^
    3d
    A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, BioNTech US Inc. | Trial completion date: Oct 2025 --> Dec 2029 | Trial primary completion date: Oct 2025 --> Dec 2029
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    2ms
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, BioNTech US Inc. | N=72 --> 22
    Enrollment change • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    3ms
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, BioNTech US Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    over1year
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=72, Recruiting, BioNTech US Inc. | N=52 --> 72
    Enrollment change • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    over1year
    NTC-001: A phase I study to test safety and efficacy of BNT221, a non-engineered neoantigen-specific T cell product, in patients with advanced or metastatic melanoma (ESMO 2023)
    Conclusions In this first in human study, BNT221 as a single infusion therapy demonstrated a tolerable safety profile, product persistence, prolonged stable disease, and tumor regressions in patients with checkpoint inhibitor-resistant metastatic melanoma. Additional study is warranted and BNT221 combination with anti-PD-1 is currently underway.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    BNT221
    almost2years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=52, Recruiting, BioNTech US Inc. | Trial primary completion date: Nov 2023 --> Oct 2025
    Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    2years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=52, Recruiting, BioNTech US Inc. | Trial completion date: Nov 2023 --> Dec 2025
    Trial completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    over3years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=52, Recruiting, BioNTech US Inc. | N=32 --> 52
    Clinical • Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    over3years
    [VIRTUAL] BNT221, an autologous neoantigen specific T cell product for adoptive cell therapy of metastatic melanoma (CIMT 2021)
    Conclusions NEO-STIM is a novel platform that is capable of generating ex vivo T cell responses to high-quality neoantigen- targets. A first in human study with this adoptive cell therapy, BNT221, in patients with metastatic melanoma is now underway.
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    BNT221
    4years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=32, Recruiting, BioNTech US Inc.
    Clinical • New P1 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221