BioNTech, BMS show encouraging Phase 2 ES-SCLC data

BioNTech SE filed a Form 6-K noting that it and Bristol Myers Squibb have presented interim data from a global randomized Phase 2 trial of pumitamig (BNT327/BMS986545) in extensive-stage small cell lung cancer.

Rhea-AI Filing Summary

BioNTech SE filed a Form 6-K noting that it and Bristol Myers Squibb have presented interim data from a global randomized Phase 2 trial of pumitamig (BNT327/BMS986545) in extensive-stage small cell lung cancer. The investigational bispecific antibody targets PD-L1 and VEGF-A and is being evaluated in combination with chemotherapy. According to the attached press release description, the interim Phase 2 data show encouraging antitumor activity in this patient population.

Insights

Biopharma clinical-development analyst

Interim Phase 2 data show encouraging activity for BioNTech/BMS bispecific in ES-SCLC.

BioNTech and Bristol Myers Squibb reported interim results from a global randomized Phase 2 study of pumitamig in extensive-stage small cell lung cancer. Pumitamig is a bispecific antibody targeting PD-L1 and VEGF-A and is tested together with chemotherapy.

The exhibit description highlights “encouraging antitumor activity,” suggesting the signal is strong enough to merit public disclosure, though specific response rates or survival data are not provided here. As an investigational asset, future value will depend on whether these interim findings translate into more mature outcomes and support later-stage trials.

Subsequent company communications or future filings may detail efficacy, safety, and development plans based on this trial (NCT06449209), which will clarify pumitamig’s potential role in ES-SCLC treatment.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did BioNTech (BNTX) disclose in this September 2025 Form 6-K?

BioNTech reported that it and Bristol Myers Squibb presented interim data from a global randomized Phase 2 trial of pumitamig plus chemotherapy in extensive-stage small cell lung cancer, with a press release attached as Exhibit 99.1.

What is pumitamig (BNT327/BMS986545) mentioned by BioNTech (BNTX)?

Pumitamig, also known as BNT327 or BMS986545, is an investigational bispecific antibody that targets PD-L1 and VEGF-A. It is being evaluated in combination with chemotherapy for patients with extensive-stage small cell lung cancer in a global Phase 2 trial.

What stage of clinical development is pumitamig in according to BioNTech’s 6-K?

Pumitamig is currently being studied in a global randomized Phase 2 clinical trial (NCT06449209). The Form 6-K notes that BioNTech and Bristol Myers Squibb presented interim data from this Phase 2 study in patients with extensive-stage small cell lung cancer.

What indication is targeted in BioNTech’s Phase 2 pumitamig trial?

The Phase 2 trial evaluates pumitamig plus chemotherapy in patients with extensive-stage small cell lung cancer. This indication involves advanced small cell lung cancer that has spread extensively, making systemic treatment a key focus of clinical research for this combination therapy.

How did BioNTech describe the pumitamig Phase 2 interim results in ES-SCLC?

The exhibit description states that the first global interim Phase 2 data for pumitamig in extensive-stage small cell lung cancer show encouraging antitumor activity. Detailed numerical efficacy or safety results are not included in the excerpt itself, only this qualitative characterization.

Which partners are involved in the pumitamig Phase 2 trial with BioNTech (BNTX)?

The trial is a collaboration between BioNTech SE and Bristol Myers Squibb Company. Both companies are evaluating the bispecific antibody pumitamig, in combination with chemotherapy, in a global randomized Phase 2 study for extensive-stage small cell lung cancer.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 09/08/2025 - 04:40 PM Learn about SEC filing dates

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 SEPTEMBER 2025

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 September 8, 2025, BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) presented interim data from a global randomized Phase 2 trial (NCT06449209) evaluating pumitamig (also known as BNT327 or BMS986545), an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer (“ES-SCLC”). 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/ 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: September 8, 2025

EXHIBIT INDEX

Exhibit			Description of Exhibit
99.1			First Disclosure of Global Interim Phase 2 Data for BioNTech and Bristol Myers Squibb PD-L1xVEGF-A Bispecific Antibody Pumitamig (BNT327/BMS986545) in Patients with Extensive-Stage Small Cell Lung Cancer Shows Encouraging Antitumor Activity