Candidate BNT162b2, candidate for messenger RNA with nucleoside change (modRNA), which encodes the complex full-length glucoprotein of the optimized SARS-CoV-2, is advancing to a dose point of 30 mg in a 2-dose regimen in the phase 2/3 study
Variety of candidates and endpoint reported through preclinical and clinical knowledge of phase 1/2 studies in the United States (C4591001) and Germany (BNT162-01)
The Phase 2/3 protocol follows all U.S. Food and Drug Administration (FDA) rules on designing clinical trials for COVID-19 vaccine studies.
Phase 2/3 of 30,000 participants over the age of 18 to 85 has begun in the United States and is expected to arrive with approximately 120 sites worldwide.
Test regions come with spaces with significant expected transmission of SARS-CoV-2 to assess whether the experimental vaccine candidate, BNT162b2, is effective in preventing COVID-19
Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review from October 2020 and, if approved or approved, plan to supply up to one hundred million doses by the end of 2020 and approximately 1.3 billion doses through the end of 2021.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced the start of a global Phase 2/3 clinical study (excluding China) on the protection and effectiveness in comparing an unmarried nucleoside-switched messenger RNA (modRNA) of its BNT162 mRNA-based vaccination program opposed to SARS-CoV-2.
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After a thorough review of the preclinical and clinical knowledge of phase 1/2 clinical trials, and in consultation with the U.S. Food and Drug Administration’s Center for Biological Assessment and Research (CBER). And global regulators Pfizer and BioNTech have selected to advance their candidate BNT162b2 vaccine for phase 2/3 study, at a dose of 30 mg on a 2-dose regimen. BNT162b2, which recently earned the U.S. Food and Drug Administration’s (FDA) Fast Track designation, encodes the optimized glucoprotein (S) for complex full-length SARS-CoV-2, which is the target of virus neutralizing antibodies.
“Our variety of candidate vaccine BNT162b2 and its advancement in a Phase 2/3 exam are the culmination of an extensive and unprecedented progression program and collaborative studies involving Pfizer, BioNTech, clinical researchers and test participants for the unmarried purpose of finding a COVID-19 RNA vaccine. The Phase 2/3 examination protocol follows all U.S. Food and Drug Administration (FDA) rules on the design of clinical trials for COVID-19 vaccine studies,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Chief Vaccine Research and Development, Pfizer. “The launch of the Phase 2/3 trial is a major step in our progress towards providing a possible vaccine to combat the ongoing COVID-19 pandemic, and we look forward to generating more knowledge as the program progresses.”
“Today we begin our complex global study, which will include up to 30,000 participating components. We decided that BNT162b2 would be our lead candidate for this 2/3 phase test after a diligent assessment of all the knowledge generated to date. This resolution reflects our Number One goal is to bring to market a well-tolerated and highly effective vaccine as temporarily as possible, while we will continue to compare our other candidate vaccines as a component of a portfolio of differentiated COVID-19 vaccines,” said Ugur Sahin, MD, CEO and co-founder of BioNTech. “Many steps have been taken towards this vital milestone and we would like to thank everyone concerned for their usual commitment.”
About candidate BNT162b2
In the preclinical and clinical studies of 4 applicants for RNA vaccines, BNT162, BNT162b1 and BNT162b2 emerged as strong applicants based on protection and immune reaction assessments. Pfizer and BioNTech have opted for BNT162b2 as a candidate to continue a Phase 2/3 exam based on all the knowledge gained from our preclinical and clinical studies, adding safe parameters of tolerance and immune reaction.
In preclinical studies, applicants BNT162b1 and BNT162b2 induced favorable responses of cd4 and CD8 T-cells specific to viral antigen, maximum degrees of neutralizing antibodies in animal species, and favorable protective effects in a SARS-CoV-2 primate challenge model.
Preliminary Phase 1/2 clinical knowledge of approximately 120 patients demonstrated a favorable general tolerance profile for BNT162b2, compared to BNT162b1, with sometimes mild to moderate and brief systemic occasions (1-2 days), such as fever, fatigue and chills and no serious adverse occasions. Two 30 g doses of BNT162b2 caused medium neutralizing titles (GMT) sometimes similar to the GMT received through candidate vaccine BNT162b1, as evidenced by past knowledge published through corporations on a prepress server. In older adults (65-85 years), two doses of 30 mg, spaced 3 weeks apart, caused a GMT neutralizing antibody greater than GMT in a panel of 38 serums from subjects who contracted SARS-CoV-2. Human participants vaccinated with BNT162b2 had a favorable width of the epitopes identified in the responses of THE NPS-CoV-2 antigen-specific T-cell compared to candidate BNT162b1. BNT162b2 demonstrated simultaneous induction of high-magnitude CD4 and CD8 T mobile responses. BNT162b2 caused T-mobile responses opposed to the receptor binding domain (RBD) and the rest of the complex glucoprotein not contained in vaccine candidate BNT162b1. Companies with an immune popularity of higher T-mobile epitopes in the ear would possibly be able to generate more consistent responses in diverse populations and in the elderly.
Corporations continue to gather knowledge of phase 1/2 trials for the 4 candidate vaccines and plan to submit knowledge on BNT162b2 for peer review and forward-looking publication in the near future. In keeping with their commitment to transparency, corporations also intend to publish the manuscript to a prepress server at the time.
About the 2/3 Phase Study
Pfizer and BioNTech have completed the Phase 2/3 protocol in reaction to comments from global regulators, adding the FDA and the Paul-Ehrlich-German Institute. Phase 2/3 is an event-based essay that is expected to recruit up to 30,000 participants between the ages of 18 and 85. Companies plan to recruit a diverse population, adding participants in spaces where significant transmission of SARS-CoV -2 is expected.
The Phase 2/3 trial is designed as a placebo 1:1 vaccine candidate, randomized and blind candidate to discharge the knowledge of safety, immune reaction and efficacy needed for regulatory review. The main evaluation criterion for the trial will be coVID-19 proccasionion in others who were not inflamed with SARS-CoV-2 prior to vaccination and coVID-19 proccasionion, regardless of whether participants have already been inflamed with SARS or not. -CoV-2. The secondary criteria come with the proccasionion of COVID-19 severe in these groups. The study will also scan the cause of SARS-CoV-2 infection, the virus that causes COVID-19. The number one efficacy research will be a second-hand research based on the number of participants with COVID-19 symptomatic disease. The verification design enables intermediate analysis and involuntary reviews through an independent external knowledge monitoring committee.
At the end of the trial, the Phase 2/3 exam is expected to be active at approximately 120 clinical research sites worldwide, adding 39 states in the United States and countries that add Argentina, Brazil and Germany. Researchers’ sites are decided on the basis of points such as clinical experience and capabilities, disease epidemiology and previous experience in clinical trials. For more information about this trial, visit ClinicalTrials.gov NCT04368728.
Pfizer and BioNTech are committed to reducing fitness disparities in underrepresented populations through the clinical trial process. To this end, many research sites are located in communities that have been disproportionately affected through COVID-19, so those most affected have the opportunity to participate. Companies also collaborate with the sites of researchers and advocacy partners to raise awareness of the importance of participation in this trial.
BNT162b2 remains the subject of a clinical examination and has not been approved for international distribution lately. If the Phase 2/3 test is successful, Pfizer and BioNTech expect to be able to apply for an emergency use authorization or some form of regulatory approval as of October 2020. If approved or approved, corporations are recently intended to supply up to one hundred million doses worldwide by the end of 2020 and around 1.3 billion doses by the end of 2021.
About Pfizer: Making Life-Changing Advances
At Pfizer, we apply science and our global resources to provide other people with remedies that in particular magnify and improve their lives. We try to mark the popularity of quality, protection and price in the discovery, progression and manufacture of fitness products, adding cutting-edge medicines and vaccines. Every day, Pfizer’s colleagues work in evolved and emerging markets to promote well-being, prevention, remedies and cures that challenge the most feared diseases of our time. In line with our duty as one of the world’s leading biopharmaceutical companies, we collaborate with fitness service providers, governments and local communities to help and expand access to affordable and reliable fitness services around the world. For over 150 years, we have tried to make a difference to everyone who depends on us. We post data that would possibly be vital to investors on our online page at www.Pfizer.com. In addition, to learn more, visit us on www.Pfizer.com and stay with us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and likes on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The data contained in this press release date from July 27, 2020. Pfizer assumes no legal responsibility to update the forward-looking statements contained in this press release as a result of new data or long-term events or developments.
A more detailed description of the hazards and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the year ended December 31, 2019 and in its upcoming reports on Form 10-Q, adding the “Risk Factors” and “Prospective Information and Factors That May Affect Future Results” sections. , as well as in its upcoming reports on Form 8-KArray, all of which are filed with the U.S. Securities and Exchange Commission. And they can be obtained at www.sec.gov and www. pfizer.com.
About BioNTech
Biopharmaceutical New Technologies is a next-generation immunotherapy company, a pioneer in new treatments for cancer and other serious diseases. The Company operates a wide variety of computer discoveries and curative drug platforms for the immediate progression of new biopharmaceuticals. Its extensive portfolio of oncology candidate products includes commercially individualized mNA-based treatments, state-of-the-art chimeric antigen receptor T cells, two-point specific control point immunomodulators, targeted anticancer antibodies, and small molecules. Building on their deep experience in the progression of mNR vaccines and their internal production capabilities, BioNTech and its partners are presenting mRN vaccine applicants for a diversity of infectious diseases, throughout their diversified oncology portfolio. BioNTech has established a wide diversity of relationships with several global pharmaceutical companies, adding Genmab, Sanofi, Bayer Animal Health, Genentech, member of the Roche Group, Genevant, Fosun Pharma and Pfizer. For more information, visit www.BioNTech.de.
BioNTech’s forward-looking statements
This press release includes BioNTech’s “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but are not limited to, statements relating to: BioNTech’s efforts to combat COVID -19; The timing of the publication of the NTB162 clinical trials and the expected publication of the knowledge of these clinical trials; The prospective number of sites and participants in our phase 2/3 trial; The timing of possible emergency use authorizations or the collaboration of approvals between BioNTech and Pfizer to expand the possible COVID-19 vaccine our expectations regarding the prospective characteristics of BNT162b2 in our Phase 2/3 trial and/or advertising use based on knowledge observations to date, adding the expected benefits over BNT162b1; and BioNTech’s ability to supply quantities of BNT162 to clinical progression and, if approved, market demand, adding our production estimates for 2020 and 2021. All forward-looking statements in this press release are based on BioNTech’s existing expectations and beliefs. long-term events, and are subject to a number of dangers and uncertainties that may also cause the actual effects to differ materially and unfavorably from those expressed or implied in such forward-looking statements. These dangers and uncertainties include, but are not limited to: festival to create a COVID-19 vaccine; The ability to produce comparable clinical outcomes in larger and more varied clinical trials; The ability to expand our production capacity well; and other potential difficulties. For an investigation of these and other hazards and uncertainties, please refer to bioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, available on the SEC’s online website at www.sec.gov. All data contained in this press release is as of the date of the press release, and BioNTech assumes no legal responsibility to update this data unless required by law.
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Contacts
Pfizer Contacts:
Media Relations Amy Rose – 1 (212) [email protected]
Investor Relations Chuck Triano – 1 (212) [email protected]
BioNTech Contacts:
Media Relations Jasmina Alatovic – (0) 6131 9084 1513 or ‘(0) 151 1978 [email protected]
Investor Relations Sylke Maas, Ph.D. – (0) 6131 9084 [email protected]