The ongoing GPS trial is an overall survival study and final analysis is expected once 80 deaths have occurred.
- As of December 26, 72 deaths have occurred, the company said on Monday.
- SELLAS had said in August that it expects the 80 events to occur by year-end.
- GPS is SELLAS’ lead candidate licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types.
Shares of SELLAS Life Sciences Group, Inc. (SLS) traded 17% higher on Monday after the company said that it is approaching the final analysis of its late-stage trial in Acute Myeloid Leukemia.
The company is currently evaluating Galinpepimut-S (GPS) as a potential maintenance therapy in patients with Acute Myeloid Leukemia who have achieved complete remission following second-line salvage therapy. AML is a fast-growing cancer of the blood and bone marrow where immature white blood cells build up, crowding out healthy cells, leading to fatigue, infections, and bleeding. GPS is SELLAS’ lead candidate licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types.
Final Analysis Nears
The ongoing GPS trial is an overall survival study and final analysis is expected once 80 deaths have occurred. As of December 26, 72 deaths have occurred, the company said on Monday. SELLAS had said in August that it expects the 80 events to occur by year-end.
“We appreciate the continued dedication of the patients, families, and investigators participating in the pivotal Phase 3 REGAL trial where survival times, fortunately for patients and caregivers, appear longer than expected,” said SELLAS CEO Angelos Stergiou. “While the 80th event has not yet occurred, and we remain fully blinded, every passing month may increase the probability of a successful study as highlighted by key opinion leaders in our recent R&D event. Conclusive data will follow the unblinding and analyses of the study results.”
Interim Analysis
In August, an Independent Data Monitoring Committee completed a pre-specified analysis of the trial and issued a positive recommendation to continue the trial without modification. No safety concerns were identified, and available efficacy data were consistent with expectations for continued trial conduct, the company then said.
The study completed enrollment in April 2024, with a total of 126 patients randomized.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around SLS stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.
A Stocktwits user called the current price “absurd” and opined the stock is worth double digits. “Right this second! Not tomorrow, not next week, not a year from now but immediately right this very second…DOUBLE DIGITS!,” they wrote.
SLS stock has more than tripled this year and risen by about 239% over the past 12 months.
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