PLOS ONE Publishes Data on Allarity Therapeutics’ DRP® Companion Diagnostic for Dovitinib
- The DRP®-Dovitinib companion diagnostic demonstrated an ability to identify advanced renal cell carcinoma patients that have improved clinical benefit from dovitinib treatment, as compared to unselected patients
BOSTON (August 30, 2023) — Allarity Therapeutics, Inc. (Allarity or the Company) (Nasdaq: ALLR), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, announced today the publication of its clinical validation of a novel drug-specific DRP®-companion diagnostic (CDx) for dovitinib in the peer-reviewed journal PLOS ONE. Data showed that the DRP®-Dovitinib CDx was able to identify a subgroup of advanced renal cell carcinoma (RCC) patients that have improved clinical benefit from treatment with dovitinib, as compared to unselected patients. PLOS ONE published the paper online today titled, “A novel drug-specific mRNA biomarker predictor for selection of patients responding to dovitinib treatment of advanced renal cell carcinoma and other solid tumors.”
“Having our work published in PLOS ONE underscores the importance and potential impact of our DRP®-Dovitinib CDx in oncology,” said Allarity’s Chief Scientific Officer and Study Author Dr. Steen Knudsen. “This is the first validated predictive biomarker in renal cell carcinoma, a long-standing goal in potentially improving the treatment of these patients. An additional prospective trial would be required before RCC patients that are candidates for dovitinib can benefit from this diagnostic breakthrough. This DRP® publication marks yet another important step forward in Allarity’s mission to redefine cancer treatment paradigms and realize true personalized cancer care.”
Dovitinib is a pan-targeted kinase inhibitor (pan-TKI) formerly developed through Phase 3 clinical studies. The DRP®-Dovitinib CDx is a complex transcriptomic signature comprising 58 mRNA biomarkers that are collectively predictive of tumor response to the drug. In the study evaluating pre-treatment biopsies of 135 advanced RCC patients, the DRP® positive subgroup (indicating that the patient was likely to respond) (N=49) had a median overall survival of 15 months (96% CI 12.94-26.25), whereas the DRP® negative subgroup (N=86) had a median overall survival of 9.13 months (95% CI 7.49-13.2). The hazard ratio was 0.60 (95% CI 0.39-0.91).
In addition to the 135 RCC biopsies, the DRP®-Dovitinib showed equally promising data in a number of other solid tumors, such as hepatocellular carcinoma (HCC), thereby demonstrating that it is independent of tumor type and has applicability beyond RCC.
The PLOS ONE article is Allarity’s 14th peer-reviewed publication of data from clinical validations of DRP® companion diagnostics for a range of different cancer therapeutics, further establishing the robustness of the DRP® platform.
Dovitinib has been the focus of numerous clinical studies, showing promising properties as an anti-cancer agent, but is not yet approved for the treatment of any cancer type. It is currently being advanced by Allarity in an ongoing Phase 1b clinical study exploring the potential synergy of dovitinib and stenoparib (a PARP inhibitor) for the treatment of advanced solid tumors, including ovarian cancer. In addition, in partnership with Allarity, Oncoheroes Biosciences has an ongoing program to develop dovitinib, together with the DRP®-dovitinib CDx, as a treatment for pediatric osteosarcoma.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP® platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer, and in Phase 1 development for advanced solid tumors in a combination treatment with dovitinib, a pan-tyrosine kinase inhibitor (pan-TKI) that has previously been developed through Phase 3 in renal cancer; and IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111, a liposomal formulation of doxorubicin for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis®, a liposomal formulation of cisplatin and its accompanying DRP®, being developed via a partnership with CHOSA Oncology AB for late-stage metastatic breast cancer. The Company is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark. For more information, please visit the Company’s website at www.Allarity.com.
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP® score, the therapeutic response rate can be significantly increased. The DRP® method build
