ACCESS Newswire

Biovica International

Share
Biovica’s DiviTum(R)TKa in Three Studies at SABCS 2021

UPPSALA, SE / ACCESSWIRE / November 19, 2021 / Biovica International (STO:BIOVIC-B) (STO:BIOVIC.B) (FRA:9II)

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.

Attachments

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

SOURCE: Biovica International



View source version on accesswire.com:
https://www.accesswire.com/673809/Biovicas-DiviTumRTKa-in-Three-Studies-at-SABCS-2021

To view this piece of content from www.accesswire.com, please give your consent at the top of this page.

About ACCESS Newswire

DK

Subscribe to releases from ACCESS Newswire

Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from ACCESS Newswire

Karbon-X Expands Blue Carbon Leadership with New Restoration Project in Guinea7.11.2025 14:00:00 CET | Press release

New initiative in the Konkouré Delta builds on Senegal's success, advancing coastal restoration, biodiversity, and community resilience across West Africa. CONAKRY, GN / ACCESS Newswire / November 7, 2025 / Building on the success of its 7,000-hectare mangrove reforestation project in Senegal-which has already generated an estimated 2.8 million tonnes of CO₂ reductions and measurable community benefits-Karbon-X Corp. (OTCQX:KARX) ("Karbon-X" or the "Company") is expanding its blue carbon leadership into the Konkouré Delta of Guinea, as blue carbon emerges as a critical frontier for climate investment and coastal resilience. Developed through ALLCOT - A Karbon-X Company, the project development and advisory arm of Karbon-X, the initiative will replicate and scale the proven model from Senegal, enhancing biodiversity, shoreline protection, and sustainable livelihoods across West Africa. Mangroves are more than trees; they are natural shields protecting coastlines, nurseries for marine li

Innodata Reports Third Quarter 2025 Results6.11.2025 22:30:00 CET | Press release

Revenue up 20% Year-Over-Year Reiterates Prior Guidance of 45% or More YoY Growth in 2025 Anticipates Transformative Growth in 2026 Based on New Wins and Strong Momentum NEW YORK CITY, NY / ACCESS Newswire / November 6, 2025 / INNODATA INC. (Nasdaq:INOD) today reported results for the third quarter ended September 30, 2025. Revenue of $62.6 million for the three months ended September 30, 2025, representing 20% year-over-year organic revenue growth. Revenue of $179.3 million for the nine months ended September 30, 2025, representing 61% year-over-year organic revenue growth. Adjusted EBITDA of $16.2 million for the three months ended September 30, 2025, an increase of $2.3 million, or 17%, from $13.9 million in the same period last year.* Adjusted EBITDA of $42.2 million for the nine months ended September 30, 2025, an increase of $21.8 million, or 106%, from $20.4 million in the same period last year.* Net income of $8.3 million, or $0.26 per basic share and $0.24 per diluted share, f

Innodata Announces New Leadership Appointments to Support Next Phase of Growth6.11.2025 22:05:00 CET | Press release

Rahul Singhal Appointed President and Chief Revenue Officer Daniel H. (Don) Callahan and General (Retired) Richard D. Clarke Appointed to Board Jack Abuhoff Appointed Chairman Stewart Massey Appointed Lead Independent Director NEW YORK, NY / ACCESS Newswire / November 6, 2025 / Innodata Inc. (Nasdaq:INOD), a global data-engineering company, today announced executive management and Board appointments to support the Company's rapid growth and continued global expansion in generative AI solutions and platforms. Rahul Singhal Appointed President and Chief Revenue Officer Rahul Singhal, formerly Innodata's Chief Product Officer and Chief Revenue Officer, has been promoted to President and Chief Revenue Officer. In his expanded role, Singhal will define the Company's overall product strategy, product roadmap, and go-to-market execution across the Company's AI, data engineering, and digital transformation businesses. "Rahul has been instrumental in shaping our strategy for sustained growth an

Innodata Launches Federal Business Unit to Support Accelerating AI Innovation Across U.S. Government6.11.2025 22:05:00 CET | Press release

New Unit Positions Company to Serve Defense, Intelligence, and Civilian Agencies with Proven AI Data Engineering, Generative AI, and Agentic AI Solutions NEW YORK, NY / ACCESS Newswire / November 6, 2025 / INNODATA INC. (Nasdaq:INOD) today announced the launch of Innodata Federal, a dedicated government-focused business unit designed to deliver mission-critical AI solutions to U.S. defense, intelligence, and civilian agencies. The new unit emerges as federal acquisition authorities are rapidly evolving to prioritize commercial innovation through Other Transaction Authorities (OTAs), Commercial Solutions Openings (CSOs), and streamlined procurement pathways that favor speed, flexibility, and proven commercial capabilities. The launch, announced alongside Innodata's earnings release and a press release announcing that General (Retired) Richard D. Clarke, a retired four-star Army general and former Commander of U.S. Special Operations Command, has joined the Innodata board, positions the

The Michelin Guide Expands Its Global Footprint with the Arrival in Aotearoa New Zealand5.11.2025 20:00:00 CET | Press release

AUCKLAND, NZ / ACCESS Newswire / November 5, 2025 / Michelin is pleased to announce the arrival of the MICHELIN Guide in Aotearoa New Zealand, marking its first-ever expansion into Oceania. The inaugural edition will cover four vibrant culinary destinations: Auckland, Wellington, Christchurch, and Queenstown. Set to be unveiled in the middle of 2026, the restaurant selection process is already under way, as MICHELIN Guide Inspectors are currently on the ground, dining anonymously to identify the very best restaurants that showcase the unique character of Auckland, Wellington, Christchurch, and Queenstown culinary scenes. Gwendal Poullennec, International Director of the MICHELIN Guide states: "We are thrilled to bring the MICHELIN Guide to Aotearoa New Zealand for the very first time. The country offers a rich and diverse culinary landscape, shaped by its indigenous Māori heritage, Pacific influences, and a new generation of chefs who champion local produce with creativity and passion.

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye