BioNTech SE - BNTX STOCK NEWS

Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for their Omicron JN.1-adapted monovalent COVID-19 vaccine, COMIRNATY JN.1. This vaccine, targeting the Omicron JN.1 lineage of SARS-CoV-2, is recommended for individuals aged 6 months and older. The decision follows pre-clinical and epidemiological data indicating an improved immune response against multiple JN.1 sublineages.

Upon authorization by the European Commission, doses will be ready to ship to EU member states. The CHMP’s recommendation is supported by extensive clinical and real-world evidence demonstrating the vaccine's safety and efficacy. This follows recent FDA guidance to adapt vaccines to target the Omicron KP.2 subvariant, with the companies starting rolling applications for approval in the U.S.

BioNTech and DualityBio's BNT324/DB-1311, an antibody-drug conjugate (ADC) targeting B7-H3, has received FDA Fast Track designation for treating advanced/metastatic castration-resistant prostate cancer (CRPC). This designation, based on preclinical and Phase 1/2 clinical data demonstrating antitumor activity and a manageable safety profile, facilitates more frequent FDA interactions and expedited regulatory review. CRPC patients, who often face poor prognosis with a 5-year survival rate of 36%, may benefit from this development. All three ADC candidates under BioNTech-DualityBio collaboration have now received FDA Fast Track designation, indicating the promise of their ADC technology.

In a Phase 2 trial, Genmab and BioNTech's investigational antibody, acasunlimab, combined with pembrolizumab showed promising results for patients with PD-L1-positive metastatic non-small cell lung cancer (mNSCLC). The trial reported a 12-month overall survival (OS) rate of 69% and a median OS of 17.5 months. A 30% overall response rate was observed in patients receiving the combination every six weeks. The study's findings will inform a planned Phase 3 trial expected to start by the end of 2024. Adverse events were mostly mild and manageable, with a lower incidence of severe events in the six-week treatment group.

BioNTech and CEPI are expanding their partnership to bolster Africa's mRNA vaccine capabilities. CEPI will provide up to $145 million to support BioNTech in Kigali, Rwanda, enhancing the facility's R&D and manufacturing capacities. This initiative aims to prepare Africa for future epidemic threats and ensure equitable vaccine access, with a focus on affordable pricing for low and middle-income countries. BioNTech plans to produce mRNA vaccines for diseases like malaria, mpox, and tuberculosis, dedicating up to 50% of its production capacity for emergency response during outbreaks. The collaboration will also support local research and development efforts to strengthen the broader African vaccine ecosystem.

MediLink Therapeutics has announced a strategic collaboration with BioNTech, granting BioNTech exclusive global rights to MediLink's TMALIN® ADC technology for several targets. BioNTech will pay $25 million upfront, with potential milestone payments up to $1.8 billion and tiered royalties on future sales. MediLink retains negotiation rights for exclusive licensing in Mainland China and adjacent regions. This expands their partnership, initially formed in October 2023, to develop the anti-HER3 ADC BNT326/YL202, reaffirming their collaborative efforts in the ADC arena.

BioNTech (Nasdaq: BNTX) will present updates on its diversified immuno-oncology pipeline at the ASCO Annual Meeting 2024 from May 31 to June 4 in Chicago. The company will showcase data from several Phase 1b/2a trials, including BNT327/PM8002, a bispecific antibody for solid tumors, and BNT311/GEN1046 for metastatic NSCLC. Preliminary data from an epidemiological study correlating ctDNA with disease-free survival in colorectal cancer will also be presented, along with real-world data on testicular germ cell tumors to inform the design of pivotal trials for BNT211 CAR-T cell therapy. BioNTech aims to advance several key programs into late-stage development, targeting ten potentially registrational trials by the end of 2024 and launching its first cancer immunotherapy by 2026.

BioNTech SE held its Annual General Meeting (AGM) on May 17, 2024, with 87.51% of share capital represented. All 14 agenda items were approved by a large majority. The company highlighted its advancements, including a strong position in the COVID-19 vaccine market, encouraging data in its oncology pipeline, and the launch of potentially registrational trials. The focus is on transforming into a multi-product company with a robust financial standing to support upcoming product launches in oncology.

BioNTech reported first quarter 2024 financial results with revenues of €187.6 million, net loss of €315.1 million, and loss per share of €1.31. The company maintained a strong financial position with €16.9 billion in cash and investments. Key highlights include advancements in clinical trials for cancer vaccines, COVID-19 variant vaccines, and ADC programs. Despite a decrease in revenues due to lower COVID-19 vaccine sales, BioNTech remains focused on commercializing its innovative R&D pipeline to become a leader in oncology and infectious diseases.