Predicine and Kintor Pharma today announced that new data on Proxalutamide (GT0918) in a Phase I/II clinical trial (NCT02826772) will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany.
Metastatic castration resistant prostate cancer (mCRPC) is a complex disease with distinct molecular features in relation to genomic instability and selective treatment pressure. The current Phase I/II clinical study evaluates Proxalutamide in mCRPC patients in the United States who progressed after both hormonal therapy (Abiraterone or Enzalutamide) and chemotherapy (Docetaxel), or cannot tolerate either or both therapies.
Predicine and Kintor Pharma have established a partnership to investigate the biomarker profiling in this clinical study by using Predicine’s proprietary GeneRADAR technology that detects genetic alterations at cell-free tumor DNA (ctDNA) and cell-free tumor RNA (ctRNA) levels. The test identified both ctDNA-based mutation (such as AR, TP53, PTEN-PI3K-AKT pathway), copy number gain (AR), copy number loss (PTEN/RB/BRCA), and ctRNA-based mutation, AR splicing variants (AR-V7, AR-V3) and fusions (TMPRSS2-ERG), cfDNA dynamics, among others. The data from Proxalutamide Phase I/II trial demonstrated the scientific value, in the clinical setting, of important clinical utility potentials in support of ctDNA+ctRNA liquid biopsy as clinical tests in non-invasive molecular profiling, monitoring therapeutic response, and deciphering the mechanism of drug activities or/and resistance.
“Non-invasive detection of genomic alterations, including transcriptional aberrations, is proven to be an essential component for personalized medicine and clinical drug development, especially as we learn more about the diversity of such alterations in human cancer,” said Dr. Jianjun Yu, VP of Translational Medicine at Predicine. “This study clearly demonstrated the clinical value of ctRNA liquid biopsy test in addition to standard ctDNA assay in biomarker analysis and suggests its potential in co-development of the drug and companion diagnostic test.”
Predicine and Kintor Pharma plan to present the biomarker and clinical outcome data during the ESMO 2018 titled Circulating tumor DNA and RNA as an exploratory biomarker to evaluate GT0918 in a Phase 1/II clinical trial in mCRPC patients.
About Kintor Pharma
Kintor Pharma is a biotech company dedicated to developing innovative therapeutics, especially in therapeutic areas of prostate, breast and liver cancers. Its leading drug candidate, Proxalutamide, is a new generation of inhibitor of androgen receptor, currently in Phase III clinical trial in China and Phase II clinical trial in the United States for mCRPC indication, and Phase I/Ib clinical trial in China for TNBC indication. Its R&D pipeline also includes “first-in-class” ALK1 antibody, PI3K/mTOR kinase targeted inhibitor, Hedgehog/SMO inhibitor, PARP inhibitor, IDO inhibitor and etc.
Predicine specializes in genomic profiling assays and is dedicated to transforming patient care and clinical drug development. Predicine has developed GeneRADAR, the industry’s first ctRNA + ctDNA liquid biopsy test, to provide a comprehensive understanding of the molecular changes in cancer. Predicine has initiated a patient enrollment program Predi-Trial to accelerate global clinical trials through biomarker-driven precision enrollment. The GeneRADAR technology and its biomarker database identify the molecular alterations in a patient’s cancer and match the patient with relevant targeted therapies, immunotherapies, and clinical trials. Through its CLIA laboratory in Hayward, CA and facility in Shanghai, Predicine partners with biopharmaceutical companies to support global clinical trials in China, U.S., Europe, APAC, and Australia.