Biovica International, a company specializing in blood-based cancer monitoring, has signed a master service agreement with an unnamed biopharmaceutical company that will allow Biovica to provide its TKa testing assay and services. The agreement, announced on March 12, 2024, includes provisions for multiple work orders, with the first valued at 1.2 MSEK.
Under the terms of the agreement, Biovica will perform TKa testing services to evaluate cell proliferation activities in pivotal drug development studies. The service will leverage Biovica's TKa assay technology and expertise in interpreting TKa measurement dynamics, contributing specifically to the development of first-in-class next-generation CDK4/6 inhibitor therapeutics for breast cancer.
Henrik Winther, SVP Business Development at Biovica, expressed enthusiasm about the partnership: "We are very happy to see the great demand for our Pharma Services Business. The agreement adds to our current list of 13 master service agreements with pharma/biotech companies and is an important step that could lead to the development of a Companion Diagnostic (CDx) product. Ultimately, the correlation between TKa, improved CDK inhibitor response, and better outcomes is what Biovica is striving for on behalf of patients."
TKa Technology and Clinical Applications
Biovica's DiviTum® TKa assay measures cell proliferation by detecting the TKa biomarker in patients' bloodstream. The technology has demonstrated its ability to provide insights into therapy effectiveness across several clinical trials. Currently, the primary application for the DiviTum® TKa test is monitoring treatment response in patients with metastatic breast cancer.
The assay has received FDA 510(k) clearance in the United States and is CE-marked in the European Union, allowing for commercial use in these key markets. This regulatory approval strengthens Biovica's position as they expand their partnerships with pharmaceutical companies for drug development applications.
Strategic Importance for Cancer Treatment
This new partnership highlights the growing importance of biomarker testing in oncology drug development. By providing real-time monitoring of cancer cell proliferation, Biovica's technology may help researchers better understand the efficacy of experimental CDK4/6 inhibitors and potentially identify patients most likely to benefit from these treatments.
The development of next-generation CDK4/6 inhibitors represents an important advancement in breast cancer treatment. Current CDK4/6 inhibitors have already transformed the treatment landscape for hormone receptor-positive, HER2-negative breast cancer, and next-generation compounds aim to improve efficacy and overcome resistance mechanisms.
If successful, the collaboration could lead to the development of a Companion Diagnostic product that would help clinicians select appropriate patients for treatment with these new therapeutics, potentially improving patient outcomes while optimizing healthcare resources.
Company Background
Biovica develops and commercializes blood-based biomarker assays designed to help oncologists monitor cancer progression. The company's vision is "Improved care for cancer patients," and it collaborates with world-leading cancer institutes and pharmaceutical companies to advance its technology.
Biovica's shares are traded on the Nasdaq First North Premier Growth Market under the ticker BIOVIC B, with FNCA Sweden AB serving as the company's Certified Adviser.
