SurVaxM (SVN53-67/M57-KLH peptide vaccine) / MimiVax, Fosun Pharma - LARVOL DELTA

Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma. (PubMed, J Clin Oncol) - P2 | "SurVaxM appeared to be safe and well tolerated. The combination represents a promising therapy for nGBM. For patients with nGBM treated in this manner, PFS may be an acceptable surrogate for OS. A large randomized clinical trial of SurVaxM for nGBM is in progress."

Clinical • Journal • P2a data • Brain Cancer • CNS Tumor • Glioblastoma • Immunology • Oncology • Solid Tumor • BIRC5 • CD8

Testing the SurVaxM Vaccine for Lung Cancer Prevention (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2029 ➔ Dec 2029 | Initiation date: Jul 2026 ➔ Oct 2026

Trial completion date • Trial initiation date • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas (clinicaltrials.gov) - P2 | N=60 | Suspended | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Suspended

Trial suspension • Endocrine Cancer • Gastrointestinal Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor

Prospective, randomized, placebo-controlled phase 2b trial of SurVaxM plus adjuvant temozolomide in newly diagnosed glioblastoma (SURVIVE). (ASCO 2026) - P2 | "Key eligibility criteria include age ≥18 years; Karnofsky performance status ≥70; pathologically confirmed cerebral GBM meeting 2021 WHO criteria with available MGMT and IDH status; gross-total or near-total resection with minimal residual enhancement on immediate postoperative MRI (≤72 hours); completion of chemoradiation with ≥75% of planned concurrent temozolomide; no evidence of progression on post-chemoradiation MRI; randomization within approximately 16–18 weeks of resection; and dexamethasone ≤4 mg/day at enrollment. The alternate hypothesis assumes a 1-year survival rate of 75% in the SurVaxM group (Arm A; comparable to a median overall survival (mOS) of 29 months assuming an exponential distribution) and 60% in the control group (Arm B; comparable to a mOS of 16 months assuming an exponential distribution). Clinical trial information: NCT05163080."

Clinical • IO biomarker • P2b data • Brain Cancer • Glioblastoma • Solid Tumor • BIRC5 • MGMT

A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Feb 2030 ➔ Dec 2027 | Trial primary completion date: Apr 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Glioma • High Grade Glioma • Medulloblastoma • Oligodendroglioma • Oncology • Pediatrics • Solid Tumor

SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: May 2026 ➔ Dec 2026

Trial completion date • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

MimiVax and Roswell Park Open Phase 2 Trial of SurVaxM for Patients with Metastatic Neuroendocrine Tumors (Newswise) - "The phase 2 study compares the safety and effect of temozolomide combined with SurVaxM to temozolomide alone in patients with metastatic NETs that are progressing."

Trial status • Gastrointestinal Neuroendocrine Tumor • Lung Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

Testing the SurVaxM Vaccine for Lung Cancer Prevention (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2027 ➔ Sep 2029 | Initiation date: Feb 2026 ➔ Jun 2026 | Trial primary completion date: Sep 2027 ➔ Mar 2029

Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

CLO26-074: A Phase I Study of Safety and Immunogenicity of Survivin Long Peptide Vaccine (SurVaxM) in Patients with Metastatic Neuroendocrine Tumors (NETs). (PubMed, J Natl Compr Canc Netw) - No abstract available

Journal • P1 data • Neuroendocrine Tumor • Oncology • Solid Tumor • BIRC5

CLO26-074: A Phase I Study of Safety and Immunogenicity of Survivin Long Peptide Vaccine (SurVaxM) in Patients with Metastatic Neuroendocrine Tumors (NETs). (PubMed, J Natl Compr Canc Netw) - No abstract available

Journal • P1 data • Neuroendocrine Tumor • Oncology • Solid Tumor • BIRC5

NCI-2015-00694: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Mar 2026 ➔ Jun 2026

Trial completion date • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

A Phase I Study of Safety and Immunogenicity of Survivin Long Peptide Vaccine (SurVaxM) in Patients with Metastatic Neuroendocrine Tumors (NETs) (NCCN 2026) - "SurvaxM is safe and demonstrates modest clinical benefits, with 29% of patients achieving a PFS > 6 months. Further studies evaluating SurVaxM in combination with temozolomide in G3 NET patients are underway."

Clinical • Metastases • P1 data • Infectious Disease • Neuroendocrine Tumor • Novel Coronavirus Disease • Oncology • Solid Tumor • BIRC5 • CD8 • CSF2 • IFNG

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Roswell Park Cancer Institute | Suspended ➔ Recruiting

Enrollment open • Endocrine Cancer • Gastrointestinal Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor

NCI-2015-00694: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Nov 2025 ➔ Mar 2026

Trial completion date • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas (clinicaltrials.gov) - P2 | N=60 | Suspended | Sponsor: Roswell Park Cancer Institute | Not yet recruiting ➔ Suspended

Trial suspension • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Biomarker Analysis Reveals Clues to Long-Term Survival in Glioblastoma Patients Treated with SurVaxM (Newswise) - "Investigators used whole-exome and RNA sequencing to identify genetic variations and levels of gene activity in the pre-treated tumors of 34 of those patients. They then compared the tumor profiles of patients who had short-term overall survival (fewer than 18 months) versus long-term overall survival (more than 18 months). They found that the tumors of long-term survivors contained especially high proportions of B cells and T cells — part of the immune system’s cancer-killing arsenal — and enriched gene sets for interferon-gamma (IFN-γ) and interferon-alpha (IFN-α), which help the immune system launch a stronger attack against the tumor....Ten patients have survived seven years or longer after receiving SurVaxM, including five patients whose disease has not recurred."

Biomarker • P2 data • Glioblastoma

Intratumoral B cell and interferon signatures in newly diagnosed glioblastoma are associated with longer survival in patients treated with SurVaxM. (PubMed, Cancer Immunol Immunother) - P2 | "A five-gene expression signature and a B cell specific signature predicted survival within the SurVaxM-treated cohort, however, these signatures were not associated with improved outcomes in a similarly treated population obtained from The Cancer Genome Atlas (TCGA) that did not receive immunotherapeutic intervention. Although prospective validation is ongoing, the findings in this discovery cohort specify molecular features of GBM associated with better overall survival and potential responsiveness to immunotherapy with SurVaxM."

IO biomarker • Journal • Retrospective data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD20

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | N=132 ➔ 60

Enrollment change • Endocrine Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Testing the SurVaxM Vaccine for Lung Cancer Prevention (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P2 trial • Lung Cancer • Oncology • Solid Tumor

Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Completed | N=14 ➔ 19 | Trial completion date: Dec 2026 ➔ Mar 2025 | Trial primary completion date: Dec 2025 ➔ Feb 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Carcinoid Tumor • Gastrointestinal Cancer • Neuroendocrine Tumor • Solid Tumor

A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: Pediatric Brain Tumor Consortium | Recruiting ➔ Active, not recruiting

Enrollment closed • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Glioma • High Grade Glioma • Medulloblastoma • Oligodendroglioma • Oncology • Pediatrics • Solid Tumor

NCI-2015-00694: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Jun 2025 ➔ Sep 2025

Trial completion date • Brain Cancer • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

Survivin Interference and SurVaxM as an Adjunct Therapy for Glioblastoma Multiforme. (PubMed, Cells) - "SurVaxM, a multiple peptide, survivin-specific vaccine, may assist in tumor cell destruction by eliciting the production of cytotoxic T-cells specific to survivin-expression glioblastoma tumors. Although phase I and II clinical trials suggest relatively safe adverse effects and potential efficacy, additional research is necessary to evaluate further how this vaccine may compare to standard treatment."

Journal • Review • Brain Cancer • Glioblastoma • Oncology • Pediatrics • Solid Tumor • BIRC5

Roswell Park Announces Positive Progress in Clinical Trial of Novel Immunotherapy SurVaxM (Cision) - "Four studies that incorporate SurVaxM are currently underway: NCT03879694, a phase 1 study in adults with neuroendocrine tumors - underway at Roswell Park under the direction of Renuka Iyer, MD, and open for recruitment."

Roswell Park Announces Positive Progress in Clinical Trial of Novel Immunotherapy SurVaxM (PRWeb) - "Roswell Park Comprehensive Cancer Center today announced that the ongoing phase 2B SURVIVE clinical trial of SurVaxM in glioblastoma will continue following an interim analysis of trial data....Based on the results of a recently completed interim futility analysis, and ongoing review by the study's Independent Data Safety Monitoring Board, the SURVIVE trial (NCT05163080) will continue as planned without modification. While regulatory requirements bar disclosure of detailed data findings from randomized, controlled studies still in progress, the findings of the interim analysis met prespecified standards for the research to continue."

Trial status • Glioblastoma