Moderna Announces Phase 2 Data on mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, to be Presented at the 2023 ASCO Annual Meeting

ASCO presentations on Saturday, June 3 at 4:30pm CDT and Monday, June 5 at 3:00pm CDT

Moderna to host investor event via webcast on Monday, June 5 at 6pm CDT

CAMBRIDGE, MA / ACCESSWIRE / May 30, 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 individualized neoantigen therapy, have been accepted for presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 2-6 in Chicago, IL. 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:

• Abstract #LBA9515: Minimal residual disease by circulating tumor DNA as a biomarker of recurrence free survival in resected high-risk melanoma patients treated with mRNA-4157/V940, a personalized cancer vaccine, and pembrolizumab
  Poster Discussion Session S406; Saturday, June 3 at 4:30 PM - 6:00 PM CDT
  Presenter: Matteo S. Carlino, PhD, MBBS, FRACP
  
• Abstract #LBA9503: Distant metastasis-free survival results from the randomized, phase 2 mRNA-4157-P201/KEYNOTE-942 trial
  Melanoma/Skin Cancers Oral Abstract Session; Monday, June 5 at 3:00 - 6:00 PM CDT
  Presenter: Muhammad Adnan Khattak, PhD, FRACP, MBBS

Moderna Investor Event

Moderna will host a live webcast on Monday, June 5 from 6:00 - 7:00pm CDT, which will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for at least 30 days following the presentation.

About mRNA-4157 (V940)

mRNA-4157 (V940) is a novel investigational messenger ribonucleic acid (mRNA)-based individualized neoantigen therapy¹ 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 DNA sequence of the patient's tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.

Individualized neoantigen therapies are designed to prime the immune system so that a patient can generate an antitumor response specific to their tumor mutation signature. 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. Based on early clinical studies, combining mRNA-4157 (V940) with KEYTRUDA may potentially provide an additive benefit and enhance T cell-mediated destruction of tumor cells.

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, Brand & Corporate Affairs
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.