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]

Core Viewpoint - The recent detection of avian bird flu in the U.S. and Australia has led to increased demand for vaccines from key players like Moderna, Novavax, and BioNTech, resulting in significant stock price rallies for these companies [1][2]. Group 1: Vaccine Companies' Responses - Moderna's stock rose by 23.4%, while Novavax and BioNTech saw increases of 16.4% and 9.3%, respectively, as fears of a bird flu outbreak grew [1]. - Moderna is already in a Phase II study for an avian flu vaccine related to the H5N1 strain, indicating proactive measures in vaccine development [6]. - Novavax is conducting a pre-clinical study for an avian flu shot and has recently partnered with Sanofi, which may enhance their vaccine development capabilities [7][8]. Group 2: Government Involvement and Supply - The U.S. government has a stockpile of H5N1 virus candidates for vaccine production, but it can only supply 135 million doses, which would cover approximately 68 million people [5]. - The government is exploring ways to supplement its vaccine supply in case of a highly transmissible avian flu outbreak [6]. Group 3: Market Sentiment and Risks - Despite the stock price increases, there is skepticism about the likelihood of a widespread avian flu outbreak, as current cases are limited to dairy workers with direct exposure to infected cattle [9][10]. - The market reaction may be premature, as the probability of avian flu mutating into a human-transmissible disease remains low at this time [10].

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 ...

MAINZ, Germany, May 21, 2024 – BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") will present clinical trial data for selected programs from the Company's diversified immuno-oncology pipeline at the American Society of Clinical Oncology ("ASCO") Annual Meeting in Chicago, Illinois, from May 31 to June 4, 2024. Moreover, in support of the Company's ongoing CAR-T cell and individualized mRNA programs, BioNTech will also present epidemiological and real-world data from two observational studies in patien ...

Planegg/Martinsried, May 21, 2024. Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of differentiated T cell immunotherapies for solid tumors and BioNTech SE (NASDAQ:BNTX, "BioNTech"))) have announced that their collaboration to advance T cell receptor (TCR) immunotherapies against cancer will extend beyond the initial three-year term outlined at the signing of the agreement in February 2022. This extension will ...

MAINZ, Germany, May 17, 2024 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, "BioNTech" or the "Company") held its Annual General Meeting ("AGM") today, May 17, 2024. A total of 87.51 per cent of the share capital was represented at the virtual assembly. There were 14 items on the agenda of the AGM. All resolutions proposed on the agenda items put to the vote at today's AGM were approved by a large majority of the shareholders. "The past few years marked a leap in competence for BioNTech," said Helmut Jeggle, ...

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Financial Data and Key Metrics Changes - The company reported total revenues of approximately EUR188 million for Q1 2024, a significant decrease from approximately EUR1.3 billion in Q1 2023 [95] - The loss per share for Q1 2024 was EUR1.31, compared to a diluted profit per share of EUR2.05 in the prior year [40] - The net loss for Q1 2024 was EUR315 million, compared to a net profit of approximately EUR502 million for the same period last year [97] Business Line Data and Key Metrics Changes - Research and development expenses increased to EUR508 million in Q1 2024 from EUR334 million in the prior year, primarily due to advancing clinical studies in the oncology pipeline [96] - Sales and marketing expenses were EUR16 million in Q1 2024, up from EUR12 million in the prior year [117] Market Data and Key Metrics Changes - The company expects to recognize approximately 90% of its full-year revenues in the last month of 2024, mostly in Q4 [118] - The company maintained a strong financial position with EUR16.9 billion in total cash and security investments at the end of the quarter [116] Company Strategy and Development Direction - The company aims to have over 10 pivotal trials running by the end of 2024, focusing on oncology products expected to reach the market by 2026 [40][122] - The strategy includes building a global commercialization team to support multiple oncology launches beginning in 2026 [60][82] - The company is focused on clinical execution this year while remaining open to synergistic assets for potential partnerships [32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the oncology pipeline, with multiple product launches anticipated [5][6] - The company is entering a catalyst-rich period with data updates expected from various product candidates across different classes [121] - Management highlighted the importance of improving capabilities to execute clinical trials effectively [26] Other Important Information - The company is preparing to launch a variant-adapted COVID-19 vaccine in over 80 geographies worldwide, with regulatory approvals expected in late July and August [50] - The company plans to present new clinical data at the upcoming ASCO conference, including updates on various oncology programs [114] Q&A Session Summary Question: What data should be expected at ASCO for the Genmab compound? - The company plans to present data for around 100 patients in the second-line non-small cell lung cancer trial with BNT311 [103] Question: What is the plan moving forward with the oncology pipeline? - The focus this year is on clinical execution, with an emphasis on synergistic assets and partnerships to enhance growth [32] Question: Can you recap a hypothetical list of the 10 potentially registrational trials? - The company is evaluating multiple scenarios and will provide updates on specific trials as they progress [132]

BioNTech's long-term outlook helped it shrug off a first-quarter loss and sinking revenue as demand for COVID-19 vaccines declined.CFO Jens Holstein said the drop for the shot was seasonal, and the company expected 90% of its revenue coming later in the year.Holstein noted that BioNTech has billions in cash on hand to drive the company's efforts into treatments for cancer. American depositary receipts (ADRs) of BioNTech (BNTX) were down less than 1% in intraday trading Monday after the COVID-19 vaccine make ...