NEW YORK – Sophia Genetics said this week that it has expanded a previously announced partnership with AstraZeneca designed to increase global access to the MSK-ACCESS liquid biopsy test powered by the Sophia DDM informatics platform. The next stage of the partnership will see Sophia and AstraZeneca deploy MSK-ACCESS to 20 undisclosed locations worldwide over the next 12 months. Additionally, through a real-world evidence study, researchers will be able to evaluate the operational benefits of liquid biopsy testing, including the speed of results and the ability of users to consistently achieve high-quality data in a variety of laboratory settings, Sophia said. MSK-ACCESS is a decentralized version of a circulating tumor DNA test developed by Memorial Sloan Kettering Cancer Center that combines the Sohpia DDM platform with MSK's scientific and clinical expertise.
Cartesian Therapeutics this week said the US Food and Drug Administration has granted rare pediatric disease designation to Descartes-08, its lead mRNA-engineered CAR T-cell therapy candidate for treating juvenile dermatomyositis (JDM), a rare autoimmune disorder. The autologous cell therapy is designed to target the B-cell maturation antigen, doesn't require preconditional chemotherapy, and doesn't use integrating vectors. The Gaithersburg, Maryland-based firm also said it is on track to file an investigational new drug application by year-end, seeking permission from the FDA to begin a Phase II pediatric basket trial to test the cell therapy's activity in patients with various neurology and rheumatology autoimmune diseases, including JDM. If Decartes-08 is approved for JDM, its rare pediatric disease designation will qualify Cartesian for a priority review voucher that it can use to take a different product application through the FDA's priority review pathway.
NS Pharma, a subsidiary of Nippon Shinyaku, this week said an antisense oligonucleotide treatment it is developing for patients with Duchenne muscular dystrophy (DMD) who have confirmed gene mutations amenable to exon 50 skipping has received the US Food and Drug Administration's rare pediatric disease designation. NS-050/NCNP-03 is designed to skip a portion of the dystrophin gene and produce a functional protein. Paramus, New Jersey-based NS Pharma is readying to test NS-050/NCNP-03's safety and efficacy in a Phase I/II trial involving DMD patients in Japan and the US.
Allarity Therapeutics said this week that its shareholders voted in favor of a reverse stock split meant to help the firm regain its listing on the Nasdaq. Allarity's board of directors approved the 1-for-30 reverse stock split. As a result, the total number of shares of Allarity's stock has been reduced to one-thirtieth of the pre-split amount. The split comes after Allarity's recent announcement that it is facing potential US Securities and Exchange Commission legal action for violating federal securities laws.
Cabrini Health and Monash University said this week that they have received a $10 million donation from the PMF Foundation to support a precision oncology genomic testing program. Cabrini and Monash will receive the funds over the course of five years, during which time they will establish a dedicated genomics laboratory and the infrastructure to genomically screen over 2,000 patients per year in Victoria, Australia.
Agilent Technologies said this week that it has received California state clinical laboratory license and CLIA certification allowing the company to launch its Biopharma CDx Services Lab in Carpinteria, California. The lab will be used to support drug development with companion diagnostic development. The company said that the lab offers innovative technologies that can be used to help assess biomarkers as well as assays that can help customers to generate robust data.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.