The preeminent biopharmaceutical entity, Oncternal Therapeutics, has constantly pushed the bounds of innovation in its dogged pursuit of creating novel oncology therapies. The burgeoning clinical-stage biotech announced two significant milestones in its ongoing Phase 1/2 studies employing its dual-action androgen receptor inhibitor, ONCT-534, specifically targeting patients who have relapsed or exhibit resistance to approved androgen receptor pathway inhibitors (ARPI).
Almost three months after confirming the enrollment of its fourth patient into the Phase 1/2 study of ONCT-534, and initiating the third dosage cohort receiving 160mg of the ARPI daily, Oncternal Therapeutics demonstrated impressive forward momentum by initiating the fourth patient dosing cohort. The patients will be administered a daily oral dose of 300mg ONCT-534, marking a considerable increase from the third dose level.
The decision to escalate the dosage was taken after meticulous data review from previous patients by the study’s Safety Review Committee (SRC). A significant part of the previous study incorporated an adaptive Bayesian Optimal Interval (BOIN) design, which informed the decision to heighten the dosage.
The ambitious biotech’s previous Phase 1/2 study involved the treatment of the first two dosing cohorts with 40 mg and 80 mg of ONCT-534 per day respectively. The approval to transition to the third dosage level by the SRC was evident proof of the robust and positive patient response to the treatment.
In addition to the company’s strides in its prostate cancer study, it has also made considerable headway in relation to aggressive B-cell lymphoma. Oncternal Therapeutics also provided an update on its dose escalation/dose expansion Phase 1/2 Study, ONCT-808-101. This trial specifically evaluates the potency of Oncternal’s ROR1-targeting autologous CAR T cell therapy, ONCT-808, for the treatment of those patients who have relapsed or refractory aggressive B-cell lymphoma, particularly those patients who did not respond to previous CD19 CAR T treatment.
The vigorous progress in both studies elucidates Oncternal’s commitment to comprehensive cancer treatment solutions, particularly for patients who present resistant or relapsed cases. Its relentless bioinnovation continues to forge new paths in accelerating transformational outcomes for patients in the oncology space.
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