Target to $77: Cancer Antigen Therapies, TCEs and in vivo CAR-T @Science Day

Research evidence excerpt

Target to $77: Cancer Antigen Therapies, TCEs and in vivo CAR-T @Science Day

odel, the addition of Signal 2

greatly improved tumor control depth and durability. Moderna plans to initiate a Phase I study

in 2027.

• EBV Vaccine mRNA-1195 to treat Multiple Sclerosis. Part A of the Phase I study

(NCT05831111) enrolled 350 EBV+ healthy volunteers randomized to 4 dose levels of

mRNA-1195 or mRNA-1189, prophylactic mRNA vaccine candidate designed to prevent EBV

infections and EBV-mediated infectious mononucleosis, or placebo. mRNA-1195 produced

durable expression of target antigens for at least 6 months after the last dose. Likewise, both

B cell nAbs and epithelial nAbs were increased for at least 6 months. EBV shedding was

reduced to near or below the lower limit of quantitation and reduced the number of patients

actively shedding by ~50%. Part B of the Phase I study is ongoing, enrolling equal numbers

of EBV+ and EBV- patients across 3 dose cohorts (N=30 each) and a placebo cohort (N=30).

Moderna expects Phase Ib data in 2H:26. Moderna is conducting the proof-of-concept Phase

II study (NCT06735248) in multiple sclerosis (MS). Moderna has fully enrolled the safety

cohort (N=12) and was cleared to continue dose escalation in the Phase II portion of the study,

in which 180 EBV+ MS patients will be randomized to 2 doses of mRNA-1195 or placebo. The

primary endpoint is safety and reactogenicity. Secondary endpoints include impact on MRI

markers of MS disease activity and humoral immunogenicity.

• In Vivo CAR-T mRNA-6007 for Autoimmune Disease. mRNA-6007 is an in vivo dual

CD19xBCMA CAR-T that uses Moderna's clinically validated LNPs coated with CD7 targeting

moieties. CD7 is expressed on all CD8+ and CD4+ T cells, as well as NK cells. In humanized