ImmunoForge Achieves Milestone with IND Approval for Pemziviptadil and KF1601 in US and Korea

ImmunoForge Achieves Significant Therapeutic Milestones

On January 14, 2025, ImmunoForge made headlines with the announcement of receiving Investigational New Drug (IND) approvals from the U.S. Food and Drug Administration for two pivotal treatments. These include the Phase 2 clinical trial of Pemziviptadil for managing cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD) and the Phase 1 trial for KF1601, an innovative treatment for Chronic Myelogenous Leukemia (CML) approved by the Ministry of Food and Drug Safety in South Korea.

Pemziviptadil: A Promising Treatment for DMD Cardiomyopathy

Pemziviptadil, designated under the development code PF1804, is a revolutionary once-weekly treatment specifically designed for DMD cardiomyopathy. The drug operates through mechanisms involving vasoactive intestinal peptide (VIP), selectively acting on the VPAC2 receptor to enhance cardiac function by improving both contraction and relaxation of the heart.

The significance of Pemziviptadil lies in its unique formulation, overcoming a previous challenge faced in the pharmaceutical development of VIP—its short half-life of less than one minute in the human body. ImmunoForge has successfully increased this duration to 60 hours by utilizing their proprietary ELP (Elastin-Like Polypeptide) platform, thereby avoiding common gastrointestinal side effects associated with traditional VIP.

Researchers have previously validated the efficacy of Pemziviptadil in non-clinical MDX mouse models to suppress cardiac dysfunction. This groundbreaking achievement marks the commencement of Phase 2 trials, slated to take place in both the United States and Korea, aimed at determining the therapeutic potentials of Pemziviptadil.

Cautioning that cardiomyopathy has become a leading cause of mortality among DMD patients, ImmunoForge's leadership foresees a substantial market potential, estimating the treatment landscape to expand into tens of trillions as they aim to fill the void left by existing medications, such as beta-blockers and calcium channel blockers, which fail to promote long-term cardiac improvement.

Understanding KF1601: A New Hope for Chronic Myelogenous Leukemia

In a parallel stride, ImmunoForge has bagged approval for the Phase 1 trial of KF1601, a novel synthetic oral Tyrosine Kinase Inhibitor (TKI) targeting BCR-ABL1. The drug showcases promising potential against the T315I mutation, a common mutation found in CML that often renders traditional therapies ineffective.

CML, accounting for around 30% of adult leukemia cases, stems from a genetic abnormality known as the Philadelphia chromosome, which causes the uncontrollable proliferation of myeloid cells. KF1601 aims to revolutionize CML treatment; its dual binding capability extends beyond existing therapeutic options, enabling it to tackle the disease's resistance and enhance safety and tolerability.

Strategic Collaborations and Future Aspirations

With both Pemziviptadil and KF1601 on the cusp of human trials, ImmunoForge co-CEOs Sung-Min Ahn and Kiho Chang are optimistic about these developments. They expressed their aspirations regarding further collaborations, stating their intention to seek joint developmental partnerships and technology transfers in light of the growing international interest.

The company is currently in the Series C funding round, with ambitions to secure technology assessments and pursue a KOSDAQ listing in the coming year. Their proactive approach is bolstered by the backing of the Korea Institute for Advancement of Technology, which has committed approximately KRW 3 billion in support for the strategic development of Pemziviptadil.

Conclusion

As ImmunoForge forges ahead with these groundbreaking treatments, both Pemziviptadil and KF1601 represent more than just emerging therapies for debilitating conditions; they embody hope for patients navigating the complexities of DMD and CML. The scientific community watches closely as the company embarks on these pivotal trials—a journey that could redefine the treatment paradigms for these diseases and improve the quality of life for thousands worldwide.