Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Sweden-based Immunovia AB cleared its final hurdle to begin selling its IMMray PanCan-d test in the United States. The test has been billed as the first blood test dedicated to the early detection of pancreatic cancer.
The IMMray PanCan-d test will be the first blood test on the market dedicated to the early detection of pancreatic cancer, the company said. By recognizing biomarker signatures, the IMMray PanCan-d test has the potential to significantly increase the survival of patients by detecting pancreatic cancer earlier, when surgical resection is possible, Immunovia announced.
The final approval was granted by the Massachusetts Department of Public Health for the company’s laboratory in Marlborough, Mass. The company said it can immediately begin to market the test with the authorization. Patrik Dahlen, Immunovia’s chief executive officer, expressed his excitement with the authorization. Dahlen called it an important milestone to be able to launch the “first non-invasive, highly accurate blood test that can help detect pancreatic cancer in early stages” in the United States.
“The IMMray PanCan-d test meets a huge clinical need and our ambition is to make the test available to individuals in all the high-risk groups for pancreatic cancer. As a first step, we will launch the test for the familial/hereditary high-risk group,” Dahlen said in a statement.
Elsewhere around the world:
Dotmatics – U.K.-based Dotmatics Ltd. has been selected by Croda International Plc to implement its Research and Development (R&D) digital program. The companies said the project will deepen Croda’s ability to innovate both externally and internally by “delivering enhanced data science capability across the company’s global R&D knowledge base through the implementation of the Dotmatics’ electronic lab notebook (ELN).” Croda expects to use the Dotmatics platform by accelerating innovation delivery. The company anticipates a move towards data mining and will provide a foundation for artificial intelligence and machine learning. Dotmatics will equip Croda scientists with a complete ELN solution including experiment capture, entity registration and sample tracking, data retrieval, and full data analytics. The unified platform will accommodate Croda’s workflow across biotechnology, synthetic chemistry, analytical chemistry, formulation and claims substantiation.
Veraxa Biotech – Germany-based Veraxa Biotech GmbH and Indivumed GmbH announced an agreement to discover and develop functional antibodies against several targets that are relevant for colorectal cancer. The targets for the antibodies have been identified through Indivumed’s recently-launched nRavel discovery solution platform and the antibody development and commercialization will be performed by Indivumed’s subsidiary, Ix Therapeutics. Veraxa is also establishing its own proprietary pipeline of therapeutic antibody candidates for further joint development with pharma partners. Indivumed’s AI-based nRavel platform, together with Indivumed’s IndivuType multi-omics database, is expected to derive more precise insights into and much better predictors for certain pathologies and diseases with high medical needs.
Avacta Group – Also based in the U.K., Avacta Group announced the first patient was dosed in a Phase I trial assessing AVA6000, a novel pro-drug of doxorubicin, a chemotherapy drug. AVA6000 is Avacta’s first therapeutic based on its proprietary pre|CISION technology. The platform uses a substrate that is specifically cleaved by the protease fibroblast activation protein alpha (FAPa). By activating chemotoxins only within the tumor microenvironment, systemic exposure to healthy tissues is limited, improving the safety and therapeutic potential of these cancer therapies, the company said. The AVA6000 study is a dose-escalation Phase I study in patients with locally advanced or metastatic selected solid tumors, known to be FAP-positive. These cohorts will receive ascending doses of AVA6000 to determine the maximum tolerated dose and establish a recommended Phase II dose. The second part of the study is an expansion phase where patients receive AVA6000 to further evaluate the safety, tolerability and clinical activity at this recommended Phase II dose across selected tumor types.
CerTest Biotec – Spain’s CerTest and BD (Becton, Dickinson and Company) announced they received a CE mark for a molecular test that can detect and distinguish between the Alpha, Beta and Gamma SARS-CoV-2 variants. The VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX can be used as a combined test with VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX, or as a reflex test to run variant identification on a SARS-CoV-2 positive sample, the companies said. The BD MAX molecular diagnostic platform is widely used in laboratories across Europe. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period. The new variant detection assay is part of a robust COVID-19 testing solution on the BD MAX System, which also includes the ability to run asymptomatic individuals using BD SARS-CoV-2 Reagents for BD MAX System and test saliva samples with both BD and VIASURE kits.
