A phase 1 clinical trial using the STAT 3 inhibitor is expected to commence at City of Hope later this year
DUARTE, Calif. — City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, has signed an exclusive, worldwide licensing agreement with Scopus BioPharma Inc., a biopharmaceutical company focused on novel therapeutics for serious diseases with significant unmet medical needs. Scopus will further develop and plans to commercialize a City of Hope first-in-class, targeted immuno-oncology gene therapy.
A first in-human phase 1 clinical trial for B cell lymphoma patients that uses the licensed gene therapy drug, CpG-STAT3siRNA, a STAT3 inhibitor, is expected to commence at City of Hope in the second half of this year.
Growing evidence links B cell non-Hodgkin lymphomas to persistent activation of STAT3, a gene that drives tumor cell growth and anti-tumor immune suppression. The STAT3 inhibitor is a highly selective and targeted therapy that silences the activity of the STAT3 gene by way of RNA interference. It also stimulates the TLR9 receptors to activate the body’s immune defense to recognize and kill cancer cells.
In preclinical testing at City of Hope, the STAT3 inhibitor has successfully reduced growth and metastasis of various preclinical tumor models, including melanoma, and colon and bladder cancers, as well as leukemia and lymphoma.
City of Hope's Hua Yu, Ph.D., Billy and Audrey L. Wilder Professor in Tumor Immunotherapy, associate chair/professor in the Department of Immuno-Oncology, and co-leader of the Cancer Immunotherapeutics Program, and Marcin Kortylewski, Ph.D., associate professor in the Department of Immuno-Oncology, who are both leading experts in the role of STAT3 in tumor angiogenesis and tumor immune evasion and in oligonucleotide-based cancer immunotherapies, developed the STAT3 inhibitor. The strategy was developed based on seminal discoveries by Yu’s team defining the key role of STAT3 in cancer cell survival and immune tolerance, combined with pioneering work by Kortylewski’s team on STAT3 targeting using TLR9-targeted delivery of siRNA oligonucleotide therapeutics into immune cells.
“City of Hope is proud to work with Scopus to bring this long-anticipated STAT3 drug to our clinical trial patients,” Yu said. “STAT3 is critical for the survival and metastasis of cancer cells, and for suppressing anti-tumor immune responses. If City of Hope and Scopus can develop the first therapy against STAT3, many cancer patients will benefit from this lifesaving drug.”
“Our laboratories were the first to demonstrate that successful cancer immunotherapy needs to be two-step since TLR9 immunostimulation is only effective when STAT3 in the tumor microenvironment is no longer active,” Kortylewski added. “It is exciting to see this technology approaching clinical application with a strong ally in biopharma.”
Both an academic medical center and a drug development powerhouse, City of Hope is known for creating the technology used in the development of human synthetic insulin and numerous breakthrough cancer drugs. Its unique research and development hybrid of the academic and commercial creates an infrastructure that enables City of Hope researchers to submit an average of 50 investigational new drug applications to the U.S. Food and Drug Administration each year. The institution currently holds more than 450 patent families.
“Scopus is extremely excited about licensing such a promising gene therapy drug with a robust intellectual property portfolio, compelling preclinical efficacy and safety profile, and a plan to enter phase 1 this year,” said Joshua R. Lamstein, Scopus co-chairman. “We are privileged to have the opportunity to work with City of Hope, a globally recognized research institution and cancer center. We are looking forward to working with Drs. Yu and Kortylewski, who are among the preeminent researchers in immuno-oncology.”
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About City of Hope
City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is the highest ranked cancer hospital in the West, according to U.S. News & World Report’s Best Hospitals: Specialty Ranking. Its main campus is located near Los Angeles, with additional locations throughout Southern California. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.