On July 7, 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 that the Company has added a second, once-a-week dose cohort in its ongoing global Phase 1 clinical trial in both the United States and China with the highly selective CDK9 inhibitor GFH009 for patients suffering from advanced relapsed or refractory lymphoma and acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, JUL 7, 2022, View Source [SID1234616529]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
SELLAS previously reported that AML patients treated twice-a-week at the 22.5mg dose level experienced no dose-limiting toxicities, including no Grade 3/4 neutropenia (an abnormally low count of neutrophils, a type of white blood cell). The patients in the AML arm of the clinical trial have entered the last twice-a-week 30mg planned dose level. Additionally, enrollment for lymphoma patients at the twice-a-week 15mg dose level cohort has been completed and safety assessments are underway. The twice-a-week dose regimens for both groups will proceed as planned and are on target for completion this year.
Given that both AML and lymphoma patients tolerated all dose levels studied to date with the twice-a-week administration as well as the efficacy signals seen with both AML and lymphoma patients, SELLAS has amended its protocol to introduce an additional single-dose cohort to study GFH009 once-a-week administration starting at the higher dose level of 30 mg.
The new, weekly single-dose cohort regimen is as follows:
Dose levels are 30mg, 45mg and 60mg once per week.
The amended protocol allows SELLAS to further escalate the doses if each level is determined safe for patients.
The new cohort is expected to take approximately one month to enroll patients and another 21 days to complete the safety assessment for each dose level.
"As we continue to evaluate GFH009 with its unique mechanism of action, increasing the dose administered and extending the administration of the dose will allow us to expand our knowledge of the drug’s safety and efficacy profile, including potentially seeing whether there are further increases in efficacy beyond the already observed efficacy for these patients," said Dragan Cicic, MD, Senior Vice President, Clinical Development, SELLAS. "With this additional valuable data on the new dose levels and regimen, SELLAS will be one step closer to discovering the optimal dosage for patients in preparation for the Phase 2 study."