Biovica is uniquely positioned to address one of the major challenges in cancer therapy today; how to better evaluate therapeutic efficacy and improve quality of life in patients with advanced stages of the disease.
A simple blood sample
DiviTum® is an innovative biomarker assay developed with the aim to monitor and predict treatment response in cancer therapy. It offers several advantages over alternative techniques that are standard in advanced breast cancer. In several clinical trials, the DiviTum® biomarker assay has demonstrated the potential to quickly evaluate treatment effect and accurately predict outcome using just a simple blood sample.
New unique data from US breast cancer congress
The results demonstrate that palbociclib significantly reduced serum TK-activity levels in patients with hormone sensitive, HER2- breast cancer already after 2 weeks of treatment. DiviTum® measured changes in serum TK-activity that was significantly correlated to the tumor Ki67 proliferation index. DiviTum® may thus serve as a non-invasive marker and early response indicator of the anti-proliferative effect of CDK4/6 inhibitors like palbociclib.
Biovica, a Swedish biotech company founded in 2009, develops and commercializes blood-based biomarker assays that improve the monitoring of modern cancer therapies and better predict patient outcome. Biovica is supported by The European Commission and has been selected to receive funding in the Horizon 2020 phase 2 program.
On the 22nd of July, Biovica had fruitful meeting with the FDA regarding Supplement II that discusses the approach for clinical validation of DiviTum. Next step is to document the conclusions from the meeting, which the FDA will review [...]
FDA-process and commercialization on track. New study results confirm the potential. Year-End Report (May-January 2018/2019)
SEK thousands Q4 18/19 Q4 17/18 May-April 18/19 May-April 17/18 Net sales 1,715 1,433 3,005 2,723 Operating profit (loss) -8,569 -4,132 -21,718 -17,956 Loss for the period -8,631 -4,176 -21,556 -18,010 Earnings per share, after dilution -0.47 -0.24 -1.18 -1.01
Biovica has a comprehensive study program with DiviTum® to demonstrate the clinical value for cancer patients. Biovica has published a summary brochure in order to share knowledge about results achieved so far with DiviTum® to researchers, oncologists and other stakeholders. The summary describes all clinical studies presented where DiviTum® is used to evaluate response to breast cancer treatment.
BEST POSSIBLE TREATMENT FROM DAY ONE
Breast cancer is the most common form of cancer among women today, affecting approximately 362,000 individuals in the EU and 233,000 in the US each year. Better tests for evaluating therapeutic efficacy, such as Biovica’s DiviTum® biomarker assay, aim to increase survival and improve quality of life.
Clinical trials and Collaborations
Biovica has successfully worked to realize its vision for Divitum® by initiating collaborations with globally-renowned research institutes such as the Karolinska Institute and the Dana Farber Cancer institute, as well as the International Breast Cancer Study Group (IBCSG) and the Breast International Group (BIG).