On May 30, 2023 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported the results of a prospective Phase 2 clinical study of the Company’s proprietary DRP technology that will be presented in a poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3, 2023 (Press release, Allarity Therapeutics, MAY 30, 2023, View Source [SID1234632228]).

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In the Phase 1/2 study, researchers analyzed the transcriptomic profiles of 37 evaluable metastatic breast cancer (mBC) patients and, based on analysis of biomarkers comprised within a DRP signature, assigned response likelihood scores (DRP 0-100) of patient tumors to a targeted, liposomal form of cisplatin (LiPlaCis). Data from the poster presentation will show that the cisplatin-DRP identified all four mBC patients who demonstrated a partial response (PR) in the trial as likely responders to the LiPlaCis treatment regimen using a DRP80+ score as a cut-off for likely responders. In addition, the cisplatin-DRP also identified mBC patients demonstrating other efficacy signals, including improved progression-free survival. Based on these data, researchers concluded that the cisplatin-DRP companion diagnostic can differentiate, in a statistically significant way, clinical responders and non-responders to cisplatin administered as LiPlaCis.

"While our proprietary DRP companion diagnostics have been extensively validated in numerous retrospective analyses across multiple forms of cancer and many drug types, these data represent the first prospective clinical study showing that our technology can predict actual patient responses ahead of potential treatment," said James G. Cullem, Chief Executive Officer of Allarity Therapeutics. "The ability to differentiate likely responders to a specific drug regimen prior to treatment has the potential to provide improved patient benefits and potential clinical trial efficiencies, and we are excited that these data will be shared with our colleagues at this year’s ASCO (Free ASCO Whitepaper) meeting."

Using a proprietary systems biology algorithm, Allarity’s DRP technology analyzes transcriptomic differences between cell lines that are sensitive and resistant to provide a biomarker signature of drug response and resistance. The DRP platform further refines the predictive signature through a clinical relevance filter (created from more than 3,000 actual tumor biopsy samples from a broad range of cancer drug clinical trials) to eliminate unnecessary biomarkers. By remaining agnostic to what influences tumor response or resistance to a drug, DRP enables the identification of unknown biomarkers crucial to drug response or resistance.

Allarity conducted the study in collaboration with investigators at hospitals in Denmark and its CRO Smerud Medical Research International AS. The LiPlaCis program is currently licensed to CHOSA Oncology AB for further clinical development.

The poster presentation details are as follows:

Poster Title: "Predictive biomarker for cisplatin in prospective phase 2 of liposomal cisplatin in metastatic breast cancer."
Authors: Nielsen, D., Jakobsen, E,H., Langkjer, S.T., Danoe, H., Balslev, E., Knoop, A., … Lassen, U.N.
Abstract Number: 3130
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: 6/3/2023, 8:00 AM-11:00 AM local time