Scopus BioPharma Announces IND Submission to FDA for Lead Drug Candidate

Drug Candidate is Distinctive RNA Therapy and Immunotherapy Developed at City of Hope for Treatment of Multiple Cancers

IND Filing a Key Milestone for Planned Phase 1 Clinical Trial to be Initiated at City of Hope

NEW YORK, NY, USA I April 26, 2021 I Scopus BioPharma Inc. (Nasdaq: "SCPS") today announced the submission of an investigational new drug application ("IND") to the United States Food and Drug Administration ("FDA") for its immuno-oncology RNA therapy for the treatment of multiple cancers. The IND filing is a key milestone for the planned Phase 1 clinical trial for B-cell non-Hodgkin lymphoma to 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.

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, "The IND submission to the FDA for a Phase 1 clinical trial for our lead drug candidate is a key milestone for Scopus. We are excited about the prospects of entering the clinic. We believe this, and other imminent developments, will be significant drivers of shareholder value."

Scopus' lead drug candidate 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 an associate professor in the Department of Immuno-Oncology.

Mr. Lamstein added, "We are privileged to be working with City of Hope. The IND submission is testament to the respective efforts and close cooperation of the Scopus and City of Hope teams. We have developed strong working relationships with Dr. Yu and Dr. Kortylewski, both preeminent researchers in immuno-oncology, and other outstanding City of Hope professionals. City of Hope's collective scientific, manufacturing, clinical, regulatory and operational capabilities are being coordinated by City of Hope's Translational Development Center (TDC). The IND submission to the FDA was accomplished on time and on budget. This was made possible by the commitment and efforts of the exceptional TDC team brought together by Ashley Baker Lee, Senior Vice President, Research Operations. We are extremely grateful to Ashley and the entire superb research operations team."

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.

SOURCE: Scopus BioPharma

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