Full Press Release Details
Initial Phase 1/2 data highlight the potential of Moderna's multiplexed mRNA approach in relapsed or refractory multiple myeloma
CAMBRIDGE, MA / ACCESS Newswire / November 4, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that initial clinical data from its ongoing Phase 1/2 study of mRNA-2808 have been selected for oral presentation at the 68th American Society of Hematology (ASH) Annual Meeting, taking place December 12-15, 2026, in New Orleans, Louisiana. 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.
At the time of the abstract submission, 12 heavily pretreated patients with relapsed or refractory multiple myeloma (median 10 prior lines of therapy) had received mRNA-2808 in the ongoing Phase 1/2 MyEngage trial (NCT07116616). Four confirmed responses, including two very good partial responses (VGPRs) and two partial responses (PRs), were observed among 11 response-evaluable patients, including patients previously treated with BCMA- and/or GPRC5D-directed therapies. All three encoded T-cell engagers were detectable in plasma, with exposure increasing across dose levels, demonstrating in vivo protein production in humans. No dose-limiting toxicities or treatment-related serious adverse events were observed. Cytokine release syndrome occurred in 5 patients (41.7%), all Grade 1, without step-up dosing. Grade ≥3 treatment-related adverse events occurred in 41.7% of patients, predominantly hematologic.
The Company expects to present updated clinical data from the ongoing Phase 1/2 MyEngage trial at the ASH annual meeting in December.
mRNA-2808 is an investigational lipid nanoparticle-formulated multiplexed mRNA therapeutic being evaluated in an ongoing Phase 1/2 clinical study (NCT07116616) in patients with relapsed or refractory multiple myeloma.
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.
With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the safety and efficacy of mRNA-2808; the potential of mRNA-2808 to treat relapsed or refractory multiple myeloma; the potential of Moderna's multiplexed mRNA approach to enable in vivo production of multiple distinct T-cell engagers; and the ongoing clinical development of mRNA-2808. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.