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Worldwide Clinical Trials - Oncology

IDP Pharma Commences Phase 1/2 Clinical Trial for IDP-121, a Novel Direct cMyc Protein Inhibitor and Degrader

Friday, October 27, 2023

IDP Pharma, a clinical-stage biotechnology company, is pioneering the development of drugs that directly target and degrade intrinsically disordered proteins (IDPs). They have announced the successful dosing of the first patient in the IDP-121-001 CASSANDRA trial, a multi-center, open-label Phase I/II study for treating hematological malignancies driven by the cMyc oncogene.

The cMyc oncogene is implicated in most cancers, with its activation occurring through genetic, epigenetic, or post-translational mechanisms in about 70% of all tumors. Inhibiting cMyc protein function has significant therapeutic potential, and IDP-121 is designed to impair cMyc protein function and selectively degrade it.

IDP-121's unique ability to engage cMyc protein directly, triggering antitumor responses in animal models. They are particularly interested in exploring its potential in hematological diseases, such as multiple myeloma, which are known to be highly dependent on cMyc. The goal is to observe a biological and clinical response confirming the broad potential of this therapeutic approach for both solid and liquid tumors.

Valentin Cabañas, the Principal Investigator at the Hospital Clínico Virgen de la Arrixaca in Spain, where the first patient was dosed, believes that IDP-121 could represent a significant shift in managing multiple myeloma due to its unique mechanism of action. The clinical trial will also include patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia since IDP-121 targets the protein involved in the development of various hematological cancers.

IDP Pharma, expressed excitement about directly targeting cMyc protein in clinical settings, considering it a landmark in oncology drug development.

IDP-121 is IDP Pharma's leading compound, and its development marks a significant step toward systematically inhibiting disease drivers in cancer mediated through IDPs, according to Santiago Esteban, Chief Executive Officer of IDP Pharma.

The study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of IDP-121. Professor Enrique Ocio, Head of Hematology at the Hospital Universitario Marqués de Valdecilla, is the principal investigator. Other medical facilities in Spain, including Hospital Vall d'Hebron, Hospital Universitario 12 de Octubre, Hospital Universitario of Salamanca, and Hospital Universitario Virgen de la Arrixaca, will also participate in the trial.

To find more information about the IDP-121 clinical trial, please visit clinicaltrials.gov (Identifier: NCT05908409).

IDP-121 is a potent and selective peptidomimetic compound that obstructs the formation of the cMyc/Max complex while enhancing cMyc degradation through cellular mechanisms. This counters the oncogenic effects of elevated cMyc protein levels, which fuel cancer cell proliferation. Preclinical studies have shown strong anti-tumor efficacy in various hematological and solid tumors, including multiple myeloma, non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC). The IDP-121-001 (CASSANDRA) trial is the first clinical study involving IDP-121, with planned future trials exploring its use in solid tumors and in combination with standard-of-care therapies.

 

Source: prnewswire.com

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