Latest news with #Biovica
Yahoo
3 hours ago
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Biovica Secures Three New Work Orders in Pharma Services of 2,5 MSEK in Value
UPPSALA, SE / / June 10, 2025 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Biovica, a leader in blood-based cancer monitoring, has signed three new work orders within its Pharma Services business, with a combined value of approximately SEK 2.5 million. The agreements are for TKa testing services with existing customers. Two of the three work orders were placed by the Tier-1 (revenues >10 BUSD) U.S. pharmaceutical company which recently entered into a broader service agreement with Biovica, including a record-breaking SEK 4 million work order. These latest orders will support the development of next-generation CDK4/6 inhibitors. The orders are a combination of retrospective analysis, that will be performed in the coming months, and prospective analysis that will be performed over ~2 years. "I'm pleased to see that our Pharma customers recognize the value of DiviTum® TKa and are returning for continued use. The reliable and meaningful data it provides continues to drive demand from leading pharmaceutical companies, who use it in the development of new cancer therapies that will benefit patients.," said Anders Rylander, CEO of Biovica. Contact Anders Rylander, CEOPhone: +46 76 666 16 47E-mail: Anders Morén, CFOPhone: +46 73 125 92 46E-mail: 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: Attachments Biovica secures three new work orders in Pharma Services of 2,5 MSEK in value SOURCE: Biovica International View the original press release on ACCESS Newswire
Yahoo
23-05-2025
- Business
- Yahoo
New DiviTum(R) TKa Data to be Presented at ASCO in Three Cancer Types
UPPSALA, SE / / 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 theGEICAM/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 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 mutatedmetastatic melanoma TKa can predict patient outcome inBRAF V600 mutated metastatic melanomaPatients with elevated TKa is an evident poor prognosis 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 abbreviationsBC Breast CancerBL Base Line - prior to treatmentBRAF 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 treatmentsDFS Disease-Free SurvivalHER2 Human Epidermal Growth Factor Receptor 2HR Hormone receptorHR+ Hormone receptor-positiveMBC Metastatic Breast CancerOS Overall SurvivalPts PatientsTKa Thymidine Kinase activity Contact Anders Rylander, CEOPhone: +46 76 666 16 47E-mail: Anders Morén, CFOPhone: +46 73 125 92 46E-mail: 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: Attachments New DiviTum® TKa data to be presented at ASCO in three cancer types SOURCE: Biovica International View the original press release on ACCESS Newswire
Yahoo
23-05-2025
- Business
- Yahoo
New DiviTum(R) TKa Data to be Presented at ASCO in Three Cancer Types
UPPSALA, SE / / 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 theGEICAM/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 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 mutatedmetastatic melanoma TKa can predict patient outcome inBRAF V600 mutated metastatic melanomaPatients with elevated TKa is an evident poor prognosis 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 abbreviationsBC Breast CancerBL Base Line - prior to treatmentBRAF 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 treatmentsDFS Disease-Free SurvivalHER2 Human Epidermal Growth Factor Receptor 2HR Hormone receptorHR+ Hormone receptor-positiveMBC Metastatic Breast CancerOS Overall SurvivalPts PatientsTKa Thymidine Kinase activity Contact Anders Rylander, CEOPhone: +46 76 666 16 47E-mail: Anders Morén, CFOPhone: +46 73 125 92 46E-mail: 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: Attachments New DiviTum® TKa data to be presented at ASCO in three cancer types SOURCE: Biovica International View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
19-05-2025
- Business
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Biovica Signs Major Service Agreement and First Study Work Order of 4 MSEK
UPPSALA, SE / / May 19, 2025 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Biovica, a leader in blood-based cancer monitoring, today announces the signing of a Master Service Agreement (MSA) with a US-based pharmaceutical and biotechnology company recognized as a Tier-1 player in oncology. A first work order has also been signed totaling SEK 4 million. Under the agreement, Biovica will provide TKa testing across multiple projects using its DiviTum® TKa assay, along with its expertise in interpreting TKa measurement dynamics to support drug development. As part of the agreement, the first work order has already been signed and pertains to a large-scale clinical trial in breast cancer. The total expected revenue from the first work order amounts to SEK 4 million. "This marks an important milestone in the continued adoption of our DiviTum TKa assay. This collaboration is our 17th broader collaboration agreement (MSA) with a pharmaceutical partner and our fourth with a Tier-1 oncology company. The agreement not only validates the clinical relevance of our TKa biomarker but also strengthens our position to co-develop a future Companion Diagnostic (CDx) product-ultimately benefiting cancer patients undergoing treatment," said Anders Rylander, CEO of Biovica. This collaboration will broaden the application of DiviTum TKa in clinical trials focused on next-generation oncology therapies, further strengthening the potential for TKa to be established as a key biomarker for therapeutic monitoring. The study is a Phase Ib/II multicenter, open-label, randomized trial. The trial focuses on patients with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer, with a total enrollment of 250 patients. Biovica will conduct all TKa testing at its U.S. laboratory, with testing services commencing early September 2025, and continuing through December 2028. Contact Anders Rylander, CEOPhone: +46 76 666 16 47E-mail: Anders Morén, CFOPhone: +46 73 125 92 46E-mail: 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: Attachments Biovica signs major service agreement and first study work order of 4 MSEK SOURCE: Biovica International View the original press release on ACCESS Newswire
Yahoo
19-05-2025
- Business
- Yahoo
Biovica Signs Major Service Agreement and First Study Work Order of 4 MSEK
UPPSALA, SE / / May 19, 2025 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Biovica, a leader in blood-based cancer monitoring, today announces the signing of a Master Service Agreement (MSA) with a US-based pharmaceutical and biotechnology company recognized as a Tier-1 player in oncology. A first work order has also been signed totaling SEK 4 million. Under the agreement, Biovica will provide TKa testing across multiple projects using its DiviTum® TKa assay, along with its expertise in interpreting TKa measurement dynamics to support drug development. As part of the agreement, the first work order has already been signed and pertains to a large-scale clinical trial in breast cancer. The total expected revenue from the first work order amounts to SEK 4 million. "This marks an important milestone in the continued adoption of our DiviTum TKa assay. This collaboration is our 17th broader collaboration agreement (MSA) with a pharmaceutical partner and our fourth with a Tier-1 oncology company. The agreement not only validates the clinical relevance of our TKa biomarker but also strengthens our position to co-develop a future Companion Diagnostic (CDx) product-ultimately benefiting cancer patients undergoing treatment," said Anders Rylander, CEO of Biovica. This collaboration will broaden the application of DiviTum TKa in clinical trials focused on next-generation oncology therapies, further strengthening the potential for TKa to be established as a key biomarker for therapeutic monitoring. The study is a Phase Ib/II multicenter, open-label, randomized trial. The trial focuses on patients with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer, with a total enrollment of 250 patients. Biovica will conduct all TKa testing at its U.S. laboratory, with testing services commencing early September 2025, and continuing through December 2028. Contact Anders Rylander, CEOPhone: +46 76 666 16 47E-mail: Anders Morén, CFOPhone: +46 73 125 92 46E-mail: 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: Attachments Biovica signs major service agreement and first study work order of 4 MSEK SOURCE: Biovica International View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
