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BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer. • Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors • 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 leading cause of cancer-related deaths among men worldwide often diagnosed at advanced disease stages; patients with metastatic castration–resistant prostate cancer (“mCRPC”), an advanced form of prostate cancer, have a 5-year survival rate of around 36% • All three clinical stage antibody-drug conjugate (“ADC”) candidates in BioNTech’s and DualityBio’s strategic collaboration have received FDA Fast Track designation supporting the potential of the companies’ ADC technology
Investigational Acasunlimab (DuoBody® -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in Patients with Previously Treated Metastatic Non-small Cell Lung Cancer (mNSCLC) - Initial data from the ongoing Phase 2 trial showed a 12-month overall survival rate of 69% and a median overall survival of 17.5 months in patients with previously treated PD-L1-positive metastatic non-small cell lung cancer treated with a combination of acasunlimab and pembrolizumab every six weeks - Data from this ongoing Phase 2 study to inform the planned pivotal Phase 3 trial, which is expected to start before the end of 2024
BioNTech and CEPI Expand Partnership to Strengthen Africa’s mRNA Vaccine Ecosystem 29 May 2024 - BioNTech and CEPI aim to enhance local R&D, clinical and commercial-scale manufacturing capacities to develop potential mRNA vaccines in Africa, for Africa - CEPI to fund up to $145 million to support BioNTech in broadening the scope of the manufacturing facility in Kigali, Rwanda, aimed at addressing needs of African countries and in compliance with global standards - Partnership intends to contribute to building a sustainable and resilient end-to-end African vaccine ecosystem - BioNTech and CEPI commit to contributing to enabling equitable access, including affordable pricing to select vaccines made at the facility for LMICs, with priority access to African countries, and committed capacity to manufacture emergency response vaccines
BioNTech to Evaluate NanoTag’s Target Labeling System in Different Therapeutic Areas BioNTech SE (Nasdaq: BNTX, “BioNTech”) and NanoTag Biotechnologies GmbH (“NanoTag”), a biotechnology company developing single-domain antibodies, today announced that BioNTech has exercised an exclusive option right under a previously signed Research Collaboration and License Agreement. BioNTech gains rights to exclusively evaluate NanoTag’s target labeling system “ALFA” across indications in oncology and infectious diseases in both a preclinical and clinical setting. The ALFA tagging system can be used to biologically label a target of interest in the laboratory setting (i.e., a protein on the cell membrane) with a protein tag. Protein tags are either short peptides or entire proteins fused to a protein of interest, providing an approach to isolate or track proteins in the cell. The tag in the ALFA system is bound specifically by a designed set of antibodies. The high specificity of the tag-antibody binding has the potential for different use cases that BioNTech intends to evaluate, including drug delivery. Under the terms of the initial agreement signed in 2022, NanoTag will now receive an option exercise fee of EUR 1 million from BioNTech for the use of the ALFA system in its candidate development, and potential additional development, regulatory and commercial milestone payments, and royalty payments. BioNTech may advance any number of products under the licensing agreement.
BioNTech to Present Clinical Data Updates for Next-Generation Immunotherapy Candidates at the ASCO Annual Meeting 2024 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 patient populations for which product candidates are being developed in the Company’s respective clinical programs.
BioNTech SE Shareholders Approve All Agenda Items at the Annual General Meeting 2024 17 May 2024 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.
BioNTech Announces First Quarter 2024 Financial Results and Corporate Update - Advancing toward goal of ten or more potentially registrational trials running by the end of 2024: first patient dosed in Phase 3 clinical trial evaluating BNT323/DB-1303 in HR+ HER2-low chemotherapy-naïve metastatic breast cancer patients, and a second Phase 3 trial with BNT323/DB-1303 in recurrent endometrial cancer planned to start soon. - Presented clinical data at the American Association for Cancer Research (“AACR”) Annual Meeting for individualized and off-the-shelf mRNA-based cancer vaccine candidates based on iNeST and FixVac platforms, including three-year follow-up data of an investigator-initiated trial in patients with resected pancreatic ductal adenocarcinoma (“PDAC”). - Planning to share additional clinical data from multiple clinical programs at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, including bispecific antibodies BNT311/GEN1046 (acasunlimab) and BNT327/PM8002 and antibody-drug conjugate (“ADC”) BNT326/YL202. - Continued development and commercial preparation for a 2024 season variant-adapted COVID-19 vaccine. - First quarter 2024 revenues of €187.6 million, net loss of €315.1 million and loss per share of €1.31 ($1.421). - Maintained strong financial position with €16.9 billion in cash, cash equivalents and security investments.
BioNTech to Report First Quarter 2024 Financial Results and Corporate Update on May 6, 2024, MAINZ, Germany, April 22, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the first quarter 2024 on Monday, May 6, 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.
Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer. BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced three-year follow-up data from a Phase 1 trial with the mRNA-based individualized neoantigen-specific immunotherapy (“iNeST”) candidate autogene cevumeran (also known as BNT122, RO7198457) in patients with resected pancreatic ductal adenocarcinoma (“PDAC”). The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells. The persistence of T cels was associated with a longer median recurrence-free survival in cancer vaccine responders.
BioNTech Announces Appointment of Annemarie Hanekamp to Management Board as Chief Commercial Officer. Mainz, Germany, March 20, 2024 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that the Supervisory Board has appointed Annemarie Hanekamp to the Management Board as Chief Commercial Officer effective July 1, 2024. She will join BioNTech from Novartis AG (“Novartis”) and succeed Sean Marett in this role. Annemarie Hanekamp is a seasoned pharmaceutical executive experienced in developing patient-focused commercial strategies for innovative oncology products encompassing sales, marketing and market access. In her new role, she will drive and execute the global commercialization strategy to leverage BioNTech’s full potential as a vertically integrated biopharmaceutical company. Annemarie Hanekamp will be responsible for building a global commercial team in preparation of BioNTech’s first oncology product launch planned in 2026 and with a focus on the Company’s lead product candidates in anticipation of ten potential indication approvals by 2030.
