Moderna Expands Its mRNA Pipeline with Three New Development Programs

mRNA-1608 is a vaccine candidate against Herpes simplex virus (HSV)

mRNA-1468 is a vaccine candidate against varicella-zoster virus (VZV) to reduce the rate of herpes zoster (shingles)

mRNA-4359 is a new checkpoint cancer vaccine

CAMBRIDGE, MA / ACCESSWIRE / February 18, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its mRNA pipeline with three new development programs. This announcement reflects the Company's commitment to expanding its portfolio building on Moderna's experience with Spikevax^®, its COVID-19 vaccine. The development programs announced today are mRNA vaccine candidates against herpes simplex virus (HSV), varicella-zoster virus (VSV) to reduce the rate of shingles and a new checkpoint cancer vaccine. HSV and VZV are latent viruses that remain in the body for life after infection and can lead to life-long medical conditions. Moderna now has five vaccine candidates against latent viruses in development, including against cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human immunodeficiency virus (HIV), HSV and VZV.

"We are pleased to announce these new development programs, which reflect the continued productivity of our platform and the potential of our mRNA technology to impact the lives of hundreds of millions of people," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are committed to addressing latent viruses with the goal of preventing the lifelong medical conditions that they cause with our mRNA vaccine programs. With our HSV and VZV vaccine candidates, we also hope to improve the quality of life for those with symptomatic disease. With our new checkpoint cancer vaccine, we look forward to exploring if we can induce T cells specific to PD-L1 and IDO1 through vaccination. Our research teams are working on additional mRNA candidates, which we look forward to sharing in the future."

Herpes simplex virus (HSV) vaccine candidate (mRNA-1608)

Moderna's herpes simplex virus (HSV) vaccine candidate (mRNA-1608) is a vaccine candidate against HSV-2 disease. Moderna expects that an HSV-2 vaccine could provide cross-protection against HSV-1. With mRNA-1608, the Company aims to induce strong antibody response with neutralizing and effector functionality combined with cell-mediated immunity. There is no vaccine approved against HSV.

Herpes simplex viruses (commonly known as herpes) are categorized into two types: HSV-1 infects the mouth, face and genitals, and HSV-2 primarily infects the genitals. Both viruses establish lifelong latent infections within nearby sensory neurons from which they can reactivate and re-infect the skin. There is a significant burden of disease from HSV genital infections. Diagnosed, symptomatic genital herpes causes a reduction in quality of life, which antivirals (current standard of care) only partially restore. In the U.S., approximately 18.6 million adults ages 18 to 49 years are living with HSV-2. Globally, approximately 5% of the population in the 18-to-49-year age range is HSV-2 seropositive. Moderna expects that an HSV vaccine could deliver similar efficacy as suppressive antiviral treatment and would likely improve compliance and quality of life.

Varicella-zoster virus (VZV) vaccine candidate (mRNA-1468)

Moderna's varicella-zoster virus (VZV) vaccine candidate (mRNA-1468) is designed to express varicella-zoster virus (VZV) glycoprotein E (gE) to reduce the rate of shingles (herpes zoster). Shingles occurs in one of three adults in their lifetime and incidence dramatically increases at approximately 50 years of age. Declining immunity in older adults decreases immunity against VZV, allowing reactivation of the virus from latently infected neurons, causing painful and itchy lesions. Moderna has published preclinical data on an mRNA vaccine encoding the VZV gE antigen.

VZV causes shingles. Serious herpes zoster complications include postherpetic neuralgia (10-13% of herpes zoster cases), bacterial coinfections, and cranial and peripheral palsies; 1-4% of HZ cases are hospitalized for complications. Severity of disease and likelihood of complications, including postherpetic neuralgia (PHN) also increases with age. Immunocompromised patients, autoimmune disease patients using immunosuppressive therapies, HIV-infected patients, hematopoietic stem cell (HSCT) and organ transplant recipients have an increased risk of developing herpes zoster. The incidence of herpes zoster has been increasing throughout the world from 0.76 per 1000 person years from 1945 to 1949, to 7.2 per 1000 person years in 2016.

Checkpoint cancer vaccine (mRNA-4359)

Moderna's new checkpoint cancer vaccine candidate (mRNA-4359) expresses Indoleamine ^2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1) antigens. Moderna designed mRNA-4359 with the goal of stimulating effector T-cells that target and kill suppressive immune and tumor cells that express target antigens. Moderna is planning to explore initial indications for advanced or metastatic cutaneous melanoma and non-small cell lung carcinoma (NSCLC).

Melanoma is the fifth most common cancer diagnosis in the U.S. It accounts for 5.3% of all new cancer diagnoses and 1.5% of all cancer-related deaths. Cutaneous melanoma is a cancer that starts in the melanocytes (pigment-producing cells) of the skin. If diagnosed at the local stage, the 5-year survival rate is approximately 95%. However, for regional or metastatic disease (stage IIIB+), 5-year survival rates decline to approximately 30 to 60%. Approximately 18,000 new patients are diagnosed with stage IIIB+ cutaneous melanoma in the U.S. Advanced melanoma, a rare and serious type of skin cancer, is responsible for most skin cancer-related deaths, despite representing only 1% of skin cancer cases. Current standard of care pembrolizumab, nivolumab or the combination of nivolumab + ipilimumab.

NSCLC frequently goes undetected, remaining asymptomatic until it has progressed to later stages. Approximately, 115,000 people are diagnosed with metastatic NSCLC or progress to metastatic disease annually in the U.S. The current approach to treatment of metastatic NSCLC treatment is dependent on the presence of PD-L1 expression. If tumor PD-L1 expression is greater than 50% pembrolizumab or atezolizumab monotherapy are preferred, while a combination of chemotherapy and pembrolizumab is preferred for patients with PD-L1 expression less than 50%.

About Moderna

In 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production. 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-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and 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 seven 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 regarding: the Company's development of vaccine candidates against herpes simplex virus (HSV, mRNA-1608) and varicella-zoster virus (VZV, mRNA-1468), and a new cancer checkpoint vaccine (mRNA-4359); the ability of these new vaccine candidates to produce the anticipated therapeutic effect, to induce an antibody response or to trigger T-cell activity, as applicable; the burden for the diseases targeted by these vaccine candidates; and plans for clinical trials of these vaccine candidates. 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 those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K 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 hereof.

Moderna Contacts

Media:
Colleen Hussey
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.