ImmunoForge Secures Approvals for Key Clinical Trials in DMD Cardiomyopathy and Chronic Myeloid Leukaemia Treatment
Wednesday, January 15, 2025
ImmunoForge has received regulatory approval for two significant clinical trials.
Cardiomyopathy is now a leading cause of mortality in DMD patients, as advancements in respiratory care have extended lifespans. DMD-related cardiomyopathy results from impaired calcium channel function due to cardiac dystrophin deficiency, leading to muscle fibre degradation and necrosis.
Current treatments focus on managing symptoms but lack long-term efficacy in addressing the condition’s root causes.
CML, a blood cancer caused by genetic abnormalities in the Philadelphia chromosome, accounts for approximately 30% of adult leukaemia cases. The disease affects 0.4 to 1.75 individuals per 100,000 annually, with variations across age, gender, and geography.
The US Food and Drug Administration (FDA) approved the Phase 2 trial of Pemziviptadil (PF1804) for treating cardiomyopathy in Duchenne muscular dystrophy (DMD).
Additionally, South Korea’s Ministry of Food and Drug Safety (MFDS) approved the Phase 1 trial of KF1601 for chronic myeloid leukaemia (CML).
Pemziviptadil, a once-weekly therapy developed using ImmunoForge’s proprietary Elastin-Like Polypeptide (ELP) platform, is designed to improve cardiac function by enhancing both contraction and relaxation.
It selectively targets vasoactive intestinal peptide receptor 2 (VPAC2) while minimising gastrointestinal side effects linked to VPAC1 activation. Preclinical studies in MDX mouse models demonstrated the drug’s potential to suppress cardiac dysfunction. Phase 2 trials will proceed in the United States and South Korea.
Pemziviptadil has also shown promise in nonclinical and early-phase trials for heart failure and pulmonary arterial hypertension, earning orphan drug designation from the FDA for both indications.
ImmunoForge’s KF1601 is a synthetic oral tyrosine kinase inhibitor (TKI) that targets BCR::ABL1 and effectively addresses the T315I mutation, a significant resistance mechanism in existing CML treatments. The drug also inhibits FLT3, offering potential benefits for patients in the advanced Blast Phase of the disease.
KF1601’s efficacy and safety were highlighted at the Molecular Cancer Society, distinguishing it as a promising candidate for CML management.
Currently undergoing Series C funding, ImmunoForge intends to apply for a technology assessment by year-end and aims for a KOSDAQ listing next year.
Source: prnewswire.com
