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SEC · EDGAR 财务披露·· 8 小时前AI 评分38

BioNTech SE 发布 BNT113 阶段 2/3 临床试验初步结果

6-K - BioNTech SE (0001776985) (Filer)

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BioNTech SE 公布 BNT113 阶段 2/3 临床试验初步结果。该试验针对晚期 HPV16 阳性头颈癌患者。试验数据已作为 6-K 文件提交至 SEC。

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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 OCTOBER 2026

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 October 13, 2026, BioNTech SE announced the first topline results from the AHEAD-MERIT Phase 2/3 clinical trial (NCT04534205) for its investigational mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran or “tenu-ra”). The press release is attached 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/ Ramon Zapata-Gomez

By:

/s/ Dr. Sierk Poetting

Name: Ramon Zapata-Gomez

Name: Dr. Sierk Poetting

Title: Chief Financial Officer

Title: Chief Operating Officer

Date: October 13, 2026


EXHIBIT INDEX

Exhibit

Description of Exhibit

99.1

BioNTech Provides Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy Candidate BNT113 in Metastatic HPV16-positive Head and Neck Cancer

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