Advanced BioDesign

Lyon (France), May 27, 2025 – Advanced BioDesign, a clinical-stage biopharmaceutical company specializing in the development of novel therapeutic approaches for resistant cancers, today announced positive interim results from the Safety Review Committee (SRC) for the second part of the Phase 1 ODYSSEY clinical trial. 

This phase of the study evaluates the tolerance of three different dosing regimens of ABD-3001, a first-in-class ALDH1 inhibitor, administered over three 28-day cycles in patients with relapsed or refractory hematologic cancers. 

The SRC, composed of three independent experts, convened after every nine patients completed their first cycle (i.e., one-third of the trial), concluded that ABD-3001 is well tolerated and has an acceptable safety profile.

“We are encouraged to see that ABD-3001 continues to demonstrate a favorable safety profile, even after multiple doses, and that the trial is advancing as planned. Additionally, we are proud to report steady progress in our Phase 1 trial recruitment, with 16 patients enrolled to date”,  said Dr. David Liens, Interim Chief Medical Officer of Advanced BioDesign. 

Upcoming Data Presentation

Interim results will be presented at Europe’s premier hemalogy event, the 2025 European Hematology Association (EHA) Congress, highlighting the global relevance of these findings.

“We are excited to share these significant data with the hematology community at EHA in June and proud to showcase the promising breakthroughs offered by this new class of therapies”, added Ismail CEYLAN, CEO of Advanced BioDesign. 

About the ODYSSEY clinical trial: ODYSSEY is a Phase I/II clinical trial for the treatment of acute myeloid leukemia (AML). It is a multicenter study, with centers in Paris, Lyon and Marseille, designed to assess the safety and tolerability of the drug candidate ABD-3001. Organized according to an adaptive design, this study integrates a first part with a single ascending dose, on six cohorts of patients, followed by a second part, during which three cohorts of patients will receive complete treatment cycles of 3 months, thus allowing initial efficacy results to be obtained. Fully funded by Advanced BioDesign, the ODYSSEY clinical trial is coordinated by Professor Régis COSTELLO (Hôpital de la Conception, Marseille), in collaboration with Doctor Lina BENAJIBA (Hôpital Saint-Louis, Paris), and Doctor Maël HEIBLIG (Hôpital Lyon Sud, Lyon).

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About Advanced BioDesign: Advanced BioDesign is a French biotechnology company developing an innovative new therapeutic approach against resistant cancers, with a first indication in acute myeloid leukemia (AML). Its first drug candidate, ABD-3001, is a first-in-class « suicide » inhibitor of class 1 aldehyde dehydrogenases (ALDH1). In January 2022, Advanced BioDesign obtained authorization from the French Agence Nationale de Sécurité du Médicament (ANSM) to launch its first human clinical trial, ODYSSEY, which began in November 2022. Based in Lyon, Advanced BioDesign is supported and accompanied by Xerys Invest funds, which have been financing its research and development programs since 2013.

For more information: https://www.a-biodesign.com; LinkedIn @Advanced BioDesign

Contact

Ismail CEYLAN / ismail.ceylan@a-biodesign.com / +33 (0)7 60 04 56 61