BioNTech SE Announces Positive Phase 2 Data for Influenza Vaccine

TL;DR

BNTX drops positive Phase 2 flu vaccine data, could be a game-changer.

AI Summary

On July 30, 2024, BioNTech SE announced positive topline data from its Phase 2 clinical trial (EudraCT No.: 2020-002195-12; NCT04526899). The trial is evaluating a novel mRNA-based vaccine candidate for the treatment of influenza.

Why It Matters

Positive trial results could lead to a new mRNA-based influenza vaccine, potentially offering improved efficacy and a new treatment option for seasonal flu.

Risk Assessment

Risk Level: medium — Clinical trial results are promising but still require further phases and regulatory approval, with inherent risks in drug development.

Key Players & Entities

• BioNTech SE (company) — Registrant and developer of the vaccine candidate
• July 30, 2024 (date) — Date of announcement
• 2020-002195-12 (other) — EudraCT number for the clinical trial
• NCT04526899 (other) — NCT number for the clinical trial

FAQ

From the Filing

0001776985-24-000064.txt : 20240730 0001776985-24-000064.hdr.sgml : 20240730 20240730090826 ACCESSION NUMBER: 0001776985-24-000064 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20240730 FILED AS OF DATE: 20240730 DATE AS OF CHANGE: 20240730 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: 241154734 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-kbnt111ph230jul2024.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 JULY 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): ☐ DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K On July 30 , 2024, BioNTech SE announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12&#59; NCT04526899) in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. 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/ Jens Holstein By: /s/ Dr. Sierk Poetting Name: Jens Holstein Name: Dr. Sierk Poetting Title: Chief Financial Officer Title: Chief Operating Officer Date: July 30 , 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 BioNTech Announces Positive Topline Phase 2 Results for mRNA Immunotherapy Candidate BNT111 in Patients with Advanced Melanoma EX-99.1 2 a99_1240730xprxbnt111xph2t.htm EX-99.1 Document Exhibit 99.1 BioNTech Announces Positive Topline Phase 2 Results for mRNA Immunotherapy Candidate BNT111 in Patients with Advanced Melanoma • Primary endpoint met in a Phase 2 trial evaluating the investigational mRNA immunotherapy BNT111 in combination with the PD-1 checkpoint inhibitor cemiplimab • Data demonstrated a statistically significant improvement of overall response rate (“ORR”) compared to historical control in patients with anti-PD-(L)1 relapsed/refractory advanced melanoma • BioNTech and Regeneron plan to present data from this trial at a forthcoming medical conference&#59; the BNT111 program received a Fast Track designation and an Orphan Drug designation from the U.S. Food and Drug Administration (“FDA”) in 2021 • BNT111 is based on BioNTech’s fully owned FixVac platform and proprietary uridine mRNA-LPX technology MAINZ, Germany, July 30, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced positive topline data from the ongoing Phase 2 clinical trial (EudraCT No.: 2020-002195-12&#59; NCT04526899)