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

Yahoo

time23-05-2025

  • 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

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

Yahoo

time23-05-2025

  • 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

DiviTum(R) TKa Data in Combination with Inflammation Proteins Presented at the AACR Meeting Enhance Precision to Predict Efficacy of Immunotherapy
DiviTum(R) TKa Data in Combination with Inflammation Proteins Presented at the AACR Meeting Enhance Precision to Predict Efficacy of Immunotherapy

Yahoo

time26-03-2025

  • Health
  • Yahoo

DiviTum(R) TKa Data in Combination with Inflammation Proteins Presented at the AACR Meeting Enhance Precision to Predict Efficacy of Immunotherapy

UPPSALA, SE / / March 26, 2025 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) Biovica, a leader in blood-based biomarker assays in oncology, today announces that an abstract with DiviTum TKa in a biomarker algorithm will be presented by Karolinska Institutet (KI) at the annual AACR meeting in Chicago on April 25-30, 2025, providing the first evidence that DiviTum TKa in combination with inflammation protein biomarkers significantly improves the ability to stratify patients likely to benefit from immunotherapy. In a translational malignant melanoma study by KI and the Karolinska University Hospital, patients with the best biomarker profile experienced a 5-year overall survival of 83 percent versus 11 percent in a cohort with a high-risk profile. Full study results will be presented on Sunday, April 27 at 2 pm CST. "Our study demonstrates the first evidence that measuring cell proliferation with DiviTum TKa in combination with pro-tumorigenic inflammation markers is of significant value and increase precision to predict treatment efficacy. We look forward to further study these biomarkers and their potential to impact long-term outcomes," said Suzanne Egyhazi Brage, Senior research specialist at Karolinska Institutet. "The results presented at AACR reinforce and broaden DiviTum TKa's utility in oncology," said Anders Rylander, CEO Biovica. "By combining DiviTum TKa with inflammation markers, we have enhanced the ability to identify patients who are more likely to respond to immunotherapy, providing a unique tool for clinicians and pharmaceutical companies developing next-generation immune-based treatments." The aim of the study was to find a solution that better can predict the efficacy of immune checkpoint inhibitors (ICI) - a class of drugs that are common when treating many solid tumors. As ICI therapy can produce severe side effects and less than half of patients benefit from treatment there is a need for better biomarkers to identify patients that will achieve positive outcomes from therapy. Additionally, according to Global Data, more than 150 drug developers are currently developing next generation ICI´s and could use improved tools to better identify responder populations, refine trial designs and demonstrate enhanced efficacy in targeted patient groups. 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 DiviTum® TKa data in combination with inflammation proteins presented at the AACR meeting enhance precision to predict efficacy of immunotherapy SOURCE: Biovica International View the original press release on ACCESS Newswire Sign in to access your portfolio

Biovica Signs Agreement With Eurobio Scientific Covering 60 Percent of European Market
Biovica Signs Agreement With Eurobio Scientific Covering 60 Percent of European Market

Yahoo

time05-03-2025

  • Business
  • Yahoo

Biovica Signs Agreement With Eurobio Scientific Covering 60 Percent of European Market

UPPSALA, SE / / March 5, 2025 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) Biovica, active in cancer monitoring, has signed a collaboration agreement with Eurobio Scientific, a leading French group in in vitro specialty medical diagnostics and life sciences, for DiviTum® TKa in Austria, Benelux, France, Germany, Switzerland and the UK. The scope of the agreement covers 60 percent of the total market potential identified as key European markets for Biovica. "Eurobio Scientific has proven itself as a strong European-based distributor with impressive growth in several areas of in-vitro diagnostics. With the help of the sales force, they took over from Myriad Genetics in Europe, we are certain they will achieve strong European sales. We are delighted to sign a comprehensive agreement with such a successful and dynamic company making DiviTum TKa available for patients on the largest markets in Europe," said Anders Rylander, CEO at Biovica. "We see great potential in DiviTum TKa, which will allow us to sell a broader range of tests to our established network of breast oncologists in the selected countries. It complements our oncology portfolio very well and our strong oncology sales force now has an even more comprehensive offering," said Denis Fortier, Chairman and CEO of Eurobio Scientific. More about Eurobio Scientific Eurobio Scientific is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 290 employees and four production units based in the Paris region, in Germany, in the Netherlands and in the United States, and several affiliates based in Dorking UK, Sissach Switzerland, Bünde Germany, Antwerp Belgium, Utrecht in The Netherlands and Milan in Italy. Eurobio Scientific's reference shareholder is the EurobioNext holding company which brings together its two directors, Jean-Michel Carle and Denis Fortier, alongside the "Pépites et Territoires" by AXA & NextStage AM investment program, managed by NextStage AM. For more information, please visit: 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 agreement with Eurobio Scientific covering 60 percent of European market SOURCE: Biovica International View the original press release on ACCESS Newswire Sign in to access your portfolio

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