On August 24, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported results from a new preclinical in vitro study for its highly selective CDK9 inhibitor, GFH009, in neuroendocrine prostate cancer (NEPC) (Press release, Sellas Life Sciences, AUG 24, 2022, View Source [SID1234618598]). The data shows that GFH009 demonstrated significant anti-tumor effects in the selected cell line at nanomolar concentrations and, in certain samples, complete growth inhibition with no viable cancer cells.
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NEPC, an aggressive variant of prostate cancer, is a rapidly growing indication which arises as a result of otherwise successful treatment of advanced prostate cancer. In up to 15 to 20 percent of patients treated with hormonal therapies for prostate adenocarcinoma, small-cell prostate cancer may develop in later stages of prostate cancer progression. This histologic transformation occurs as a mechanism of treatment resistance. Aggressive NEPC represents a lethal endpoint in the progression of prostate cancer from prostate adenocarcinoma to castration-resistant prostate cancer (CRPC) to NEPC. Median survival for NEPC patients whose cancer arose from prior prostate adenocarcinoma is estimated at only 5.4 months.
The conversion to NEPC is associated with recurrent genetic lesions including mutation or deletion of RB1 and TP53 as well as the overexpression and genomic amplification of MYCN. SELLAS believes that all forms of MYC may be susceptible to CDK9 inhibition and the data from the in vitro study, conducted at an independent, third-party contract research organization, Translational Drug Development (TD2), supported this supposition, resulting in 38 nM median IC50 value.
"We are very excited with this first confirmation of our hypothesis that GFH009 could address NEPC, a rapidly growing indication," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS. "About one in eight men will be diagnosed with prostate cancer during his lifetime and any significant change in the course of treatment for this cancer has potential for outsized consequences."
About Translational Drug Development (TD2)
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.