CGT IN ONCOLOGY

Recently released results of the REACTIVE Phase 2 trial for Amphera's MesoPhercell therapy for resected pancreatic cancer demonstrated a 2-year recurrencefree survival rate of 64%, compared to 40% expected, and an overall survival rateof 83%, with low-grade side effects. The trial involved 38 patients receivingbi-weekly therapy and booster injections at 4 and 7 months and showcased arobust immune response.

EMERGING TECHNOLOGY IN CGT

Multiply Labs announced a collaboration with LegendBiotech to automate cell therapy manufacturing usingadvanced robotic systems. Multiply Labs' technologyenables autonomous manufacturing, offering morerapid adoption when compared to traditionalautomation approaches that require changes tomanufacturing processes. In recent studies, it hasdemonstrated statistically equivalent quality comparedto manual processes.

CGT IN HEMATOLOGY

BMS announced that the EMA has validated its Type IIvariation application to expand the indication forBREYANZI, a CAR-T cell therapy, in adult patients withrelapsed or refractory follicular lymphoma (FL) whohave received two or more prior lines of systemictherapy. The application is based off of the Phase 2TRANSCEND FL trial in which BREYANZI demonstrateda high overall response rate, along with durableresponses and a consistent safety profile.

CGT IN HEMATOLOGY

Pfizer recently released results from thepivotal BENEGENE-2 trial, demonstratingthat gene therapy with BEQVEZ reducedannualized bleeding episodes by 71% andtreated bleeding episodes by 78% inhemophilia B patients. Additionally, over80% of participants maintained mildhemophilia factor IX levels for 15-24months post-infusion, providing the basisfor FDA approval earlier this year.

EMERGING TECHNOLOGY IN CGT

In an effort to bring more cell & gene therapies to market, a numberof life sciences companies have recently formed partnerships withcutting-edge technology companies. Sony and Cellares, a celltherapy manufacturer, are working together to integrate Sony'shigh-speed, high-purity cell-sorting technology into Cellares'automated Cell Shuttle, which enhances the scalability andefficiency of sorting-dependent therapies like regulatory T cellsand hematopoietic stem cells. Evotec SE and Novo Nordisk alsorecently announced a partnership to develop next-generation stemcell therapies, with Novo Nordisk providing funding for Evotec'sR&D in exchange for exclusive rights in specific therapeutic areas.

SUPPLY CHAIN SOLUTIONS

Vertex recently announced a long-termcommercial supply agreement with Lonza, aleader in global supply chain & manufacturing,for CASGEVY, the first CRISPR/Cas9 gene-editedcell therapy for transfusion-dependent betathalassemia or sickle cell disease. Thisagreement grants Vertex access to Lonza'smanufacturing network and expertise to ensurethe continued availability of Casgevy.