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 recurrence free survival rate of 64%, compared to 40% expected, and an overall survival rate of 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 using advanced robotic systems. Multiply Labs' technologyenables autonomous manufacturing, offering more rapid adoption when compared to traditional automation approaches that require changes to manufacturing processes. In recent studies, it has demonstrated statistically equivalent quality compared to manual processes.

CGT IN HEMATOLOGY

BMS announced that the EMA has validated its Type II variation application to expand the indication for BREYANZI, a CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemictherapy. The application is based off of the Phase 2TRANSCEND FL trial in which BREYANZI demonstrated a high overall response rate, along with durable responses and a consistent safety profile.

CGT IN HEMATOLOGY

Pfizer recently released results from the pivotal BENEGENE-2 trial, demonstrating that gene therapy with BEQVEZ reducedannualized bleeding episodes by 71% and treated bleeding episodes by 78% in hemophilia 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 number of life sciences companies have recently formed partnerships with cutting-edge technology companies. Sony and Cellares, a cell therapy manufacturer, are working together to integrate Sony'shigh-speed, high-purity cell-sorting technology into Cellares'automated Cell Shuttle, which enhances the scalability and efficiency of sorting-dependent therapies like regulatory T cells and hematopoietic stem cells. Evotec SE and Novo Nordisk also recently announced a partnership to develop next-generation stem cell 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-term commercial 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. This agreement grants Vertex access to Lonza'smanufacturing network and expertise to ensure the continued availability of Casgevy.