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The Janssen Pharmaceutical Companies of Johnson & Johnson today announced it will present data from six company-sponsored studies in support of their respiratory syncytial virus adult vaccine candidate at the Eighth European Scientific Working Group on Influenza meeting . The cornerstone of Janssen's presence at ESWI will be a series of presentations detailing findings from the Phase 2b CYPRESS trial in adults at ...

The Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) today announced it will present data from six company-sponsored studies in support of their respiratory syncytial virus (RSV) adult vaccine candidate at the Eighth European Scientific Working Group on Influenza (ESWI) meeting . The cornerstone of Janssen's presence at ESWI will be a series of presentations detailing findings from the Phase 2b CYPRESS trial in adults at increased risk for RSV.

"There is no vaccine or broadly indicated antiviral treatment available for RSV in older adults, and the threat of RSV remains critical," said Penny Heaton , M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. "We are proud to be leading the charge in developing a potential vaccine to help address unmet need, and look forward to presenting new data from our Phase 2b CYPRESS study. Topline results showed our RSV vaccine candidate met its primary and secondary safety and efficacy endpoints, which is a significant step forward as we continue to research a preventive option to protect against lower respiratory tract disease associated with RSV."

In addition to detailed findings from the CYPRESS study, a late-breaker abstract detailing the humoral immune response elicited by Janssen's RSV adult vaccine will be presented. Immunogenicity data from a Phase 1/2a trial of this vaccine will also be shared.

Data will be showcased at ESWI during the following timeframes:

Date/Time
(All times CEST)

Title

December 7, 2021

12:00 – 13:45

An Ad26.RSV.preF-based Vaccine is Effective for Prevention of RSV-mediated Lower Respiratory Tract Disease and Reduces Symptom Severity in Vaccine Recipients With RSV Infection: A Phase 2b Study in Older Adults

December 7, 2021

12:00 – 13:45

Immunogenicity Evaluation and Regimen Selection of Prophylactic Ad26.RSV.preF Vaccine Combinations: A Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Phase 1/2a Study in Adults ≥60 Years of Age

December 7, 2021

12:00 – 13:45

Safety and Tolerability of an Ad26.RSV.preF-based Vaccine in a Randomized, Double-blind, Placebo-controlled, Phase 2b Study in Adults Aged ≥65 Years

December 7, 2021

16:00 – 17:45

Late Breaker

Ad26.RSV.preF-based Vaccine Regimen Induced Antibody Fc-Effector Functions and Neutralization are Associated With Protection From Respiratory Syncytial Virus Infection

TIME TBD

Correlation Between Patient-reported and Clinician-assessed RSV Symptoms and Case Definition to Capture Moderate-to-Severe RSV Disease in Adults Aged ≥65 Years: A Randomized, Placebo-controlled, Phase 2b Study

TIME TBD

Measurement of Symptoms in Respiratory Syncytial Virus–Infected Adults: Meaningful Within-Patient Change Thresholds for the Respiratory Infection Intensity and Impact Questionnaire (RiiQ)

Janssen's RSV vaccine candidate is currently in Phase 3 trials. The Company announced the initiation of the EVERGREEN study in October to evaluate its vaccine candidate versus placebo in approximately 23,000 adults aged 60 years and older throughout North America and a selection of countries across Europe , Asia and the Southern Hemisphere.

In September 2019 , the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Janssen's RSV adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years or older. This was based on clinical data indicating the potential for substantial improvement compared to available standard of care on a clinically significant endpoint(s).

In November 2020 , the European Medicines Agency's Committee for Medicinal Products for Human Use designated Janssen's RSV adult vaccine candidate as eligible for the priority medicines (PRIME) scheme based on promising clinical data and an unmet need for a prophylactic option to prevent RSV in older adults.

About Respiratory Syncytial Virus (RSV)
Respiratory syncytial virus (RSV) is a prevalent, highly contagious respiratory virus and a leading cause of bronchitis, bronchiolitis and pneumonia, affecting more than 64 million people worldwide in a typical year. Because the symptoms of RSV can be difficult to distinguish from influenza or other respiratory infections, such as COVID-19, many who are infected with RSV remain undiagnosed.

Older adults, young children and those with underlying health conditions are most at risk. RSV disproportionately impacts adults over 60 years and high-risk adults over 18 years who are more likely to develop a LRTD. Between 3-7 percent of older adults (age 60 and older) and 4-10 percent of high-risk adults (age 18 and older) experience RSV in a typical year.

With no preventive vaccine or effective antiviral treatment available, RSV remains a major global public health concern and is a substantial health and economic burden globally.

About CYPRESS (NCT03982199)
CYPRESS (NCT03982199) is a randomized, double-blind, placebo-controlled Phase 2b trial. The trial enrolled 5,782 participants (2,891 in each study arm) aged 65 years and older. The participants were randomized 1:1 prior to the RSV season to receive Janssen's RSV adult vaccine candidate or placebo. Immunogenicity and safety assessments were performed in a subset of approximately 200 and 695 participants, respectively. Disease symptoms were collected through a questionnaire and/or by a clinician's assessment. For further information, please see: https://clinicaltrials.gov/ct2/show/NCT03982199 .

About EVERGREEN (NCT04908683)
The EVERGREEN study (NCT04908683) is a randomized, double-blind, placebo-controlled Phase 3 efficacy study, which aims to confirm the efficacy of the vaccine candidate in the prevention of reverse transcription polymerase chain reaction (RT-PCR) confirmed lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) when compared to placebo in adults aged 60 years and older. The clinical trial is being conducted in countries in North America , Europe , Africa , Latin America and Asia Pacific . Trial participants will be randomized to receive either one dose of active vaccine candidate or placebo. Prior to the following RSV season, participants who received the active vaccine will be re-randomized to receive either the active vaccine again, or placebo. Participants will be followed for at least two RSV seasons. For further information, please see: https://clinicaltrials.gov/ct2/show/NCT04908683 .

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com . Follow us at @JanssenGlobal.

Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for RSV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021 , including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Media Contact:
Ashley Georgian
+31 6 1185 8094
AGeorgi3@its.jnj.com

Investor Relations:
Jennifer McIntyre
+1 732-524-3922

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SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson

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