MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemipl ...

MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemipl ...

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") will announce its financial results for the second quarter 2024 on Monday, August 5, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. About BioNTech To access the live conference call via telephone, please register via ...

MAINZ, Germany, July 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") will announce its financial results for the second quarter 2024 on Monday, August 5, 2024. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. EDT (2:00 p.m. CEST) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Onc ...

Core Viewpoint - The European Medicines Agency (EMA) has recommended updating COVID-19 vaccines to target the new JN.1 variant, which is expected to enhance vaccine effectiveness as the virus continues to evolve [1][4][17]. Group 1: Vaccine Development and Approval - Pfizer and BioNTech's Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) has received a recommendation for marketing authorization from the EMA's Committee for Medicinal Products for Human Use (CHMP) for individuals aged 6 months and older [4][17]. - The recommendation is based on comprehensive clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the vaccine, which shows improved immune response against multiple JN.1 sublineages compared to previous versions [4][17]. - The updated vaccine is ready for immediate shipment to EU member states upon authorization by the European Commission, which is expected to make a decision soon [17]. Group 2: Vaccine Composition and Administration - The COMIRNATY vaccine is administered as a single dose for individuals aged 5 years and older, while infants and children aged 6 months to 4 years receive a three-dose series [5][6]. - The vaccine's formulation includes mRNA encoding for the spike protein of the JN.1 variant, which is designed to enhance the immune response against this specific lineage [4][17]. Group 3: Safety and Efficacy Data - The safety profile of the COMIRNATY vaccine has been evaluated, with common side effects including injection site pain, fatigue, and headache, which are generally mild to moderate and resolve within a few days [7][8]. - Observational data from vaccinated pregnant women during the second and third trimesters have not shown an increase in adverse pregnancy outcomes, indicating a favorable safety profile for the vaccine in this population [8]. Group 4: Market Readiness and Future Plans - Pfizer and BioNTech are proactively manufacturing the JN.1-adapted vaccine to ensure supply readiness ahead of the anticipated increase in demand during the fall and winter seasons [17][18]. - The companies are also initiating rolling applications with the U.S. FDA for approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines, indicating ongoing efforts to adapt to evolving COVID-19 variants [18].

Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors1,2 With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration ("FDA") to support development and expedite regulatory review Prostate cancer is the second ...

COPENHAGEN, Denmark, and MAINZ, Germany, June 1, 2024 — Genmab A/S (NASDAQ:GMAB, "Genmab"))) and BioNTech SE (NASDAQ:BNTX, "BioNTech"))) today announced initial data from the ongoing Phase 2 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PD-L(1)-positive metastatic non-small cell lung cancer ("mNSCLC") who had disease progression following one or more ...

Core Insights - MediLink Therapeutics has announced a strategic collaboration with BioNTech, granting BioNTech an exclusive option for a global license to MediLink's TMALIN® antibody-drug conjugate (ADC) platform for several novel targets [1][2] Group 1: Collaboration Details - MediLink will receive an upfront payment of $25 million and could earn up to $1.8 billion in additional milestone payments, along with tiered royalties on future global annual net sales [2] - MediLink retains the right of first negotiation for future collaborations regarding these ADC product candidates in the Mainland China market and potentially in Hong Kong, Macau, or Taiwan [2] Group 2: Previous Collaborations - The new agreement expands upon a previous collaboration established in October 2023, where MediLink and BioNTech entered into a global license agreement to develop BNT326/YL202, a next-generation anti-HER3 ADC [3] Group 3: Company Overview - MediLink Therapeutics, founded in 2020, focuses on developing conjugated drugs with global competitiveness and has developed the proprietary TMALIN® ADC technology platform [4] - The TMALIN® platform enables the creation of homogeneous ADCs with a high drug-antibody ratio and improved therapeutic window for solid tumors, addressing unmet medical needs [4][5]

A bird flu outbreak could spur demand for vaccines from these key players, but is it likely? Shares of vaccine stocks Moderna (MRNA 0.42%), Novavax (NVAX -3.50%), and BioNTech SE (BNTX -3.23%) rallied this week, appreciating 23.4%, 16.4%, and 9.3%, respectively, through Thursday trading, according to data from S&P Global Market Intelligence. Unlike the COVID-19 pandemic, when the U.S. government subsidized private companies to make the COVID- 19 vaccine, the government actually has a stockpile of H5N1 virus ...

Highlights of BioNTech's updates to be presented at the ASCO Annual Meeting 2024: BioNTech has established a diversified clinical oncology pipeline based on its modular multi-platform approach. The Company is advancing more than 20 clinical programs in unmet medical need solid tumor indications, including mRNA-based immunotherapies, targeted therapies entailing cell therapies and antibody- drug conjugates (ADCs), and novel immunomodulators. These candidates are currently being evaluated in more than 30 clin ...