NEW YORK – ImmPact Bio this week opened a manufacturing facility in Los Angeles that meets good manufacturing practices (GMP) requirements to produce its autologous CAR T-cell therapies. The facility will support production of its lead candidate, IMPT-314, a CD19/CD20 bispecific CAR T-cell therapy being developed for B-cell mediated malignancies and autoimmune diseases. The firm expects to begin treating patients in a Phase I trial of IMPT-314 in aggressive B-cell lymphoma in the second quarter.
Singlera Genomics said this week that it has received breakthrough device designation from the US Food and Drug Administration for its PDACatch assay, a DNA methylation-based liquid biopsy test for the detection of pancreatic adenocarcinoma in individuals at high risk for the disease. Singlera's technology has previously been demonstrated to detect five types of cancer in the blood. Breakthrough designation from the FDA offers accelerated assessment and review pathways, and the company said it is in the process of launching a prospective study and clinical trial aimed at supporting a bid for premarket approval.
CRISPR Therapeutics in a first quarter earnings report this week said regulatory applications it submitted to the European Medicines Agency and UK's Medicines and Healthcare Products Regulatory Agency with Vertex Pharmaceuticals for exagamglogene autotemcel (exa-cel) have been accepted by the agencies and are currently under review. Exa-cel is an ex vivo therapy that uses CRISPR-Cas9 gene editing on patients' hematopoietic stem cells and is designed to treat sickle cell disease and transfusion-dependent beta thalassemia.
The company also said it expects to move multiple in vivo gene editing candidates into clinical trials in the next 12 months, including its lead in vivo program, CTX310. CRISPR Therapeutics plans to start clinical trials for CTX310 this year; the drug targets angiopoietin-related protein 3 (ANGPTL3) in the liver and is designed to lower plasma low-density lipoprotein cholesterol and triglycerides, risk factors for atherosclerotic cardiovascular disease.
Ratio Therapeutics said this week that it has opened a new headquarters and R&D facility in Boston, in which it will further advance its radiopharmaceutical therapies for patients with multiple cancer types. The new 19,000-square-foot facility will include office space as well as biochemistry, medicinal chemistry, radiochemistry, and biology laboratories.
Agilent Technologies said last month that it has signed a memorandum of understanding with South Korean genomic services and biopharma company Theragen Bio to improve precision oncology through bioinformatics. As part of the agreement, the firms plan to combine their strengths in cancer genomic profiling design, engineering knowledge, and software to increase localized analysis capabilities and accelerate treatment decisions.
DermTech this week said it has signed new agreements with a Blues plan in South Carolina and the United Mine Workers of America Health and Retirement Funds. As a result, about 1.7 million members of the Blues plan of South Carolina and 90,000 beneficiaries of UMWA Funds will have access to the company's DermTech Melanoma Test. The deal took effect April 1. The RT-PCR-based test is for assessing skin lesions, moles, or dark skin spots for melanoma.
Decibel Therapeutics this week said the Spanish Agency of Medicines and Medical Devices has cleared its clinical trial application, granting permission to start a Phase I/II trial of its lead gene therapy, DB-OTO, in pediatric patients with a type of congenital hearing loss. Decibel and Regeneron Pharmaceuticals are codeveloping DB-OTO, an adeno-associated virus-based gene therapy designed to restore hearing in those who have hearing loss due to mutations of the otoferlin gene.
The partners already have permission from regulators in the US and UK to conduct the Phase I/II trial of DB-OTO, dubbed CHORD, in which the company is evaluating the gene therapy's safety, tolerability, and efficacy. Additionally, Decibel is tracking patients' auditory brain response, a physiologic measure of hearing sensitivity, following DB-OTO treatment. At trial sites in the UK and Spain, Decibel will enroll infants two years of age and younger. The Boston-based firm is expecting the first data readout from the trial in Q1 2024.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.