NEW YORK – Nest Genomics last week said the company's Nest Genetics Copilot software has been added to the Athenahealth Marketplace, an app store in which customers using Athenahealth's electronic health record (EHR) system or other tools can shop for software from companies that integrate with the EHR. Nest Genetics Copilot aims to support physicians as they manage genomics-guided care, with tools for risk assessments, tailored education, genetic test ordering, genetic results, and clinical decision support.
CSL Behring has struck an outcome-based commercial agreement with Amgros, the Danish procurement authority, to establish national reimbursement for the company's gene therapy Hemgenix (etranacogene dezaparvovec) for eligible hemophilia B patients, the company said this week. The agreement, which makes Denmark the first country in the Nordic region to cover Hemgenix using this type of a performance-based model, follows a positive recommendation for reimbursement from the Danish Medicines Council in June. As part of the outcome-based agreement, Denmark will only incur costs if the gene therapy proves effective over an agreed upon period.
Sunnyvale, California-based BioCardia this week announced that it has completed the randomized, controlled Phase III CardiAMP HF trial, in which it is evaluating its autologous cell therapy, CardiAMP, as a treatment for heart failure of reduced ejection fraction. BioCardia earlier this year launched a new pivotal Phase III trial, after determining that the CardiAMP HF trial was unlikely to meet its primary endpoint. Still, BioCardia has continued to monitor patients enrolled in CardiAMP HF and expects to share top-line results in Q1 2025. The company has also submitted an annual report on the clinical trial to the US Food and Drug Administration detailing its plans for complete patient follow-up and intends to request a meeting with the regulator to discuss the results.
Cancer assay developer Delfi Diagnostics said this week that its Delfi-Tumor Fraction (Delfi-TF) Monitoring cell-free DNA assay has been selected by Incendia Therapeutics to evaluate treatment response and disease progression in patients enrolled in a Phase I clinical trial. The trial is designed to evaluate the safety and tolerability of Incendia's PRTH-101 alone or in combination with pembrolizumab in adults with advanced or metastatic solid tumors.
Canadian biotech firm Telo Genomics this week said it has amended its deal with the Mayo Clinic, extending the original 2019 agreement to include Mayo’s participation in the company’s Physician Experience Program using Telo’s TeloView SMM prognostic test for smoldering multiple myeloma patients. SMM is a precursor to active multiple myeloma. Patient samples will also be used to validate TeloView NDMM, a test in development for newly diagnosed multiple myeloma patients. The validation is being carried out in anticipation of the test being offered as a laboratory-developed test by Telo. TeloView NDMM would enable the identification of patients who will relapse on first-line therapy within a year or confirm that patients are stable in remission on the treatment at the time of testing, Telo said. It added that it has completed the endpoints for the validation of TeloView SMM, and the test is now offered as an LDT.
The US Food and Drug Administration has granted Thousand Oaks, California-based Capsida Biotherapeutics orphan drug designation for CAP-002, the company said this week. CAP-002 is Capsida's lead investigational gene therapy candidate, which it's developing as a treatment for developmental and epileptic encephalopathy (DEE) caused by mutations in the STXBP1 gene. The gene therapy is currently in investigational new drug (IND)-enabling studies, and Capsida said it expects it to enter clinical trials in the first half of 2025.
Eisai this week said that it completed enrollment earlier this month for the Phase III AHEAD 3-45 study, in which the company is investigating whether the beta-amyloid-targeting drug Leqembi (lecanemab), which is approved as a treatment for early Alzheimer's patients, can be administered to patients with elevated levels of beta-amyloid, but without Alzheimer's symptoms, to delay or prevent cognitive decline. Eisai previously said it hoped to receive approval for Leqembi in a presymptomatic Alzheimer's indication in fiscal 2028.
The AbbVie Foundation this week donated $75 million to the University of Chicago to support construction of UChicago Medicine's new cancer pavilion, which will house research to advance cancer treatments, develop personalized cancer care, and address inequities in access to advanced therapies.
Carsgen Therapeutics on Thursday said the US Food and Drug Administration lifted clinical holds on trials of its autologous CAR T-cell therapy products zevorcabtagene autoleucel (CT053), satricabtagene autoleucel (CT041), and CT071 in the US. The FDA had paused the trials in 2023 based on findings during an inspection of Carsgen's manufacturing site in Durham, North Carolina.
Lyell Immunopharma announced this week that it has completed its acquisition of ImmPACT Bio announced earlier this month. Lyell had paid $30 million upfront and 37.5 million shares of its common stock in the deal to bring ImmPACT's autologous CAR T-cell therapy candidate IMPT-314 into its pipeline. Lyell will develop IMPT-314 as a treatment for patients with hematologic malignancies, including B-cell non-Hodgkin lymphoma.
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.