated
inflammation frequently promotes tumor growth, CRV431’s
demonstrated reduction in neutrophils represents an additional
anti-tumor effect. Finally, a marker of cell proliferation
indicated that both CRV431 and the anti-PD1 antibody decreased
tumor cell proliferation to similar degrees. These results
complement previously published findings of CRV431’s anti-tumor
activity in a different HCC model in which liver tumors developed
spontaneously in mice with long-term, diabetes-associated,
NASH-like disease.1
“CRV431 significantly decreased tumor burden in
two distinct liver cancer models, suggesting that it exhibits
anti-cancer activity across a range of HCC tumor subtypes and
mutations,” said Daren Ure, PhD, Hepion’s Chief Scientific Officer.
“It was also very encouraging to see that CRV431 positively altered
inflammatory and immune cell populations in the tumors, which is a
cornerstone of modern cancer therapy.”
FibroFind CEO, Prof Jelena Mann, PhD, commented,
"FibroFind is delighted with the outcome of this study, which
indicates potential for CRV431 to bring about a reduction in tumour
burden in what is an aggressive orthotopic model of liver cancer.
The observation that CRV431 brings about a change in the neutrophil
component of the tumour is particularly fascinating given the
emerging role of this immune cell in many different cancers.”
“HCC is the most common primary liver cancer, is
often related to NASH, and is a leading cause of death worldwide,”
commented Robert Foster, PharmD, PhD, Hepion’s CEO. “There is a
constant and urgent need for new drug development to augment
surgical interventions, including liver transplantation, when
treating patients with HCC. The findings from this study bode well
for the continued development of CRV431 as a drug candidate for
treating liver diseases, including HCC and NASH. CRV431 targets the
liver, and its anti-inflammatory and anti-fibrotic effects have
been demonstrated in many liver disease models. More recently,
CRV431 has shown positive changes in ALT and Pro-C3 in a 28-day
NASH Phase 2a clinical trial, indicating its anti-inflammatory and
antifibrotic effects. Having a single drug candidate with
demonstrated beneficial activity in both NASH and HCC is quite
remarkable and represents an opportunity for Hepion to further
explore CRV431’s potential in HCC while continuing to advance its
clinical program in NASH.”
Reference
1 Kuo et al. A Pan-Cyclophilin Inhibitor,
CRV431, Decreases Fibrosis and Tumor Development in Chronic Liver
Disease Models, J. Pharmacol. Exp. Therap. (2019) 371(2):231-241;
doi:10.1124/jpet.119.261099.
About Hepion
Pharmaceuticals
The Company's lead drug candidate, CRV431, is a
potent inhibitor of cyclophilins, which are involved in many
disease processes. CRV431 is currently in clinical-phase
development for the treatment of NASH, with the potential to play
an important role in the overall treatment of liver disease - from
triggering events through to end-stage disease. CRV431 has been
shown to reduce liver fibrosis and hepatocellular carcinoma tumor
burden in experimental models of NASH; and has demonstrated
antiviral activities towards HBV, HCV, and HDV through several
mechanisms, in nonclinical studies.
Hepion has created a proprietary AI platform,
called AI-POWR™, which stands for Artificial
Intelligence - Precision Medicine;
Omics (including genomics, proteomics,
metabolomics, transcriptomics, and lipidomics);
World database access; and
Response and clinical outcomes. Hepion intends to
use AI-POWR™ to help identify which NASH patients will best respond
to CRV431, potentially shortening development timelines and
increasing the delta between placebo and treatment groups. In
addition to using AI-POWR™ to drive its ongoing NASH clinical
development program, Hepion intends to use the platform to identify
additional potential indications for CRV431 to expand the company's
footprint in the cyclophilin inhibition therapeutic space.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimated,” and “intend,” among others.
These forward-looking statements are based on Hepion
Pharmaceuticals’ current expectations and actual results could
differ materially. There are a number of factors that could cause
actual events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not
limited to, substantial competition; our ability to continue as a
going concern; our need for additional financing; uncertainties of
patent protection and litigation; risks associated with delays,
increased costs and funding shortages caused by the COVID-19
pandemic; uncertainties with respect to lengthy and expensive
clinical trials, that results of earlier studies and trials may not
be predictive of future trial results; uncertainties of government
or third party payer reimbursement; limited sales and marketing
efforts and dependence upon third parties; and risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. As with any drug candidates under
development, there are significant risks in the development,
regulatory approval, and commercialization of new products. There
are no guarantees that future clinical trials discussed in this
press release will be completed or successful, or that any product
will receive regulatory approval for any indication or prove to be
commercially successful. Hepion Pharmaceuticals does not undertake
an obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in Hepion
Pharmaceuticals’ Form 10-K for the year ended December 31, 2020,
and other periodic reports filed with the Securities and Exchange
Commission.
For further information, please contact:
Stephen KilmerHepion Pharmaceuticals Investor
RelationsDirect: (646)
274-3580skilmer@hepionpharma.com
Hepion Pharmaceuticals (NASDAQ:HEPA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Hepion Pharmaceuticals (NASDAQ:HEPA)
Historical Stock Chart
From Apr 2023 to Apr 2024