Following recent events, SELLAS Life Sciences Group Inc. (NASD: SLS) has increased 9.58% to $2.63 in after-hours trading.
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Recent SLS advancements
SELLAS (SLS) recently announced the dosage of the first patient in its Phase 1 clinical study of its primary clinical candidate galinpepimut-S (GPS) in China by 3D Medicines Inc., SELLAS’ licensee for the development and commercialization of GPS in China, Hong Kong, Macau, and Taiwan (3D189 in China).
Patients with acute myeloid leukemia in complete remission or those with multiple myeloma, non-lymphoma, Hodgkin’s, or higher-risk myelodysplastic syndrome who have received at least first-line standard therapy and achieved a complete or partial response are eligible for the Phase 1 clinical trial, which is an open-label, single-arm, multicenter study. For the trial, 3D Medicines hopes to enroll fifteen individuals.
An essential step in the advancement of GPS’s clinical research worldwide was reached with the dosing of the first patient in Phase 1 clinical study for GPS, or 3D189, conducted by 3D Medicines in China. The clinical program for GPS at 3D Medicines is on track, and SELLAS will get the study’s findings.
SLS to host an update call
Additionally, on November 14, 2022, SLS will conduct a conference call to provide an update on its Phase 3 REGAL clinical study of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML).
The call will be moderated by members of the SELLAS management team, including its President and CEO, Angelos Stergiou, MD, ScD h.c., and Senior Vice President, Clinical Development, Dragan Cicic, MD. They will be joined by renowned cancer researcher M. Yair Levy, M.D., Director of Hematologic Malignancies Research at the Baylor University Medical Center, and member of the REGAL Steering Committee.
A poster by SLS was shown
GFH009, a clinical-stage small molecule from SELLAS that is very powerful, highly selective, and inhibits cyclin-dependent kinase 9, has presented findings from a bioequivalence trial (CDK9). GFH009 is given intravenously as a solution in the current Phase 1 clinical study for GFH009 monotherapy in patients with relapsed/refractory hematologic diseases, including acute myeloid leukemia and lymphoma. The bioequivalence research was conducted to assess how various formulations affected the preclinical pharmacokinetic (PK) profile of GFH009. Pharmacokinetics and Bioequivalence of Two Formulations of GFH009 Maleate Injection in Sprague Dawley Rats was the topic of a presentation presented at this year’s Meeting of the Society of Hematologic Oncology (SOHO) by Dr. Dragan Cicic, Senior Vice President, Clinical Development, of SELLAS (SLS).
