New DiviTum(R) TKa Data to be Presented at ASCO in Three Cancer Types

UPPSALA, SE / ACCESS Newswire / May 23, 2025 /Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Biovica, active in cancer monitoring, today announces that three abstracts based on studies using the blood test DiviTum TKa will be presented at the world 's largest cancer meeting, the American Society of Clinical Oncology (ASCO), May 30 - June 3, 2025. ASCO is the world 's largest and most influential oncology conference, bringing together approximately 31,000 oncology professionals.

The new data further validates DiviTum TKa as a predictive biomarker across three cancer indications:

• Hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients treated with CDK4/6 inhibitors in the high-profile PEARL study

• BRAF V600-mutated metastatic melanoma treated with Immune Checkpoint Inhibitors (ICI)

• Ovarian cancer treated with platinum-based chemotherapy

While the PEARL study represents a large-scale trial that addresses a key clinical decision-making challenge in MBC - whether to select newer versus established treatment combinations - the studies in melanoma and ovarian cancer are more exploratory in nature.

" It is exciting that DiviTum TKa will be presented to such a large audience as a predictive biomarker for personalized treatment selection in MBC, malignant melanoma , and ovarian cancer, thereby significantly extending the number of patients who can benefit from DiviTum TKa. Equally exciting, that DiviTum TKa can also predict outcomes for patients receiving the new generation Immune Checkpoint Inhibitors for malignant melanoma," said Anders Rylander, CEO of Biovica.

Thank you to the long list of partners in eight European countries, who have contributed to bringing about new knowledge.

More about the

Abstract Title	Institution	Patient Population	Key Findings
"Thymidine kinase activity (TKa) as independent predictor of outcome in metastatic breast cancer (MBC) patients in the GEICAM/2013-02 PEARL trial: A predictive biomarker for personalized treatment selection between Capecitabine vs ET + Palbociclib in MBC"	GEICAM, Spain	Treatment for HR+/HER2- metastatic breast cancer (MBC) with early (≤12 months) progression.	TKa can predict for personalized treatment selection between Capecitabine vs ET + Palbociclib CT vs a CDK4/6 inhibitor influence TKa response differently, and the direction and magnitude of the TKa response can predict for benefit to a specific therapy. The original PEARL study analysis showed no outcome differences between Cape vs ET + Palbo in HR+/HER2- MBC pts, however assessment of TKa before and during therapy identified which patients had the highest probability of responding.
"Serum Thymidine Kinase Activity (TKa) as a Potential Biomarker in the Sequential Immunotherapy and Targeted Therapy for Metastatic BRAF V600 Mutated Melanoma (SECOMBIT) trial"	30 centers in: Austria, France Greece, Italy, Spain, Sweden, and Switzerland	BRAF V600 mutated metastatic melanoma	TKa can predict patient outcome in BRAF V600 mutated metastatic melanoma Patients with elevated TKa is an evident poor prognosis group. First study to evaluate the role of TKa as a biomarker in a prospective clinical trial in patients with metastatic melanoma.
"Thymidine kinase activity as a prognostic and predictive tool in blood samples from primary ovarian cancer patients"	University of Duisburg-Essen, Germany	Ovarian Cancer	Baseline TKa levels in both serum and plasma significantly correlated with OS and DFS, which identifies circulating TKa as a promising prognostic marker in OC. It might further serve as a predictive marker for response to platinum-based chemotherapy. However, prospective validation of these results is needed in order to further specify the clinical value of TKa.

List of abbreviations
BC Breast Cancer
BL Base Line - prior to treatment
BRAF V600 BRAF is a human gene responsible for producing the protein B-Raf, which is involved in signaling direct cell growth. The V600E mutation describes an amino acid substitution at position 600 in BRAF from a valine (V) to a glutamic acid (E)
CDK4/6i CDK4/6 inhibitor treatments
DFS Disease-Free Survival
HER2 Human Epidermal Growth Factor Receptor 2
HR Hormone receptor
HR+ Hormone receptor-positive
MBC Metastatic Breast Cancer
OS Overall Survival
Pts Patients
TKa Thymidine Kinase activity

Contact

Anders Rylander, CEO
Phone: +46 76 666 16 47
E-mail: anders.rylander@biovica.com

Anders Morén, CFO
Phone: +46 73 125 92 46
E-mail: anders.moren@biovica.com

Biovica - Treatment decisions with greater confidence

Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica 's assay, DiviTum® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica 's vision is: "Improved care for cancer patients." Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica 's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company 's Certified Adviser. For more information, please visit: www.biovica.com

Attachments

New DiviTum® TKa data to be presented at ASCO in three cancer types

SOURCE: Biovica International

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