NEW YORK – CureMatch said this week that it has joined CancerX, an accelerator launched by the White House to boost innovation as part of the Cancer Moonshot. CureMatch aims to collaborate with other organizations in the field of precision oncology through its membership in CancerX.
The European Commission (EC) this week granted orphan drug designation to ALX Oncology's CD47 inhibitor evorpacept for the treatment of patients with HER2-positive gastric cancer and gastroesophageal junction adenocarcinoma. ALX is currently studying evorpacept in combination with trastuzumab, paclitaxel, and Eli Lilly's Cyramza (ramucirumab) in HER2-positive gastric cancer in a Phase II trial. Drugs that receive orphan drug designation from the EC qualify for protocol assistance, possible exemptions or reductions in regulatory fees, and 10 years of market exclusivity in the European Union if approved.
The US Food and Drug Administration granted fast-track designation to AC Immune for its anti-amyloid immunotherapy candidate for Alzheimer's disease, ACI-24.060, the Swiss biopharmaceutical firm said this week. ACI-24.060 is designed to induce a polyclonal antibody response against amyloid-beta to clear existing plaque and inhibit new plaque formation in the brain for patients with prodromal Alzheimer’s disease and in adults with Down syndrome, and who must have amyloid-beta pathology confirmed by a PET scan. AC Immune expects to have interim safety and immunogenicity data in the second half of the year and initial data on amyloid plaque clearance in the first half of 2024.
Viracta Therapeutics said this week that its Phase II study cohort of relapsed or refractory Epstein-Barr virus (EBV)-positive peripheral T-cell lymphoma met the pre-specified efficacy threshold for expansion into stage II of the study. Viracta is evaluating its HDAC inhibitor nanatinostat in combination with the antiviral agent valganciclovir in several subtypes of EBV-positive lymphomas in the study. The cohort of EBV-positive peripheral T-cell lymphoma patients will now expand enrollment from 10 to 21 patients.
Italian biotechnology company Genenta Science this week said it received orphan drug designation from the European Commission for Temferon, a cell therapy for patients with glioblastoma multiforme — the most common type of malignant primary brain tumor — and with unmethylated MGMT gene promoter. The treatment involves ex vivo gene transfer into autologous hematopoietic stem cells, so that the cells express interferon alpha, an immunomodulatory protein, within solid tumors.
NorthStar Medical Radioisotopes and Nucleus RadioPharma said this week that they have entered into an agreement through which NorthStar will supply the therapeutic radioisotope actinium-225 to the contract development and manufacturing organization Nucleus. Nucleus will then provide the isotope to partners for use in targeted radiopharmaceutical development, including radioligands to treat various cancers.
The University of Manchester and Cancer Research UK said this week that they have joined a European consortium to improve access to precision oncology dubbed PRIME-ROSE. The consortium includes 24 partners who have agreed to work with regulators, policymakers, healthcare providers, and patient advocacy groups to implement precision oncology into routine clinical practice. The consortium is conducting a trial dubbed DETERMINE to improve access to precision medicine across rare tumor types.
The American Association for Cancer Research said this week that it has selected four new institutions to join its Project GENIE consortium to contribute clinical and genomic data to its public database. The new members are Children's Hospital Los Angeles, Korea University Anam Hospital, Louisiana State University Health Sciences Center New Orleans, and Sylvester Comprehensive Cancer Center at the University of Miami School of Medicine. The next release, GENIE 14.0-public, will be available in July 2023 and will contain more than 183,000 sequenced samples from over 161,000 patients, one of the largest public cancer genomic data sets to date.
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.