BioNTech SE American Depositary Share - BNTX STOCK NEWS

The CEOs of nine major biopharmaceutical companies, including BioNTech SE (BNTX), have united to pledge prioritizing the safety and well-being of vaccinated individuals in the development of COVID-19 vaccines. This historic commitment emphasizes adherence to high ethical standards and sound scientific principles throughout vaccine trials. They assure that regulatory processes will involve large, randomized clinical trials with diverse participants. The companies aim to bolster public confidence in the vaccine approval process, showcasing their extensive experience in developing vaccines to address global health threats.

Pfizer and BioNTech have released Phase 1 data for the BNT162b2 vaccine targeting SARS-CoV-2, showing strong immunogenicity. After the second dose, younger adults had neutralizing geometric mean titers (GMTs) 3.8 times higher than convalescent sera, while older adults had GMTs 1.6 times higher. The vaccine was well tolerated, with mild to moderate fever in under 20% of participants. Over 11,000 participants are enrolled in ongoing trials, with regulatory review anticipated by October 2020. If approved, they plan to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.

BioNTech SE (Nasdaq: BNTX) announced key advancements in its clinical pipeline, reporting a successful initiation of the pivotal Phase 2b/3 trial for the BNT162 COVID-19 vaccine. Initial commercial supply agreements have been signed for over 250 million doses with several countries. The company ended Q2 2020 with cash and equivalents totaling €573 million, raising an additional €681 million from recent offerings. However, a net loss of €88.3 million was recorded for Q2, reflecting increased research and development expenditures. Financial guidance indicates expected cash usage between €450 million and €600 million for 2020.

BioNTech (BNTX) will announce its Q2 2020 financial results on August 11, 2020, followed by a conference call at 08:00 a.m. EDT. Investors can access a webcast of the event and see a slide presentation. The company focuses on immunotherapy, developing innovative treatments for cancer and infectious diseases using mRNA technology. BioNTech collaborates with several major pharmaceutical companies, including Pfizer and Sanofi, to advance its diverse pipeline of therapies and vaccines.

BioNTech (BNTX) and Fosun Pharma announce the initiation of a Phase 1 clinical trial for the COVID-19 vaccine candidate BNT162b1 in China, enrolling 144 participants aged 18-55 and over 55. The trial, approved by the NMPA, aims to evaluate safety and immunogenicity, with participants receiving two doses of either 10µg or 30µg of the vaccine or placebo. The study builds on prior trials in Germany and the U.S. and could support regulatory approval in China. If successful, Fosun Pharma will exclusively commercialize the vaccine in mainland China.

Pfizer and BioNTech have signed an agreement with Japan's Ministry of Health to supply 120 million doses of their BNT162 mRNA vaccine, pending regulatory approval, starting in 2021. The companies are advancing their clinical trials for BNT162, aiming for regulatory review by October 2020. They plan to manufacture up to 100 million doses by the end of 2020 and 1.3 billion doses by the end of 2021. Recent trials for the BNT162b1 and BNT162b2 candidates received Fast Track designation from the FDA, indicating promising data from initial studies.

BioNTech has announced a collaboration with Regeneron to conduct a Phase 2 clinical trial combining BNT111 FixVac and Libtayo for treating melanoma, specifically in patients with anti-PD-1 refractory melanoma. This partnership aims to explore the potential of these two immunotherapies to enhance treatment outcomes. The study will share development costs equally, with both companies retaining commercial rights to their respective therapies. The trial is expected to begin in Q4 2020, following further details to be disclosed in Q3 2020.

BioNTech (BNTX) announced preliminary Phase 1 results from the Lipo-MERIT trial for its cancer vaccine BNT111, showing a favorable tolerability profile in 89 advanced melanoma patients. Efficacy analysis indicated durable responses in a subset of 42 patients previously treated with checkpoint inhibitors, with BNT111 leading to significant T-cell activation. The company plans to commence a Phase 2 trial with potential registrational implications.

Pfizer and BioNTech have initiated a global Phase 2/3 clinical trial for their BNT162b2 vaccine candidate, targeting COVID-19 with a 30 µg dose in a two-dose regimen. The study will enroll up to 30,000 participants aged 18 to 85, with expected sites across 120 locations globally, including areas with high SARS-CoV-2 transmission. If successful, the companies aim to seek regulatory review in October 2020 and supply 100 million doses by year-end, with a total of 1.3 billion doses by the end of 2021.