Biovica announces initial results in clinical genomics study of DiviTum®TKa
November 18, 2020 — Biovica, active in cancer diagnostics, today announced that initial results from the PROMISE study (NCT03281902) will be presented at the San Antonio Breast Cancer Symposium (December 8-11, 2020).
The PROMISE Study is evaluating the use of genomics in correlation with TK activity (TKa) to improve monitoring of breast cancer treatment.
“We are developing increased knowledge regarding the use of genomics and TKa measurements as tools for potential early identification of tumor response and resistance when treating patients with hormone receptor positive, HER2-negative metastatic breast cancer,” said Ciara O´Sullivan, M.B, B.Ch. BAO, an oncologist at Mayo Clinic and principal investigator of the study.
For the study, researchers used DiviTum®TKa to analyze serum samples from patients with metastatic breast cancer collected pre-treatment and after two cycles of standard combination treatment of endocrine therapy and a CDK 4/6 inhibitor. The aim of the study is to analyze the predictive capacity of DiviTum®TKa to evaluate efficacy and provide a comprehensive genomic assessment in order to identify novel genomic variants and pathways associated with an early decline in TKa.
Sixty-three patients were enrolled on PROMISE, which closed to new patient accrual in July 2020. In this initial analysis of 32 patients, there was a difference in genomic expression depending on whether patients had high or low TKa levels. The pattern between TKa and individual patients’ genomic expression profiles may be important for future monitoring of metastatic breast cancer, with the goal of testing new therapeutic approaches to overcome resistance to CDK4/6 inhibitors and endocrine therapy. The study is ongoing and will report updated data from additional time points and greater numbers of patients in the future.
“We are excited to once again collaborate with the Mayo Clinic in this important study to increase knowledge about resistance mechanisms and using DiviTum®TKa together with other biomarkers in the monitoring of metastatic breast cancer,” said Anders Rylander, CEO of Biovica.
Biovica – Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays to evaluate efficacy of cancer treatments. Biovica’s assay DiviTum® measure cell proliferation by detecting a biomarker in the blood stream. The assay has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. The first application for DiviTum is monitoring of treatment for patients with metastatic breast cancer. Biovica's vision is that all cancer patients will get an optimal treatment from day one. Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum is CE-marked and registered with the Swedish Medical Products Agency. Biovica's shares are traded on the Nasdaq First North Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser, firstname.lastname@example.org, +46 8 528 00 399. For more information please visit: www.biovica.com.
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