New Phase 2 dosing of stenoparib to start testing in ovarian cancer
Allarity Therapeutics will soon start enrolling patients at several US sites
Allarity Therapeutics will soon start recruiting patients at several U.S. sites for a new dosing protocol in its Phase 2 trial testing stenoparib in women with advanced ovarian cancer, the company has announced.
This follows the recent approval of the new Phase 2 PREDICT 2X-121 trial (NCT03878849) protocol, with key data expected by the end of summer 2026. These data will support the start of future pivotal registration studies, which serve as the basis for a potential approval. The company will also pursue advantaged regulatory pathways this year, which may accelerate the treatment’s approval.
Besides testing stenoparib, the trial will also use the company’s Drug Response Predictor – DRP technology to select patients who, based on their cancer’s gene expression profile, are more likely to benefit from stenoparib.
“The intensive review and finalization of this new protocol … marks a critical milestone in our effort to accelerate stenoparib as a potentially safer, more effective alternative to additional lines of chemotherapy,” Thomas Jensen, Allarity’s CEO, said in a company press release. “We are particularly excited about the prospects of this trial advancing stenoparib’s journey toward commercialization.”
Stenoparib works to inhibit PARP1/2 and tankyrase 1/2 enzymes
Stenoparib, previously known as 2X-121, is an oral small molecule that works by inhibiting PARP1/2 and tankyrase 1/2 enzymes, or proteins. Tankyrases, in particular, are enzymes that regulate a signaling pathway called Wnt, which has been implicated in the development and progression of several cancers, including ovarian cancer.
The treatment was initially developed by Eisai, with Allarity later securing the exclusive rights for its development and commercialization.
The ongoing PREDICT 2X-121 trial is testing the stenoparib’s efficacy in 60 women with advanced ovarian cancer, previously treated with at least two chemotherapies, and who were more likely to respond to treatment based on DRP technology.
The treatment was given orally at a dose of 600 mg twice daily, in 28-day cycles. Data from this trial revealed a consistent clinical benefit of stenoparib in women with advanced ovarian cancer, including two patients being treated for about 1.5 years without disease progression.
The new protocol was built upon this clinical experience and will introduce an additional dose level to assess whether treatment benefit could be further enhanced. It was developed with feedback from oncology experts who have been treating patients in the PREDICT 2X-121 trial and the U.S. Food and Drug Administration (FDA), and was approved by the Institutional Review Board of the first trial sites.
The protocol addresses the recent FDA’s “Project Optimus” guidelines, which aim to improve the selection of a treatment dosing regimen that maximizes drug efficacy, as well as its safety and tolerability.
“This new protocol simultaneously allows us to accelerate the development of stenoparib alongside the stenoparib-DRP as a companion diagnostic,” Jensen said. “Pushing both in parallel will generate the critical data needed to support timely, connected regulatory approval for both.”
The DRP technology leverages patients’ tumor gene profiling and expression, through millions of data points that feed the proprietary DRP algorithm. The system further refines a tumor response profile using a clinical relevance filter that eliminates unneeded biomarkers.
The technology was shown to be able to significantly predict the clinical outcome in cancer patients treated with a given drug in clinical studies. It may be used for several cancer types and is patented for more than 70 cancer medications.
