Innovate Biopharmaceuticals Inc. (Nasdaq: INNT), a clinical stage
biotechnology company focused on developing novel therapeutics for
autoimmune and inflammatory diseases with its lead drug comprising
a new class of medicines based on gut-restricted peptides which
re-normalize the gut-epithelial barrier and the gut-liver axis,
announced today it shall collaborate with Laurence Zitvogel, MD,
PhD, Department of Immuno-Oncology, Institut Gustave Roussy,
Villejuif, France, using larazotide acetate, Innovate’s lead drug,
which is entering the first ever Phase 3 trial for celiac disease
in the second quarter of 2019.
Professor Zitvogel’s work focuses on intestinal
microbiome dysbiosis and its effects on responses to chemotherapy
and checkpoint inhibitors suggesting a nexus between the gut and
immune surveillance of cancers.1,2 Her team and others have found
that primary resistance to immune checkpoint inhibitors, such as
CTLA-4 and PD-1 based immunotherapies, can be attributed to
abnormal gut microbial composition.3
Intestinal permeability is compromised in
numerous diseases where a disruption of the epithelial barrier that
separates the lumen from the host’s immune system may contribute to
uncontrolled inflammation. Larazotide is a gut-restricted peptide
which has been shown to re-normalize intestinal permeability in
various inflammatory and metabolic preclinical models. Through this
collaboration, Innovate and Pr. Zitvogel seek to understand how the
therapeutic effect of immune checkpoint inhibitors such as
antibodies to CTLA-4 and PD-1, is modulated by blocking
translocation of bacterial antigens and toxins and certain
metabolites from interacting with the host immune system in
pre-clinical oncology models.
This emerging area of groundbreaking research
looking at uncovering the role of the gut microbiome in the
induction of cancer and response to immune checkpoint and
chemotherapy, will be one of only four afternoon educational
sessions to be held on Friday afternoon, March 29, 2019, titled
“Modulating the Gut Microbiome to Treat Dysbiosis and Cancer” at
the 2019 American Association for Cancer Research (AACR) Annual
Meeting, at the Georgia World Congress Center in Atlanta,
Georgia.
Sandeep Laumas, M.D., CEO of Innovate, stated,
“We are pleased to work with Professor Zitvogel to understand how
larazotide’s re-normalization of intestinal permeability could
affect the immune checkpoint therapeutic response in tumor models
as well further help elucidate the complex interaction of the gut
microbiome with the immune system in cancer.”
Pr. Zitvogel, MD, PhD, Scientific Director of
the Gustave Roussy Immuno-Oncology Program, said, "We need to
deconvolute the delicate interactions between the intestinal
epithelial cells, the microbiome and the immune system in the gut
and their consequences on tumor immunosurveillance. I am excited to
study how larazotide could normalize these interactions in advanced
cancer patients to optimize their therapies."
About larazotide acetate for celiac
disease In celiac disease, larazotide is the only drug
which has successfully met its primary endpoint with statistical
significance in a Phase 2b efficacy clinical trial (342 patients).
Innovate completed the End of Phase 2 Meeting with
the FDA and is preparing to launch the Phase 3
registration clinical trials for celiac disease in the second
quarter of 2019. Nearly 600 subjects have been exposed to
larazotide in clinical trials, and a safety profile comparable to
placebo has been demonstrated. Larazotide has received Fast Track
designation from the FDA for celiac disease.
About Innovate Biopharmaceuticals, Inc.
(Nasdaq: INNT) Innovate is a clinical stage biotechnology
company focused on developing novel therapeutics for autoimmune and
inflammatory diseases. Innovate’s lead drug candidate, larazotide
acetate, has a mechanism of action that renormalizes the
dysfunctional intestinal barrier by decreasing intestinal
permeability and reducing antigen trafficking, such as gliadin
fragments in celiac disease, and bacterial toxins and immunogenic
antigens in nonalcoholic steatohepatitis (NASH). In several
diseases, including celiac disease, NASH, Crohn’s disease,
ulcerative colitis, irritable bowel syndrome (IBS), type 1 diabetes
mellitus (T1DM), chronic kidney disease (CKD), the intestinal
barrier is dysfunctional with increased permeability.
About Gustave RoussyInstitut
Gustave Roussy, leader in the fight against cancer in Europe, is a
worldwide recognized comprehensive cancer centre dedicated to
patient care and clinical research. It brings together 3,100
professionals whose missions are care, research and teaching.
Forward Looking Statements This
press release includes forward-looking statements including, but
not limited to, statements related to the development of drug
candidates, our operations and business strategy, our expected
financial results, and corporate updates. The forward-looking
statements contained in this press release are based on
management’s current expectations and are subject to substantial
risks, uncertainty and changes in circumstances. Actual results may
differ materially from those expressed by these expectations due to
risks and uncertainties, including, among others, those related to
our ability to obtain additional capital on favorable terms to us,
or at all, including, without limitation, to fund our current and
future preclinical studies and clinical trials and the success,
timing and cost of our drug development program and our ongoing or
future preclinical studies and clinical trials, including, without
limitation, the possibility of unfavorable new clinical and
preclinical data and additional analyses of existing data, as well
as the risks that prior clinical and preclinical results may not be
replicated. These risks and uncertainties include, but may not be
limited to, those described in our Annual Report on Form 10-K filed
with the SEC on March 18, 2019, and in any
subsequent filings with the SEC. Forward-looking statements
speak only as of the date of this press release, and we undertake
no obligation to review or update any forward-looking statement
except as may be required by applicable law.
SOURCE: Innovate Biopharmaceuticals, Inc.
Contact: Jennifer K. Zimmons,
Ph.D. Investor Relations Tel: +1-917-214-3514 Email:
jzimmons@innovatebiopharma.com www.innovatebiopharma.com
References:1Vétizou, M., Pitt,
J.M., Daillère, R., Lepage, P., Waldschmitt, N., Flament, C.,
Rusakiewicz, S., Routy, B., Roberti, M.P., Duong, C.P. and
Poirier-Colame, V., 2015. Anticancer immunotherapy by CTLA-4
blockade relies on the gut microbiota. Science, 350(6264),
pp.1079-1084. 10.1126/science.aad1329.
2Routy, B., Le Chatelier, E., Derosa, L., Duong,
C.P., Alou, M.T., Daillère, R., Fluckiger, A., Messaoudene, M.,
Rauber, C., Roberti, M.P. and Fidelle, M., 2018. Gut microbiome
influences efficacy of PD-1–based immunotherapy against epithelial
tumors. Science, 359(6371), pp.91-97.
10.1126/science.aan3706.
3Gopalakrishnan, V., Spencer, C.N., Nezi, L.,
Reuben, A., Andrews, M.C., Karpinets, T.V., Prieto, P.A., Vicente,
D., Hoffman, K., Wei, S.C. and Cogdill, A.P., 2018. Gut microbiome
modulates response to anti–PD-1 immunotherapy in melanoma patients.
Science, 359(6371), pp.97-103. 10.1126/science.aan4236.
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