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DRUG:

NOUS-209

i
Other names: GAd20-209-FSP, NOUS-209, MVA-209-FSP
Associations
Company:
Nouscom
Drug class:
Immunostimulant
Related drugs:
Associations
22d
NOUS-209 off-the-shelf immunotherapy has the potential to hit primary and metachronous colorectal and urothelial cancer in Lynch syndrome. (PubMed, Mol Cancer Ther)
These findings demonstrated that NOUS-209 FSMs are present in both CRCs and UCs in LS, expanding the therapeutic potential of NOUS-209 beyond CRC. Moreover, the emergence of novel targetable FSMs in metachronous tumors suggests that NOUS-209 immunotherapy may be effective in the prevention of both primary and metachronous LS-associated cancers.
Journal • IO biomarker
|
MSI (Microsatellite instability)
|
NOUS-209
2ms
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
P1/2, N=45, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2025 --> Sep 2026
Trial completion date • IO biomarker
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF mutation
|
NOUS-209
3ms
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
P1/2, N=45, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2026 --> Sep 2025
Trial completion date • IO biomarker
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF mutation
|
NOUS-209
4ms
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
P1/2, N=44, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2025 --> Jul 2026
Trial completion date • IO biomarker
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF mutation
|
NOUS-209
5ms
KEYNOTE-E58: Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
P1/2, N=115, Active, not recruiting, Nouscom SRL | Trial primary completion date: Apr 2025 --> Oct 2026
Trial primary completion date
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Keytruda (pembrolizumab) • NOUS-209
8ms
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
P1/2, N=44, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
Enrollment closed • IO biomarker
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF mutation
|
NOUS-209
9ms
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
P1/2, N=60, Recruiting, National Cancer Institute (NCI) | Active, not recruiting --> Recruiting | Trial primary completion date: Jul 2025 --> Mar 2025
Enrollment open • Trial primary completion date
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF mutation
|
NOUS-209
12ms
Characterization of shared neoantigens landscape in Mismatch Repair Deficient Endometrial Cancer. (PubMed, NPJ Precis Oncol)
A high coverage emerged from the comparative analysis of the EC FSPs with the content of the previously validated NOUS-209 vaccine. We obtained pieces of evidence of FSPs translation as expressed proteins from Ribo-seq, supporting the potential as the target of vaccination. The development of a nAgs-based vaccine strategy in MMRd EC may be further explored.
Journal • Mismatch repair
|
MLH1 (MutL homolog 1)
|
MSI-H/dMMR
|
NOUS-209
1year
KEYNOTE-E58: Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors (clinicaltrials.gov)
P1/2, N=115, Active, not recruiting, Nouscom SRL | Recruiting --> Active, not recruiting | Trial completion date: Jul 2026 --> Nov 2026
Enrollment closed • Trial completion date
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Keytruda (pembrolizumab) • NOUS-209
1year
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
P1/2, N=60, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting
Enrollment closed
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
|
NOUS-209
over1year
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
P1/2, N=60, Recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Mar 2025 --> Jul 2025
Trial completion date • Trial primary completion date
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
|
NOUS-209
over1year
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients (clinicaltrials.gov)
P1/2, N=60, Recruiting, National Cancer Institute (NCI) | N=45 --> 60 | Trial completion date: Jul 2025 --> Mar 2025 | Trial primary completion date: Jul 2025 --> Mar 2025
Enrollment change • Trial completion date • Trial primary completion date
|
BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
BRAF mutation • MSH2 mutation • MLH1 mutation • PMS2 mutation
|
NOUS-209