^
1m
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
2ms
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
1year
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
over1year
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
almost2years
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
Clinical • New P1 trial
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation
|
BNT221