Drugs / Galinpepimut-S
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04040231 | Jul 2019 → Nov 2024 | Wilms tumor, malignant pleural mesothelioma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03761914 | Sep 2019 → Jul 2022 | acute myeloid leukemia, colorectal cancer, ovarian cancer, small cell lung carcinoma +1 | Sellas Life Sciences Group | Completed | No outcome recorded |
| Phase 1/2 | NCT01827137 | Apr 2013 → Dec 2016 | plasma cell myeloma | Sellas Life Sciences Group | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01266083 | Jan 2011 → Sep 2016 | acute lymphoblastic leukemia, acute myeloid leukemia | Sellas Life Sciences Group | Completed | No outcome recorded |
| Phase 2 | NCT01265433 | Dec 2010 → Nov 2016 | malignant pleural mesothelioma | Sellas Life Sciences Group | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04229979 | Feb 2021 → Dec 2025 overdue | acute myeloid leukemia | Sellas Life Sciences Group | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05593185 | — | acute myeloid leukemia, myelodysplastic syndrome | Sellas Life Sciences Group | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2025-01-23 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia sellaslifesciences.com ↗
Following this interim analysis triggered by 60 events (deaths) in the study population, the IDMC has recommended that the trial continue without modifications. |
| 2024-10-15 | Sellas Life Sciences Group | Regulatory SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric Acute Myeloid Leukemia sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to Galinpepimut-S (GPS), an immunotherapeutic targeting Wilms Tumor-1 (WT1), for the treatment of pediatric acute myeloid leukemia (AML). |
| 2023-12-27 | Sellas Life Sciences Group | Results SELLAS Life Sciences Reports Positive Follow-Up Immune Response and Survival Data in Completed Phase 1 Study of Galinpepimut-S Combined with Opdivo® in Advanced Malignant Pleural Mesothelioma sellaslifesciences.com ↗ |
| 2023-11-06 | Sellas Life Sciences Group | Results SELLAS Life Sciences Presents Positive Key Immunobiological and Clinical Data from Phase 1/2 Trial of Galinpepimut-S (GPS) in Combination with Keytruda® in WT1+ Platinum-Resistant Advanced Ovarian Cancer at the International Gynecologic Cancer Society 2023 Annual Global Meeting sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced final clinical and immunobiological data from the Phase 1/2 clinical trial of galinpepimut-S (GPS) in combination with pembrolizumab (Keytruda®) in Wilms’ tumor-1 (WT1)-positive platinum-resistant ovarian cancer (NCT03761914). |
| 2023-06-28 | Sellas Life Sciences Group | Results SELLAS Life Sciences Reports Positive Data in Completed Phase 1 Study of Galinpepimut-S Combined with Opdivo® in Advanced Malignant Pleural Mesothelioma sellaslifesciences.com ↗
70.3 weeks (17.6 months) median overall survival (OS) in patients who received the combination therapy (9/10 patients) and 54.1 weeks (13.5 months) for all ten patients (nine patients with combination therapy and one GPS only patient). |
| 2023-03-07 | Sellas Life Sciences Group | Results SELLAS Announces Publication of Positive GPS Clinical Data in Ovarian Cancer in Peer Reviewed Journal sellaslifesciences.com ↗
Immune Response Translated into Clear Clinical Benefit with 70% One-Year Progression-Free Survival Demonstrated in GPS-Treated Patients |
| 2022-11-14 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Update on Phase 3 REGAL Clinical Trial Evaluating Lead Asset, Galinpepimut-S, in Acute Myeloid Leukemia sellaslifesciences.com ↗
Accordingly, the overall duration of the REGAL study is now expected to be longer than initially predicted. |
| 2022-11-10 | Sellas Life Sciences Group | Results SELLAS Announces Confirmatory Top-Line Data Showing Survival and Clinical Benefits Based on the Final Analysis of the Phase 1/2 Clinical Trial of Galinpepimut-S in Combination with Keytruda® (pembrolizumab) in Patients with WT1+ Platinum-Resistant Advanced Ovarian Cancer sellaslifesciences.com ↗
Median Overall Survival for GPS Combination (GPS in Combination with Keytruda) was 18.4 Months Compared to 13.8 months in a Checkpoint Inhibitor Single Agent Study in a Similar Patient Population Treated with Checkpoint Inhibitor Alone |
| 2022-06-08 | Sellas Life Sciences Group | Results SELLAS Life Sciences Reports Encouraging Updated Clinical Data Indicating Increased Survival from Ongoing Phase 1 Mesothelioma Study of Galinpepimut-S Combined with Opdivo sellaslifesciences.com ↗ |
| 2022-05-26 | Sellas Life Sciences Group | Results SELLAS Reports Preliminary Data Showing Clinical Benefit from Phase 1/2 Clinical Trial of Galinpepimut-S (GPS) in Combination with Keytruda® in Patients with WT1+ Advanced Ovarian Cancer sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced top-line clinical data from its Phase 1/2 trial of galinpepimut-S (GPS), the Company’s Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients diagnosed with WT1(+) relapsed or refractory platinum resistant advanced metastatic ovarian cancer. |
| 2022-04-06 | Sellas Life Sciences Group | Regulatory SELLAS Life Sciences Announces Achievement of Development Milestone for Approval of IND for Galinpepimut-S in China sellaslifesciences.com ↗
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that an Investigational New Drug (“IND”) application to initiate the first clinical trial in China for 3D189, also known as SELLAS’ galinpepimut-S (GPS), has been approved by China’s National Medical Products Administration (“NMPA”). |
| 2022-04-05 | Sellas Life Sciences Group | Regulatory SELLAS Life Sciences Provides Business Update and First Quarter 2022 Highlights sellaslifesciences.com ↗
IND Application in China for Phase I Study of GPS Approved by China’s NMPA |
| 2021-06-30 | Sellas Life Sciences Group | Results SELLAS Reports Promising Updated Clinical Data and Initial Immune Response Profiles from Ongoing Phase 1/2 Study of Galinpepimut-S (GPS) Combined with Keytruda for Treating WT1+ Advanced Ovarian Cancer sellaslifesciences.com ↗
Updated Data Shows 100 Percent of Patients Alive and 45.5 Percent Continuing Investigational Therapy as of the Latest Follow-Up |
| 2021-06-24 | Sellas Life Sciences Group | Results SELLAS Reports Encouraging Updated Clinical Data from Ongoing Mesothelioma Study of Galinpepimut-S (GPS) Combined with Opdivo sellaslifesciences.com ↗
Updated Data Show Median Overall Survival of 35.4 Weeks in Patients Treated With Combination Therapy for at Least One Month |
| 2020-12-21 | Sellas Life Sciences Group | Results SELLAS Announces Promising Initial Clinical Data for Galinpepimut-S (GPS) in Combination with Checkpoint Inhibitors in Two Solid Tumor Indications sellaslifesciences.com ↗
In this difficult to treat patient population, at the first assessment time-point of 6 weeks post-therapy initiation, 100% of the patients were free of disease progression. |
| 2020-09-09 | Sellas Life Sciences Group | Regulatory SELLAS Receives IMPD Approval from the French Regulatory Authority for its Pivotal Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia sellaslifesciences.com ↗ |
| 2020-02-26 | Sellas Life Sciences Group | Results SELLAS Announces Positive Follow-Up Phase 1/2 Clinical Data for Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) sellaslifesciences.com ↗
The 21-month survival data observed further increases our confidence in the potential of GPS as a maintenance treatment for AML patients in CR2, the same patient population as our pivotal Phase 3 study, known as REGAL. |
| 2019-11-14 | Sellas Life Sciences Group | Results SELLAS Life Sciences Provides Business Update and Reports Third Quarter 2019 Financial Results sellaslifesciences.com ↗
These follow-up data now show that three of the 11 patients enrolled in the study have continued to show no signs of disease progression. |
| 2018-09-13 | Sellas Life Sciences Group | Regulatory SELLAS Receives Orphan Medicinal Product Designation Approval by the Committee for Orphan Medicinal Products of the European Medicines Agency for Galinpepimut-S for the Treatment of Patients with Multiple Myeloma sellaslifesciences.com ↗
“This OMPD endorsement by the COMP of the EMA for GPS in MM complements the orphan designation awarded by the US FDA for this product in the same indication,” |
| 2018-07-20 | Sellas Life Sciences Group | Regulatory SELLAS Receives Fast Track Designation from FDA for Galinpepimut-S for the Treatment of Patients with Multiple Myeloma sellaslifesciences.com ↗
SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead asset, galinpepimut-S (GPS), for the treatment of multiple myeloma (MM). |
| 2018-06-04 | Sellas Life Sciences Group | Results SELLAS Life Sciences Presents Interim Phase 1 Clinical Data of Galinpepimut-S (GPS) in Combination with Nivolumab to Treat Wilms Tumor 1 Positive (WT1+) Ovarian Cancer Patients at ASCO 2018 sellaslifesciences.com ↗
Data support continued development of GPS in combination with PD-1 inhibitors |
| 2018-05-09 | Sellas Life Sciences Group | Regulatory SELLAS Life Sciences Receives FDA Orphan Drug Designation for Galinpepimut-S (GPS) for Treatment of Multiple Myeloma (MM) sellaslifesciences.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its novel drug candidate, galinpepimut-S (GPS), for the treatment of multiple myeloma (MM). |
| 2018-03-19 | Sellas Life Sciences Group | Results SELLAS Life Sciences’ Phase 2 Results for Galinpepimut-S in High-Risk Multiple Myeloma Presented at European Society for Blood and Marrow Transplantation Meeting sellaslifesciences.com ↗
Median progression-free survival (PFS) of 23.6 months was reported in the high-risk disease setting, compared to historically inferior outcomes while on an immunomodulatory drug (IMID) or proteasome inhibitor post-ASCT maintenance. |
| 2018-02-27 | Sellas Life Sciences Group | Results Data From SELLAS Life Sciences’ Positive Phase 2 Acute Myeloid Leukemia Study Published in American Society of Hematology’s Journal, Blood Advances sellaslifesciences.com ↗
GPS met its pre-specified primary endpoint of ≥34% actual overall survival (OS) rate at three years with a GPS-induced OS rate of 47.4%. |
| 2017-09-14 | Sellas Life Sciences Group | Results SELLAS' Galinpepimut-S Induces Specific, Robust and Durable Immune Responses in Patients With High-Risk Multiple Myeloma - Correlated With Clinical Benefit sellaslifesciences.com ↗
SELLAS Life Sciences Group Ltd. (SELLAS), a privately-held, oncology-focused, clinical stage biopharmaceutical company, today reported that its WT1-targeting immuno-oncology (IO) treatment, galinpepimut-S, led to mounting of specific, potent and durable immune responses (IRs) in multiple myeloma (MM) patients. |
| 2017-03-01 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Updated Positive Phase 2 Data Reinforcing Meaningful Clinical Benefit of its WT1 Immunotherapeutic Anti-cancer Treatment in Multiple Myeloma Patients sellaslifesciences.com ↗
Consistent with preliminary data, the updated results indicate a meaningful clinical benefit among high-risk MM patients, positioning galinpepimut-S as a potential first-in-class immunotherapeutic cancer treatment. |
| 2016-10-13 | Sellas Life Sciences Group | Results SELLAS™ Life Sciences Announces Positive Interim Phase II Results from its WT1 Immunotherapeutic Anti-cancer Treatment in Multiple Myeloma Patients sellaslifesciences.com ↗
The study, which commenced in June 2014 and enrolled a total of 19 patients, demonstrated 86% actuarial overall survival (OS) of 18 months, with 17 of the 18 evaluable patients still alive today. |
| 2016-09-19 | Sellas Life Sciences Group | Regulatory SELLAS™ Life Sciences Receives FDA Fast Track Designation of Galinpepimut-S for the Treatment of Malignant Pleural Mesothelioma sellaslifesciences.com ↗
SELLAS™ Life Sciences Group (SELLAS), a development-stage biopharmaceutical company focused on developing innovative products to treat cancer, today announced that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for galinpepimut-S for the treatment of Malignant Pleural Mesothelioma (MPM) patients. |
| 2016-06-06 | Sellas Life Sciences Group | Results SELLAS™ Life Sciences Announces Exciting Results for Galinpepimut-S, the Company’s WT1 Vaccine, in Patients with Acute Myeloid Leukemia (AML) and Malignant Pleural Mesothelioma (MPM), as Presented at the 2016 ASCO Annual Meeting sellaslifesciences.com ↗ |
| 2016-05-04 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Positive WT1 Cancer Vaccine (galinpepimut-S) Clinical Results at the 13th International Conference of the International Mesothelioma Interest Group (iMig) sellaslifesciences.com ↗
The trial showed a median overall survival of 21.4 months for WT1 vaccine-treated patients versus a median 16.6 months overall survival for patients in the placebo control arm. |
| 2016-04-05 | Sellas Life Sciences Group | Regulatory SELLAS Life Sciences Group Receives a Favorable Opinion for European Orphan Drug Designations for WT1 Cancer Vaccine (galinpepimut-S) for the Treatment of Acute Myeloid Leukemia and for Malignant Pleural Mesothelioma sellaslifesciences.com ↗
the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has rendered a favorable opinion as regards Orphan Drug Designation for the Company’s WT1 cancer vaccine |
All press releases naming this drug 59 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | galinpepimut-S | “Participants will receive the galinpepimut-S vaccine and nivolumab over 16 weeks in the initial treatment phase.” NCT04040231 ↗ |
| Action | Deplete | “train the immune system to recognize and kill the cancerous cells containing WT1” NCT01827137 ↗ |
| Modality | Vaccine | “a Wilms Tumor-1 (WT1) vaccine” NCT01265433 ↗ |
| Route | Subcutaneous | “Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self administered)...” NCT01265433 ↗ |