NEW YORK – Sophia Genetics this week launched a global consortium called Sophia Unity designed to accelerate cancer research, advance drug development, and support data-driven patient care. The new network will conduct research using Sophia CarePath, the multimodal module of the Sophia DDM platform, to aggregate and analyze complex real-world data, which will then be harmonized and curated using Sophia's AI technology and proprietary algorithms. Members of the network will then have access to this curated data to support oncology research. Sophia said that Memorial Sloan Kettering Cancer Center will be the first member of the consortium, with additional members announced in coming months.
Eisai and Biogen this week announced that their codeveloped Alzheimer's drug Leqembi (lecanemab), which targets beta-amyloid proteins, has been approved by South Korea's Ministry of Food and Drug Safety. Tokyo-based Eisai, which serves as the lead for Leqembi's development and regulatory submissions globally, will distribute the product and conduct information provision activities in South Korea. This marks the fourth country to grant approval to Leqembi following the US, Japan, and China.
German health informatics company Lifespin said this week that it has partnered with Acibadem University (ACU) and Acibadem Healthcare Group of Turkey to develop the use of metabolomics in personalized medicine. Under the agreement, Lifespin and ACU will combine their respective expertise to build an AI-enabled, NMR-based metabolomics precision medicine platform, and Lifespin will deploy its products across ACU's network through a software-as-a-service model. The partners also plan to collaborate on the digitalization of ACU's biobank and other healthcare-related projects. In addition, they intend to create a regional data analysis and data production center laboratory to help develop Lifespin's products and distribute them globally. Lifespin said it has built a database of metabolomic health profiles across more than 240,000 individuals with and without disease.
The European Commission has granted orphan medicinal product designation to Rocket Pharmaceuticals' investigational gene therapy for PKP2-related arrhythmogenic cardiomyopathy based on a positive opinion issued by the European Medicines Agency's Committee for Orphan Medicinal Products, the Cranbury, New Jersey-based firm said this week. Rocket Pharmaceuticals is currently enrolling patients in a Phase I dose-escalation trial to evaluate the safety and preliminary effects of the gene therapy candidate, RP-A601.
Cincinnati Children's Hospital Medical Center this week said it's begun work on an Applied Gene and Cell Therapy Center. About 100 Cincinnati Children's employees will work at the new center, preparing cell and gene therapies for clinical trials, focusing on treatments for cancer, blood diseases, and genetic conditions. Cincinnati Children's is investing $60 million in the design, construction, and equipment for the center, including renovating an existing building in Sharonville, Ohio, where the center will be based, with the renovation expected to be completed by next summer.
The Department of Health Abu Dhabi (DoH) and Eli Lilly Suisse said this week that they have signed a memorandum of understanding with the goal of collaborating to enhance the care of neurodegenerative patients in the Emirate of Abu Dhabi. Under the agreement the DoH will establish a center of excellence in neurodegenerative disease care that will include therapeutic innovations, advanced diagnostic technologies, and advances in patient monitoring and follow-up protocols.
Sanofi this week said it closed its acquisition of the biotech company Inhibrx and Inhibrx's alpha-1 antitrypsin deficiency candidate SAR447537, previously known as INBRX-101. The acquisition, initially announced in January, was completed through a merger of Inhibrx and a wholly owned subsidiary of Sanofi, Aventis. The combined company will go by Inhibrx and continue as a wholly owned subsidiary of Sanofi.
A new publicly traded company that spun off from Inhibrx, Inhibrx Biosciences, will continue as a separate entity and maintain all of the assets not related to SAR447537. Inhibrx owns 8 percent of Inhibrx Biosciences.
Germany's Evaluation Committee has issued regulations for companion diagnostics payment for Menarini Group's Orserdu (elacestrant), a treatment for ER-positive, HER2-negative advanced breast cancer with ESR1 mutations. The standardized evaluation scale (EBM) will now include PCR-based circulating tumor DNA (ctDNA) tests for ESRI mutations and ctDNA tests for PIK3CA and ESR1 mutation status. An existing code for determination of PIK3CA mutation status alone will be deleted from the EBM. The changes go into effect in July. This is because the patient population eligible for Orserdu overlaps significantly with those eligible for Novartis' PI3Kα inhibitor Piqray (inavolisib), for which detection of activating mutations in ESR1 and PIK3CA is required.
The Association of Cancer Care Centers (ACCC) this week announced an online resource to support oncology professionals integrating biomarker testing into their electronic health record (EHR) systems. The resource, which ACCC refers to as a virtual roadmap, outlines how multidisciplinary cancer care teams can better incorporate ordering of biomarker testing and structured data from biomarker test results into EHRs. The roadmap was developed in partnership with the LUNGevity Foundation, an organization that funds lung cancer research, and support from AstraZeneca and Genentech.
Finnish bioinformatics firm Euformatics, in partnership with Finland's BC Platforms and Hungary's Oncompass Medicine and Genomate Health, has been awarded the third and final phase of a contract for the development of clinical reporting of somatic samples for a buyer consortium of seven central European hospitals, represented by Medical University Graz. The companies originally announced their partnership in 2022 to deliver the first two phases of the project, called Instand-NGS4P, a Horizon 2020 project designed to improve cancer diagnoses through integrated and standardized next-generation sequencing workflows, alongside integrated data from cancer gene testing, pharmacogenetic testing, and e-medication. The total pre-commercial procurement budget of the project is approximately €8 million ($8.2 million).
The European Council this week adopted measures to delay some deadlines of the In Vitro Diagnostic Medical Device Regulation, as well as a gradual rollout of the European Database on Medical Devices.
The council also adopted a measure requiring manufacturers to warn of potential shortages of critical medical devices and in vitro diagnostics. The measures were proposed in January by the European Commission, and in April, the European Parliament agreed to adopt them.
Following this week's action, the measures will become effective upon their publication in the Official Journal of the European Union.
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