On June 27, 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 a clinical update on the ongoing Phase 1 dose-escalating clinical trial of GFH009, its novel and highly selective CDK9 inhibitor, in advanced relapsed and refractory lymphoma and acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, JUN 27, 2022, View Source [SID1234616268]).
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In the AML group, patients treated at the 22.5 mg dose level experienced no dose limiting toxicities, including no grade 3/4 neutropenias (an abnormally low count of neutrophils, a type of white blood cell). The AML group has entered the last planned dose level of 30 mg. As previously reported, significant anti-leukemic effects (i.e., greater or equal to 50 percent decrease in bone marrow blasts following GFH009 monotherapy) have been observed in AML patients treated sufficiently long enough to assess efficacy at previous dose levels.
In the lymphoma group, the 15 mg dose level cohort has completed enrollment. Safety assessments for this cohort are currently underway. In the previous 9 mg dose level cohort, one patient, with peripheral T-cell lymphoma, an aggressive type of lymphoma that develops from mature-stage T-cells and natural killer (NK) cells who was refractory to three prior lines of therapy, demonstrated a partial response as seen on a computerized tomography (CT) scan.
"We continue to see positive results in our clinical efforts for GFH009, especially in assessing the safety in patients with lymphoma and AML," said Dragan Cicic, MD, Senior Vice President, Clinical Development of SELLAS. "The clinical process for safety is to determine the highest dose level patients can tolerate without experiencing adverse events or side effects. Not only does GFH009 appear to be safe at the dose levels studied to date, but we have also observed efficacy in lower dose levels. These results are encouraging as we continue to increase dose levels and assess accordingly."