Moderna Announces Phase 2 Data on mRNA-4157/V940, an Investigational mRNA Personalized Cancer Vaccine, to be Presented at the 2023 AACR Annual Meeting

CAMBRIDGE, MA / ACCESSWIRE / March 14, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that two abstracts on mRNA-4157/V940 an investigational mRNA personalized cancer vaccine, have been accepted for presentation at the 2023 American Association of Cancer Research (AACR) Annual Meeting being held April 14-19 in Orlando, FL. mRNA-4157/V940 is being jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.

The two abstract titles are:

• Presentation #CT001: A personalized cancer vaccine, mRNA-4157, combined with pembrolizumab versus pembrolizumab in patients with resected high-risk melanoma: Efficacy and safety results from the randomized, open- label Phase 2 mRNA-4157-P201/Keynote-942 trial. Harnessing the Immune System in the Clinic.
  Session: Clinical Trials Plenary; Sunday, April 16 at 1:00-3:00 PM ET.
  Presenter: Dr. Jeffrey S. Weber
  
• Poster Session #CT224: Evaluation of minimal residual disease as a predictive biomarker of recurrence free survival in high-risk melanoma patients treated with a combination of mRNA-4157, a personalized cancer vaccine, and pembrolizumab.
  Session: Phase II Clinical Trials 2; Tuesday, April 18 at 9:00 AM - 12:30 PM ET.
  Author: Dr. Ryan J. Sullivan

AACR will post the text of late-breaking and clinical trials abstracts in the AACR Annual Meeting online itinerary planner and Annual Meeting app on April 14, 2023 at 12:00 PM ET.

Moderna's exhibit booth at the AACR Annual Meeting is booth #2664.

About mRNA-4157/V940

Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. mRNA-4157/V940 is a novel investigational messenger ribonucleic acid (mRNA)-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the patient's tumor. Upon administration into the body, the algorithmically derived and mRNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.

mRNA-4157/V940 is being developed in combination with KEYTRUDA. mRNA-4157/V940 is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient's tumor. KEYTRUDA is an immunotherapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells.

Moderna and Merck plan to initiate a Phase 3 study in adjuvant melanoma in 2023 and expect to rapidly expand to additional tumor types, including non-small cell lung cancer.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology Fand manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.

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 development of mRNA-4157/V940; the ability of mRNA-4157/V940 to stimulate an immune response; and plans to initiate a Phase 3 study in adjuvant melanoma in 2023 and to rapidly expand to additional tumor types, including non-small cell lung cancer. 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, 2022, 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.

Media:
Colleen Hussey
Senior Director, Corporate Communications
617-335-1374
Colleen.Hussey@modernatx.com

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

SOURCE: Moderna, Inc.