![Julien, J.-P., & Wilson, I. A. (2014). Crystal structure of human Fab PGDM1400, a broadly reactive and potent HIV-1 neutralizing antibody [PDB entry 4RQQ]. Protein Data Bank. https://doi.org/10.2210/p](https://lapal.ch/storage/illustrations/a5qDCcYQUdrTek3sxMQNiDhpN19nt0AC0rex356v.png)
Drug name
Last update: Aug 2026PGDM1400 (mAb)
Drug information
PGDM1400
Not provided
Biotherapeutic
bNAb targeting the apex of the HIV-1 envelope trimer
PGDM1400 is a naturally occurring broadly neutralizing antibody (bNAb) that targets the apex of the HIV-1 envelope (Env) trimer. Its mechanism of action includes inhibition of both cell-free and cell-to-cell viral entry, induction of phagocytosis by macrophages, and antibody-dependent cellular cytotoxicity (ADCC) mediated by natural killer (NK) cells. Additionally, PGDM1400 enhances dendritic cell maturation and activity. In a recent pharmacokinetic study comparing dual bNAb therapy (PGDM1400+VRC07-523LS) with triple bNAb therapy (PGDM1400+PGT121+VRC07-523LS), the estimated half-life of PGDM1400 was 25 days. Notably, two of twelve participants exhibited preexisting mutations that conferred resistance to PGDM1400.
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Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
- Treatment
Administration route
Intravenous
Associated long-acting platforms
Solution
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Every 6 months
- Every 4 months
Dosage
3mg/kg; 10 mg/kg; 20 mg/kg and 30 mg/kg
30 mg/kg
Not provided
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Associated compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Allergy and Infectious Diseases (NIAID) is part of the U.S. National Institutes of Health (NIH) dedicated to advancing research on infectious, immunologic, and allergic diseases. Established over 60 years ago, NIAID conducts both basic and applied research aimed at understanding, diagnosing, treating, and preventing a wide range of diseases that impact global health.
Drug structure
Scale-up and manufacturing prospects
Not provided
Bioreactors
The synthesis of PGDM1400, is typically performed using recombinant DNA technology. 1. Gene Identification and Cloning: The heavy and light chain variable regions of PGDM1400 are identified from B cells of HIV-infected individuals with broad serum neutralization. These genes are then cloned into expression vectors with appropriate constant regions (e.g., IgG1). 2. Expression: HEK293 or CHO cells 3. Purification using protein A/G affinity chromatography
1. Protein A/G affinity chromatography 2. SDS-PAGE 3. HPLC 4. ELISA 5. Neutralization assay
Excipients & delivery device(s)
No proprietary excipient used
No novel excipient or existing excipient used
No residual solvent used
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
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Broadly neutralizing antibody and uses thereof
The present invention relates to an exceptionally broad and potent neutralizing antibody which may comprise cross-clade neutralizing coverage of 83% at a median IC50 of 0.003 µg/ml, compositions containing the same and uses thereof.
EP2975053A1
Not provided
Cornell University Scripps Research Institute International AIDS Vaccine Initiative Inc
Not provided
June 10, 2035
Granted in US and EPO (AT, BE, CH, DE, FR, GB, LI, NL)