Advanced BioDesign

• Initial clinical data for ABD-3001 in AML have led French health authorities to approve a compassionate use program for the treatment.

• Thanks to these results, the second part of the First-in-human ODYSSEY study, initially in Phase I, will evaluate the safety and efficacy of ABD-3001 as a monotherapy.

Lyon (France), October 28, 2024 – Advanced BioDesign, a biotech company specializing in the development of new therapeutic approaches to resistant cancers, today announces the new design of the second part of its ODYSSEY clinical trial, evaluating ABD-3001, its first-in-class selective ALDH1A inhibitor in patients with relapsed/refractory (r/r) Acute Myeloid Leukemia (AML). Topline data is expected during the third quarter of this year.

Originally conceived as a multiple ascending dose study in a 3ti3 cohort over one month, this study is evolving into a randomized trial which will 36 R/R AML patients, 12 patients per regimen of ABD-3001 extending the treatment up to three months. This development marks the transition from a Phase 1/2 trial to a Phase 2a trial.

In addition to safety and tolerability of ABD-3001 in primary endpoints. Additional endpoints are overall response rate (ORR), duration of response (DOR), event free survival (EFS), overall survival (OS), and pharmacokinetic (PK) and pharmacodynamic (PD) assessments.

This extremely favorable development follows the first part of the ODYSSEY clinical trial, which demonstrated promising results in terms of safety and tolerability, as well as preliminary signs of hematological improvements. These positive results have led the French health authorities to approve a compassionate use treatment for one patient.

“This new design, validated by our Scientific Review Committee (SRC) and French authorities, will allow us to investigate not only the tolerability but also the efficacy of ABD-3001 monotherapy. The high potential demonstrated in the first part of ODYSSEY offers hope for providing alternative therapeutic benefits to patients suffering from acute myeloid leukemia”, said Ismail CEYLAN, CEO of Advanced BioDesign.

“We are thrilled to see the first patient dosed in this newly designed trial. I am delighted with the dedication of all my colleagues s involved in determining if ABD-3001 monotherapy can provide therapeutic benefits for patients”, added Professor Regis Costello, Head of the Hematology and Cell Therapy in Oncology Department in Marseille (CEPCM, Timone Hospital), and principal investigator and coordinator of the ODYSSEY study.

“We are excited about the start of our Phase 2a trial and are grateful for the support of the participating cancer centers, investors, Xerys Invest, and contributors like BPI France. This is an important milestone for our company. This study paves the way for using ALDH inhibitors to address the significant challenge of cancer resistance globally”, concluded Ismail CEYLAN.

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.

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).