ClinicaSpace
Early-stage clinical data from our company and others point to the Wnt/β-catenin pathway as a new avenue for targeting multiple cancer types.
The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same time, the Centers for Medicare & Medicaid Services has revealed plans to expand the Cell and Gene Therapy Access Model to increase patient access to these products.
As both Taysha Gene Therapies and Neurogene warm up for an important year of readouts, the Rett syndrome community is hopeful of seeing a therapy that can truly change the disease’s path.
A combination of Tango Therapeutics’ vopimetostat and Revolution Medicines’ recently approved Rasonque led to a response rate of 82% in an ongoing Phase 1/2 trial—a drop from 92% that was reported in June in fewer patients.
A combination of the personalized cancer vaccine intismeran autogene and Merck’s Keytruda just barely cleared analysts’ expectations for recurrence-free survival, leaving questions as to its applicability to tumor types beyond melanoma.
At the European Society for Medical Oncology meeting this weekend, Merck will showcase three late-stage trials of its Kelun-Biotech–partnered TROP2-directed antibody sac-TMT that VP of Chemistry Alan Northrup says gets the payload release “just right.”
Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession.
At the European Society of Medical Oncology meeting in Madrid this weekend, analysts will be watching for detailed data on Merck and Moderna’s personalized cancer vaccine, Summit and Akeso’s PD-1xVEGF bispecific therapy, and a host of antibody-drug conjugates.
While GLP-1 medicines have become synonymous with weight loss, at least one expert thinks amylin would have been the go-to target if biopharma had been focused on the blockbuster indication 10 years ago. A new wave of therapies is now exploring this potentially gentler mechanism.
Leveraging recently proposed regulatory flexibilities, the gene-editing sector is working to cut R&D costs and unlock indications that were previously economically unviable, according to a new playbook published by the Alliance for Regenerative Medicine.