BioNTech's Cancer Drug Gets FDA Fast Track
Ticker: BNTX · Form: 6-K · Filed: 2024-06-24T00:00:00.000Z
Sentiment: bullish
Topics: drug-designation, oncology, FDA, collaboration
Related Tickers: BNTX
TL;DR
BioNTech's cancer drug DB-1305 gets FDA Fast Track for HER2+ breast cancer.
AI Summary
On June 24, 2024, BioNTech SE and Duality Biologics (Suzhou) Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to their investigational antibody-drug conjugate, hit-to-lead candidate DB-1305, for the treatment of patients with advanced or metastatic HER2-positive breast cancer. This designation is intended to expedite the development and review of drugs for serious conditions.
Why It Matters
The FDA's Fast Track designation for DB-1305 could accelerate the development and potential approval of a new treatment option for HER2-positive breast cancer patients, offering hope for improved outcomes.
Risk Assessment
Risk Level: medium — While Fast Track designation is positive, the drug is still investigational and faces significant clinical development and regulatory hurdles before potential market approval.
Key Players & Entities
- BioNTech SE (company) — Registrant and collaborator
- Duality Biologics (Suzhou) Co., Ltd. (company) — Collaborator
- U.S. Food and Drug Administration (company) — Regulatory body granting designation
- DB-1305 (drug) — Investigational antibody-drug conjugate
- June 24, 2024 (date) — Date of announcement
FAQ
What is the specific indication for which DB-1305 received Fast Track designation?
DB-1305 received Fast Track designation for the treatment of patients with advanced or metastatic HER2-positive breast cancer.
Who are the companies involved in the development of DB-1305?
BioNTech SE and Duality Biologics (Suzhou) Co., Ltd. are involved in the development of DB-1305.
What is the significance of the Fast Track designation granted by the FDA?
The Fast Track designation is intended to expedite the development and review of drugs for serious conditions, potentially leading to earlier market access.
What type of drug is DB-1305?
DB-1305 is an investigational antibody-drug conjugate.
When was the Fast Track designation announced?
The Fast Track designation was announced on June 24, 2024.
From the Filing
0001776985-24-000057.txt : 20240624 0001776985-24-000057.hdr.sgml : 20240624 20240624080743 ACCESSION NUMBER: 0001776985-24-000057 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20240624 FILED AS OF DATE: 20240624 DATE AS OF CHANGE: 20240624 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: 241062154 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-kbnt324fasttrack24ju.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): ☐ DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K On June 24, 2024, BioNTech SE and Duality Biologics (Suzhou) Co., Ltd. announced that the U.S. Food and Drug Administration granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration–resistant prostate cancer who have progressed on or after standard systemic regimens. 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: June 24, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer EX-99.1 2 ex991bnt324fast-track24jun.htm EX-99.1 Document Exhibit 99.1          BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer • Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors i,ii • With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration (“FDA”) to support development and expedite regulatory review • Prostate cancer is the second leading cause of cancer-related deaths among men worldwide iii often diagnosed at advanced disease stages; patients with metastatic castration–resistant prostate cancer (“mCRPC”), an advanced form of prostate cancer, have a 5-year survival rate of around 36% iv • All three clinical stage antibody-d