BIONTECH - BNTX STOCK NEWS

Pfizer and BioNTech announced results from a Phase 3 randomized trial for their COVID-19 vaccine booster, demonstrating a relative vaccine efficacy of 95.6% against disease during a period dominated by the Delta variant. The trial involved over 10,000 participants aged 16 and older, showing a favorable safety profile. The companies plan to submit these findings to the FDA, EMA, and other regulators to support licensure in the U.S. and abroad, highlighting the importance of booster shots in combating COVID-19.

Pfizer and BioNTech have announced the first results from a Phase 3 trial for a COVID-19 vaccine booster, revealing a relative efficacy of 95.6% against disease during Delta's prevalence. The trial included over 10,000 participants aged 16 and older, showing the booster restored vaccine protection to levels seen after the initial two doses and had a favorable safety profile. The companies plan to submit these results to regulatory agencies for licensure in the U.S. and globally.

BioNTech (Nasdaq: BNTX) and Pfizer announced on October 4, 2021, that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the COVID-19 vaccine's booster dose for individuals 18 and older. The decision awaits the European Commission's final approval, expected soon. Clinical trial data demonstrated that the booster dose significantly increased neutralizing antibodies against various SARS-CoV-2 variants. The companies assure existing supply agreements for the vaccine, including boosters, remain unaffected.

BioNTech (BNTX) announced its participation in the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) from November 10-14, 2021, showcasing its diverse oncology pipeline. The company will present six posters and one presentation, including first-in-human data across multiple programs. CMO Dr. Özlem Türeci emphasized the progress in their oncology portfolio, highlighting efforts to advance cancer immunotherapy. Key presentations will include data on multiple innovative therapies and their clinical activities in various cancers.

Genmab A/S (NASDAQ: GMAB) announced multiple presentations at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021), held November 10-14 in Washington, DC. The highlights include a mini-oral presentation of the first-in-human trial for DuoBody®-CD40×4-1BB (GEN1042) and a poster on DuoBody®-PD-L1×4-1BB (GEN1046). Both investigational bispecific antibodies are co-developed with BioNTech (NASDAQ: BNTX). Genmab emphasizes its commitment to advancing cancer treatment through these innovative therapies.

BioNTech has initiated a randomized Phase 2 trial of its individualized mRNA cancer vaccine BNT122 for high-risk colorectal cancer patients, targeting around 200 individuals with circulating tumor DNA post-treatment. Conducted in the US, Germany, Spain, and Belgium, the trial aims to assess autogene cevumeran against standard watchful waiting. Primary endpoint is disease-free survival, with secondary goals including overall survival. This effort builds on prior positive Phase 1 results, indicating potential for significant clinical impact in colorectal cancer treatment.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have submitted data to the U.S. FDA for their COVID-19 vaccine aimed at children aged 5 to <12 years. The Phase 2/3 trial included 2,268 participants and showed a favorable safety profile with robust neutralizing antibody responses from a 10 μg two-dose regimen. A formal request for Emergency Use Authorization (EUA) is expected in the coming weeks, with plans for submissions to other regulatory authorities, including the European Medicines Agency (EMA).

Topline results for younger cohorts (ages 2-5 and 6 months-2 years) are anticipated in Q4 2021.

The FDA has granted Emergency Use Authorization (EUA) for a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 and older, as well as those aged 18-64 at high risk. The booster, to be administered at least six months after the primary series, is backed by clinical data demonstrating strong immune response against COVID-19 variants. The reactogenicity profile post-booster is mild to moderate, similar to the primary series. The vaccine continues to be supplied under existing agreements, with a commitment to provide two billion doses to lower-income countries by 2022.

BioNTech has expanded its agreement with the U.S. government to supply an additional 500 million doses of its COVID-19 vaccine, bringing the total to one billion doses for donation to low- and middle-income countries. This effort aligns with the companies' commitment to provide two billion doses globally by the end of 2022. Deliveries are anticipated to complete by September 2022, with production occurring at U.S. facilities. This strategic collaboration aims to ensure equitable vaccine access worldwide amidst the ongoing pandemic.