Moderna Announces First Patient Dosed in Phase 1/2 Study of Investigational T-Cell Engager for Multiple Myeloma

Rhea-AI Summary

Moderna (NASDAQ:MRNA) announced on November 3, 2025 that the first patient has been dosed in a Phase 1/2 dose‑escalation study of mRNA‑2808, an investigational mRNA‑based T‑cell engager (TCE) for relapsed or refractory multiple myeloma (RRMM).

mRNA‑2808 encodes three TCEs that target three validated myeloma‑associated antigens to address tumor heterogeneity and potential target‑mediated resistance. The first dose was given at SCRI Oncology Partners in Nashville in collaboration with Sarah Cannon Research Institute. The study (NCT07116616) will evaluate safety and tolerability in adults aged 18 and older.

Positive

• First patient dosed in Phase 1/2 study (Nov 3, 2025)
• mRNA‑2808 encodes three T‑cell engagers targeting three antigens
• Trial collaboration with SCRI provides clinical site access in Nashville

Negative

• Study is an early stage dose‑escalation trial with no efficacy data yet
• Primary objective is safety and tolerability, not near‑term commercialization

Insights

Clinical Development Analyst

Moderna dosed the first patient in a Phase 1/2 study of its multiplexed T‑cell engager mRNA-2808 on November 3, 2025.

Moderna initiated first‑in‑human dosing of mRNA-2808, an mRNA-encoded multiplexed T‑cell engager targeting three validated myeloma antigens. The trial is a dose‑escalation Phase 1/2 study (NCT07116616) in relapsed or refractory multiple myeloma patients. This action moves the program from preclinical into clinical testing, enabling safety, tolerability and early pharmacology data collection.

This milestone’s value depends on forthcoming safety and dose‑finding results; early dosing alone does not demonstrate efficacy. Key dependencies include dose‑limiting toxicity findings, tolerability across dose cohorts, and any signs of target engagement or clinical responses. Watch for initial safety readouts and cohort expansion decisions over the next 6–18 months and registry updates tied to NCT07116616.

CAMBRIDGE, MA / ACCESS Newswire / November 3, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, the Company's investigational mRNA-based T-cell engager (TCE) for participants with relapsed or refractory multiple myeloma (RRMM). The first dose was administered at SCRI Oncology Partners in Nashville, Tennessee, in collaboration with Sarah Cannon Research Institute (SCRI).

mRNA-2808 is an investigational, multiplexed therapy that encodes three TCEs that target three validated myeloma-associated antigens. This novel strategy aims to address tumor heterogeneity and overcome known mechanisms of target-mediated resistance.

"This is an important milestone as it is Moderna's first T-cell engager therapy to be dosed in a patient. Given the vast unmet needs in multiple myeloma, I believe we can help improve the lives of these patients with innovative therapies," said Dr. Kyle Holen, Head of Development, Oncology at Moderna. "Our mRNA platform uniquely allows for the multiplexing of several T-cell engager targets, designed to attack the disease from multiple angles to overcome, reduce and prevent escape mechanisms. We are proud to launch our first, of what we hope are many, T-cell engager therapies as we continue on our mission to transform cancer care for patients in need."

"Multiple myeloma is a complex cancer with many patients inevitably developing a resistance to available therapies, and attaining sustained disease control remains a challenge," said Dr. Hans Lee, Director of Myeloma Research at SCRI and Hematologist and Medical Oncologist at SCRI Oncology Partners. "At SCRI, our mission is to bring tomorrow's breakthroughs to the patients who need them today. mRNA-based therapies could change the way we think about treating cancers like multiple myeloma, and we are proud to provide our patients with access to this clinical trial."

This study (NCT07116616) is a dose escalation study evaluating the safety and tolerability of mRNA-2808 in RRMM patients aged 18 years and older. To learn more about eligibility, please click here.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including pioneering work on COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives 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 (formerly Twitter), 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 potential for Moderna's mRNA platform to help transform cancer care; and the potential of mRNA-2808 to address tumor heterogeneity and overcome known mechanisms of target-mediated resistance. 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, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, 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
Head of Global Media Relations
+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

What did Moderna (MRNA) announce on November 3, 2025 about mRNA‑2808?

Moderna announced the first patient was dosed in a Phase 1/2 study of mRNA‑2808 for relapsed or refractory multiple myeloma.

What is mRNA‑2808 and how does it work in the MRNA clinical trial?

mRNA‑2808 is an investigational mRNA‑based therapy that encodes three T‑cell engagers targeting three validated myeloma antigens to address tumor heterogeneity.

Where was the first patient dosed for Moderna's mRNA‑2808 study (MRNA)?

The first dose was administered at SCRI Oncology Partners in Nashville, Tennessee, in collaboration with Sarah Cannon Research Institute.

What is the design and primary goal of the mRNA‑2808 study (NCT07116616)?

The study is a Phase 1/2 dose‑escalation trial evaluating the safety and tolerability of mRNA‑2808 in RRMM patients aged 18 and older.

Does the November 3, 2025 Moderna announcement include clinical efficacy results for mRNA‑2808?

No; the announcement reports first patient dosing and that the trial will evaluate safety and tolerability, not efficacy readouts.