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PVX-410
i
Other names: XBP1-US/XBP1-SP/CD138/CS1 multipeptide vaccine PVX-410, PVX 410, PVX-410
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Company:
OncoPep
Drug class:
CS-1 inhibitor, CD138 inhibitor, XBP1 inhibitor
Related drugs:
1m
A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM (clinicaltrials.gov)
P1, N=19, Active, not recruiting, Massachusetts General Hospital | Phase classification: P1b --> P1 | Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Sep 2024
Phase classification • Trial completion date • Trial primary completion date • Epigenetic controller
|
lenalidomide • Hiltonol (poly-ICLC) • PVX-410 • citarinostat (ACY-241)
5ms
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Massachusetts General Hospital
Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • HLA-A2 positive
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Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
6ms
PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=20, Active, not recruiting, Massachusetts General Hospital | Phase classification: P1b --> P1 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Jun 2024
Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative
|
Keytruda (pembrolizumab) • PVX-410
6ms
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Massachusetts General Hospital | Phase classification: P1b --> P1
Phase classification • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • HLA-A2 positive
|
Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
7ms
Immune Profiling and Responses of Smoldering Multiple Myeloma Patients Treated in a Phase Ib Study of Pvx-410 Vaccine Targeting XBP1/CD138/CS1 Antigens, and Citarinostat, a Histone Deacetylase Inhibitor (HDACi) with and without Lenalidomide (ASH 2023)
There was one grade 3 trAE: specifically, a thromboembolic event in one patient who was receiving lenalidomide and despite aspirin prophylaxis, but who fully recovered. PB and marrow transcriptome profiling along with the immunogenicity studies are in progress and will be presented. We will evaluate whether PB mononuclear cells have the potential to replace BM as a surrogate for genetic and immunological surveillance in SMM, as we anticipate that further understanding of the immune alterations among patients with SMM and the response to immunomodulatory therapy may provide insight on early intervention and prevention of progression to symptomatic disease.
Clinical • P1 data • Epigenetic controller
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • SDC1 (Syndecan 1) • XBP1 (X-box-binding protein 1)
|
lenalidomide • PVX-410 • aspirin • citarinostat (ACY-241)
over1year
PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P1b, N=20, Active, not recruiting, Massachusetts General Hospital | Trial primary completion date: Dec 2022 --> Jun 2023
Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative
|
Keytruda (pembrolizumab) • PVX-410
over1year
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov)
P1b, N=22, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Dec 2021 --> Jun 2023
Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative • HLA-A2 positive
|
Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
over2years
Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer (clinicaltrials.gov)
P2, N=53, Not yet recruiting, OncoPep, Inc. | Initiation date: Apr 2021 --> Nov 2021
Clinical • Trial initiation date
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • HLA-A2 positive
|
Keytruda (pembrolizumab) • PVX-410
3years
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer (clinicaltrials.gov)
P1b, N=22, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Feb 2022 --> Sep 2022 | Trial primary completion date: Feb 2021 --> Dec 2021
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative
|
Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
3years
PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
P1b, N=20, Active, not recruiting, Massachusetts General Hospital | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Dec 2022
Clinical • Enrollment closed • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative
|
Keytruda (pembrolizumab) • PVX-410
over3years
A Single-Arm, Open-Label, Multi-Center Phase II Study to Evaluate the Combination of PVX-410 + Pembrolizumab + Chemotherapy for Frontline Therapy of Metastatic, PD-L1+ Triple-Negative Breast Cancer (TNBC) in HLA-A2-Positive Patients (clinicaltrials.gov)
P2, N=53, Not yet recruiting, OncoPep, Inc.
Clinical • New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • PVX-410
over4years
A phase 1b study of PVX-410 (PVX) vaccine plus durvalumab (DUR) as adjuvant therapy in HLA-A2+ early stage triple negative breast cancer (eTNBC) to assess safety and immune response (SABCS 2019)
Pts received 6 doses of 800ug PVX (subcutaneously) emulsified in Montanide and co-administered with Hiltonol (IM) every 2 weeks, and 2 doses of 1500mg DUR (IV) concurrent with the 4th and 6th vaccine treatments. Immune response data demonstrate that PVX induces antigen-specific T cell expansion and activation in these pts as observed by increases in PVX tetramer, IFN?, TNF?, IL-2 and CD137 positive T cells. These immune responses to PVX persisted for up to 6 months in most patients, indicating a prolonged immune response.
Clinical • P1 data
|
IL2 (Interleukin 2)
|
Imfinzi (durvalumab) • Hiltonol (poly-ICLC) • PVX-410
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