Moderna Announces Oral Presentation of mRNA-2808 Clinical Data at 2026 American Society of Hematology Annual Meeting

Four confirmed responses were observed among 11 evaluable patients, including patients previously treated with BCMA- and/or GPRC5D-directed therapies.

Rhea-AI Summary

Moderna (NASDAQ:MRNA) announced initial mRNA-2808 clinical results selected for oral presentation at the ASH meeting on December 12, 2026.

At abstract submission, the ongoing Phase 1/2 MyEngage trial had treated 12 patients with multiple myeloma that returned or resisted treatment; the median was 10 prior treatment lines. Among 11 response-evaluable patients, there were four confirmed responses: two very good partial responses and two partial responses. All three encoded T-cell engagers, proteins targeting cancer cells, were detectable in plasma, with exposure increasing across doses. No dose-limiting toxicities or treatment-related serious adverse events were observed. Cytokine release syndrome occurred in five patients (41.7%), all Grade 1, without step-up dosing. Grade 3 or higher treatment-related adverse events occurred in 41.7%, predominantly affecting blood cells. Moderna expects updated data at the December meeting.

Positive

• Minor pointFour confirmed responses among 11 evaluable patients included two very good partial responses and two partial responses.
• Minor pointAll three encoded T-cell engagers were detectable in plasma, with exposure increasing across dose levels.
• Minor pointNo dose-limiting toxicities or treatment-related serious adverse events were observed.

Negative

• Minor pointGrade 3 or higher treatment-related adverse events occurred in 41.7% of patients, predominantly affecting blood cells.
• Minor pointCytokine release syndrome occurred in five patients (41.7%), all Grade 1, without step-up dosing.

Key Figures

Patients treated: 12 patients Prior lines of therapy: Median 10 prior lines Confirmed responses: 4 responses (2 VGPRs and 2 PRs) +4 more

Patients treated

12 patients

At abstract submission in the ongoing Phase 1/2 study

Prior lines of therapy

Median 10 prior lines

Heavily pretreated patients

Confirmed responses

4 responses (2 VGPRs and 2 PRs)

Among 11 response-evaluable patients

Dose-limiting toxicities

None observed

Ongoing Phase 1/2 study

Treatment-related serious adverse events

None observed

Ongoing Phase 1/2 study

Cytokine release syndrome

5 patients (41.7%), all Grade 1

Occurred without step-up dosing

Grade ≥3 treatment-related adverse events

41.7% of patients

Predominantly hematologic

Key Terms

multiple myeloma, t-cell engagers, dose-limiting toxicities, cytokine release syndrome, +1 more

5 terms

multiple myeloma medical

"patients with relapsed or refractory multiple myeloma"

A cancer of the blood that starts in plasma cells, the immune system’s antibody-producing cells in bone marrow. It behaves like a factory where the workers go rogue, crowding out healthy cells and causing bone damage, anemia and infections; treatments and trial results can sharply affect drug sales, regulatory approvals and company valuations, so progress or setbacks are closely watched by investors.

t-cell engagers medical

"production of three distinct T-cell engagers"

T-cell engagers are engineered proteins that act like microscopic matchmakers, physically bringing a patient’s immune T cells into close contact with diseased cells so the immune system can recognize and kill them. Investors track them because they represent a promising class of therapies that can drive strong clinical benefits and commercial value if trials succeed, but they also carry development, safety and regulatory risks that can rapidly change a company’s market outlook.

dose-limiting toxicities medical

"No dose-limiting toxicities or treatment-related serious adverse events"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

cytokine release syndrome medical

"Cytokine release syndrome occurred in 5 patients"

An intense immune overreaction in which the body's defense system releases a large surge of signaling proteins, causing fever, low blood pressure, breathing trouble or organ stress; imagine the immune system's alarm going into overdrive and flooding the body with emergency responders. Investors care because this side effect can slow or block regulatory approval, increase clinical trial costs and liabilities, limit how widely a therapy can be used, and therefore affect a drug's market value and sales potential.

lipid nanoparticle-formulated technical

"an investigational lipid nanoparticle-formulated multiplexed mRNA therapeutic"

A formulation that uses tiny, engineered particles made of fats (lipids) to encase and carry a drug or vaccine ingredient into the body. Lipid nanoparticles (LNPs) protect sensitive payloads (commonly nucleic acids like mRNA or siRNA) from degradation in the bloodstream, help the payload cross cell membranes, and control where and how it is released; typical LNPs combine ionizable lipids, structural lipids (e.g., phospholipids, cholesterol) and surface-modifying lipids (e.g., PEG-lipids). It describes the delivery technology and not the active pharmaceutical ingredient itself, and it can affect handling, storage, dosing route, and how the product distributes in the body.

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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.

Presentation Details

• Abstract title: Initial results from a first-in-human phase 1/2 trial of mRNA-2808, a multiplexed mRNA therapeutic encoding BCMA, GPRC5D, and FcRH5-targeted T-cell engagers, in relapsed/refractory multiple myeloma
• Presentation: Oral presentation, December 12, 2026, 2:15-2:30 PM CT, Abstract #266
• Meeting: 68th ASH Annual Meeting, December 12-15, 2026, New Orleans, Louisiana

About mRNA-2808

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.

About Moderna

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.

Forward-Looking Statements

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.

Moderna Contacts

Media:

Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What responses did Moderna report in the mRNA-2808 MyEngage trial?

There were four confirmed responses among 11 response-evaluable patients: two very good partial responses and two partial responses. Responses included patients previously treated with BCMA- and/or GPRC5D-directed therapies. At abstract submission, 12 heavily pretreated patients had received mRNA-2808, with a median of 10 prior treatment lines.

What does Moderna's investigational mRNA-2808 therapy target?

mRNA-2808 is designed to enable production inside the body of three distinct T-cell engagers targeting BCMA, GPRC5D and FcRH5. It is an investigational multiplexed mRNA therapeutic formulated in lipid nanoparticles and is being evaluated in the ongoing Phase 1/2 MyEngage trial for relapsed or refractory multiple myeloma.