PMC-403
PMC-403 is a novel agonistic antibody that binds to human TIE2 receptor. Activation of TIE2 receptors results in a normalization of pathologically leaky blood vessels in vascular-related diseases. It is being developed as a therapeutic drug for vessel-related ocular diseases, such as age-related macular degeneration (AMD), diabetic retinopathy (DR), and macular edema.
In the preclinical studies, PMC-403 showed similar retinal leakage reduction to aflibercept, the best-selling drug, in ophthalmology market. The significance of this data is that PMC-403’s novel TIE2-activating mechanism can be used in the VEGF-exclusive market to treat patients who show low or no response to the existing therapeutics.
Also, amongst the main pathophysiology factors of vessel-related ocular diseases (angiogenesis, leakage, and inflammation), PMC-403 shows improvement in all three factors, while anti-VEGF drugs show weak effect in controlling inflammation.
In April 2022, the GLP-Tox study revealed that PMC-403 does not show any serious adverse events, meaning it is safe enough to be administered in human trials. The Company plans to submit an IND in 4Q22 for a phase I ophthalmology trial.
The vessel-normalizing mechanism of PMC-403 can also be utilized in many other vascular-related diseases. In August 2020, PharmAbcine signed a Materials Cooperative Research and Development Agreement (MCRADA) with National Institutes of Health (NIH) to conduct collaborative studies in evaluating PMC-403’s therapeutic effect for Systemic Capillary Leak Syndrome (SCLS, Clarkson Disease), a fatal orphan disease with no approved treatments available. The study has entered a nonclinical phase and is well underway.