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.