Allarity to begin enrollments for Phase 2 protocol to advance stenoparib

Allarity (ALLR) Therapeutics announced that the new protocol for its Phase 2 clinical trial of stenoparib in ovarian cancer is set to begin and will be expected to provide critical data by end of summer 2026 for a pivotal registration trial. The new protocol design was constructed following in-depth review of the Company’s ongoing Phase 2 clinical data in collaboration with key ovarian cancer thought leaders and treating physicians, including the gynecologic oncologists who have been treating patients with stenoparib in the ongoing phase 2 study. This comprehensive review revealed compelling evidence for stenoparib’s durable clinical benefit in platinum-resistant, advanced ovarian cancer patients, including a complete, confirmed response as well as two patients remaining on therapy without progression for more than 17 months. The protocol reflects the feedback of these gynecologic oncology experts as well as input from the FDA. The protocol has now also been approved by the Institutional Review Board of the first trial sites, paving the way for the trial to begin patient enrollment immediately. Anticipating IRB approval, to advance stenoparib, Allarity recently completed a new drug manufacturing campaign and has readied finished drug product for delivery to sites to expedite patient enrollment. This new protocol was designed expressly to enrich the understanding of clinical benefit in a well-defined ovarian cancer patient population with significant unmet medical need. In addition to further deepening the clinical experience for stenoparib, this trial will allow for the evaluation of the impact of stenoparib on the Wnt pathway, a critical cellular signaling pathway implicated in advanced ovarian cancer and multiple other malignancies, including colon cancer. A deeper understanding of stenoparib’s role in modulating the Wnt pathway would further differentiate stenoparib in the $9B+ PARP inhibitor market. The ongoing Phase 2 study was the first stenoparib study to assess twice-daily dosing and showed clear evidence for clinical benefit. The new protocol will build upon this clinical experience with the current dose while introducing an additional dose level to assess whether clinical benefit can be further enhanced. Ultimately, this trial will allow Allarity to address the FDA’s recent “Project Optimus” guidelines and will set the stage for pivotal registration studies. Allarity expects to pursue multiple advantaged regulatory pathways to expedite approval in the first half of 2025.