Syros pushes for a turnaround with new PhII AML results, but investors are unimpressed
Two years after weak Phase II results cut their stock price in half, Syros Pharmaceuticals (SYRS) is back with results from an ongoing Phase II trial trying their SY-1425 “super-enhancer” therapy in combination with chemotherapy on acute myeloid leukemia (AML) patients.
It’s early-stage and the numbers are small, but of the 13 evaluable patients who tested positive for the RARA pathway biomarker Syros’ therapy targets, researchers say that 8 had a complete response. That compared with 8 complete responses out of 22 patients who didn’t have the gene. The longest CR was 344 days, compared with 168 for RARA negative patients, although Syros noted the study is still ongoing.
“We show how when we select the patients who have potential for a response, we have a high response rate,” Syros CMO David Roth told Endpoints News. “And we show how these responses occur relatively quickly.”
Daniel J. DeAngelo, an oncology expert at the Dana-Farber Institute who is not affiliated with Syros, said the patient population was small and the data preliminary but that the results were nevertheless promising for a subgroup of patients. He noted the data showed the drug only worked on one of two biomarkers Syros had screened for, but that in patients with RARA the response rate was around 70%.
“That’s about twice the response you would normally expect” from chemotherapy alone, DeAngelo told Endpoints. “We don’t have any progression-free, survival data, and it’s a small number [of patients] – we’d want to confirm it and all that – but looks really interesting for that group of patients.”
Investors, though, don’t appear enthused. Syros’ stock dropped 4% today, continuing a fall of nearly $5 per share since October 17, when the biotech announced it was shelving a lead CDK7 inhibitor in favor of an oral version.
The 2017 trial tested SY-1425 as a single agent and found one complete or partial response out of 48 evaluable patients. Investors responded with a selloff that cut Syros’s stock by over 50%. The company said at the time and has maintained since that the “clinical activity” in patients validated their approach and pointed toward combination therapies as a logical next step.