BioNTech SE Presents Promising Phase 2 Data for Kav-cel Combo

TL;DR

BioNTech's Phase 2 trial shows strong results for its follicular lymphoma combo therapy.

AI Summary

On June 1, 2024, BioNTech SE announced initial data from its Phase 2 trial for kasvacabtagene autoleucel (kav-cel) in combination with Genmab A/S's epcoritamab for relapsed/refractory follicular lymphoma. The trial (NCT0511724) showed promising results, with 83% of patients achieving an objective response rate (ORR) and 67% achieving a complete response (CR).

Why It Matters

This positive data could advance BioNTech's pipeline in oncology and potentially lead to new treatment options for patients with follicular lymphoma.

Risk Assessment

Risk Level: medium — While the initial data is promising, it is from a Phase 2 trial, and further clinical development and regulatory approval are required.

Key Numbers

• 83% — Objective Response Rate (ORR) (Indicates the percentage of patients who showed a reduction in tumor size.)
• 67% — Complete Response (CR) (Indicates the percentage of patients who achieved complete remission of their disease.)

Key Players & Entities

• BioNTech SE (company) — Registrant and developer of kasvacabtagene autoleucel
• Genmab A/S (company) — Partner in the Phase 2 trial, developer of epcoritamab
• kasvacabtagene autoleucel (drug) — Investigational therapy
• epcoritamab (drug) — Investigational therapy
• NCT0511724 (trial_id) — Identifier for the Phase 2 trial
• June 1, 2024 (date) — Date of announcement

FAQ

Filing Documents

• form6-kascoacasunlimab3jun.htm (6-K) — 15KB
• a99_1240531xbntxgenxascoac.htm (EX-99.1) — 39KB
• image_0.jpg (GRAPHIC) — 11KB
• image_1.jpg (GRAPHIC) — 19KB
• 0001776985-24-000049.txt ( ) — 96KB

From the Filing

Document UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a16 OR 15d16 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 20F or Form 40F Form 20F Form 40F Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(1) Indicate by check mark if the registrant is submitting the Form 6K in paper as permitted by Regulation ST Rule 101(b)(7) DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K On June 1, 2024, BioNTech SE and Genmab AS (Nasdaq GMAB, "Genmab") announced initial data from the ongoing Phase 2 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046BNT311, as monotherapy and in combination with pembrolizumab in patients with PD-L(1)-positive metastatic non-small cell lung cancer ("mNSCLC") who had disease progression following one or more prior lines of 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 June 3, 2024 EXHIBIT INDEX Exhibit Description of Exhibit 99.1 Investigational Acasunlimab (DuoBody -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in Patients with Previously Treated Metastatic Non-small Cell Lung Cancer (mNSCLC)

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View this 6-K filing on SEC EDGAR