IDP Pharma announces first patient dosed in a Phase 1/2 Clinical Trial of IDP-121, a direct cMyc protein inhibitor and degrader

• IDP-121 is IDP Pharma's lead asset using its proprietary intrametics^™ technology platform enabling inhibition and cellular degradation of intrinsically disordered proteins (IDPs)
• Targeting cMyc, a pivotal protein in tumorigenesis, is a unique opportunity in cancer therapy
• First patient successfully dosed in clinical Phase I/II dose escalation and expansion study in relapsed/refractory hematological malignancies

BARCELONA, Spain, Oct. 26, 2023 /PRNewswire/ -- 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 protein 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" said Dr. Laura Nevola, IDP's Chief Scientific Officer.

According to Valentin Cabañas, the PI of the Hospital Clínico 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 Professor 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" said Santiago Esteban, Chief Executive Officer 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 Professor Enrique Ocio, Head of Hematology of the Hospital Universitario Marqués de Valdecilla, and the study includes other four medical facilities in Spain: Hospital Vall d'Hebron, Hospital Universitario 12 de Octubre, Hospital Universitario of Salamanca, and Hospital Universitario Virgen de la Arrixaca.

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

About IDP-121

IDP-121 is a potent, selective peptidomimetic that acts by simultaneously obstructing the formation of the cMyc/Max complex while also augmenting cMyc degradation through the intrinsic cellular machinery. This effectively counters the oncogenic impact of elevated cMyc protein levels that fuel the proliferation of cancer cells. Preclinical investigations of IDP-121 have revealed strong anti-tumor efficacy across various hematological and solid tumors, including multiple myeloma, non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC). IDP-121-001 (CASSANDRA) is the first clinical study involving IDP-121. Planned future clinical trials will include exploration in solid tumors and in combination with standard of care therapies.

About IDP Pharma

IDP Pharma is a clinical-stage biotech company developing the first direct inhibitors and degraders of intrinsically disordered proteins (IDPs), a novel class of disease drivers previously considered undruggable. Thanks to its proprietary intrametics^tm platform, the company has successfully developed a pipeline of first in class drugs targeting IDPs, leading the field since its foundation. The company is headquartered in Parc Científic de Barcelona (PCB), in Barcelona, Spain.

More information please visit www.idp-pharma.com

Forward-looking statements

The forward-looking statements made in this press release relate only to the events or information as of the date on which the statements are made in this article. You should read this article completely and with the understanding that actual future results with IDP-121 may be materially different from what we expect. Statements contained in this press release are made as of the date of this document and any further interpretation may change considering future developments.

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For further inquiries please contact:
IDP Pharma
Santiago Esteban, Ph.D., Chief Executive Officer
E-mail: s.esteban@idp-pharma.com

LifeSpring Life Sciences Communication, Amsterdam
Léon Melens
Tel: +31 6 538 16 427
E-mail: lmelens@lifespring.nl