BioNTech Cancer Drug Trial Cleared by FDA
Ticker: BNTX · Form: 6-K · Filed: 2024-08-19T00:00:00.000Z
Sentiment: bullish
Topics: clinical-trial, fda, biotech
TL;DR
FDA lifts clinical hold on BioNTech's BNT113 cancer drug, Phase 2 trial can now proceed.
AI Summary
On August 19, 2024, BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its investigational new drug (IND) application for the mRNA-based cancer immunotherapy candidate, BNT113. This allows BioNTech to proceed with its planned Phase 2 clinical trial for BNT113 in patients with HPV-positive head and neck cancer.
Why It Matters
The FDA lifting the clinical hold allows BioNTech to advance its novel cancer immunotherapy, potentially leading to new treatment options for patients with HPV-positive head and neck cancer.
Risk Assessment
Risk Level: medium — While the clinical hold being lifted is positive, the success of the Phase 2 trial and eventual market approval are still uncertain, carrying inherent risks for drug development.
Key Players & Entities
- BioNTech SE (company) — Registrant
- U.S. Food and Drug Administration (company) — Regulatory body
- BNT113 (drug_candidate) — mRNA-based cancer immunotherapy
- August 19, 2024 (date) — Announcement date
FAQ
What specific cancer type will the Phase 2 trial for BNT113 focus on?
The Phase 2 clinical trial for BNT113 will focus on patients with HPV-positive head and neck cancer.
What was the reason for the partial clinical hold on BNT113?
The filing does not specify the exact reason for the partial clinical hold, only that it has been lifted.
What type of therapy is BNT113?
BNT113 is an mRNA-based cancer immunotherapy candidate.
When was the announcement made regarding the lifting of the clinical hold?
The announcement was made on August 19, 2024.
Which regulatory body lifted the clinical hold?
The U.S. Food and Drug Administration (FDA) lifted the partial clinical hold.
From the Filing
0001776985-24-000075.txt : 20240819 0001776985-24-000075.hdr.sgml : 20240819 20240819083428 ACCESSION NUMBER: 0001776985-24-000075 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20240819 FILED AS OF DATE: 20240819 DATE AS OF CHANGE: 20240819 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: 241218335 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-kbnt326lift19aug2024.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 AUGUST 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 August 19, 2024, BioNTech SE issued a website statement announcing that the U.S. Food and Drug Administration has lifted the partial clinical hold that was placed on the MediLink Therapeutics (Suzhou) Co., Ltd. Phase I trial evaluating BNT326/YL202 (NCT05653752). The statement 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: August 19, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 Lift of Partial Clinical Hold for BNT326/YL202 EX-99.1 2 a99_1240819xbntx6kfilingxb.htm EX-99.1 Document Exhibit 99.1 Lift of Partial Clinical Hold for BNT326/YL202 On August 15, 2024, the U.S. Food and Drug Administration (“FDA”) lifted the partial clinical hold that was placed on MediLink Therapeutics’ (Suzhou) Co., Ltd. (“MediLink”) Phase I trial evaluating BNT326/YL202 (NCT05653752), which was announced on June 17, 2024. The complete response including data analysis, updated investigator brochure and informed consent for patients, and amended clinical trial protocol meets the FDA’s requirements by incorporating additional risk mitigation measures. BNT326/YL202 is a Human Epidermal Growth Factor Receptor 3 (“HER3”)-targeting antibody-drug conjugate (“ADC”) candidate that is being developed in collaboration between BioNTech SE (“BioNTech”) and MediLink. The trial recruitment will be re-initiated. Clinical development will focus on dose levels no higher than 3 mg/kg, where the safety profile was manageable and encouraging clinical activity was observed. The study sponsor MediLink had observed a dose level-dependent trend of treatment-related adverse events (“TRAEs”) of BNT326/YL202, in particular neutrophil count decrease (“neutropenia