Redeye:

Biovica: Signs a master agreement for TKa testing with leading pharma company
RESEARCH NOTE
2024-03-07
09:38
The Master Agreement is distinctly positive and adds to the potential sales contribution, which can be very substantial with an exponential increase from the initial first order of SEK 1.7m, if a candidate is approved and the approval includes Biovica’s DiviTum as part of the label (companion diagnostics or CDx). We look forward to Biovica’s Q3 report next week with an update on both sales and the progress made in clinical therapeutic and pharma sales.
Johan Unnerus
This master agreement is for testing services, and the first order accounts for SEK 1.7m, including Tka tests and services like interpretation of the TKa dynamics. These services suggest that this tier 1 pharma collaboration relates to the CDK inhibitors, where DiviTum has a well-established track record in providing early results and indications of changing dynamics, especially in the metastatic breast cancer segment.

Biovica refers to the potential CDx status in this collaboration. This suggests that the collaboration is based on a project in the early Phase 2 stage where it is still possible to change the setup ahead of larger pivotal clinical trials.

Biovica’s earlier Q2 update revealed that the company had 19 pharma collaborations, and the announcement confirms that this network continues to grow.

https://www.biospace.com/article/releases/biovica-signs-master-service-agreement-for-tka-testing-with-leading-pharma-company/

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Redeye Research on Biovica published today:

Biovica: Signs another back-to-back master service agreement for DiviTum TKa testing

RESEARCH NOTE

2024-03-12

09:24

Biovica, active in blood-based cancer monitoring, has signed a master service agreement, enabling Biovica to provide its TKa testing assay and testing services. The agreement holds room for several expected work orders, the first of which is 1.2 MSEK.

Full research available for free:

https://www.redeye.se/research/990064/biovica-signs-another-back-to-back-master-service-agreement-for-divitum-tka-testing?utm_source=note&utm_medium=email&notificationId=0ea95660-5b71-44fc-914a-05f8632926d7

Biovica signs master service agreement
Biovica, active in blood-based cancer monitoring, has signed a master service agreement with a biopharmaceutical company enabling Biovica to provide its TKa testing assay and testing services. The agreement holds room for several work orders, the first of which is 1.2 MSEK.

The service agreement allows Biovica to perform TKa testing services enabling evaluation of cell proliferation activities in for example pivotal drug development studies by this new customer. The test service is focused on the use of Biovica’s TKa assay and expertise within the interpretation of TKa measurement dynamics.

Through the agreement, Biovica will be contributing to the development of first-in-class next generation of CDK4/6 inhibitor therapeutics in breast cancer.

"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", said Henrik Winther, SVP Business Development, Biovica.

Biovica is delivering a positive news every day.

Todays news:

Interventional DiviTum® TKa trial launches at Washington University
Biovica, active in blood-based cancer monitoring, today announces that a clinical trial, BettER, is being launched at Washington University School of Medicine in St. Louis. The study is aimed at evaluating whether patients with HR+ HER2- metastatic or unresectable breast cancer benefit from DiviTum® TKa

"We are thrilled to once again collaborate with Washington University on another trial. This time it is a translational trial, which if successful would pave the way for increased uptake of DiviTum TKa, for the benefit of breast cancer patients," said Anders Rylander, CEO of Biovica.

“We are excited to offer patients with ER+ HER2- advanced breast cancer the opportunity to incorporate TK testing with the goal of further tailoring treatment, reducing unnecessary toxicity and improving patient outcomes,” says Katherine Clifton, M.D who is a breast medical oncologist and the lead investigator of the trial at Washington University School of Medicine in St. Louis.

The BettER study seeks to evaluate the impact of early therapeutic switching based on biomarker-driven insights, utilizing DiviTum TKa to guide treatment decisions. The study will enroll 50 patients, assessing the effectiveness of modifying treatment based on TKa levels measured at baseline and shortly after treatment initiation. Patients demonstrating insufficient TKa suppression will be recommended for an alternative therapy, potentially enhancing treatment outcomes.

Ikke mange som følger dette selskapet. Men når suksessen er et faktum så blir det nok mer enn nok skriverier om aksjen!!!

Biovica receives positive patent notification for immunotherapies
Biovica, active in blood-based cancer monitoring, has received a positive International Preliminary Report on Patentability (IPRP) covering the use of TKa as a prognostic and monitoring marker in cancer treatment outside the CDK 4/6 inhibitor space, expanding the market potential for the DiviTum TKa technology by four to six times.

“This is a very important step for Biovica in making our DiviTum TKa technology more broadly available as a liquid based tool for the monitoring of drug efficaciousness within cancer treatment, thereby increasing the market reach and helping more patients receive the most optimal treatment”, said Anders Rylander, CEO of Biovica.

The IPRP is issued by the European Patent Office (EPO) which is also the International Examining Authority making any additional submission for an international patent in Europe uncalled for.

Also, EPO has concluded that all claims are indeed novel and inventive and covers “cancer” as a broadly used term – not only a single cancer disease. As the IPRP is entirely positive the EPO is expected to follow this opinion in the European phase, making an early grant in Europe very likely.

In other territories outside of Europe, it will be the national patent authority’s decision as to what extent they take the IPRP into account during examination. The IPRP will now be sent by the International Bureau of the World Intellectual Property Organization to the various designated offices for their consideration during the national phases.

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Redeye today on Biovica

Biovica: A positive International Preliminary Report on Patentability (IPRP)

RESEARCH NOTE

2024-03-19

11:01

Today’s announcement opens the possibility of international patent protection for DiviTum outside the breast cancer space, including the market for checkpoint inhibitors. Our view is that this is mainly positive regarding the prospects of securing future CDx (companion diagnostic) collaborations. Biovica has already secured many collaborations in the core Breast Cancer market related to CDK 4/6 space, and this announcement expands the potential market.

Full research for free:

https://www.redeye.se/research/991445/biovica-a-positive-international-preliminary-report-on-patentability-iprp?utm_source=note&utm_medium=email&notificationId=ef8bec4d-92e2-47cc-ad76-4b15e7b98dd4

The new investor presentation from today

https://ir.financialhearings.com/cord-communications-investor-day-2024-biovica?seek=1070

Redeye research on Biovica - free with registration

https://www.redeye.se/api/articles/download-file/c1374432-5e87-3ca5-83f2-897cba2f0558/Biovica%3A%20Continuous%20high%20growth%20rates%20from%20modest%20absolute%20levels

Another good news today

Biovica signs agreement with clinical-stage US biotech company
Biovica, active in blood-based cancer monitoring, has signed a Master Service Agreement (MSA) with a US-based biotech company focusing on next generation CDK inhibitors.

Under the agreement, Biovica will provide TKa testing services utilizing Biovica’s DiviTum® TKa assay and expertise in interpreting TKa measurement dynamics to support drug development and dosage optimization. The agreement will expand DiviTum TKa’s inclusion into a growing list of clinical trials investigating the potential of next generation CDK inhibitor treatment and therefore further increase the likelihood of establishing TKa as a monitoring companion biomarker.

"We continue to experience strong growing demand for our Pharma Services Business and are pleased to see yet another agreement within our core area CDK inhibitors. The agreement adds to our existing portfolio of 14 master service agreements and is an important step towards developing a Companion Diagnostic (CDx) product," said Anders Rylander, CEO of Biovica.

Biovica – Treatment decisions with greater confidence