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SLS Stock Hits Over 4-Year High: CEO Eyes FDA Talks, ‘Whole Gamut’ Of Cancer Uses For GPS

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Sellas Life Sciences Group's stock surged significantly due to promising developments in their acute myeloid leukemia (AML) study. The company's CEO discussed potential FDA pathways and broader applications for their drug galinpepimut-S (GPS), while also highlighting progress with their second AML drug, SLS009.
  • The Phase 3 Regal study for GPS in AML patients nearing completion, with the company anticipating topline data soon. CEO Angelos Stergiou expressed optimism, noting unexpectedly long survival times in the study, which could increase the probability of a successful outcome.
  • Stergiou outlined a potential regulatory path involving a pre-BLA meeting and filing shortly after positive topline data release. He also indicated GPS's potential expansion into up to 20 other tumor types expressing Wilms’ Tumor 1 (WT1), the cancer target it attacks.
  • Investors are also closely watching SLS009, a selective CDK9 inhibitor. Encouraging Phase 2 data suggests "extraordinary synergy" with venetoclax in patients with resistant AML, showing significant improvements in response rates and survival.
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