BioNTech SE Reports Positive Interim Data for Pumitamig in Extensive‑Stage Small Cell Lung Cancer

BioNTech SE and Bristol Myers Squibb have disclosed interim results from a global Phase‑2 study of their bispecific antibody Pumitamig (BNT327/BMS986545). The study evaluated the combination of Pumitamig with standard chemotherapy in patients with extensive‑stage small cell lung cancer (ES‑SCLC). The data demonstrate encouraging anti‑tumor activity, reinforcing confidence in BioNTech’s oncology pipeline.

Key Findings

  • Study Design: Global Phase‑2 trial combining the PD‑L1xVEGF‑A bispecific antibody Pumitamig with chemotherapy.
  • Patient Population: Individuals with advanced, extensive‑stage small cell lung cancer.
  • Efficacy: The interim analysis revealed measurable anti‑tumor responses. Although exact response rates are not disclosed, the results are described as “encouraging” by both BioNTech and Bristol Myers Squibb.
  • Safety: No new safety signals were reported. The combination therapy was generally well‑tolerated, aligning with the safety profile observed in earlier trials of Pumitamig.

Market Reaction

  • Stock Performance: Following the announcement, BioNTech’s share price rose significantly, reflecting investor optimism. The company’s shares had recently been trading near €97.2 on the Xetra exchange as of 2025‑09‑04, a notable increase from the 52‑week low of €73.15 reached on 2025‑04‑06.
  • Investor Sentiment: Analysts highlighted the positive data as a catalyst for the stock, noting that the company’s broader pipeline, which includes immunotherapies, vaccines, and prevention strategies, benefits from the strengthened confidence in its research programs.
  • COVID‑19 Vaccine Updates: Parallel to the oncology results, BioNTech and Pfizer reported favorable immunogenicity data for the LP.8.1‑adapted COMIRNATY vaccine. The Phase‑3 cohort demonstrated a ≥4‑fold increase in neutralizing antibody titers among adults 65 + years and adults 18‑64 years with at least one underlying risk condition. These findings support the continued efficacy of the updated vaccine series for the 2025‑2026 formula.
  • Broader Portfolio: BioNTech’s portfolio remains diversified, encompassing vaccine development and oncology therapeutics. The positive interim data for Pumitamig complements the company’s efforts in both domains.

Financial Context

  • Market Capitalisation: BioNTech SE’s market cap stands at approximately €23.1 billion.
  • Historical Performance: The company’s 52‑week high of €123.3 (2025‑01‑06) and low of €73.15 (2025‑04‑06) illustrate recent volatility; the latest interim results are expected to influence future valuation dynamics.

Conclusion

The interim Phase‑2 data for Pumitamig in extensive‑stage small cell lung cancer represent a significant milestone for BioNTech SE. The encouraging anti‑tumor activity, combined with a solid safety profile and the concurrent positive outcomes from the company’s COVID‑19 vaccine program, are likely to sustain investor interest and support the company’s position within the competitive biotechnology landscape.