BioNTech prepares for FDA filing of first cancer drug

GERMANY – BioNTech is advancing toward its first cancer drug approval with BNT323, a HER2-targeted antibody-drug conjugate (ADC) developed in collaboration with China’s Duality Biologics.

The company plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2025 for the treatment of advanced endometrial cancer.

BNT323, also known as trastuzumab pamirtecan, has shown promising results in a Phase 1/2 clinical trial involving patients with HER2-expressing advanced endometrial carcinoma.

The trial included patients with varying levels of HER2 expression (IHC3+, 2+, 1+, or ISH-positive). Data from this cohort are expected in 2025 and will inform the FDA submission.

In December 2023, the FDA granted Breakthrough Therapy designation to BNT323 for the treatment of advanced endometrial cancer in patients who progressed on or after immune checkpoint inhibitors. This designation is based on encouraging early data demonstrating anti-tumor activity.

To mitigate potential supply chain risks, especially amid global trade uncertainties, BioNTech is diversifying its manufacturing base for BNT323.

The company currently relies on a China-based contract development and manufacturing organization (CDMO) but plans to establish additional supply nodes to reduce dependency on a single source.

Financially, BioNTech reported first-quarter sales of €183 million and a net loss of €416 million. Despite the loss, the company maintains a strong cash position of €15.9 billion as of March 31, 2025, which supports its ongoing investment in oncology programs, including BNT323.

In addition to BNT323, BioNTech is focusing on other oncology candidates like BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, and its mRNA cancer immunotherapy platform.

These programs are part of BioNTech’s strategy to become a fully integrated immunotherapy company.

Leadership changes are also underway, with CFO Jens Holstein set to retire at the end of June. Ramón Zapata-Gomez, formerly of Novartis, will assume the CFO role starting in July.