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.
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.
“This
regulatory authorization marks a major milestone for Odimma Therapeutics as we
transition into the clinical stage,” said Jean-Marc Limacher, MD, Chairman and
Chief Medical Officer of Odimma Therapeutics. “It reflects the extensive
development work required to establish a clinically applicable personalized
immunotherapy platform.”
“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.
About
Odimma Therapeutics
Odimma Therapeutics is a French biotechnology company developing personalized
cancer immunotherapies based on synthetic DNA manufacturing and immune
activation technologies designed to improve the efficacy of immunotherapy in
solid tumors.