Cancer company Oncternal Therapeutics is folding all its clinical trials and laying off staff, turning its energy toward exploring strategic alternatives such as asset sales, a merger or acquisition.
The San Diego-based biotech is terminating early-stage clinical trials evaluating ONCT-534, a dual-action androgen receptor inhibitor designed to treat metastatic castration resistant cancer, and ONCT-808, a ROR1-targeting autologous CAR-T for aggressive B-cell lymphoma, according to a Sept. 12 company release.
The move comes after ONCT-534 failed to turn up meaningful disease improvements in an interim phase 1/2 analysis, while ONCT-808 was tied to a patient death. In December 2023, interim phase 1/2 results revealed a death due to complications of shock at the highest dose of ONCT-808 tested.
The patient was one of three receiving treatment and was the first to receive the next dose level, which tripled the number of CAR T cells to 3 million per kilogram, according to Oncternal. The company described the patient as an 80-year-old male who had undergone four previous lines of cancer treatment, including CD19 CAR-T therapy.
“In light of these data and the challenging financing environment, we intend to explore strategic options with the hope of advancing and realizing value from our pipeline including ONCT-534, ONCT-808, zilovertamab and ONCT-216,” Oncternal President and CEO James Breitmeyer, M.D., Ph.D., said in the company release.
Zilovertamab is a clinical-stage monoclonal antibody designed to inhibit the function of ROR1 to treat several cancer forms. The mAb has snagged FDA orphan drug designations in mantle cell lymphoma and chronic lymphocytic leukemia. Then there’s ONCT-216, a clinical small-molecule inhibitor taking aim at Ewing sarcoma, a rare tumor type that forms in bones or soft tissue. The asset has nabbed rare pediatric disease designation, orphan drug designation and fast track status in the indication.
As the biotech seeks out options for its programs, the company will reduce its workforce to save cash, according to the release. While the company didn’t share specifics about the layoffs, Fierce Biotech has reached out for comment and will update this article if new information becomes available.
The biotech’s stock has plummeted 60% since market close yesterday, sinking from $4.05 per share to $1.67 this morning.