Scopus BioPharma Announces FDA Approval of IND Application for Lead Drug Candidate
May 24 2021 - 9:30AM
Scopus BioPharma Inc. (Nasdaq:
“SCPS”) today announced the approval of an investigational
new drug application (“IND”) by the United States Food and Drug
Administration (“FDA”) for CpG-STAT3siRNA, the company’s
distinctive immuno-oncology RNA therapy for the treatment of
multiple cancers.
A Phase 1 clinical trial for B-cell non-Hodgkin
lymphoma will be initiated at City of Hope.
Scopus is a biopharmaceutical company developing
transformational therapeutics based on groundbreaking scientific
and medical discoveries. City of Hope is a world-renowned
independent research and treatment center for cancer, diabetes and
other life-threatening diseases near Los Angeles, California.
CpG-STAT3siRNA encompasses both RNA therapy and
immunotherapy by synthetically linking siRNA to an oligonucleotide
TLR9 agonist, creating the potential for targeted gene silencing
with simultaneous TLR stimulation and immune activation in the
tumor microenvironment. This highly-distinctive drug candidate was
developed in the City of Hope laboratories of Hua Yu, Ph.D. and
Marcin Kortylewski, Ph.D. Yu is co-leader of the Cancer
Immunotherapeutics Program and Billy and Audrey L. Wilder Professor
in Tumor Immunotherapy. Kortylewski is a professor in the
Department of Immuno-Oncology.
About Scopus BioPharma
Scopus BioPharma Inc. is a biopharmaceutical
company developing transformational therapeutics capitalizing on
groundbreaking scientific and medical discoveries from leading
research and academic institutions. The company’s lead drug
candidate is a novel, targeted immuno-oncology RNA therapy for the
treatment of multiple cancers. This drug candidate is highly
distinctive, encompassing both RNA therapy and immunotherapy by
synthetically linking siRNA to an oligonucleotide TLR9 agonist,
creating the potential for targeted gene silencing with
simultaneous TLR stimulation and immune activation in the tumor
microenvironment. The company is also developing additional new
chemical entities to treat other serious diseases with significant
unmet medical needs, including systemic sclerosis.
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Forward-Looking Statements
This press release may include forward-looking
statements that involve risks and uncertainties. Forward-looking
statements are statements that are not historical facts. Such
forward-looking statements are subject to risks (including those
set forth in the company’s offering circular filed with the U.S.
Securities and Exchange Commission) and uncertainties which could
cause actual results to differ from the forward-looking statements.
The company expressly disclaims any obligations or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in the company’s
expectations with respect thereto or any change in events,
conditions or circumstances on which any statement is based.
Investors should realize that if our underlying assumptions for the
projections contained herein prove inaccurate or that known or
unknown risks or uncertainties materialize, actual results could
vary materially from our expectations and projections.
Contact
Rodd Leeds/David WaldmanCrescendo
Communications, LLCTel: (212) 671-1020Email:
SCPS@crescendo-ir.com
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