A major regulatory milestone brings ODI-2001 one step closer to delivering a new generation of personalised immunotherapy to patients.
Odimma Therapeutics, a biotechnology company developing next-generation personalized cancer immunotherapies, today announced that the French National Agency for Medicines and Health Products Safety (ANSM) has authorized the Centre Georges François Leclerc (CGFL) to initiate a Phase I clinical trial of ODI-2001 in patients with solid tumors.
This authorization confirms that the manufacturing, quality, preclinical and clinical components of the clinical trial application have been reviewed and deemed acceptable for first-in-human administration. The study represents the first clinical evaluation of Odimma’s personalized immunotherapy platform.
“This regulatory authorization marks a major milestone for Odimma Therapeutics as we transition into the clinical stage,” said Jean-Marc Limacher, MD, Chairman, Co-Founder and Chief Medical Officer of Odimma Therapeutics. “It reflects the extensive development work required to establish a clinically applicable personalized immunotherapy platform.”
ODI-2001 is a multi-component immunotherapy designed to induce tumor-specific immune responses through a personalized neoantigen approach combining synthetic DNA, Modified Vaccinia Ankara (MVA), and immune checkpoint blockade. The therapy is produced individually for each patient based on tumor-specific mutations.
The trial is sponsored by the Centre Georges François Leclerc (CGFL) in Dijon, France, and will be conducted at specialized oncology centers.
“Personalized neoantigen immunotherapies represent one of the most promising strategies to extend the benefit of immunotherapy to a broader population of patients. This study will evaluate the feasibility of manufacturing and administering an innovative individualized treatment in a real clinical setting, which represents an important step for the field,” said Prof. Ghiringhelli, MD, PhD, Principal Investigator of the study at the Centre Georges François Leclerc.
The Phase I study is designed to evaluate safety, tolerability, feasibility, as well as exploratory immunologic and clinical endpoints.
