Sitoiganap (ERC1671) / Epitopoietic Research Corp - LARVOL DELTA

Glioblastoma Cell Lysate and Adjuvant Nanovaccines via Strategic Vaccination Completely Regress Established Murine Tumors. (PubMed, Adv Healthc Mater) - "In an orthotopic hRas-GBM model induced by a lentiviral plasmid, GlioVac resulted in ≈100% complete tumor regression. These findings suggest that GlioVac provides a personalized therapeutic vaccine strategy for glioblastoma."

Journal • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • HRAS

ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme (clinicaltrials.gov) - P2 | N=84 | Active, not recruiting | Sponsor: Epitopoietic Research Corporation | Trial completion date: Mar 2023 ➔ Jun 2026 | Trial primary completion date: Mar 2023 ➔ Mar 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Gliosarcoma • Malignant Glioma • Oncology • Sarcoma • Solid Tumor • CD4 • CSF2

Gliovac/ERC1671/SITOIGANAP : AN ANTI-CANCER IMMUNOTHERAPY – PRODUCT AND PROGRESS (Epitopoietic Research Corp Press Release) - "The Gliovac/ERC1671/SITOIGANAP approach is a cell-based therapy recognised by Health Authorities as an ATMP (Advance Therapeutic Medicinal product) by the Committee for Advanced Therapies at the EMA (Record reference: EMA/CAT/324279/2012). Gliovac/ERC1671/SITOIGANAP has been granted an Orphan drug designation by the Committee for Orphan Medicinal Products at the EMA in November 2013 (Record reference: EU 3/13/1211) and by FDA (12/01/2011)."

Orphan drug • Glioblastoma

ERC Granted FDA Fast Track Designation for Sitoiganap in Patients with Recurrent Glioblastoma (GlobeNewswire) - "ERC Belgium S.A....announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sitoiganap® (Gliovac or ERC1671) ERC’s cell-based immunotherapy for the treatment of glioblastoma, the most aggressive form of brain cancer...The FDA stated, 'That Sitoiganap, combined with GM-CSF and cyclophosphamide and bevacizumab, for the treatment of recurrent glioblastoma to improve overall survival meets the criteria for Fast Track designation.' Fast Track addresses a broad range of serious conditions."

Fast track • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

PHASE 2 STUDY OF ERC1671 PLUS BEVACIZUMAB VS BEVACIZUMAB PLUS PLACEBO IN RECURRENT GBM INTERIM RESULTS AND CORRELATIONS WITH CD4+ T LYMPHOCYTE COUNTS (SNO 2018) - P2; "The addition of ERC1671/GM-CSF/cyclophosphamide to bevacizumab resulted in a potential survival benefit with minimal additional toxicity. The maximal CD4+ T lymphocyte count in the peripheral blood correlated with OS. The study is ongoing with the addition of two other sites."

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

[VIRTUAL] Double-Blinded, Placebo Controlled Phase 2 Study of ERC1671 in Recurrent Glioblastoma: Vaccine Overall Survival in Bevacizumab Naive and Bevacizumab Resistant Patients (SNO 2020) - "Goals of this ongoing, phase 2 study are to determine the safety and effectiveness (overall survival) of ERC1671 in combination with GM-CSF and cyclophosphamide as an add-on treatment to bevacizumab at the time of GBM recurrence. First clinical results for toxicity show no difference in the distribution of AEs between the Vaccine and Placebo groups, with no Gr4/Gr5 AEs in either group. This phase 2 randomized, double-blinded study is ongoing, with the addition of one more site."

Clinical • P2 data • Glioblastoma • Oncology • Solid Tumor • CSF2

A Prospective, Cohort Study of SITOIGANAP to Treat Glioblastoma When Given in Combination With Granulocyte-Macrophage Colony-Stimulating Factor/Cyclophosphamide/Bevacizumab/Nivolumab or Granulocyte-Macrophage Colony-Stimulating Factor/Cyclophosphamide/Bevacizumab/Pembrolizumab in Patients Who Failed Prior Treatment With Surgical Resection, Radiation, and Temozolomide. (PubMed, Front Oncol) - "The enrollment and end-of-study CD3/CD4 T-lymphocyte counts strongly correlate with OS. The addition of SITOIGANAP/GM-CSF/cyclophosphamide to bevacizumab and an anti-PD-1 monoclonal antibody resulted in a significant survival benefit compared to historic control values in rGBM with minimal toxicity compared to current therapy."

Combination therapy • Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD4 • CSF2

ERC Announces Publication of Positive Efficacy Data with Sitoiganap in Patients with Recurrent Glioblastoma (GlobeNewswire) - "ERC Belgium S.A....announced publication of its most recent efficacy data in the May 2022 edition of Frontiers in Oncology. The authors reported striking efficacy and safety of a therapeutic vaccine SITOIGANAP administered to 21 patients with recurrent glioblastoma (rGBM). Glioblastoma has a dismal prognosis with half of rGBM patients dying within 8 months of recurrence of the disease. Data presented by the authors show that treatment with Sitoiganap (also called Gliovac or ERC1671) more than doubles median overall survival to 19.6 months. This is an unprecedented level of effectiveness for a disease for which new therapies have shown no improvement in the past twenty years....The current study reported 1-year survival of 61% of the Sitoiganap-treated patients, and 2-year survival was 45%. As important was the observation that courses of Sitoiganap treatment were well tolerated with minimal toxicity over current therapy."

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

ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Epitopoietic Research Corporation

Combination therapy • New P2 trial • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • CD4

ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme (clinicaltrials.gov) - P2; N=84; Active, not recruiting; Sponsor: University of California, Irvine; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Brain Cancer • Glioblastoma • Glioma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor • CD4 • CSF2 • IL10 • IL2RA • IL6 • MRI

ERC-USA Announces FDA Recommendation for Early Termination of Phase 2 Clinical Trial of ERC1671 (Gliovac or Sitoiganap) and Application for Registration Trial for Treatment of Glioblastoma (GlobeNewswire) - “ERC-USA and the University of California, Irvine (UCI), today announce that the FDA has recommended early termination of the onging Phase 2 clinical trial titled ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma in a letter dated April 2, 2021…The FDA further recommended that the parties pursue a randomized confirmatory Phase 3 registration trial to support a licensing application in the form of a biologics license application (BLA).”

Trial termination • Glioblastoma • Oncology

ERC Announces Interim Results from Phase 2 Trial of Immunotherapy ERC1671 in Recurrent Glioblastoma Patients (Businesswire) - P2, N=84; NCT01903330; "ERC Belgium...has announced promising interim results in the phase 2 clinical trial for ERC1671 (also known as Gliovac or SITOIGANAP) under FDA IND 15430 at the University of California, Irvine Medical Center in Orange, California. The trial, 'ERC1671/GM CSF/Cyclophosphamide+Bevacizumab vs Placebo'...with recurrent GBM...first 10 patients from the study demonstrated....6-month overall survival (OS) rate of 100%. 12-month OS rate of 40%. Median OS is 46 weeks (10.5 months)."

P2 data • Glioblastoma • Oncology

"ERC1671 #immunotherapy shows early promise in recurrent #glioblastoma via @OncLive. https://t.co/llCAKMXye8" (@CarThera_)

Glioblastoma • Oncology • Solid Tumor

"Additional- ERC1671 rGBM- NCT01903330, Dana Farber, Mass General, U of CA, Irvine ERC1671 Immunotherapy Shows Early Promise in Recurrent Glioblastoma https://t.co/jtpfmNguLy via @onclive trial- https://t.co/bf6Rh3RqQR" (@RayTobin11)

Glioblastoma • Oncology • Solid Tumor

ERC-USA Announces Expansion of Glioblastoma Right-to-Try Treatment for ERC1671 with NYU Winthrop Hospital (Businesswire) - "ERC-USA…announced that NYU Winthrop Hospital (NYU) has agreed to treat one of its recurrent, refractory glioblastoma multiforme (GBM) patients with ERC’s lead therapy, ERC1671, under federal and state Right-to-Try laws (RTT)….ERC will shortly publish a summary of its RTT experience that will include the total number of patients and median survival data."

Clinical • P2 data • Brain Cancer • Glioblastoma • Oncology

"#ERCBelgium Submits #MarketingAuthorizationApplication to #EuropeanMedicinesAgency (#EMA) for #Glioblastoma #Immunotherapy, #SITOIGANAP https://t.co/oVLF6BzwOL" (@1stOncology)

European regulatory • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Belgium Submits Marketing Authorization Application to European Medicines Agency (EMA) for Glioblastoma Immunotherapy, SITOIGANAP (Businesswire) - "ERC Belgium...announced that it has submitted to the EMA its Marketing Authorization Application (MAA) for conditional approval of its lead product SITOIGANAP (ERC1671) to treat recurrent glioblastoma (GBM). The MAA contains observations suggesting safety and efficacy of SITOIGANAP demonstrated from the interim data of a randomized double-blind phase II trial. The data show that administration of SITOIGANAP/GM-CSF/Cyclophosphamide combined with bevacizumab results in a clinically meaningful survival benefit with minimal toxicity."

European regulatory • P2 data • Glioblastoma • Oncology

Double-Blinded, Placebo Controlled Phase 2 Study of ERC1671 in Recurrent Glioblastoma: OS Correlations with Initial and Maximum CD4+T Lymphocyte Count in the Peripheral Blood. (SNO 2019) - No abstract available.

Clinical • P2 data

ERC-USA sponsors ancillary meeting to discuss outcomes from its clinical trial and right to try patient experience of ERC1671 in recurrent glioblastoma (GlobeNewswire) - "ERC-USA announces today it will be holding an ancillary meeting to discuss clinical outcomes of its Phase 2 clinical trial of ERC1671 in recurrent glioblastoma, as well as its experience with its Right To Try patients. The meeting will be held concurrently with the 24^th Annual Meeting of the Society for Neuro-Oncology at the JW Marriott Phoenix Desert Ridge Hotel on Friday, November 22, 2019."

P2 data

ERC-USA initiates therapy under right to try law with first patient in California using investigational compound ERC1671 for treatment of glioblastoma (GlobeNewswire) - "ERC-USA and the University of California, Irvine have initiated treatment with the company’s investigational compound ERC1671...in a patient with aggressive brain cancer who did not qualify for the ongoing trial. This patient will be treated under the Right to Try Law of 2017, which allows patients to undergo treatment with an experimental compound who may not qualify to participate in a registered clinical trial."

Enrollment status