Scopus BioPharma Announces FDA Approval of IND Application for Lead Drug Candidate
Scopus BioPharma (Nasdaq: SCPS) has received FDA approval for an investigational new drug application for its unique immuno-oncology RNA therapy, CpG-STAT3siRNA. This therapy targets multiple cancers and a Phase 1 clinical trial for B-cell non-Hodgkin lymphoma will commence at City of Hope. The innovative therapy combines RNA therapy with immunotherapy, using a TLR9 agonist to enhance immune response in tumors. The firm's focus on groundbreaking therapies aims to address significant medical needs, positioning SCPS for potential market growth.
- FDA approval for CpG-STAT3siRNA enhances credibility and market presence.
- Initiation of Phase 1 clinical trial may lead to valuable clinical data.
- Unique combination of RNA therapy and immunotherapy could provide a competitive edge.
- None.
CpG-STAT3siRNA is a Distinctive RNA Therapy and Immunotherapy Developed at City of Hope
A Phase 1 Clinical Trial Will be Initiated at City of Hope
NEW YORK, May 24, 2021 (GLOBE NEWSWIRE) -- 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. Receive updates by following Scopus BioPharma on Twitter here.
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 Waldman
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: SCPS@crescendo-ir.com
FAQ
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