• ImmunoForge secures FDA approval for Phase 2 trials of Pemziviptadil, targeting cardiomyopathy in Duchenne Muscular Dystrophy patients.
  • The company also gains clearance for Phase 1 trials of KF1601, a novel therapy for drug-resistant chronic myeloid leukemia.

South Korea-based biopharmaceutical company ImmunoForge has received U.S. Food and Drug Administration (FDA) approval to begin Phase 2 clinical trials of Pemziviptadil (PF1804), a potential treatment for Duchenne Muscular Dystrophy (DMD) cardiomyopathy. The trials will take place in the United States and Korea, aiming to address a critical unmet need for effective therapies in this area.

DMD, a rare genetic disorder affecting approximately 500,000 people worldwide, primarily impacts skeletal and cardiac muscles. Due to advancements in respiratory care, cardiomyopathy has become the leading cause of death for DMD patients, most of whom develop this condition in their 30s. Existing treatments, such as beta-blockers and calcium channel blockers, focus on symptom management rather than addressing the underlying cardiac dysfunction.

Pemziviptadil, developed using ImmunoForge's Elastin-Like Polypeptide (ELP) platform, is a vasoactive intestinal peptide (VIP) designed to selectively target the VPAC2 receptor, improving both cardiac contraction and relaxation. The ELP platform extends the peptide’s half-life to 60 hours, significantly overcoming the challenge of VIP’s rapid degradation in the body. Preclinical studies in MDX mouse models demonstrated its potential to suppress cardiac dysfunction.

“Based on this FDA approval, we aim to confirm the therapeutic effects of Pemziviptadil in the Phase 2 trials and establish a strong position in the DMD cardiomyopathy market, where effective treatments are scarce,” said ImmunoForge’s co-CEOs Sung-min Ahn and Kiho Chang.

The company also announced regulatory approval from the Korea Ministry of Food and Drug Safety for Phase 1 trials of KF1601, a novel tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML). KF1601 targets BCR::ABL1 mutations, including the drug-resistant T315I mutation, and has shown promising safety and efficacy in preclinical studies.

As ImmunoForge moves forward with clinical trials, it is also advancing Series C funding efforts and plans to pursue a KOSDAQ listing next year.

Edited by Harshajit Sarmah