A fourth child has died after developing liver complications on a trial of Astellas Pharma Inc.’s gene therapy for rare neuromuscular disease, after FDA advisers noted the problems on the ASPIRO study in a discussion on gene therapy safety. Last week, Astellas announced that it had stopped dosing on ASPIRO after a safety issue involving liver function emerged in the trial of the gene therapy AT-132, aimed at the life-threatening rare disease X-linked myotubular myopathy.
Shares of antibody drug conjugate developer Mersana Therapeutics Inc. (NASDAQ:MRSN) fell 39.1% to $8.56 on Sept. 10 after the company disclosed a second death from pneumonitis in the ongoing phase I trial testing its antibody drug conjugate, upifitamab rilsodotin against tumor types likely to express the sodium-dependent phosphate transport protein NaPi2b, such as ovarian cancer.
Apellis Pharmaceuticals Inc.’s win with one phase III trial and narrow miss with an identical one testing pegcetacoplan in geographic atrophy secondary to age-related macular degeneration caused Wall Street to punish the company while rewarding competitor Iveric Bio Inc.
DUBLIN – In biopharma, U.S. patent grants hardly represent big news. Without them, you simply don’t get to sit at the table. So Onk Therapeutics Ltd.’s receipt of U.S. patent no. 11104735 covering CISH gene knockouts in natural killer (NK) cell therapies for cancer is not a major event in the general scheme of things. At the same time, it is a vitally important enabler for a company that is, paradoxically, both an early mover in the field but also a laggard in the highly competitive race to move NK cells into clinical development.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alvotech, Apellis, Astrazeneca, Azurx, Cartargia, Cassiopea, Cytodyn, Mersana, Rezolute, Scpharmaceuticals, Senhwa, Sunovion.
Astrazeneca plc is eyeing an addition to its respiratory diseases portfolio after a potential first-in-class “rescue” asthma inhaler, PT-027, met its goals in two phase III trials.
Chinese companies are finding that their COVID-19 vaccines are effective as booster shots and against variants of the virus, as data from more studies emerge.
PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.
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