Allarity Therapeutics, Inc. has announced the expansion of their Phase 2 clinical trial for stenoparib, a dual PARP/Wnt pathway inhibitor, aimed at treating advanced ovarian cancer. Their recent decision seeks to accelerate the drug’s clinical development and work towards FDA regulatory approval. The expansion aims to optimize stenoparib’s dosage while refining the Drug Response Predictor (DRP®) patient selection criteria to maximize observed clinical benefits. By doing this, Allarity Therapeutics aspires to establish stenoparib as a pivotal treatment for advanced ovarian cancer, offering new hope where other treatments have failed.
Strategic Expansion of Phase 2 Trial
The expansion emerges from an in-depth review of accumulated clinical data, conducted in collaboration with leading clinical investigators, resulting in a refined protocol targeting a specific patient cohort. This cohort comprises patients with advanced, recurrent, platinum-resistant ovarian cancer who have shown sustainable clinical benefits in the current trials. Despite having exhausted standard chemotherapy options and facing limited treatment alternatives, these patients have responded positively to stenoparib, warranting deeper investigation.
One of the primary aims of this expanded trial is to amass a more substantial clinical data set to bolster regulatory approval processes. A significant interest lies in understanding the therapeutic mechanisms of stenoparib, especially its impact on the Wnt pathway. The Wnt pathway is a crucial cellular mechanism associated with advanced ovarian cancers and many other cancers, including colon cancer. By inhibiting this pathway, stenoparib may offer a unique advantage over other investigational cancer treatments, distinguishing itself through its dual-targeted inhibitory action.
Focus on Patient Selection and DRP® Technology
Allarity’s strategy involves refining the DRP® to better identify patients who will most likely benefit from stenoparib treatment. This enhancement requires assessing DRP® scores for all enrolled patients, creating a robust data set to refine DRP® cutoff values accurately. This meticulous approach is critical for seeking regulatory approval of DRP® as a companion diagnostic tool specific to stenoparib, ensuring that only those with a high likelihood of responding to the drug are selected for treatment.
Allarity Therapeutics has historically reported long-lasting clinical benefits for patients with advanced, recurrent ovarian cancer, with some patients remaining on therapy for more than 14 months. These promising outcomes support the company’s strategy to navigate a more favorable regulatory path for expedited approval. By focusing on optimizing patient selection criteria through DRP® technology, the expanded trial aims to enhance the clinical development of stenoparib significantly, offering a potential breakthrough in ovarian cancer treatment.
Patient Enrollment and Trial Sites
Anticipated to begin in the first half of 2025, the expanded Phase 2 trial’s patient enrollment is pending final protocol review by regulatory authorities. Initial recruitment will primarily target leading trial sites in the United States, with a potential expansion to additional sites in the United Kingdom if necessary. This strategic approach ensures comprehensive data gathering from a diverse patient population, improving the robustness of clinical findings and facilitating a thorough understanding of stenoparib’s efficacy in varied demographics.
Thomas Jensen, CEO of Allarity Therapeutics, emphasized that patients previously treated with stenoparib had diverse and extensive treatment histories, often being heavily pre-treated. This new clinical trial protocol is designed explicitly for a well-defined and commercially significant patient group in dire need of newer, safer treatment alternatives to chemotherapy, which is notorious for its significant side effects. Jensen highlighted the company’s eagerness to commence patient enrollment following regulatory approval, reflecting their commitment to offering better treatment options.
Mechanism of Action and Therapeutic Potential
Stenoparib, developed as an orally available small molecule, functions as a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. The interest in tankyrases stems from their role in regulating the Wnt signaling pathway, which is implicated in the development and progression of numerous cancers, including ovarian cancer. By inhibiting both PARP and the Wnt pathway, stenoparib exhibits potent therapeutic potential, possibly offering more effective treatment options for various cancer types, such as ovarian cancer.
Allarity Therapeutics holds the exclusive global development and commercialization rights for stenoparib, which was originally developed by Eisai Co. Ltd and formerly known as E7449 and 2X-121. This strategic partnership enhances Allarity’s capability to advance this promising treatment to the market, addressing a significant unmet medical need in cancer therapy by improving patient outcomes through innovative, targeted treatment approaches.
Commitment to Personalized Cancer Treatment
Allarity Therapeutics, Inc. has announced that they are expanding their Phase 2 clinical trial for stenoparib, a dual inhibitor of both the PARP and Wnt pathways, designed to treat advanced ovarian cancer. This expansion intends to bolster the accelerated clinical development of stenoparib and advance toward securing FDA regulatory approval. The primary goal of this expansion is to find the optimal dosage of stenoparib while also refining the Drug Response Predictor (DRP®) criteria used for selecting patients to ensure the best possible clinical outcomes. Through this process, Allarity Therapeutics aims to establish stenoparib as a groundbreaking treatment for patients with advanced ovarian cancer, providing a new ray of hope where previous treatments may have fallen short. By carefully selecting the right patients and optimizing the drug’s usage, the company hopes to demonstrate significant clinical benefits and pave the way for broader approval and availability of this promising therapy.
