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Pfizer Inc. (NYSE: PFE) announced today the presentation of data from a Phase 2 study on its candidate, PF-06482077, candidate conjugate vaccine against 20-valent pneumococcus (20vPnC). ), for the prevention of invasive diseases and pneumonia caused by Streptococcus pneumoniae serotypes contained in the vaccine in adults aged 18 years and older. The presentation was made at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam, the Netherlands. The Pfizers 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F).
The safety and immunogenicity results of this study suggest that our 20vPnC candidate, who initiated Phase 3 development in adults last year, could potentially offer full coverage of Additional serotypes causing pneumococcal infection globally and in the United States, as evidenced by the receipt by the FDA of an innovative treatment. said Kathrin U. Jansen, Ph.D., senior vice president and head of vaccine research and development, Pfizer. We believe that all the protection offered by Prevenar 13 to adults has not yet been fulfilled. At the same time, the world of health still needs protection against the potential effects of invasive pneumococcal disease and pneumonia caused by other serotypes not yet covered by existing conjugate vaccines.
The Phase 2 study was a double-blind, randomized, active-controlled study of 444 adult subjects aged 60 to 64 years. Subjects received a single injection of 20vPnC or Prevnar 13 (vaccination 1). One month later, patients receiving 20vPnC received a placebo injection in saline, and subjects receiving Prevnar 13 received the 23-valent polysaccharide vaccine (Vaccination 2). Local reactions and systemic events were recorded for 10 and 7 days respectively after vaccination 1 and adverse event (AE) data were collected for one month after each vaccination. Immunogenicity was badessed by measuring the antibody badociated with serotype specific bacterial killing (opsonophagocytic activity). [OPA]) before vaccination and one month after each vaccination. The study was designed to describe the safety and immunogenicity data with 20vPnC in a population of older adults. Given the stage of the study, there was no hypothesis test and the data were summarized.
Of the 444 subjects enrolled, 443 received vaccine 1 and 427 vaccine 2. Robust responses to OPA were observed for the 20 serotypes of the 20vPnC group vaccine. The average geometric folds of the OPA compared to the initial values range from 6.1 to 68.6 for the serotypes common to Prevnar 13 and from 9 to 112.2 for the seven additional serotypes not included in Prevnar 13.
Injection site reactions (redness, swelling or pain) and systemic event rates were similar after vaccination with 20vPnC or Prevnar 13, with severe reactions at the injection site or events reported in less than 1% of 20vPnC recipients. No deaths or serious adverse events considered related to the vaccine were reported in the study. The overall safety profile of 20vPnC in this study was consistent with the historical experience with Prevnar 13.
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The conclusions on the safety and immunogenicity of this phase 2 study confirm the progression of phase 3 clinical development for indication in adults that began in December 2018.
The seven new serotypes included in 20vPnC are global causes of invasive pneumococcal disease,1,2,3,4,5 and are badociated with high case fatality rates,6,7,8,9 antibiotic resistance5,10,11 and / or meningitis.12,13 Together, the 20 serotypes included in 20vPnC are responsible for the majority of circulating pneumococcal disease in adults in the United States and around the world.14,15,16,17,18,19,20
About the 20vPnC Phase 3 Program
Pfizer began participating in three phase 3 trials (NCT03828617, NCT03835975 and NCT03760146) evaluating 20vPnC in adults. Together, these three trials will include more than 6,000 adult subjects, including vaccine-naive adult populations and adults already vaccinated against pneumococcus.
Pfizers' pivotal Phase 3 development program for 20vPnC includes three clinical trials on vaccine-naive adult populations and adults already vaccinated against pneumococcus.
The pivotal phase 3 trial involves approximately 3880 adults and aims to compare immune responses following 20vPnC with 60-year-old control subjects receiving the 13-valent pneumococcal conjugate vaccine and the polysaccharide vaccine against 23-valent pneumococcus; to evaluate the immunogenicity of 20vPnC in adults aged 18-59; and describe the 20vPnC safety profile in adults ¥ 18 years old. You can find more information about the study at www.clinicaltrials.gov under the ID NCT03760146.
Another phase 3 trial was launched on February 12, 2019 and is expected to recruit approximately 875 adults. It is designed to describe the safety and immunogenicity of 20vPnC in adults 65 years of age and older already vaccinated against pneumococcus. You will find more information about this study on www.clinicaltrials.gov under ID NCT03835975.
A third phase 3 trial was launched on February 14, 2019 and is expected to recruit approximately 1,610 adults. The study is designed to provide additional safety data and to evaluate three different batches of 20vPnC in adults 18 to 49 years old. You will find more information about this study on www.clinicaltrials.gov under identifier NCT03828617.
About 20vPnC
On September 20, 2018, Pfizer announced that the Food and Drug Administration (FDA) is providing a revolutionary 20vPnC therapy designation for the prevention of invasive disease and pneumonia in adults 18 years of age and older. The Innovative Therapy designation is designed to accelerate the development and review of drugs and vaccines to treat or prevent serious conditions. Preliminary clinical evidence indicates that the drug or vaccine may demonstrate a substantial improvement over available treatment on one or more clinically significant parameters.21 Drugs and vaccines that receive the disruptive therapy designation are eligible for all the features of the FDA Fast Track designation, which may include more frequent communication with the FDA regarding the drug development plan and the drug. eligibility for accelerated approval and priority review, if the relevant criteria are met.22
The FDA previously granted the Fast Track designation of 20vPnC in September 2017 to adults 18 years of age and older.23 The FDA's Fast Track approach is a process designed to facilitate the development and rapid review of new drugs and vaccines to treat or prevent serious conditions and to address an unmet medical need.22
In addition, in May 2017, the FDA granted expedited status for a pediatric indication of 20vPnC and clinical development is underway.
Pfizer Inc: Working Together for a Healthier World "¢
At Pfizer, we apply science and our global resources to provide treatments for people who are expanding and improving dramatically. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes drugs and vaccines, as well as many of the world's most trusted consumer health products. Every day, Pfizer's colleagues work in developed and emerging markets to advance the well-being, prevention, treatment and cure of the most feared diseases of our time. In keeping with our responsibility as one of the world's leading innovative biopharmaceutical companies, we collaborate with healthcare providers, governments and local communities to support and expand access to reliable health care. and affordable around the world. For more than 150 years, we have been working to make a difference for everyone who counts on us. We regularly post information that may be important to investors on our website www.pfizer.com. In addition, to learn more, visit www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer
NOTICE OF DISCLOSURE: The information contained in this press release is dated April 13, 2019. Pfizer does not badume any obligation to update the forward-looking statements contained in this news release as a result of new information or any other information. events or future developments.
This release contains forward-looking information on the Pfott 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) vaccine candidate, PF-06482077, including the potential regulatory submission, timing and potential benefits, which involve uncertainties and risks significant differences that could result in a significant difference between the actual and the actual results. or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical parameters, the start and / or completion dates of our clinical trials, the submission dates regulatory, regulatory and / or introductory approval dates, as well as the potential for new adverse clinical data and additional badyzes of existing clinical data; the risk that clinical trial data will be subject to different interpretations and badessments by regulators; whether regulators will be satisfied with the design and results of our clinical studies; if and when license applications for organic products may be filed in any jurisdiction for 20vPnC for any indication; if and when such applications can be approved by the regulatory authorities, this will depend on a multitude of factors, including determining whether the product's benefits exceed its known risks, determining the product's effectiveness and, in particular, case of approval, if the 20vPnC will be commercially successful; regulatory authority decisions that impact labeling, manufacturing processes, security and / or other issues that may affect the availability or commercial potential of 20vPnC; uncertainties regarding the possibility of obtaining recommendations from vaccine technical committees and other public health authorities regarding the 20vPnC and uncertainties regarding the commercial impact of these recommendations; and competitive developments.
A more detailed description of the risks and uncertainties can be found in the Annual Report on Pfizers Form 10-K for the year ended December 31, 2018 and subsequent reports on Form 10-Q, including in sections following: Risk Factors and Transfer Later. Seek information and factors that may affect future results, as well as in its subsequent reports on Form 8-K, all of which are filed with the US Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
References:
1Baisells E, Guillot L, Nair H, et al. Distribution of serotypes of Streptococcus pneumoniae causing invasive infection in children after PCV: systematic review and meta-badysis. PlosOne. 2017 12 (5): e0177113. 2Hausdorff W & Hanage W. Intermediate Outcomes of an Environmental Experiment Pneumococcal Conjugate Vaccination and Serotype Replacement. Hum Vaccine Immunother. 2016 12 (2): 358-374. 3Cohen R, Cohen J, Chalumeau M, et al. Impact of Pneumococcal Conjugate Vaccines on Children in High and Non-High Income Countries. Vaccines Expert Rev. 2017 16 (6): 625-640. 4Moore M, R Link-Gelles, Schaffner W, et al. Effect of the use of 13-valent pneumococcal conjugate vaccine in children on invasive pneumococcal infection in children and adults in the United States: badysis of multisite surveillance in population. Lancet Infect Dis. 2015; 15 (3): 301-309. 5Metcalf B, Gertz RE, Gladstone RA, et al. Strain characteristics and distribution in pneumococci of children with invasive disease before and after implementation of the 13-valent conjugate vaccine in the United States. Clin Microbiol Infect. 2016 22 (1): 60. e9-60. e29. 6Oligbu G, Collins S, Sheppard CL, et al. Infant deaths from invasive pneumococcal disease in England and Wales, 2006 "2014. Clin Infect Dis. 2017 65 (2): 308-314. 7Van Hoek, Andrews N, Waight PA, et al. Effect of serotype on the focus and mortality of invasive pneumococcal disease: coverage of different vaccines and overview of serotypes other than vaccines. PlosOne. 2012; 7 (7): 39150 e. 8Stanek R, Norton N, Mufson M. A 32-year study of the impact of pneumococcal vaccines on invasive Streptococcus pneumoniae disease. I am J Med Sci. 2016 352 (6): 563-573. 9Harboe ZB, RW Thomsen, Riis A, et al. Pneumococcal serotypes and mortality following invasive pneumococcal disease: a population-based cohort study. PlosOne. 2009; 6 (5): 1000081 e. tenTomczyk S, Lynfield R, Schaffner W, et al. Prevention of invasive pneumococcal disease not suspected of antibiotics with pneumococcal 13-val conjugate vaccine. Clin Infect Dis. 2016 62 (9): 1119-1125. 11Mendes RE, Hollingsworth RC, Costello A, et al. Non-invasive serotypes of Streptococcus pneumoniae found in adult patients hospitalized in the United States from 2009 to 2012. Antimicrobial Agents Chemother. 2015; 59 (9): 5595-5601. 12Olarte L, Barson WJ, Lin PL et al. Impact of 13-valent pneumococcal conjugate vaccine on pneumococcal meningitis in American children. Clin Infect Dis. 2015; 61 (5): 767-775. 13Thigpen TM, CG Whitney, NE Messonnier, et al. Bacterial Meningitis in the United States, 1998 "2007. NEJM. 2011; 364 (21): 2016-2025. 14Centers for Disaster Control and Prevention. Active bacterial nucleus (ABC) monitoring. National Center for Immunization and Respiratory Diseases. Atlanta, GA. 15Ladhani, SN, Collins S, Djennad A, et al. Rapid increase in the number of non-vaccinal serotypes causing invasive pneumococcal infection in England and Wales, 2000 '17: National prospective cohort study of observation. Lancet Infect Dis. 2018; 18 (4): 441-451. 16 Mention R, Espa ± PP, Prez-Trallero E, et al. Burden of PCV13 serotypes in pneumococcal pneumonia hospitalized in Spain according to a new test for the detection of urinary antigen. CAPA study. Vaccine. 2017 35 (39): 5264-5270. 17Azzari C, Cortimiglia M, Nieddu F, et al. Distribution of pneumococcal serotypes in adults with invasive disease and in carrier children in Italy: should we expect protection of the adult flock by vaccination of infants? Hum Vaccine Immunother. 2016 12 (2): 344-350. 18Pivlishi T. Impact of PCV13 on the burden of invasive pneumococcal disease and the distribution of serotypes in US disease control and prevention centers. Advisory Committee on Immunization Practices. October 24th, 2018. 19European Center for Disease Prevention and Control. Invasive pneumococcal disease. In: ECDC. Annual epidemiological report for 2016. Stockholm: ECDC; 2018. 20Beall B, Chochua S, Gertz RE Jr et al. Descriptive atlas based on the population of invasive pneumococcal strains recovered in the United States in 2016-2016. Microbiol before. 2018; 19 (9). 21US Food and Drug Administration. Revolutionary Therapy https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm 22 US Food and Drug Administration. Fast Track https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm 23 Archived data. Pfizer Inc., New York, NY
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