BioNTech SE: 3-Year Pancreatic Cancer Trial Data Released

TL;DR

BioNTech drops 3-year pancreatic cancer mRNA immunotherapy data from Phase 1 trial.

AI Summary

On April 7, 2024, BioNTech SE announced three-year follow-up data from a Phase 1 trial of its mRNA-based individualized neoantigen-specific immunotherapy. The trial focused on patients with resected pancreatic cancer.

Why It Matters

This data provides long-term insights into the efficacy and safety of BioNTech's personalized mRNA cancer immunotherapy, potentially impacting future treatment strategies for pancreatic cancer.

Risk Assessment

Risk Level: low — This filing is an update on clinical trial data, which is standard for a pharmaceutical company and does not represent a significant new risk.

Key Numbers

• 3-year — Follow-up period (Duration of data presented from the Phase 1 trial.)

Key Players & Entities

• BioNTech SE (company) — Registrant
• April 7, 2024 (date) — Announcement date
• Phase 1 trial (clinical_trial) — Study being reported on
• mRNA-based individualized neoantigen-specific immunotherapy (drug_candidate) — Therapy under investigation
• pancreatic cancer (disease) — Indication for the therapy

FAQ

Filing Documents

• form6-kaacr8apr2024.htm (6-K) — 13KB
• ex_99aacrautogenecevumeran.htm (EX-99.1) — 32KB
• image_0.jpg (GRAPHIC) — 19KB
• 0001776985-24-000032.txt ( ) — 73KB

From the Filing

Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a16 OR 15d16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FOR THE MONTH OF APRIL 2024 COMMISSION FILE NUMBER 001-39081 BioNTech SE (Translation of registrant's name into English) An der Goldgrube 12 D-55131 Mainz Germany +49 6131-9084-0 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20F or Form 40F Form 20F Form 40F Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(1) Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(7) DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K On April 7, 2024, BioNTech SE 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 press release is attached hereto as Exhibit 99.1. SIGNATURE Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. BioNTech SE By s Dr. Sierk Poetting Name Dr. Sierk Poetting Title Chief Operating Officer Date April 8, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 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

View Full Filing

View this 6-K filing on SEC EDGAR