Moderna administered the first patient dose of its investigational mRNA‑based T‑cell engager, mRNA‑2808, in a Phase 1/2 study for relapsed or refractory multiple myeloma on November 3, 2025. The dose was delivered at SCRI Oncology Partners in Nashville, Tennessee, in partnership with the Sarah Cannon Research Institute.
The study, registered as NCT07116616, is an open‑label, multicenter trial evaluating safety and tolerability of mRNA‑2808 in adults aged 18 and older. mRNA‑2808 encodes three T‑cell engagers that target multiple antigens on myeloma cells, aiming to address tumor heterogeneity and resistance to existing therapies.
Moderna’s oncology pipeline represents a strategic shift as the company seeks to diversify beyond its COVID‑19 vaccine business. In the third quarter of 2024, Moderna reported $1.9 billion in revenue and a net income of $13 million, while the third quarter of 2025 is projected to generate $860 million in sales and a loss of $2.15 per share. COVID‑19 vaccine revenue fell to $100 million in Q2 2025, a 38 % decline from the previous year, prompting the company to lower its 2025 revenue guidance to $1.5–$2.5 billion.
The first‑in‑human dose of mRNA‑2808 is a critical milestone that could position Moderna as a leader in the rapidly evolving multiple myeloma treatment landscape, which currently includes immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, and CAR‑T therapies. By leveraging its mRNA platform, Moderna aims to offer a multiplexed T‑cell engager approach that may overcome resistance mechanisms and improve patient outcomes.
Management emphasized that the oncology program is a key component of the company’s long‑term growth strategy, especially as it implements cost‑cutting measures and seeks new revenue streams in high‑need therapeutic areas.
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