Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults

Results from multiple Phase 3 trials of V116 and a real-world evidence study of pneumococcal serotypes presented at the 13^th Meeting of the International Society of Pneumonia and Pneumococcal Diseases

If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive data from multiple Phase 3 studies evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 13^th Meeting of the International Society of Pneumonia and Pneumococcal Diseases (ISPPD) in Cape Town, South Africa.

Across the clinical studies presented, V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine in a variety of adult populations, including those who had not previously received a pneumococcal vaccine (pneumococcal vaccine-naïve), those who had previously received a pneumococcal vaccine (pneumococcal vaccine-experienced) and those with an increased risk of pneumococcal disease, including people living with human immunodeficiency virus (HIV). V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

“Invasive pneumococcal disease and pneumococcal pneumonia can cause serious illness, especially in older adults and those with immunocompromising conditions,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee. “These positive data demonstrate the potential for V116 to address an unmet need in adult pneumococcal disease prevention.”

Key findings from the studies include:

• In pneumococcal vaccine-naïve adults 50 years of age and older (STRIDE-3 sub-group), V116 was immunogenic for all 21 serotypes across the studied age groups (50–64, 65–74 and 75–84 years), as assessed by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30;
• In pneumococcal vaccine-experienced adults 50 years of age and older (STRIDE-6), V116 elicited comparable immune responses for the serotypes shared with PCV15 (pneumococcal 15-valent conjugate vaccine) or PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) and higher immune responses for the serotypes covered by V116 only, regardless of the previous pneumococcal vaccine received or time since prior pneumococcal vaccination, as assessed by serotype-specific OPA GMTs at Day 30;
• In adults 18 years of age and older living with HIV (STRIDE-7), V116 elicited comparable immune responses to PCV15+PPSV23 for all 13 shared serotypes and higher immune responses for the eight serotypes covered by V116 only, as assessed by serotype-specific OPA GMTs and Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at Day 30;
• Across all presented studies, V116 demonstrated a safety profile comparable to the studied comparators, including PCV20 (pneumococcal 20-valent conjugate vaccine), PCV15 and PPSV23.

“The extensive data presented this week reaffirm our confidence in the potential clinical value V116 could provide to a range of adult populations,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are encouraged by the results of these studies showing that V116 has generated immune responses to the serotypes responsible for the majority of adult invasive pneumococcal disease.”

In addition to Phase 3 clinical data on V116, Merck also presented preliminary data from the real-world evidence study in the U.S., Pneumococcal Pneumonia Epidemiology, Urine Serotyping, and Mental Outcomes (PNEUMO), which found that among 2,065 adults 50 years of age and older hospitalized with community-acquired pneumonia between 2018 and 2022, 242 pneumococcal serotypes were detected. Of these serotypes, approximately 84% were covered by V116. One fourth (approximately 25%) of the detected serotypes were covered only by V116 and not by PCV15 or PCV20.

Results from the PNEUMO study support that the serotypes in V116 account for the majority of pneumococcal disease (including invasive and non-invasive) in adults 50 years of age and older. These data are consistent with CDC surveillance data for invasive pneumococcal disease from 2018-2021, which show that V116 covers serotypes responsible for approximately 83% of invasive pneumococcal disease, including the eight serotypes unique to V116 which are responsible for approximately 30% of invasive pneumococcal disease in individuals 65 years of age and older.

Several of the studies presented at ISPPD were included in the filing submission to the U.S. Food and Drug Administration (FDA). The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults. An overview of the V116 late-stage development program is available here.

Summary of Findings from Select Studies Presented at ISPPD

Data from STRIDE-3 Sub-group (Abstract #379)

The sub-group analysis of the pivotal STRIDE-3 (NCT05425732) trial evaluated immunogenicity in adults 50 years of age and older who had not previously received a pneumococcal vaccine (Cohort 1) by age groups (50–64, 65–74 and 75–84 years) (n=2,362). Results found that V116 was immunogenic for all 21 vaccine serotypes across the studied age sub-groups, as assessed by serotype-specific OPA GMTs 30 days post-vaccination. There was a slight downward trend in immune responses in adults 65–74 years of age and 75 years of age and older compared to adults 50–64 years of age. V116 had a safety profile comparable to PCV20. Results from the STRIDE-3 trial were presented at the World Vaccine Congress West Coast in November 2023.

Data from STRIDE-6 and STRIDE-6 Sub-group (Abstracts #353 and #520)

STRIDE-6 (NCT05420961) is a Phase 3 trial investigating V116 in adults 50 years of age and older who had previously received a pneumococcal vaccine at least one year prior (n=712). Participants were enrolled based on previous pneumococcal vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and received either V116, PCV15 or PPSV23.

Results showed that V116 was immunogenic across all cohorts, as assessed by OPA GMTs 30 days post-vaccination, and that V116 elicited comparable immune responses to the serotypes also covered by PCV15 and PPSV23 and higher immune responses for the serotypes covered only by V116. A STRIDE-6 sub-group analysis evaluating immunogenicity across all cohorts by time since prior pneumococcal vaccination found that V116 elicited comparable immune responses regardless of time since prior pneumococcal vaccination, including more than 10 years post-vaccination with PPSV23 (n=56), and 5–9 years post-vaccination with either PPSV23 or other pneumococcal vaccines (n=208). In this study, V116 had a safety profile comparable to both PCV15 and PPSV23.

Data from STRIDE-7 (Abstract #1093)

STRIDE-7 (NCT05393037) is a Phase 3, double-blind study of V116 in adults living with HIV (n=304). Results showed that V116 was immunogenic for all serotypes covered by the vaccine, as assessed by OPA GMTs and IgG GMCs 30 days post-vaccination. V116 elicited comparable immune responses to the comparator, PCV15+PPSV23, for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by V116. Fewer participants experienced adverse events (AEs) with V116 (71.6%) compared with PCV15+PPSV23 (91%), primarily due to fewer injection-site AEs.

Data from STRIDE-9 (Abstract #1085)

STRIDE-9 (NCT05633992) is a Phase 3, randomized, double-blind, active-comparator controlled study, which investigated V116 in Japanese adults 65 years of age and older who had not previously received a pneumococcal vaccine (n=450). Serotype-specific OPA responses were measured at baseline and 30 days post-vaccination and results demonstrated that V116 elicited noninferior immune responses for the 12 serotypes shared with PPSV23 and serotype 15B, (which is included in PPSV23 but not included in V116). V116 also elicited higher immune responses for the serotypes only covered by V116 and not PPSV23. V116 also had a comparable safety profile to PPSV23.

Data from PNEUMO U.S. Serotype Distribution Study (Abstract #308)

The PNEUMO U.S. study evaluated pneumococcal serotype distribution among adults 50 years of age and older hospitalized with community-acquired pneumonia (n=2,065), one of the non-invasive forms of pneumococcal disease, between 2018 and 2022 in three hospitals in Tennessee and Georgia. Urine samples from patients were evaluated for antigens from 30 pneumococcal serotypes using novel serotype-specific urinary antigen detection (SSUAD) assays (all serotypes in PCV15, PCV20 and V116 are included except 15B). Among the 242 serotypes detected by SSUAD assays, approximately 84% were covered by V116, compared to approximately 64% covered by PCV20. One fourth (approximately 25%) of the detected serotypes were covered by V116 only and not by PCV15 or PCV20.

Additional Clinical Study Results Presented at ISPPD (Abstract #382 and #355)

Data from Phase 3 clinical studies STRIDE-4 (NCT05464420) and STRIDE-5 (NCT05526716) were also presented at ISPPD.

About V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. V116 is specifically designed to address Streptococcus pneumoniae serotypes predominantly responsible for adult pneumococcal disease, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B, which account for approximately 30% of adult disease, according to CDC data from 2018-2021. The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data. V116 is designed to be administered as a single dose to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.

The V116 Phase 3 program includes multiple studies, including STRIDE-3 (NCT05425732), STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037), STRIDE-8 (NCT05696080), STRIDE-9 (NCT05633992) and STRIDE-10 (NCT05569954).

About Pneumococcal Disease

Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae. There are more than 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Certain serotypes threaten to put more people at risk for invasive pneumococcal illnesses, such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord), as well as non-invasive pneumonia (when pneumococcal disease is confined to the lungs).

While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include older adults and those with certain chronic or immunocompromising health conditions, such as heart disease, lung disease and liver disease. Mortality from invasive pneumococcal disease is highest among adults 50 years of age and older.

Merck’s Commitment to Pneumococcal Disease Protection

Merck has been at the forefront of pneumococcal disease prevention through vaccination for more than four decades and remains committed to helping to protect people of all ages from this disease. Merck’s ongoing pneumococcal vaccine development program is designed to provide options that address the specific needs of different populations, including infants and children, healthy adults and at-risk sub-groups. This approach recognizes that disease burden in pediatric and adult populations is often driven by different bacterial strains, or serotypes, and aims to address unmet needs by offering vaccine options that target serotypes posing the greatest global risk to each population. To learn more about Merck’s pipeline, visit www.merck.com.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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