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Drug information

Drug's link(s)
Generic name

PGT-121

Brand names

Not provided

Compound type

Biotherapeutic

Drug class/category

bNAb targeting gp120 on HIV-1 virus envelope

Summary

PGT-121 is a broadly neutralizing monoclonal antibody (bnMAb) that targets the V3-glycan epitope of the HIV-1 gp120 envelope glycoprotein. PGT122, a structurally related antibody, interacts with the gp120 outer domain at a more vertical angle relative to the apex of the viral envelope spike. The estimated serum half-life of PGT121 ranges from approximately 14 to 22 days. Following antigen binding, the PGT-121-HIV complex exhibits a sink effect, leading to rapid systemic clearance. In a phase 1 clinical trial, no treatment-related adverse events were reported; however, immune-related grade 3 adverse events were observed.

Approval status

Not approved yet.

Regulatory authorities

Not approved yet.

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Intravenous, Subcutaneous

Associated long-acting platforms

Solution

Use of drug

Ease of administration
  • Administered by a community health worker
  • Administered by a nurse
  • Administered by a specialty health worker
Frequency of administration
  • Other/Variable/Unknown : Once every 12 weeks
User acceptance
Not provided

Dosage

Available dose and strength

3mg/kg; 10 mg/kg and 30 mg/kg (under investigation)

Maximum dose

30 mg/kg

Recommended dosing regimen

PGT-121 3 mg/kg given once every 12 weeks PGT-121 10 mg/kg given once every 12 weeks PGT-121 30 mg/kg given once every 12 weeks

Additional comments

Not provided

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Not provided

Associated technologies

Not provided

Additional information

Not provided

Developer(s)

Beth Israel Deaconess Medical Center
Originator
United States of America

Beth Israel Deaconess Medical Center

The Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, led by Dr. Dan Barouch, focuses on developing vaccines against infectious diseases, including HIV and COVID-19. It comprises primary and affiliate faculty dedicated to virology, vaccinology, and related disciplines. Research from the Barouch Laboratory within this center is pioneering HIV eradication.

IAVI
Originator
United Stated of America

IAVI

The International AIDS Vaccine Initiative (IAVI) Neutralizing Antibody Center focuses on advancing HIV vaccine research by developing broadly neutralizing antibodies (bnAbs).

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Lyophilizers, Mixers and Granulators, Ampoule/Vial Filling Machines, Sealing Machines

Manufacturing

Manufacturing Process include: 1. Substitution of Amino Acid Residues: Heavy Chain (VH)/Light Chain (VL) 2. Mammalian cell expression 3. Glycoengineering to enhance Fc-effector function (e.g., afucosylation) 4. Formulation optimization: Excipients improve stability and solubility 5. Sequential vaccination: Elicits PGT-121-like bnAbs in animal models

Specific analytical instrument required for characterization of formulation

1. HPLC 2. Mass Spectrometry 3. Spectrometers 4. pH meter 5. Yeast Surface Display 6. FACS (Fluorescence-Activated Cell Sorting) 7. Deep Sequencing

Excipients & delivery device(s)

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Delivery device(s)

No delivery device

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

Description

Antibody therapies for human immunodeficiency virus (hiv)

Brief description

Featured are PGT121 variant antibodies or fragments thereof, which can be administered, e.g., as antibody therapies for treating human immunodeficiency virus (HIV) infection. In particular, featured are methods of treating subjects infected with HIV and/or blocking HIV infections in subjects at risk of HIV transmission using the PGT121 variant antibodies or fragments thereof.

Representative patent

WO2019226829A1

Category

Not provided

Patent holder

Beth Israel Deaconess Medical Center, Inc.

Exclusivity

Not provided

Expiration date

November 28, 2039

Status

Active