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microcapbiotech

01/27/22 12:09 AM

#31744 RE: Gatta-git-it #31743

In 2019 they went from about $75 to about $5 and been between $5 and $15 up and down since then.

current SLS P3 trial:
Based on the above data and following review by the FDA, a pivotal Phase 3 clinical trial, the REGAL study, for AML patients in CR2 was commenced in January 2020. The REGAL study is a 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators’ choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is the overall survival (OS) from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The study is expected to enroll approximately 116 patients across approximately 50 clinical sites in the United States and Europe.

Their P3 also has Fast Track and Orphan Drug.
https://clinicaltrials.gov/ct2/show/NCT04229979
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022

We ain't the only ones trying for cures.
We should find out soon how SLS did.

hanscott

01/27/22 5:02 PM

#31751 RE: Gatta-git-it #31743

Re. Sellas Life Sciences AML clinical trials.

They use a WT1 vaccine and are targeting a different patient population than MRKR - AML patients who "Are not candidates at the time of study entry for allogeneic stem cell transplant (Allo-SCT)." MRKR is targeting AML patients post-Allo stem cell transplantation.

For their PI/II clinical trial: they tested their WT1 vaccine in combination with pembrolizumab/Keytruda, an antibody that acts as a PD1 checkpoint inhibitor (PD1 is a receptor on T Cells, which when activated by tumor cells shuts down T cell activation).

For their PIII clinical trial they are comparing their WT1 vaccine alone to several "best available" chemotherapies.

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I'd love to see multipronged attack using MRKR's therapy combined with checkpoint inhibitors like Keytruda (PD1 inhibitor) and/or AK117 (CD47 inhibitor) - and something like ImmunoGen's CD123-targeting Antibody-Drug-Conjugate that kills AML cells.