Senex Biotechnology has announced the notice of allowance from the European Patent Office for composition of matter claims on SNX631-6 and its congeners, solidifying its position in the development of cancer therapeutics. SNX631-6 is a selective inhibitor of CDK8 and CDK19, kinases involved in transcriptional reprogramming, a critical process for adaptive drug resistance and metastasis in cancer.
Targeting CDK8/19 for Cancer Therapy
CDK8 and CDK19 are pleiotropic regulators of gene expression, playing a crucial role in cancer cells' ability to adapt to adverse conditions. Inhibition of these kinases has shown promise in overcoming drug resistance and preventing metastasis across various cancer types. Senex Biotechnology scientists, in collaboration with researchers at the University of South Carolina, have demonstrated the efficacy of CDK8/19 inhibition in castration-resistant prostate cancer, all major forms of breast cancer, ovarian cancer, osteosarcoma, leukemia, and metastatic colon cancer.
SNX631-6: A Potential Best-in-Class Inhibitor
According to Dennis I. Goldberg, Ph.D., CEO of Senex Biotechnology, SNX631-6 is considered a potential best-in-class CDK8/19 inhibitor. It exhibits low nanomolar potency, outstanding target specificity, and excellent oral bioavailability. These attributes contribute to the favorable safety profile observed in IND-enabling toxicology studies.
Clinical Development Plans
Senex Biotechnology is advancing SNX631-6 towards clinical trials, with plans to initiate first-in-human studies in drug-resistant metastatic cancer in 2026. The company has completed IND-enabling toxicology studies in male animals, supported by a grant from the Department of Defense Prostate Cancer Program, and will complete similar 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.
Broad Spectrum of Activity
Igor B. Roninson, Ph.D., Founder and Chief Science Officer at Senex Biotechnology, highlighted the extensive in vivo data generated with SNX631-6. The drug candidate has demonstrated potency in various primary and metastatic cancer models, both as a single agent and as a potentiator of approved drugs, with a notable lack of toxicity in long-term studies.
Given the broad spectrum of activity of SNX631-6 across many cancer types, Senex Biotechnology plans to focus its initial Phase 1 clinical trial on a diverse array of cancer patients. The intent is to identify those cancers that show the most promising activities in preclinical studies and initial human clinical investigations as the company proceeds to Phase 2 clinical studies, according to George Wilding, M.D., Chief Medical Officer at Senex Biotechnology.
