BioNTech Partner's Drug IND Application Placed on Clinical Hold

TL;DR

FDA puts clinical hold on BioNTech partner's drug ONC-390 IND, halting US trials.

AI Summary

BioNTech SE announced on December 13, 2024, that its partner OncoC4, Inc. has been informed by the U.S. Food and Drug Administration (FDA) regarding the investigational new drug (IND) application for ONC-390. The FDA has placed a clinical hold on the IND application, meaning further clinical trials for ONC-390 cannot proceed in the United States at this time.

Why It Matters

This clinical hold by the FDA prevents OncoC4 from initiating U.S. trials for ONC-390, potentially delaying its development and market entry for the drug.

Risk Assessment

Risk Level: medium — A clinical hold on an IND application signifies regulatory hurdles that could delay or halt the drug's development, impacting BioNTech's partnership and potential future revenue.

Key Players & Entities

• BioNTech SE (company) — Registrant and partner's collaborator
• OncoC4, Inc. (company) — BioNTech's partner
• ONC-390 (drug) — Investigational drug
• U.S. Food and Drug Administration (company) — Regulator

FAQ

From the Filing

0001776985-24-000098.txt : 20241213 0001776985-24-000098.hdr.sgml : 20241213 20241213160112 ACCESSION NUMBER: 0001776985-24-000098 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20241213 FILED AS OF DATE: 20241213 DATE AS OF CHANGE: 20241213 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: 241548254 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-kbnt316holdlift13dec.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 DECEMBER 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 (“BioNTech”) has been informed by its partner OncoC4, Inc. (“OncoC4”) that the U.S. Food and Drug Administration (“FDA”) has lifted the partial clinical hold on PRESERVE-003 (NCT05671510), a two-stage, open-label, randomized Phase 3 trial evaluating the efficacy and safety of BNT316/ONC-392 (gotistobart) as monotherapy in patients with metastatic non-small cell lung cancer (NSCLC) that progressed under previous PD-(L)1-inhibitor treatment. Based on the available trial data and following an alignment with the FDA, the companies will solely continue enrollment of patients with squamous NSCLC. The partial clinical hold on the study was previously announced by BioNTech on October 18, 2024, following OncoC4’s communication to the FDA after an assessment of the trial data by the independent Data Monitoring Committee which identified a possible variance in results between the squamous and non-squamous NSCLC patient populations. The partial clinical hold only affected new patient enrollment and did not impact patients already enrolled in the trial. Trials evaluating BNT316/ONC-392 in other indications also remained unaffected. About BNT316/ONC-392 (gotistobart) BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody candidate jointly being developed by BioNTech and OncoC4. BNT316/ONC-392 is currently in late-stage clinical development as monotherapy or combination therapy in various cancer indications. The immune checkpoint receptor CTLA-4 inhibits T cell immune response and reduces the activity of T cells in recognizing and eliminating cancer cells. This mechanism is also exploited by cancer cells to prevent them from being eliminated by T cells. Blocking CTLA-4 may help to preserve T cell activity and enhance anti-tumor activity. BNT316/ONC-392 was designed with the aim to address this mechanism while preserving CTLA-4 recycling and thus the immunosuppressive T cell (regulatory T cells, or “Tregs”) function in the peripheral tissues. This approach aims to give rise to fewer immune-related adverse effects and a mor