Drug intelligence / Profile preview

Sitoiganap

Development stage
Phase 2
Lead developer
ERC Belgium
Modality
Vaccines & Immunotherapeutics
Administration
Intradermal, Intramuscular
01

Overview

Sitoiganap is an investigational, personalised multivalent glioma cell-and-lysate therapeutic vaccine developed by Epitopoietic Research Corporation for recurrent or progressive malignant glioma, particularly glioblastoma and gliosarcoma. Also known as ERC1671 and Gliovac, it contains haptenised and irradiated or inactivated autologous and allogeneic glioma tumour cells plus their lysates; the allogeneic material is sourced from three donor glioblastoma tumours. The product is intended to induce an immune response against shared and patient-specific glioma antigens, using allogeneic tumour material to help break immune tolerance to the patient's tumour. It has been evaluated in Phase 2 studies in combination regimens including GM-CSF, low-dose cyclophosphamide, bevacizumab, and, in a planned study, pembrolizumab. The European marketing-authorisation application for progressive or recurrent malignant glioma was withdrawn on May 2, 2022. ([ema.europa.eu](https://www.ema.europa.eu/en/documents/overview/questions-and-answers-withdrawal-application-marketing-authorisation-sitoiganap_en.pdf))

Brand names
SitoiganapGliovac
Other names
Sitoiganap
02

Targets

MAGEA8 (Melanoma-associated antigen 8)

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