Oncternal Therapeutics Halts Clinical Trials, Explores Strategic Alternatives

Oncternal Therapeutics, a biopharmaceutical company, has announced the discontinuation of its phase 1/2 ONCT-808-101 clinical trial and all other ongoing clinical trials in its pipeline. The decision comes after the company evaluated the available clinical data and capital requirements, leading to the exploration of strategic alternatives to advance and realize value from its pipeline.

Unlocking Potential Amidst Challenges: Oncternal's Strategic Shift

Discontinuation of ONCT-808-101 Trial

Oncternal Therapeutics has made the decision to discontinue its phase 1/2 ONCT-808-101 clinical trial (NCT05588440), which was evaluating ONCT-808, an investigational chimeric antigen receptor T-cell (CAR-T) therapy, for the treatment of relapsed/refractory (r/r) aggressive B-cell lymphoma. Despite the observed antitumor activity and a complete metabolic response that lasted 8 months, the company noted the occurrence of a fatal adverse event in one patient, leading to the discontinuation of the trial.

Halting Other Pipeline Candidates

Alongside the ONCT-808 study, Oncternal is also discontinuing clinical trials for all other candidates in its pipeline, including ONCT-534, a dual-action androgen receptor inhibitor; zilovertamab, an investigational monoclonal antibody intended to inhibit the function of ROR1; and ONCT-216, an investigational targeted small-molecule inhibitor of the E26 transformation-specific family of oncoproteins. The company cited available clinical data and capital requirements as the driving factors behind this decision.

Exploring Strategic Alternatives

In light of the discontinuation of its clinical trials, Oncternal Therapeutics has stated that it will be reducing its workforce to preserve resources as it explores strategic alternatives. These alternatives may include asset sales, licensing or other strategic transactions, a merger, reverse merger, acquisition, or other business combination. The company aims to advance and realize value from its pipeline, including ONCT-534, ONCT-808, zilovertamab, and ONCT-216.

Addressing Unmet Needs and Challenges

James Breitmeyer, MD, PhD, the president and chief executive officer of Oncternal, expressed disappointment in the early results of the ONCT-534 study, which was designed to address important unmet medical needs for patients with advanced prostate cancer. However, the company remains committed to exploring strategic options to potentially advance and realize value from its pipeline, including the promising ONCT-808 CAR-T therapy.

Prioritizing Patient Safety and Transparency

Oncternal Therapeutics has been transparent about the safety concerns that led to the discontinuation of the ONCT-808-101 trial. The company reported the death of a patient due to complications consistent with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome. Oncternal stated that it was seeking to modify the trial's protocol and had been in communication with the FDA regarding such changes, underscoring its commitment to patient safety.Despite the challenges faced, Oncternal Therapeutics remains focused on exploring strategic alternatives to advance its pipeline and address unmet medical needs. The company's decision to discontinue its clinical trials and explore new opportunities reflects its commitment to responsible stewardship of resources and a dedication to finding the best path forward for its innovative therapies.