Drugs / SVN53-67/M57-KLH Peptide Vaccine
SVN53-67/M57-KLH Peptide Vaccine
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04978727 | Jul 2022 → Dec 2027 expected | anaplastic astrocytoma, anaplastic ependymoma, anaplastic oligodendroglioma, diffuse intrinsic pontine glioma +3 | Children's Oncology Group | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03879694 | Jun 2019 → Feb 2025 | atypical carcinoid tumor, lung carcinoid tumor, pancreatic neuroendocrine tumor | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02334865 | Apr 2017 → Sep 2022 overdue | plasma cell myeloma | Roswell Park Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01250470 | Sep 2012 → May 2014 | anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, giant cell glioblastoma +1 | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT06202066 | Jul 2026 → Oct 2027 expected | cancer, lung neuroendocrine neoplasm, pancreatic neuroendocrine neoplasm | Roswell Park Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07169617 | Jul 2026 → Mar 2029 expected | lung carcinoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04013672 | Mar 2020 → Aug 2021 | glioblastoma | David Peereboom | Completed | No outcome recorded |
| Phase 2 | NCT02455557 | May 2015 → Oct 2019 overdue | gliosarcoma | Roswell Park Cancer Institute | Active not recruiting | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT04802447 | — | glioblastoma | Roswell Park Cancer Institute | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05163080 Comparator | Nov 2021 → Aug 2024 | glioblastoma | MimiVax, LLC | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-02-13 | MimiVax, LLC | Results MimiVax Announces Positive Interim Analysis in Ongoing SurVaxM Clinical Trial mimivax.com ↗
MimiVax, Inc., a leader in clinical-stage pharmaceutical research, today announced that its now fully enrolled Phase 2b clinical trial of SurVaxM in glioblastoma, [ SURVIVE ] ( NCT05163080 ), has successfully progressed following the first interim analysis of trial data. |
| 2023-10-12 | MimiVax, LLC | Regulatory MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma mimivax.com ↗
the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MimiVax’s SurVaxM vaccine |
| 2022-12-15 | MimiVax, LLC | Results MimiVax Announces Positive Final Data from the Phase IIa Study of SurVaxM for Newly Diagnosed Glioblastoma Published Today in the Journal of Clinical Oncology mimivax.com ↗
The current study found that 51% of nGBM patients receiving SurVaxM had survived at least 2 years and 41% had survived 3 years, considerably higher rates than has been seen historically from standard care. |
| 2021-11-15 | MimiVax, LLC | Regulatory MimiVax, LLC Receives FDA Approval to Initiate a New Phase 2b Clinical Study for the Treatment of Newly Diagnosed Glioblastoma mimivax.com ↗
MimiVax LLC , a clinical-stage biotechnology company in Buffalo, NY, USA, developing immunotherapeutics for cancer and autoimmune diseases, announced today that the company has received a “Study May Proceed” notification from the United States Food and Drug Administration (FDA) to begin a Phase 2b trial, for SurVaxM in newly diagnosed glioblastoma entitled “SURVIVE.” |
| 2019-05-29 | MimiVax, LLC | Results MimiVax to present results of SurVaxM immunotherapy in glioblastoma at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting mimivax.com ↗
Updated median progression free survival (mPFS) is now 15.5 months from diagnosis. |
| 2017-08-07 | MimiVax, LLC | Regulatory MimiVax awarded Orphan Drug Designation by US FDA for SurVaxM to treat glioblastoma patients mimivax.com ↗
The U.S. Food and Drug Administration has awarded orphan drug status to a promising immunotherapy vaccine developed at Roswell Park Comprehensive Cancer Center. |
All press releases naming this drug 10 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SVN53-67/M57-KLH Peptide Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06202066 ↗ |
| Known as | SurVaxM | “SurVaxM is a peptide vaccine conjugate that has been shown to activate the immune system against its target molecule survivin, which is highly expressed by glioblastoma cells” PMID 36521103 ↗ Dec 20225“a survivin peptide vaccine called SurVaxM” NCT07169617 ↗ |
| Known as | SVN53-67/M57-KLH | “This is a multicenter pilot study of SurVaxM (SVN53-67/M57-KLH) for children and young adults with progressive or relapsed medulloblastoma, high grade glioma, ependymoma and...” NCT04978727 ↗5“yielding a molecule designated as SVN53-67/M57-KLH. The SVN53-67/M57-KLH conjugate (SurVaxM)produces immune responses in mice and humans that are cross-reactive to the...” NCT05163080 ↗ “the SVN53-67/M57-KLH peptide in Montanide ISA 51 (Montanide ISA-51/survivin peptide vaccine) plus with GM-CSF (sargramostim).” NCT01250470 ↗ “Each participant will receive 4 doses of SVN53-67/M57-KLH (SurVaxM) spaced two weeks apart.” NCT04802447 ↗ |
| Action | Deplete | “Vaccines made from survivin peptide may help the body build an effective immune response to kill tumor cells.” NCT01250470 ↗ |
| Modality | Vaccine | “survivin peptide vaccine” NCT01250470 ↗ |
| Route | Subcutaneous | “Patients receive Montanide ISA-51/survivin peptide vaccine subcutaneously (SC)” NCT01250470 ↗ |
| Target | BIRC5 | “Baculoviral IAP repeat-containing protein 5 vaccine antigen” CHEMBL4650424 ↗ |