SLS Stock Snaps 2-Day Slide: Sellas’ SLS009 AML Trial Spotlights Big Pharma Drug Combo From ABBV, RHHBY And BMY

• SLS009 is being tested in AML with Venetoclax and Azacitidine, established cancer drugs sold by AbbVie/Roche’s Genentech and Bristol Myers Squibb.
• The drug targets CDK9, a protein that helps cancer cells survive and grow, and is being studied in patients with high-risk AML.
• The SLS009 study remains recruiting, with an estimated enrollment of 160 patients and primary completion expected in late 2026.

Shares of Sellas Life Sciences (SLS) snapped a two-day slide on Wednesday after the drugmaker’s updated SLS009 trial record put fresh attention on its second AML drug and its use of established cancer drugs from major pharma players. 

SLS stock rose 2% on Wednesday to end at $13.76, but shares headed for their worst week in over a month. 

Sellas AML Trial Uses Big Pharma Drugs 

According to an updated ClinicalTrials.gov record, SLS009, formerly known as GFH009, is being studied in acute myeloid leukemia (AML) in combination with Venetoclax and Azacitidine. Venetoclax is sold as Venclexta/Venclyxto by AbbVie and Roche’s Genentech, while Azacitidine is marketed as Vidaza and Onureg by Bristol Myers Squibb after its acquisition of Celgene.

The trial update comes at a critical time for Sellas, with investors already focused on the company’s Phase 3 Regal trial of GPS (galinpepimut-S) in AML, as it nears its final survival analysis. The SLS009 study is an early- to mid-stage trial testing the drug in patients with high-risk AML. SLS009 blocks CDK9, a protein that enables cancer cells to survive and grow. 

The drug is being tested both as a single agent and in combination with Venetoclax and Azacitidine. In relapsed or refractory AML, the combo is being evaluated in patients whose disease has relapsed on, or is resistant to, Venetoclax-based regimens. The trial also includes cohorts for AML patients with ASXL1 mutations and other Myelodysplasia-related mutations.

The study remains recruiting, with an estimated enrollment of 160 patients. Primary completion is expected in late 2026, while full study completion is estimated for the end of 2027. 

Sellas’ 2022 Deal Fuels AML Pipeline

SLS009 also traces back to Sellas’ 2022 licensing deal with GenFleet Therapeutics, under which Sellas obtained worldwide rights outside Greater China to GFH009, the CDK9 inhibitor now known as SLS009. The company also said it planned to study GFH009 in combination with Venetoclax and Azacitidine in AML, citing preclinical evidence of strong benefits with Venetoclax.

That earlier strategy is now reflected in the current trial design, where SLS009 is being tested on top of the same big-pharma AML treatment backbone.

SLS Investors Watch Regal Finish Line

While SLS009 is an additional catalyst for Sellas investors, focus is still on Regal, the company’s Phase 3 GPS trial in AML. The study has reached 78 of the 80 events needed for final analysis, putting it near the finish line.

CEO Angelos Stergiou pushed back on recent criticism in a Wednesday LinkedIn post, urging investors to “separate the noise from the data.” He said that slower event accrual does not necessarily mean the control arm is outperforming, and could instead signal a stronger active arm, given GPS’s potential to create a durable long-term survival benefit.

Stergiou also rejected calls to stop the trial at 78 events, saying, “Events are our statistical currency,” and warning that stopping early could raise regulatory and timing-bias concerns.

How Do Retail Traders Feel About SLS?

On Stocktwits, retail sentiment for SLS was ‘bullish’ amid a 102% jump in 24-hour message volumes.

One user said, “$SLS it was impossible not to buy a little bit more with this kind of dip right before the rip. It is crystal clear we are on the cusp of the 80th event PR.  Dr. Stergiou could not have been clearer.”

Another user said, “$SLS Coherent post from a CEO debunking all the FUD and then some. Believe in the product, believe in the execution, hold, profit.”

SLS stock has surged 558% over the past year. 

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