Biovica, active in cancer diagnostics, today announced that results from three different studies using DiviTum®TKa, including a budget impact model, will be presented at the world's largest breast cancer symposium, San Antonio Breast Cancer Symposium (SABCS), in early December. The studies are of a next generation CDK inhibitor, samuraciclib from Carrick Therapeutics, the biomarker study PROMISE performed at the Mayo Clinic, and the DiviTum®TKa budget impact model. All studies focused on the role of DiviTum®TKa in monitoring treatment in women with metastatic breast cancer.

Biovica and Carrick Therapeutics have collaborated on generating TK activity (TKa) data in the phase 1/2A study of samuraciclib (NCT033638939), a first-in-class, oral, selective inhibitor of CDK7 that recently received fast track designation from the US Food and Drug Administration (FDA). The study demonstrates the potential association of TKa levels with treatment effect for this next generation CDK inhibitor.
P1-18-10 A clinical study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced triple negative breast cancer (TNBC)

DiviTum®TKa results from the clinical study PROMISE (NCT03281902) conducted at the Mayo Clinic show the association of TKa with progression free survival. The study results are a continuation of the results presented on SABCS 2020. Since then, the study has continued and samples from almost twice as many patients have been tested for TKa, with the new results confirming the initial analysis and earlier DiviTum®TKa results – i.e., the usage of DiviTum®TKa as a valuable tool in the evaluation of treatment effect in metastatic breast cancer.
P5-13-22 Serum thymidine kinase 1 activity (TKa) levels and progression-free survival (PFS) in patients (pts) with hormone receptor positive (HR+) HER2-negative metastatic breast cancer (MBC) on palbociclib (Pb) and endocrine therapy (ET)

Additional results of the healthcare DiviTum®TKa Budget Impact Model show the potential for DiviTum®TKa to substantially reduce the number of CT scans and bone scans used in monitoring women with metastatic breast cancer. As these scans are both costly and a burden on patients, this reinforces the potential benefit of DiviTum®TKa to healthcare systems and to patients. Additionally, the test may enable early identification when a treatment is not effective and therefore enable overall savings of three times the added spend on the DiviTum®TKa test.
P3-03-05 The budget impact of the DiviTum®TKa assay in postmenopausal women with hormone receptor positive metastatic breast cancer

“The data on DiviTum®TKa being presented at SABCS strengthens the scientific and economic foundation for the role of the test in the care of breast cancer patients. We are very pleased with these results,” said Anders Rylander, CEO of Biovica.

The San Antonio Breast Cancer Symposium, SABCS, runs December 7-10, 2021.

Contact

Anders Rylander, CEO
Phone: +46-18-444 48 35
E-mail: anders.rylander@biovica.com

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, info@fnca.se, +46 8 528 00 399. For more information please visit: www.biovica.com.

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Biovica’s DiviTum®TKa in three studies at SABCS 2021

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