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DRUG:

Zeltherva (galinpepimut-S)

i
Other names: FPI-01, WT-1 analog peptide vaccine, SLS-001, SLS001, WT1 Cancer Vaccine, WT-1 Vaccine, 3D189, 3D-189
Company:
3DMed, Ayala Pharma, Memorial Sloan-Kettering Cancer Center, SELLAS Life Sciences
Drug class:
Wilms tumor 1 inhibitor
3d
Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov)
P1/2, N=26, Completed, Sellas Life Sciences Group | Active, not recruiting --> Completed | N=90 --> 26
Trial completion • Enrollment change • Combination therapy • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PGR (Progesterone receptor) • WT1 (WT1 Transcription Factor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
|
HER-2 negative • KRAS wild-type • RAS wild-type • BRCA mutation • PGR negative
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
3d
Using a Targeted Cancer Vaccine (Galinpepimut-S) with Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Nov 2024 | Trial primary completion date: Jul 2025 --> Nov 2024
Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition
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WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
1m
Enrollment change
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WT1 (WT1 Transcription Factor)
|
Zeltherva (galinpepimut-S)
2ms
WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation (clinicaltrials.gov)
P1/2, N=20, Completed, Sellas Life Sciences Group | Unknown status --> Completed | Phase classification: PN/A --> P1/2
Trial completion • Phase classification
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WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule)
|
WT1 expression • WT1 positive
|
lenalidomide • bortezomib • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
3ms
Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov)
P1, N=15, Active, not recruiting, 3D Medicines | Trial primary completion date: May 2024 --> Dec 2024
Trial primary completion date
|
WT1 (WT1 Transcription Factor)
|
Zeltherva (galinpepimut-S)
3ms
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Checkpoint inhibition
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
8ms
SLSG18-301: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov)
P3, N=126, Active, not recruiting, Sellas Life Sciences Group | Recruiting --> Active, not recruiting
Enrollment closed
|
Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S) • hydroxyurea • Leukine (sargramostim)
1year
Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov)
P1, N=15, Active, not recruiting, 3D Medicines | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> May 2024
Enrollment closed • Trial primary completion date
|
WT1 (WT1 Transcription Factor)
|
WT1 expression • WT1 positive
|
Zeltherva (galinpepimut-S)
1year
PHASE 1/2 STUDY OF GALINPEPIMUT-S PLUS PEMBROLIZUMAB COMBINATION IN PATIENTS WITH WT1+ PLATINUM-RESISTANT OVARIAN CANCER IN 2ND/3RD LINE OF THERAPY (IGCS 2023)
Safety: N=25, GPS alone=8 (due to disease progression); >1 dose of combination =17. Median age: 64-yrs; median number of prior lines: 2. Five patients experienced 11 SAEs, one of which was drug related.
Clinical • P1/2 data
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CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule) • CSF2 (Colony stimulating factor 2)
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S)
over1year
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024
Trial completion date • Trial primary completion date • Checkpoint inhibition
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
over1year
Phase I Study of a Multivalent WT1 Peptide Vaccine (Galinpepimut-S) in Combination with Nivolumab in Patients with WT1-Expressing Ovarian Cancer in Second or Third Remission. (PubMed, Cancers (Basel))
Therapy included six (every two weeks) subcutaneous inoculations of galinpepimut-S vaccine adjuvanted with Montanide, low-dose subcutaneous sargramostim at the injection site, with intravenous nivolumab over 12 weeks, and up to six additional doses until disease progression or toxicity. Coadministration of galinpepimut-S and nivolumab demonstrated a tolerable toxicity profile and induced immune responses, as indicated by immunophenotyping and WT1-specific IgG production. Exploratory analysis for efficacy yielded a promising 1-year PFS rate.
P1 data • Journal • Combination therapy
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
almost2years
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed • Checkpoint inhibition
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
2years
Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov)
P1, N=15, Recruiting, 3D Medicines | Not yet recruiting --> Recruiting | Trial completion date: Jun 2024 --> Dec 2024
Enrollment open • Trial completion date
|
WT1 (WT1 Transcription Factor)
|
WT1 expression • WT1 positive
|
Zeltherva (galinpepimut-S)
over2years
New P1 trial
|
WT1 (WT1 Transcription Factor)
|
WT1 expression • WT1 positive
|
Zeltherva (galinpepimut-S)
over2years
Acute Onset, Rapidly Progressive Anti-Yo Positive Paraneoplastic Cerebellar Degeneration, Associated with Ovarian Cancer, in the Setting of Immune Checkpoint Inhibitor Pembrolizumab Use: a Case Report (AAN 2022)
The patient was on a clinical trial with Galinpepimut-S, a Wilms’ tumor 1 peptide vaccine, and pembrolizumab, an immune checkpoint inhibitor, and she had received six cycles when she developed the symptoms. To the best of our knowledge, this is the first case reported for acute onset, rapidly progressive anti-Yo positive paraneoplastic cerebellar degeneration associated with an immune checkpoint inhibitor, pembrolizumab use. Early recognition of the condition and timely discontinuation of an immune checkpoint inhibitor is crucial for the neurological outcome.
Clinical • Checkpoint inhibition
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WT1 (WT1 Transcription Factor)
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S)
over2years
Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov)
P1/2, N=90, Active, not recruiting, Sellas Life Sciences Group | Recruiting --> Active, not recruiting | Trial completion date: Apr 2024 --> Apr 2023 | Trial primary completion date: Jan 2024 --> Nov 2022
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PGR (Progesterone receptor) • WT1 (WT1 Transcription Factor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
|
HER-2 negative • KRAS wild-type • RAS wild-type • BRCA mutation • PGR negative
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S) • hydroxyurea
over3years
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov)
P1, N=10, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2023
Clinical • Trial completion date • Trial primary completion date • Checkpoint inhibition
|
WT1 (WT1 Transcription Factor)
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S) • Leukine (sargramostim)
over3years
A Phase I Study of WT1 or NY-ESO-1 Vaccine and Nivolumab For Recurrent Ovarian Cancer (clinicaltrials.gov)
P1, N=11, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=20 --> 11 | Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Apr 2022 --> Apr 2023
Clinical • Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
WT1 (WT1 Transcription Factor) • MUC16 (Mucin 16, Cell Surface Associated) • CTAG1B (Cancer/testis antigen 1B)
|
WT1 expression • CTAG1B expression • WT1 positive
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S)
over3years
Galinpepimut-S (GPS): an investigational agent for the treatment of acute myeloid leukemia. (PubMed, Expert Opin Investig Drugs)
Introduction: Acute myeloid leukemia (AML) is a disorder wherein clonal expansion of undifferentiated myeloid precursors results in compromised hematopoiesis and bone marrow failure. GPS has been shown to be safe and tolerable in phase 1 and phase 2 studies and is now being evaluated in a phase 3 study.Expert opinion: Given the unmet need in the treatment of relapsed and refractory AML, especially among the elderly and patients with comorbidities who are not fit enough to undergo traditional salvage treatments, GPS could potentially fill the gap for this subset of patients. Future clinical trials utilizing GPS in second complete remission 2 (CR2) compared to best available therapy in AML and in combination with other immunotherapeutic agents (like pembrolizumab) for treatment for various malignancies are underway.
Journal
|
WT1 (WT1 Transcription Factor)
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S)
over3years
Clinical • New P3 trial
|
WT1 (WT1 Transcription Factor)
|
Venclexta (venetoclax) • cytarabine • azacitidine • decitabine • Zeltherva (galinpepimut-S)
over3years
Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov)
P1/2, N=90, Recruiting, Sellas Life Sciences Group | Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Dec 2020 --> Jan 2024
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PGR (Progesterone receptor) • WT1 (WT1 Transcription Factor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
|
HER-2 negative • BRCA mutation • PGR negative
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S) • hydroxyurea
almost4years
A Phase I Study of WT1 or NY-ESO-1 Vaccine and Nivolumab For Recurrent Ovarian Cancer (clinicaltrials.gov)
P1, N=20, Recruiting, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Recruiting | N=11 --> 20 | Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Apr 2021 --> Apr 2022
Clinical • Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
WT1 (WT1 Transcription Factor) • MUC16 (Mucin 16, Cell Surface Associated) • CTAG1B (Cancer/testis antigen 1B)
|
WT1 expression • CTAG1B expression • WT1 positive
|
Opdivo (nivolumab) • Zeltherva (galinpepimut-S)
4years
Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov)
P1/2, N=90, Recruiting, Sellas Life Sciences Group | Trial completion date: Jul 2021 --> Apr 2023
Clinical • Trial completion date • Combination therapy • BRCA Biomarker • PD(L)-1 Biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • PGR (Progesterone receptor) • WT1 (WT1 Transcription Factor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
|
HER-2 negative • BRCA mutation • PGR negative
|
Keytruda (pembrolizumab) • Zeltherva (galinpepimut-S) • hydroxyurea