IDP Pharma announces first patient dosed in a Phase 1/2 Clinical Trial of IDP-121
IDP Pharma, a clinical-stage biotechnology company pioneering the development of drugs that directly engage and degrade intrinsically disordered proteins (IDPs), today announced that the first patient has been successfully dosed in its IDP-121-001 CASSANDRA trial, a multi-center, open-label Phase I/II study for the treatment of cMyc driven hematological malignancies.
The cMyc oncogene is activated in most cancers by genetic, epigenetic or post- translational mechanisms, and cMyc function is altered in approximately 70% of all tumours. The intrinsic connection between cMyc protein and tumorigenesis highlights the potential therapeutic significance of its inhibition. IDP-121 is designed to impair cMyc protein function and selectively degrade the target.
“IDP-121 has demonstrated the unique ability to directly engage cMyc protein, triggering antitumor response in several animal models. We are particularly interested in the exploration in hematological diseases, including multiple myeloma, that we know are heavily cMyc dependent and give us the opportunity to quickly measure the on-target effect. Ultimately, we hope to see biological and clinical response that will confirm the broad potential of this therapeutic approach across solid and liquid tumors” says Dr. Laura Nevola, IDP’s Chief Scientific Officer.
According to Valentin Cabañas, principal investigator at the l’Hospital Clínico Universitario Virgen de la Arrixaca (Murcia, Spain), where the first patient was dosed, the use of IDP-121 for the treatment of multiple myeloma “could potentially represent a major shift in the disease management due to the exploitation of a mechanism of action previously uncharted for targeting myeloma cells”. The clinical trial will also include patients of non-Hodgkin lymphoma and chronic lymphocytic leukemia, as this new drug “acts on the protein involved in the development of several hematological cancers beyond multiple myeloma”.
“This is an extremely important next step in the understanding and relevance of cMyc and its role in cancer development and progression. The ability to directly target cMyc protein in the clinic is very exciting and the exploration of IDP-121 in this Phase I study could be a landmark in oncology drug development”, said Prof. Dean Felsher, Scientific Adviser to IDP Pharma and Professor in the Division of Oncology within the Departments of Medicine and Pathology at Stanford University.
“IDP-121 is IDP Pharma’s lead compound and the announcement today represents a major step towards the systematic and direct inhibition of disease drivers in cancer mediated through IDPs” says Santiago Esteban, CEO of IDP Pharma.
The study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of IDP-121. The principal investigator is Prof.Enrique Ocio, head of Hematology of the Hospital Universitario Marqués de Valdecilla, and the study includes other four medical facilities in Spain: Hospital Universitario Vall d’Hebron, Hospital Universitario 12 de Octubre, Hospital Universitario of Salamanca, and Hospital Clínico Universitario Virgen de la Arrixaca.