Drug intelligence / Profile preview

BNT221

Development stage
Preclinical
Lead developer
BioNTech
Modality
Native Immune Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

BNT221 is a **personalized, neoantigen-specific autologous T cell therapy** developed for the treatment of advanced or metastatic melanoma, especially in patients whose disease has progressed after immune checkpoint blockade or BRAF-targeted therapy. The therapy involves isolating T cells from a patient's blood and expanding those specific to tumor neoantigens using a proprietary ex vivo process called NEO-STIM. The resulting product, containing polyclonal CD4+ and CD8+ T cells reactive to multiple patient-specific tumor neoantigens, is administered back to the patient following lymphodepletion. The therapy is designed to maximize tumor-specific cytotoxicity while minimizing off-target effects by leveraging the unique mutations found in each patient's tumor. Phase 1 trial results show the approach is feasible, safe, can generate cytotoxic and polyfunctional neoantigen-reactive T cell populations, and demonstrates clinical proof of concept—though with limited objective responses to date. This cell therapy is part of a broader class related to Tumor-Infiltrating Lymphocyte (TIL) therapies and is under investigation both as monotherapy and in combination with immune checkpoint inhibitors[1][3][4][7][9][10].

Other names
NEOSTIM
02

Targets

pMHC (Peptide-MHC complex family)

Beyond the preview

Go deeper on BNT221.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on BNT221.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call