SELLAS announces promising initial results from the SLS009 Phase 1 lymphoma group study, advancing to Phase 2 clinical trial

SELLAS Life Sciences Group, Inc., an advanced clinical stage biopharmaceutical firm concentrating on innovating new treatment options for various forms of cancer, today shared promising preliminary results from the segment of patients with recurrent or unresponsive lymphoma in the Phase 1 dosage-enhancement study of its CDK9 inhibitor, SLS009 (GFH009).

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All primary and secondary research aims, including those related to safety, clinical efficiency, pharmacokinetics, and pharmacodynamics, have been successfully achieved. The suggested Phase 2 dosage for lymphoma patients has been identified at the highest assessed level of 100 mg, provided as a once-weekly infusion. 

The ceiling tolerated dosage was not met. One out of five patients treated with a 100 mg dosage had a dose-limiting toxicity. There were no dose-limiting toxic events at any other dosage levels, and the study was not marred by any unexpected toxicity. 

"We are thrilled to reveal impactful preliminary results from the Phase 1 trial of SLS009 for lymphoma patients, reinforcing the encouraging results in acute myeloid leukemia patients that we announced earlier this year," stated Angelos Stergiou, MD, ScD h.c., the President and Chief Executive Officer of SELLAS.

Stergiou went on to say, "The data proves significant anti-cancer activity and clinical responses when used as standalone therapy. Given its positive therapeutic profile, SLS009 is increasingly being acknowledged as a possible treatment for individuals suffering from hematologic cancers who have already gone through all available treatment routes. Our ally, GenFleet Therapeutics, is planning to propel GFH009 (SLS009) into Phase 2 clinical research in China for patients with peripheral T-cell lymphoma later this year."

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According to the data provided by the Synapse Database, As of September 28, 2023, there are 52 investigational drugs for the CDK9 target, including 87 indications,71 R&D institutions involved, with related clinical trials reaching 173，and as many as 2685 patents.

The aim of creating GFH-009 is to establish a viable therapy alternative for individuals afflicted with diverse forms of cancers and pathologies related to the urogenital, hemic, and lymphatic systems. The medicinal drug intends to disrupt the aberrant cellular proliferation and division procedures associated with these illnesses by focusing on CDK9.