FDA slaps a hold on an AML trial as Marker scraps a failing ovarian cancer program, sinking shares
The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.
The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.
The company said the FDA raised concerns following Marker’s IND application. FDA guidelines say the agency will respond within 30 days of receiving Marker’s response — which should mean before the end of November.
“The FDA reviewed our submission and requested additional information regarding certain quality and technical specifications for two reagents supplied by third-party vendors that are used in our manufacturing process,” Marker wrote. “Because the FDA requires these data in order to clear the IND, the Marker AML trial has been placed on clinical hold until our complete response to the technical questions is satisfactory to the FDA.”
Marker’s stock $MRKR fell 27%, from a previous close of $3.92 per share to $2.87.
The FDA halt comes as one of several notable holds the regulator has instituted over the last few weeks, including two for RegenxBio, one for Novartis and one for Solid Biosciences, which saw its Duchenne’s muscular dystrophy held up again yesterday after resolving a hold just 18 months ago. RegenxBio responded to its holds by suing the FDA.
Marker spun out of Baylor College of Medicine 4 years ago with a reported $20 million in early backing, and it merged last year with TapImmune. The AML drug is on Marker’s top programs and attempts to retrain a patients’ T cells to recognize specific tumor types. They had hoped to dose their first Phase II patient before the end of the year.
With the ovarian program also scrapped, Marker is left with a handful of clinical studies, including a T cell vaccine program that is now in Phase II for breast cancer patients. An early analysis of that study showed 31 out of 34 patients had a “meaningful” immune response, Marker said.