Senex Biotechnology Receives Notice of Allowance for Novel CDK8/19 Inhibitors from European Patent Office
Dennis Goldberg, CEO of Senex Biotechnology
European Patent Expands Upon Similar Patent Granted by the USPTO
Senex Biotechnology scientists and their colleagues at the University of South Carolina have demonstrated the importance of genetic or pharmacological inhibition of CDK8 and CDK19 in multiple cancers, including castration resistant prostate cancer, all major forms of breast cancer, ovarian cancer, osteosarcoma, leukemia and metastatic colon cancer. The Company has completed IND-enabling toxicology in male animals, supported by a grant from the Department of Defense Prostate Cancer Program and will complete similar toxicology studies in female animals, along with the manufacture of the clinical drug product in support of an IND filing in the first quarter of 2026.
“The European patent for SNX631-6, combined with the previously issued US patent, provides Senex with broad protection for the novel class of drugs. The Company believes that SNX631-6, the Company’s clinical candidate, is the best-in-class CDK8/19 inhibitor, with low nanomolar potency, outstanding target specificity and excellent oral bioavailability. These attributes contribute to the excellent safety profile seen in our IND-enabling toxicology studies. Senex plans to initiate first in human studies in drug-resistant metastatic cancer 2026"- Dennis I. Goldberg, Ph.D., Chief Executive Officer at Senex Biotechnology.
“I am very excited about the plethora of in vivo data that we have generated with our CDK8/19 inhibitor drug candidate, including its potency in different primary and metastatic cancer models, its activity as a single agent and as a potentiator of different approved drugs, and its remarkable lack of toxicity in long term studies. I have great hopes that our therapeutic strategy will have a major impact on solving the clinical problem of drug resistance, the key cause of cancer intractability” - Igor B. Roninson, Ph.D., Founder and Chief Science Officer at Senex Biotechnology.
“Given the very broad spectrum of activity of our SNX631-6 in many cancer types, we will focus our initial phase I clinical trial on broad array of cancer patients with the intent of identifying those cancers which show the most promising activities in our preclinical studies and initial human clinical investigations as we proceed to Phase 2 clinical studies” - George Wilding, M.D., Chief Medical Officer at Senex Biotechnology.
About Senex Biotechnology
Senex Biotechnology is a drug discovery and development company focused on cancer therapeutics. Senex’s lead program targets CDK8/19, proteins that regulate gene expression and is required by cancer cells to adapt to adversarial conditions; such adaptation leads to cancer drug resistance and metastasis. Senex is developing highly selective small-molecule inhibitors of CDK8/19 for the treatment of presently incurable types of prostate cancer, breast cancer, ovarian cancer, osteosarcoma and leukemia. We are also investigating the utility of these inhibitors for different cancers in combination with other therapeutics, as well as for inflammation, cardiovascular and other diseases. Our latest, highly potent and selective drug candidate is anticipated to enter clinical trials in 2026.
Senex was founded by Dr. Igor Roninson, based on the discovery in his academic laboratory of a novel biological pathway associated with aging (senescence) and involved in cancer and other chronic diseases, as well as the use of functional genomics technologies to identify novel drug targets that are required by tumor cell but not by normal tissues. Senex has won 16 competitive grant awards from the National Institutes of Health, Department of Defense Congressionally Directed Medical Research Programs (DoD CDMRP) and the Alzheimer’s Drug Discovery Foundation. The Company’s work on prostate cancer drug development was supported by a Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute and a Prostate Cancer Research Program Translational Science Award from the DoD CDMRP.
For further information, visit www.senexbio.com.
Contact information:
Dennis I Goldberg
Senex Biotechnology, Inc.
goldberg@senexbio.com
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