Leronlimab is under clinical development by Cytodyn and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Leronlimab’s likelihood of approval (LoA) and phase transition for Solid Tumor took place on 27 Jun 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Leronlimab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Leronlimab overview

Leronlimab (PRO-140) is under development for the treatment for human immunodeficiency virus (HIV) infection, metastasis triple-negative breast cancer, HER2 positive metastatic breast cancer (MBC), glioblastoma, throat cancer, stomach cancer, testicular cancer, ovarian cancer, uterine cancer, bladder cancer, coronavirus disease 2019 (COVID-19) pneumonia, prostate cancer, non-alcoholic steatohepatitis (NASH), liver, lung, melanoma,gastric (stomach), pancreatic cancers, prolonged coronavirus disease 2019 (covid-19) symptoms [long-haulers], Coronavirus disease 2019 (COVID-19). It is an investigational humanized IgG4 monoclonal antibody. The drug candidate is administered intravenously and subcutaneously. PRO-140 is a humanized IgG4 antibody acts by targeting the Human Immunodeficiency Virus (HIV) co-receptor CCR5 without affecting the normal function of the molecule. PRO-140 is part of a new class of HIV therapies known as entry inhibitors which may be useful as a pre-exposure (PrEP) or post-exposure (PEP) prophylaxis agent. It was also under development for the treatment for multiple sclerosis.

It was under development for the treatment of graft-versus-host disease (GvHD) and metastatic colorectal cancer.

Cytodyn overview

Cytodyn is a biotechnology company. It focused on developing treatments in the areas of human immunodeficiency virus (“HIV”), cancer, immunology, and novel coronavirus disease corvid 19. The company provide treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. Leronlimab belongs to a class of HIV therapies known as entry inhibitors which block HIV from entering and infecting specific cells. Cytodyn uses prostate diagnostic test to determine outcomes of patients diagnosed with prostate cancer. It works in collaboration with pharmaceutical and biotechnology companies to develop its products. The company has operational presence in Florida, the US. Cytodyn is headquartered in Vancouver, Washington, the US.

Quick View Leronlimab LOA Data

Report Segments
  • Innovator
Drug Name
  • Leronlimab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Gastrointestinal
  • Hormonal Disorders
  • Immunology
  • Infectious Disease
  • Musculoskeletal Disorders
  • Oncology
Key Developers
  • Sponsor Company: Cytodyn
  • Originator: Progenics Pharmaceuticals
Highest Development Stage
  • Filing rejected/Withdrawn

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.