SAPECMERAN AUTOGENE
UNII 2E99S2VU5M

Substance Identification & Data

This profile provides standardized clinical and technical data for Sapecmeran Autogene, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 2E99S2VU5M.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2805319-17-7 and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

2E99S2VU5M

CAS Registry Number

2805319-17-7

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

SAPECMERAN AUTOGENE

Official standardized name for this substance within the FDA UNII nomenclature system.

NCI Thesaurus

C156926

National Cancer Institute reference terminology for clinical and research data.

INN ID

13101

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

MN-168

Identifier assigned by the United States Adopted Names Council.

Substance Type

Sapecmeran Autogene

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Sapecmeran Autogene. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

Sapecmeran Autogene

Common Names & Synonyms

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 [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]

Technical Codes

GRT-R902

External Clinical & Regulatory Resources

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