BNT327 by BioNTech: status and timeline

BNT327

Bispecific antibody combining PD-L1 and VEGF blockade. Targets tumors resistant to checkpoint inhibitors alone.

PilotStage 3 of 5

Phase 3 ROSETTA Lung-01 (small cell lung cancer); Phase 2/3 Lung-02 (NSCLC); Phase 2 (TNBC, mesothelioma).

Updated Jun 2025Checked 10 Oct0 updates this week

Milestones

Next · Phase 3 ROSETTA Lung-01 enrollment ongoing

Program initiation and preclinical development2022Complete.
Orphan Drug Designation for small cell lung cancerJun 2025Complete.
BMS partnership agreementJun 2025Complete.
Phase 3 ROSETTA Lung-01 enrollment ongoingTarget 2025Current milestone.
Phase 3 efficacy readoutTarget 2028Not yet reached.

Most important updates

Upcoming

2025Phase 3 ROSETTA Lung-01 enrollment ongoing (next)
2028Phase 3 efficacy readout

Current obstacles

Overcoming checkpoint inhibitor resistancePatients who escape PD-L1 blockade must respond to the dual mechanism. Must prove across tumor types.
Combination toxicityPD-L1 + VEGF inhibition raises immune-related and vascular adverse events. Balancing efficacy and safety.

Physics limits

Multiple escape mechanismsAntigen loss, immunosuppressive cell infiltration, and metabolic changes all enable resistance. No single combination blocks all.
VEGF off-target costVEGF is needed for normal vessel growth and healing. Systemic VEGF inhibition causes hypertension, clots, and poor healing.

How it works

3 parts

PD-L1 blockade

Release immune recognition

Blocks tumor PD-L1 ligand, freeing immune cells to recognize and attack tumor.

VEGF neutralization

Cut off tumor blood supply

Blocks VEGF growth factors tumors secrete to form new vessels. Combines both mechanisms.

Bispecific molecule

Two targets, one antibody

Single molecule with two binding domains; better pharmacokinetics than two separate antibodies.

Spec sheet

Spec	BNT327
Mechanism of action	PD-L1 × VEGF bispecific antibody^R (reported)
FDA Orphan Drug Designation	Small cell lung cancer (SCLC), June 2025^R (reported)
BMS partnership value	$11.1B total ($1.5B + $2B + up to $7.6B)^R (reported)

^R reported by the company

Update log

2 updates

Jun 2025

Major: BioNTech receives FDA Orphan Drug Designation for BNT327 in small cell lung cancerPressRegulatory
Major: Bristol Myers Squibb and BioNTech announce $11.1 billion BNT327 partnershipPressPartnership

About BioNTech

The team behind BNT327

BioNTech

mRNA vaccines, cancer immunotherapy, oncology, personalized medicine

BioNTech develops mRNA vaccines and immunotherapies for cancer and infectious disease. Founded 2008, public since 2019. In 2025 acquired CureVac and partnered with BMS on BNT327.

Publicly traded on Nasdaq (BNTX); 7,269 employees as of March 2026. Full-year 2025 revenue: €2.87 billion.
June 2025 BMS partnership: $1.5B upfront + $2B non-contingent + up to $7.6B in milestones for BNT327.
June 2025: Acquired CureVac for $1.25 billion to expand mRNA oncology pipeline.

biontech.com (opens biontech.com)Company profile →

Founded: 200818 yrs
Headquarters: Germany
Status: Public
Listed: BNTX (opens google.com)NASDAQ
Valuation: public
Staff: ~7,269Mar 2026
Last round: IPO (Nasdaq) · $150MOct 2019
Works in: BiotechRNA medicines
Coverage: 1 program · 3 updateslatest 1 Jun 2025checked 10 Oct
Partners: Bristol Myers Squibb (opens biontech.com)Pfizer (opens pfizer.com)Genentech (opens gene.com)
People: Uğur Şahin (opens en.wikipedia.org)Co-founderÖzlem Türeci (opens en.wikipedia.org)Co-founderChristoph Huber (opens linkedin.com)Co-founder

Spec

BNT327

Mechanism of action

PD-L1 × VEGF bispecific antibody^R (reported)

FDA Orphan Drug Designation

Small cell lung cancer (SCLC), June 2025^R (reported)

BMS partnership value

$11.1B total ($1.5B + $2B + up to $7.6B)^R (reported)