Moderna, Inc. (NASDAQ:MRNA) said initial clinical data from its ongoing Phase 1/2 study of mRNA-2808 have been selected for an oral presentation at the 68th American Society of Hematology Annual Meeting. The meeting is scheduled for December 12-15, 2026, in New Orleans, Louisiana.
The presentation is scheduled for December 12, 2026, from 2:15-2:30 PM CT under Abstract #266. The abstract covers initial results from the first-in-human Phase 1/2 evaluation of mRNA-2808 in patients with relapsed or refractory multiple myeloma.
Moderna expects to present updated clinical data from the ongoing study at the ASH annual meeting in December.
At the time of abstract submission, 12 heavily pretreated patients had received mRNA-2808 in the Phase 1/2 MyEngage trial, identified as NCT07116616. The patients had a median of 10 prior lines of therapy.
Among 11 response-evaluable patients, four confirmed responses were reported. These included two very good partial responses (VGPRs) and two partial responses (PRs). The responding group included patients who had previously received BCMA- and/or GPRC5D-directed therapies.
mRNA-2808 is an investigational, lipid nanoparticle-formulated multiplexed mRNA therapeutic. It is designed to support production in the body of three T-cell engagers directed at BCMA, GPRC5D and FcRH5.
All three encoded T-cell engagers were detected in plasma, while exposure increased across dose levels. Moderna said these findings demonstrated in vivo protein production in humans.
Moderna reported no dose-limiting toxicities and no treatment-related serious adverse events in the initial data. Cytokine release syndrome occurred in 5 patients (41.7%); all cases were Grade 1 and occurred without step-up dosing.
Grade ≥3 treatment-related adverse events occurred in 41.7% of patients and were predominantly hematologic.
Moderna will give an oral presentation on initial mRNA-2808 data at the 68th ASH Annual Meeting.
The presentation is scheduled for December 12, 2026, from 2:15-2:30 PM CT under Abstract #266.
At abstract submission, 12 patients had received mRNA-2808, with a median of 10 prior lines of therapy.
Four confirmed responses were observed among 11 response-evaluable patients.
Cytokine release syndrome occurred in 5 patients (41.7%), all at Grade 1, while Grade ≥3 treatment-related adverse events occurred in 41.7% of patients.
Moderna announced on November 4, 2026 that initial clinical data from its ongoing Phase 1/2 study of mRNA-2808 had been selected for oral presentation at the 68th American Society of Hematology Annual Meeting. The presentation will cover the first-in-human study of the investigational therapy in relapsed or refractory multiple myeloma.
Moderna will present the data at the 68th American Society of Hematology Annual Meeting, taking place December 12-15, 2026, in New Orleans, Louisiana. The oral presentation is scheduled for December 12, 2026, from 2:15-2:30 PM CT, under Abstract #266.
mRNA-2808 is an investigational multiplexed mRNA therapeutic designed to enable in vivo production of three distinct T-cell engagers targeting BCMA, GPRC5D and FcRH5. It is formulated in a lipid nanoparticle.
Moderna is evaluating mRNA-2808 in an ongoing Phase 1/2 clinical study called the MyEngage trial, identified as NCT07116616. The study is being conducted in patients with relapsed or refractory multiple myeloma.
At the time of abstract submission, 12 heavily pretreated patients with relapsed or refractory multiple myeloma had received mRNA-2808. The patients had a median of 10 prior lines of therapy.
Four confirmed responses were observed among 11 response-evaluable patients, including two very good partial responses and two partial responses. The data came from the ongoing Phase 1/2 MyEngage trial.
The four confirmed responses included patients previously treated with BCMA- and/or GPRC5D-directed therapies. The source does not provide a separate response count for those previously treated groups.
All three encoded T-cell engagers were detectable in plasma, with exposure increasing across dose levels. Moderna said this demonstrated in vivo protein production in humans.
Moderna reported no dose-limiting toxicities or treatment-related serious adverse events in the initial data. The company also reported that cytokine release syndrome occurred in 5 patients (41.7%), all at Grade 1, without step-up dosing.
Grade ≥3 treatment-related adverse events occurred in 41.7% of patients, according to Moderna. The company said these events were predominantly haematologic.
Moderna expects to present updated clinical data from the ongoing Phase 1/2 MyEngage trial at the ASH annual meeting in December. The meeting is scheduled for December 12-15, 2026.
Moderna's shares trade on NASDAQ under the ticker symbol NASDAQ:MRNA.