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dapatifagene navolactibac
- Development stage
- Phase 1
- Lead developer
- Oragenics
- Modality
- Live Biotherapeutic Products → Microbiome Therapeutics, Gene Therapies
- Administration
- Topical, Buccal
01
Overview
Dapatifagene navolactibac (brand name AG013) is a live biotherapeutic product developed by Oragenics, Inc., in collaboration with Intrexon Corporation. It consists of a genetically modified strain of *Lactococcus lactis* (sAGX0085) engineered to secrete human Trefoil Factor 1 (hTFF1). Administered as an oral rinse, the drug is designed to prevent severe oral mucositis in cancer patients undergoing chemoradiation by delivering hTFF1 directly to the oral mucosal tissues. This locally-acting protein provides a cytoprotective effect, helping to protect against and repair mucosal damage. As of 2019, dapatifagene navolactibac had received its generic name from the WHO and was undergoing Phase 2 clinical trials for this indication.
- Brand names
- AG013AG-013AG 013
- Other names
- ActoBiotic AG013
02
Targets
Blo t (Blomia tropicalis allergen)Mucin carbohydrate glycotopes
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