Drug intelligence / Profile preview

FRAME-001 + pembrolizumab

Development stage
Phase 2
Lead developer
BioNTech
Modality
Vaccines & Immunotherapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Peptides
Administration
Subcutaneous, Intravenous
01

Overview

**FRAME-001 + pembrolizumab** is an investigational co-administration regimen for advanced non-small cell lung cancer consisting of FRAME-001, a personalized therapeutic peptide vaccine selected from each patient's tumor-specific frameshift-derived neoantigens, and pembrolizumab, a programmed cell death protein 1 inhibitor. FRAME-001 is designed from whole-genome and RNA sequencing of a tumor biopsy to identify expressed frameshift mutations and formulate selected neoantigen peptides intended to elicit tumor-directed T-cell immunity. Pembrolizumab blocks PD-1-mediated inhibitory signaling, with the intended effect of sustaining vaccine-induced antitumor immune responses. The regimen was evaluated in a Phase 2 study in patients with advanced non-small cell lung cancer with stable disease after first-line pembrolizumab-based treatment. ([clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04998474))

Other names
FRAME-001 + Keytrudapembrolizumab + FRAME-001
02

Targets

MHC I (MHC class I})PDCD1 (Programmed cell death protein 1 receptor)Patient-specific tumor frameshift neoantigens

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