Merck Presents Positive Results from Phase 1/2 Study Evaluating V116, the Company’s Investigational Pneumococcal Conjugate Vaccine for Adults

Rhea-AI Summary

Merck (NYSE: MRK) announced positive results from the Phase 1/2 study of V116, a 21-valent pneumococcal conjugate vaccine. The study demonstrated V116's safety and immunogenicity in adults aged 18-49 and 50 and older, meeting primary immunogenicity objectives. In Phase 2, V116 showed non-inferior responses to PNEUMOVAX 23 for shared serotypes and superior responses for unique serotypes. V116 targets serotypes responsible for 85% of invasive pneumococcal disease in adults 65 and older. It received Breakthrough Therapy Designation from the FDA for preventing invasive pneumococcal disease.

Positive

• V116 met primary immunogenicity objectives in both Phase 1 and Phase 2 studies.
• Demonstrated superior immune responses for unique serotypes compared to PNEUMOVAX 23.
• Received Breakthrough Therapy Designation from the FDA.
• Targets serotypes responsible for 85% of invasive pneumococcal disease in adults aged 65 and over.

Negative

• None.

V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019 ¹

Broad Phase 3 clinical program for V116 in vaccine-naïve and vaccine-experienced adults planned to start in July 2022

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of positive results from the Phase 1/2 study, V116-001, evaluating the safety, tolerability and immunogenicity of V116, the company’s investigational 21-valent pneumococcal conjugate vaccine (PCV), in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2). In both populations, V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX^®23 (Pneumococcal Vaccine Polyvalent) across age groups. In the Phase 2 part of the study, V116 demonstrated non-inferior immune responses to PNEUMOVAX 23 for all shared serotypes, and superior immune responses for the serotypes included in V116 but not included in PNEUMOVAX 23, based on study-defined criteria. Responses were measured 30 days post-vaccination by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs), a measure of functional antibody activity.

Data from V116-001, in addition to other data from the company’s pneumococcal vaccines portfolio, are being featured at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12) taking place in Toronto from June 19-23, 2022. The full study results from V116-001 will be published in a scientific journal in the future.

Earlier this year, V116 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older. This includes eight serotypes not included in any currently licensed pneumococcal vaccine.

"Our encouraging data at ISPPD reflect the potential of V116 and Merck’s tailored approach to developing pneumococcal vaccines to meet the specific needs of different populations,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “Consistent with our portfolio strategy, V116 is designed to specifically target serotypes that are responsible for 85 percent of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019¹. Importantly, the eight serotypes in V116 that are not included in any currently-licensed pneumococcal vaccine account for over 30 percent of this disease burden alone.¹”

Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae, or pneumococcus. Invasive forms of pneumococcal disease (IPD) can cause serious and potentially life-threatening infections such as bacteremia (infection in the bloodstream) and meningitis (infection of the coverings of the brain and spinal cord). Pneumonia (infection in the lungs), with or without bacteremia, also can occur. While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include adults 65 years of age and older and those with certain chronic or immunocompromising health conditions.

About V116-001

V116-001 is a two-part, randomized, comparator-controlled, double-blind Phase 1/2 study that assessed the safety, tolerability and immunogenicity of a single dose of V116 in healthy adults who have not previously received any pneumococcal vaccine.

In the Phase 1 part of the study, adults aged 18 to 49 years of age (n=90) were randomized 1:1:1 to receive either a single dose of V116-1 (2 µg dose/each Pneumococcal polysaccharide (PnPs)), V116-2 (4 µg dose/each PnPs), or PNEUMOVAX 23. Pneumococcal serotype-specific OPA was measured prior to, and 30 days postvaccination (Day 30). Immune responses at Day 30 in the V116-1 and V116-2 groups were generally comparable to PNEUMOVAX 23 for the serotypes common to both vaccines and higher than PNEUMOVAX 23 for the serotypes unique to V116. At Day 30, the OPA GMTs were higher in the V116-2 group compared to the V116-1 group for all serotypes except 9N. The Phase 1 safety and immunogenicity data supported the continued development of V116 for the prevention of pneumococcal disease in adults.

In Phase 2, adults aged 50 years or older (n=508) were randomized 1:1, stratified by age (50-64 years, 65-74 years, and 75 years or older), to receive either a single dose of V116 (4 µg dose/each PnPs) or PNEUMOVAX 23. Pneumococcal serotype-specific OPA and Immunoglobulin G (IgG) were measured prior to, and 30 days postvaccination (Day 30). V116 met noninferiority criteria compared to PNEUMOVAX 23 for all shared serotypes and met superiority criteria for the unique serotypes based on assessment of the lower bound of the GMT ratios, using study-defined thresholds.

Safety was evaluated based on the proportion of participants with adverse events following vaccination. In both parts of V116-001, V116 was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX 23.

Indication for PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent)

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F).

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Select Safety Information for PNEUMOVAX 23

PNEUMOVAX 23 is contraindicated in individuals with a history of a hypersensitivity reaction to any component of PNEUMOVAX 23.

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures or neurosurgical procedures.

The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 for the first time in a clinical trial, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

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 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 the global outbreak of novel coronavirus disease (COVID-19); 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, 2021 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for PNEUMOVAX 23 at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf and Patient Information for PNEUMOVAX 23 at http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf.

¹Centers for Disease Control and Prevention, IPD serotype data 2019, as compiled from data provided through Active Bacterial Core surveillance (ABCs).

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Source: Merck & Co., Inc.

FAQ

What were the results of the Phase 1/2 study for V116 by Merck?

The Phase 1/2 study reported that V116 met primary immunogenicity objectives and was well-tolerated in adults aged 18-49 and 50 and older.

How does V116 compare to PNEUMOVAX 23?

V116 showed non-inferior immune responses for shared serotypes and superior immune responses for unique serotypes compared to PNEUMOVAX 23.

What is the significance of V116's Breakthrough Therapy Designation?

The Breakthrough Therapy Designation from the FDA signifies the potential of V116 to address unmet medical needs in preventing invasive pneumococcal disease.

What age group is V116 targeting?

V116 is specifically designed to target adults aged 65 and over, who account for a significant portion of invasive pneumococcal disease cases.

When is the broader clinical program for V116 expected to start?

A broad Phase 3 clinical program for V116 is planned to start in July 2022.