BioNTech cancer vaccine BNT151 gets FDA green light for Phase 1 trial

TL;DR

FDA approves BioNTech/MediLink cancer vaccine BNT151 for Phase 1 trial.

AI Summary

BioNTech SE announced on June 17, 2024, that its partner MediLink Therapeutics (Suzhou) Co., Ltd. has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1 clinical trial for their novel mRNA-based cancer vaccine, candidate BNT151. This vaccine targets specific tumor mutations and is intended for patients with certain types of cancer.

Why It Matters

The FDA's clearance allows BioNTech and MediLink to test a new mRNA cancer therapy in humans, potentially offering a novel treatment option for patients with specific tumor mutations.

Risk Assessment

Risk Level: medium — Clinical trial advancements carry inherent risks, as the success of BNT151 in human trials is not guaranteed and regulatory approvals are subject to ongoing evaluation.

Key Players & Entities

• BioNTech SE (company) — Registrant
• MediLink Therapeutics (Suzhou) Co., Ltd (company) — Partner company
• BNT151 (drug_candidate) — mRNA-based cancer vaccine
• U.S. Food and Drug Administration (FDA) (company) — Regulatory body

FAQ

From the Filing

0001776985-24-000055.txt : 20240617 0001776985-24-000055.hdr.sgml : 20240617 20240617071830 ACCESSION NUMBER: 0001776985-24-000055 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20240617 FILED AS OF DATE: 20240617 DATE AS OF CHANGE: 20240617 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BioNTech SE CENTRAL INDEX KEY: 0001776985 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: 2M FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39081 FILM NUMBER: 241046946 BUSINESS ADDRESS: STREET 1: AN DER GOLDGRUBE 12 CITY: MAINZ STATE: 2M ZIP: 55131 BUSINESS PHONE: 0049613190840 MAIL ADDRESS: STREET 1: AN DER GOLDGRUBE 12 CITY: MAINZ STATE: 2M ZIP: 55131 6-K 1 form6-kml14jun2024.htm 6-K Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 FOR THE MONTH OF JUNE 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 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐ Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐ Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐ INFORMATION INCLUDED AS PART OF THIS FORM 6-K BioNTech SE has been informed by its partner MediLink Therapeutics (Suzhou) Co., Ltd (“MediLink”) that the U.S. Food and Drug Administration (“FDA”) has placed a partial clinical hold on the multicenter, open-label, first-in-human Phase 1 clinical (NCT05653752) trial sponsored by MediLink that evaluates the early-stage antibody-drug conjugate (“ADC”) product candidate BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic epidermal growth factor receptor (“EGFR”)-mutated non-small cell lung cancer (“NSCLC”) or HR+/HER2-negative breast cancer. The partial hold affects the enrollment of new patients in the trial in the U.S. The FDA has shared with MediLink concerns that BNT326/YL202 may, at higher doses, expose human subjects to unreasonable and significant risk of illness or injuries. In order to address the FDA requests, certain steps need to be taken, including reviewing clinical and safety data, sharing available pharmacological data with the Agency and providing additional information in the investigators brochure regarding the safety findings including grade 5 adverse events observed in studies YL202-INT-101-01 and YL202-CN-201-01. MediLink has taken actions to pause enrollment of new patients in the U.S. and address the FDA requirements. 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/ Jens Holstein By: /s/ Dr. Sierk Poetting Name: Jens Holstein Name: Dr. Sierk Poetting Title: Chief Financial Officer Title: Chief Operating Officer Date: June 17, 2024