SAPECMERAN AUTOGENE

UNII:	2E99S2VU5M
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	SAPECMERAN AUTOGENE
GSRS Full Record:	2E99S2VU5M i

2805319-17-7
GRT-R902
RNA (venezuelan equine encephalitis virus-derived construct GRT-R902 structural polyprotein gene deletion-containing plus tumor-specific neoantigen prototype cassette-expressing)
SAPECMERAN AUTOGENE [USAN]
Sapecmeran Autogene
Sapecmeran autogene [WHO-DD]
Self-amplifying mRNA (samRNA) vector based on Venezuelan equine encephalitis virus (VEEV). Sequences encoding the structural proteins of VEEV are deleted and replaced by a patient-specific cassette expressing 20 tumor-specific neoantigens (TSNAs). The vector encodes the VEEV proteins as well as the 5ʹ and 3ʹ RNA sequences required for RNA replication but encodes no structural proteins, so no infectious viral particle is formed. The VEEV subgenomic 26S promoter located 5ʹ of the inserted TSNA cassette drives expression of the TSNAs. The patient-specific TSNA cassette is inserted into the GRT-R902 (pUC02-ATG-VEE-eGFP) backbone vector. This plasmid is used as a template to synthesize the drug substance by in vitro transcription, which is then formulated using lipid nanoparticles to make the patient-specific vaccine. The sequence of the TSNA cassette is different for each patient and is designed by the proprietary algorithm EDGE based on the tumor-specific information derived from each patient.
sapecmeran autogene [INN]

Note

UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication. Please report any problems/errors associated with this data to FDA-SRS@fda.hhs.gov.

SAPECMERAN AUTOGENE

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