NEW YORK – The US Food and Drug Administration this week granted fast-track designation to BioNTech and Duality Biologics' TROP2-targeted antibody-drug conjugate BNT325/DB-1305 for the treatment of platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. The firms are studying BNT325/DB-1305 in a Phase I/II study in patients with TROP2-expressing advanced solid tumors. With fast-track designation, a sponsor can meet with the FDA more frequently to get advice on developing fast-track designated agents, submit data on a rolling basis, and apply for accelerated approval or priority review.
Quest Diagnostics and Fitbit said this week that they are collaborating to study if wearable devices can improve metabolic health. The IRB-approved study aims to evaluate the effect of wearables on users' behaviors as assessed based on objective laboratory test results. The companies plan to invite roughly 1,500 Fitbit users to join and consent to share three months of their Fitbit data. These users will also be given the opportunity to receive laboratory testing at no cost using a panel of blood tests specifically designed to assess metabolic health, including blood sugar, cholesterol and triglycerides.
Myriad Genetics completed its acquisition of select assets from Intermountain Health’s Intermountain Precision Genomics (IPG) laboratory business, Myriad said this week. Assets included the Precise Tumor Test, the Precise Liquid Test, and IPG’s CLIA-certified lab in St. George, Utah. IPG had previously offered Myriad’s Precise Tumor Test as TheraMap: Solid Tumor and moving forward, Myriad intends to operate TheraMap: Solid Tumor solely as Precise Tumor. Precise Liquid will launch later this year and IPG has completed all validation studies needed to support its local coverage determination. Additionally, it submitted clinical evidence of test performance for Precise Liquid for Medicare reimbursement in December.
The University of California, Los Angeles, this week said it is setting up the Connor Dunn Endowed Fund in Preventive Cardiovascular Health in its cardiology division after receiving a $2 million gift from an alumnus, given in honor of his late son. The endowed fund will support the work of Tamer Sallam, vice chair of UCLA's department of medicine and executive director of the UCLA Specialty Training and Advanced Research Program, who researches how genetics affect cardiometabolic diseases. The gift will support several projects related to discovery and clinical care, including multidisciplinary pilot studies.
ITM Isotope Technologies Munich said this week that the New Jersey Department of Health has granted it a license to operate as a virtual manufacturer, meaning the firm can distribute radiopharmaceuticals in the United States. Last year, ITM opened a US headquarters in Princeton, New Jersey. Now, the new regulatory licensure lets the firm manufacture its products for both diagnostic and therapeutic applications.
Gilead Sciences subsidiary Kite said this week that the US Food and Drug Administration has approved a manufacturing change for the autologous CAR T-cell therapy Yescarta (axicabtagene ciloleucel). The change is meant to shave off two days from the time between harvesting a patient’s immune cells, editing them to express the CD19-directed chimeric antigen receptor, and reinfusing them as a one-time treatment. Previously, this took 16 days. With the new manufacturing change, the turnaround time is expected to be 14 days.
Cleveland-based Abeona Therapeutics this week said it remains on track to receive a decision from the US Food and Drug Administration on its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa by May 25, as the firm had announced in November. Abeona has completed the mid-cycle review meeting for its biologics license application for prademagene zamikeracel, or pz-cel for short, and the FDA has completed its bioresearch monitoring inspection of Abeona, though the company has not yet received the agency's formal report.
Biosyngen said this week that the US Food and Drug Administration has granted fast-track designation to the firm's autologous tumor infiltrating lymphocyte (TIL) therapy, BST02. The designation is meant to speed up the drug review process for agents designed for patient populations with unmet medical needs. Biosyngen is evaluating its candidate in a Phase I/II clinical trial for patients with hepatocellular carcinoma and cholangiocarcinoma.
Tyra Biosciences this week said it has received rare pediatric disease designation from the US Food and Drug Administration for TYRA-300, an investigational oral FGFR3 selective inhibitor treatment for achondroplasia, the most common form of dwarfism often caused by a mutation in the FGFR3 gene. The Carlsbad, California-based biotech firm said it is planning to submit an investigational new drug application to the FDA to start a randomized Phase II trial evaluating multiple dose cohorts of the drug in children with the condition in the second half of 2024.
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.