On August 9, 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 preclinical in vitro studies for its highly selective CDK9 inhibitor, GFH009, in solid cancer and acute myeloid leukemia (AML) cell lines (Press release, Sellas Life Sciences, AUG 9, 2022, View Source [SID1234617948]). The data shows that GFH009 demonstrated significant anti-tumor effects in all four selected cell lines. In three out of the four cell lines, GFH009 inhibited cancer cell growth by 90 to 100 percent.
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The in vitro studies were conducted at an independent, third-party contract research organization, Translational Drug Development (TD2), and the following cell lines were selected for the studies based on their unique characteristics, combined with GFH009’s mechanism of action:
RH30: a pediatric soft tissue sarcoma cell line that is a model for studying high-risk pediatric rhabdomyosarcoma, an indication for which currently available treatments are limited to high-dose chemotherapy with unsatisfactory results. RH30 cells are driven by PAX3-FOXO1, a transcription factor whose expression is strictly needed for tumor cell survival. RH30 is also dependent on MYCN, a major target of CDK9 inhibition. Treatment with GFH009 resulted in 90 percent or more cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at the highest dose levels.
NCI-H209: a small cell lung cancer cell line characterized by the loss of function of two major tumor suppressor genes, RB1 and TP53. This cell line also expresses MCL-1, a major target of CDK9 inhibition. Treatment with GFH009 resulted in 90 percent or more cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at highest dose levels.
SKOV-3: an ovarian cancer cell line containing the wild type BRCA1 gene and highly expresses CDK9. Treatment with GFH009 resulted in more than 50 percent cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial.
OCI-AML-2: an AML cell line that develops resistance to the chemotherapy venetoclax on exposure. Treatment with GFH009 resulted in 90 to 100 percent cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at the highest dose levels.
"The data from preclinical studies that we are reporting today demonstrates that certain cancer cell lines, whose survival depends on specific changes in the cell, can be identified and treated with GFH009," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS. "Through identifying specific genes in cancer cells, GFH009 has shown in these preclinical studies the ability to stop the transcription and expression from gene to protein, inhibiting cancer cell growth altogether. We will utilize this important information as we design our clinical development program for GFH009 in adult and pediatric tumor types."
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.