Advanced BioDesign

Lyon (France), September 4th, 2025 – Advanced BioDesign, a French clinical-stage biotechnology company focused on developing innovative therapies for treatment-resistant cancers, today announced that the first patient in France has been treated with its lead investigational drug, ABD-3001, under a compassionate access authorization for relapsed and refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL).

This treatment was made possible through the compassionate access authorization (AAC) granted by the French National Agency for Medicines and Health Products Safety (ANSM). AACs are issued at the request of a physician or healthcare institution for named patients, allowing access to investigational drugs not yet approved or under marketing authorization for the specific indication.

“Providing ABD-3001 under compassionate access in France highlights both the urgent need for innovative therapies in relapsed/refractory malignancies and the strong interest from French healthcare institutions in our cutting-edge approach,” said Ismail Ceylan, CEO of Advanced BioDesign. “By combining scientific innovation with compassionate care, we aim to bring new hope to patients facing the most difficult therapeutic challenges.”

T-ALL is an aggressive form of blood cancer that originates in immature T lymphocytes (a type of white blood cell) in the bone marrow. It accounts for approximately 12–15% of pediatric and up to 25% of adult acute lymphoblastic leukemia (ALL) cases. T-ALL progresses rapidly and can spread to the lymph nodes, liver, spleen, and central nervous system. Relapses occur in about 20% of children and 40% of adults, often within two years of diagnosis. These relapse cases are difficult to treat and require more intensive or novel therapeutic approaches.

The patient, who had previously received multiple lines of therapy, was selected for treatment with ABD-3001 through the ALL-TARGET program (NCT05832125) and received the treatment at Versailles Hospital, by Prof Philippe Rousselot. Supported by the GRAALL consortium and managed by Prof. Asnafi of Necker-Enfants Malades Hospital ALL-TARGET is an integrated therapeutic strategy designed to address the urgent needs of patients with R/R T-ALL. The program includes in vitro sensitivity testing of patient-derived cells against a panel of therapeutic agents to guide personalized treatment decisions in order to improve outcomes in this aggressive leukemia subtype.

“We are excited to have access to ABD-3001 for the treatment of this patient under compassionate access,” said Prof Rousselot. “Allow R/R T-ALL patient benefit this new therapeutic approaches is a great achievement of the ALL-TARGET precision medicine project.”

About ABD-3001: ABD-3001 is the pharmacological form of DIMATE, a first-in-class « suicide » inhibitor of class 1 aldehyde dehydrogenases (ALDH1). This innovative molecule was developed to target a key survival mechanism of cancer cells. It works by blocking ALDH, which tumor cells often use to protect themselves from oxidative stress. By inhibiting this enzyme, DIMATE creates an internal imbalance that leads to cancer cell death, while largely sparing healthy cells. This approach aims to overcome resistance mechanisms to standard chemotherapy.

Currently being evaluated in a Phase 1 clinical trial, ODYSSEY, DIMATE could offer an innovative therapeutic option for patients with no remaining treatment alternatives.

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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