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MELBOURNE, Australia, December 8, 2023 —BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that it has signed a multi-year strategic partnership with the State of Victoria in Australia to strengthen the local mRNA ecosystem and facilitate innovations deriving from it. Building on a Letter of Intent agreed on in October 2022, the strategic partnership is aimed at providing high-tech manufacturing capabilities and BioNTech’s expertise to curate encouraging projects for further research and development. The State of Victoria has contracted BioNTech to develop and commission a state-of-the-art mRNA manufacturing facility tailored to the needs of the local mRNA ecosystem to strengthen local manufacturing. The site is intended to support R&D and clinical-scale manufacturing of investigational mRNA-based medicines from the local ecosystem as well as from other third parties globally. The facility will be based on the Company’s high-tech, digital manufacturing units called BioNTainers. One unit will be equipped to manufacture mRNA and the formulated drug. The second unit will enable aseptic filling. The BioNTainer units are designed to offer manufacturing solutions in line with the local ecosystem’s needs. The site in Victoria will be located at the Bundoora campus of La Trobe University in the Melbourne region. Its groundbreaking is planned in 2024.
MAINZ, Germany, November 6, 2023 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three and nine months ended September 30, 2023, and provided an update on its corporate progress. “Over the last quarter, we complemented our investigational pipeline with ADC candidates, initiated later-stage clinical trials and presented significant data across modalities including cancer vaccines, cell therapies, ADCs and immune checkpoint modulators. Our strategy focuses on assembling a diverse toolbox of complementary technologies to deliver novel therapies, aiming to improve the standard-of-care for cancer patients,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “We combine our internal innovation engine with a high-performance partnership model to transform healthcare and improve patients' quality of life.”
BioNTech SE will present data updates across multiple immuno-oncology programs at the Society for Immunotherapy of Cancer’s (“SITC”) 38th Annual Meeting in San Diego, USA, from November 1-5, 2023. The updates will feature one oral and four poster presentations for the investigational anti-CTLA-4 monoclonal antibody candidate BNT316/ONC-392 (gotistobart), the FixVac off-the-shelf mRNA cancer vaccine BNT116, the ex-vivo T cell therapy BNT221, and the two bi-specific antibodies BNT312/GEN1042 and BNT313/GEN1053. The full abstracts are available on the SITC Annual Meeting website.
Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19 Lead formulations evaluated in the Phase 1/2 study demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. Safety profile of the mRNA-based combination vaccine candidates consistent with the companies’ COVID-19 vaccine. The companies plan to start a pivotal Phase 3 trial in the coming months.
BioNTech Presents Positive Phase 1/2 Data Update for CAR-T Cell Therapy Candidate BNT211 in Advanced Solid Tumors at ESMO Congress 2023 BNT211 combines two innovative approaches in one regimen with first-in-class potential: an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (“CARVac”). Data presented at ESMO Congress 2023 demonstrates that the application of CARVac increases the persistence of the adoptively transferred autologous CAR-T cells. BNT211 continues to show encouraging antitumor activity in patients with CLDN6-positive relapsed or refractory advanced solid tumors. Follow-up of efficacy data at 1x108 CAR-T cells with or without CARVac shows an overall response rate (“ORR”) of 59% and a disease control rate (“DCR”) of 95%, with the CARVac cohort demonstrating a prolonged persistence of CAR-T cells.
BioNTech to Report Third Quarter Financial Results and Corporate Update on November 6, 2023, And to Host Innovation Series Day on November 7, 2023 BioNTech SE will announce its financial results for the third quarter 2023 on Monday, November 6th, 2023. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update for the third quarter 2023. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance. The slide presentation and audio of the webcast will be available via this link. Additionally, BioNTech will host the second edition of the Company’s Innovation Series on Tuesday, November 7th, 2023. The event will provide an update on BioNTech’s clinical progress across its pipeline and provide a deep dive into scientific and technological innovations from its proprietary research engine. Investors and the interested public are invited to join a webcast with investment analysts at 9:00 a.m. ET (3:00 p.m. CET). The slide presentation and audio of the webcast will be available via this link.
BioNTech Expands Late-Stage Clinical Oncology Portfolio with Initiation of further Phase 2 Trial with mRNA-based Individualized Neoantigen Specific Immunotherapy in New Cancer Indication Initiation of Phase 2 builds on data from a Phase 1 clinical trial evaluating the safety and tolerability of autogene cevumeran (BNT122, RO7198457) in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and standard of care chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC). The Phase 2 trial is expected to enroll approximately 260 patients with PDAC at clinical trial sites initially in the United States, followed by Europe and Asia Pacific region. This is the third later-stage trial with a product candidate based on BioNTech’s individualized cancer vaccine platform iNeST aimed at treating patients with solid tumors in a high unmet need indication.
BioNTech to Present Multiple Program Updates Across Modalities at ESMO Congress 2023 Program updates include new data for investigational CAR-T and ex-vivo T cell therapies, a novel ADC, a FixVac off-the-shelf mRNA cancer vaccine, and a bi-specific antibody. New data from BioNTech’s investigational autologous CAR-T therapy BNT211 demonstrate the potential of the Company’s innovative approach of combining an autologous CAR-T cell therapy targeting Claudin-6 (“CLDN6”) with a CLDN6-encoding CAR-T cell amplifying mRNA vaccine (“CARVac”). First-in-human data from Phase 1/2 study with next-generation Trop-2 targeting ADC candidate BNT325 (DB-1305) in advanced/metastatic solid tumors show encouraging initial efficacy signals and a manageable safety profile. BioNTech advances key clinical programs into late-stage development while strengthening its clinical-stage oncology pipeline with synergistic potential.
Update Regarding Pfizer’s Statement on COMIRNATY-Related Write-Offs On October 13, 2023, Pfizer Inc. (NYSE: PFE, “Pfizer”), a collaboration partner of BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), announced a non-cash charge for inventory write-offs and other charges related to COMIRNATY of $0.9 billion. The Company has been informed by Pfizer that the majority of the write-offs relate to raw materials, mainly formulation-related lipids, purchased during the pandemic, as well as COVID-19 vaccine doses adapted to other, non-XBB.1.5 variants produced at risk. According to Pfizer, the write-offs do not address the Pfizer-BioNTech COVID-19 Vaccine adapted to the XBB.1.5 variant, which has been approved and is being marketed in key geographies. BioNTech is evaluating the potential impact of Pfizer’s write-offs and other charges related to COMIRNATY on the Company’s financial results. BioNTech’s current expectation is that the Company is likely to recognize the effect of Pfizer’s inventory write-offs and other charges related to COMIRNATY in the third quarter of 2023 up to €0.9 billion, which represents BioNTech’s half under the gross profit-sharing agreement with Pfizer. Any such write-offs will reduce the revenues the Company would report for 2023. BioNTech expects to release its financial report for the third quarter of 2023 on November 6, 2023.
Statement on Katalin Karikó and Drew Weissman awarded the Nobel Prize in Medicine 2023. All of us at BioNTech applaud Kati (Katalin) Karikó and Drew Weissman on their Nobel Prize in Physiology or Medicine for pioneering nucleoside base modifications, which were one of the key innovations applied to our mRNA-based COVID-19 vaccine. We value both for their passion, persistence, and commitment. This Nobel Prize is a reminder for scientists around the world to continue to engage in rigorous research and development with the great aspiration to unlock the full potential of new drug classes. Gratulálunk and congrats!
