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

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

Survivin-based vaccine induces durable tumor regression when integrated with specific sequential antiangiogenic and immune checkpoint therapies (ITOC 2025) - "Conclusions This study demonstrates that the survivin peptide vaccine, when precisely integrated with Axitinib and anti-PD1, achieves a clear synergy on profound tumor regression and durable immune responses in an orthotopic renal carcinoma model. Tritherapy significantly outperforms monotherapies and double combinations in tumor control. These findings underscore the critical role of treatment sequencing and position the vaccine as a cornerstone for innovative combinatorial cancer therapies."

Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BIRC5 • CD4 • CD8 • GZMB • IFNG • IL2

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: Dec 2024 ➔ Jun 2025

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

MimiVax Announces Positive Interim Analysis in Ongoing SurVaxM Clinical Trial (PRNewswire) - "MimiVax...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. The analysis, conducted as part of the company's rigorous clinical development program, has provided valuable insights that support the continued advancement of the trial....While the company is unable to disclose specific details about the interim analysis due to regulatory requirements set forth by the U.S. Food and Drug Administration (FDA), MimiVax remains confident in the potential of SurVaxM and is committed to advancing the study as planned....Based on the results of the recent interim futility analysis, and ongoing review by the study's Independent Data Safety Monitoring Committee, the SURVIVE trial will continue as designed without modification....The company will provide updates at appropriate milestones, in accordance with regulatory requirements."

DSMB • Enrollment closed • Glioblastoma

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 | Recruiting | Sponsor: Pediatric Brain Tumor Consortium | Trial completion date: Jun 2028 ➔ Feb 2030 | Trial primary completion date: Aug 2025 ➔ Apr 2027

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

MimiVax and UI Pharmaceuticals Achieve Milestone in SurVaxM Production for Glioblastoma Treatment (PRNewswire) - "MimiVax, Inc. and UI Pharmaceuticals are proud to announce the successful clinical manufacture of SurVaxM...at UIP's recently qualified $26M sterile manufacturing facility. This collaboration combines MimiVax's innovative research with UIP's expertise in formulation development and sterile production, accelerating the path to potentially transformative therapies for patients."

Commercial • Glioblastoma

Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Metastases • Trial completion date • Trial primary completion date • Carcinoid Tumor • Endocrine Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

A multicenter, randomized, controlled phase 2b trial of survivin vaccine SurVaxM plus adjuvant temozolomide for newly-diagnosed glioblastoma (SURVIVE) (SNO 2024) - P2 | "A single sequential OS-driven interim analysis is planned when 50% of deaths occur. Trial is fully enrolled (NCT05163080)."

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

A multicenter, randomized, controlled phase 2b trial of survivin vaccine SurVaxM plus adjuvant temozolomide for newly-diagnosed glioblastoma (SURVIVE) (SNO 2024) - P2 | "A single sequential OS-driven interim analysis is planned when 50% of deaths occur. Trial is fully enrolled (NCT05163080)."

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

Immunotherapeutic Advances in Glioma Management: The Rise of Vaccine-Based Approaches (EANO 2024) - "For example, the IMA950 peptide vaccine resulted in progression-free survival rates of 74% at 6 months and 31% at 9 months in newly diagnosed GBM patients. Similarly, the SurVaxM peptide vaccine led to 95.2% of patients remaining progression-free at 6 months, with an average progression-free survival of 11.4 months and an overall survival of 25.9 months...Dendritic cell vaccines, such as DCVax-L and α-type-1 DC vaccines, demonstrated improvements in overall survival in GBM patients, with long-term benefits observed in patients with a methylated MGMT promoter... Glioma vaccines show promise in stimulating immune responses against tumours, offering potential benefits alongside standard treatments. Challenges in assessing vaccine efficacy and addressing treatment-related adverse effects emphasise the need for further research and clinical trials. Challenges like tumour heterogeneity and immune evasion persist, but advances in genetic engineering and immunotherapy offer hope..."

IO biomarker • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • CSF2

Updates for newly diagnosed and recurrent glioblastoma: a review of recent clinical trials. (PubMed, Curr Opin Neurol) - "Although progress to improve outcomes for GBM patients has been modest, multiple novel strategies utilizing combination therapies, focused ultrasound to improve drug delivery, and novel immunotherapies are underway."

Journal • Review • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

RESURGe: Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence (clinicaltrials.gov) - P2 | N=41 | Completed | Sponsor: David Peereboom | Active, not recruiting ➔ Completed

Trial completion • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors (clinicaltrials.gov) - P2 | N=132 | Not yet recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Jan 2028 ➔ Oct 2028 | Initiation date: Jul 2024 ➔ Oct 2024 | Trial primary completion date: Jan 2027 ➔ Oct 2027

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Phase 2 trial of pembrolizumab plus SurVaxM for patients with glioblastoma at first recurrence (RESURGe). (ASCO 2024) - P2 | "Clinical Trial Registration Number: NCT04013672"

Clinical • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

A multicenter, randomized controlled phase 2b trial of survivin vaccine SurVaxM plus adjuvant temozolomide for newly diagnosed glioblastoma (SURVIVE). (ASCO 2024) - P2 | "A single sequential OS-driven interim analysis is planned when 50% of OS events (deaths) occur. 205 patients have been enrolled as of January 2024."

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

US FDA awards Supplemental Orphan Drug Designation to SurVaxM to now include treatment of Malignant Glioma (PRNewswire) - "MimiVax Inc...today announced that the United States Food and Drug Administration (FDA) has awarded a supplemental orphan drug designation to MimiVax's SurVaxM vaccine to now include malignant glioma. Currently, SurVaxM vaccine is being studied as a treatment for newly diagnosed glioblastoma (nGBM) in a phase 2b randomized clinical study (the SURVIVE trial) which will assess the efficacy of SurVaxM in a large patient population with nGBM. This supplemental orphan drug designation greatly expands the potential for SurVaxM's use in other forms of pediatric and adult malignant gliomas."

Orphan drug • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor