Advanced BioDesign

Advanced BioDesign’s winning project is its first-in-human clinical trial of its drug candidate ABD-3001 for patients with acute myeloid leukaemia (AML) who are resistant to standard treatments.
As part of the France 2030 plan, the « i-Demo » scheme supports the development of highly innovative, high added-value products and services to strengthen France’s scientific and technological capabilities.

Lyon, 24th July 2023 – Advanced BioDesign, a French biotechnology company specialising in the development of a new range of targeted oncology therapies, has announced that its « ODYSSEY » project has won the « i-Demo » call for projects operated by Bpifrance. Bpifrance supports innovative companies and project leaders who, either individually or as part of collaborative programmes, need access to funding to cover the risks involved with their R&D and innovation projects.

The ODYSSEY project selected aims to develop a new treatment for acute myeloid leukaemia (AML), which could help meet the needs of 45,000 patients a year who have reached a plateau in their treatment. The aim of this multicentre Phase I/II (first-in-human) clinical trial is to assess the safety, pharmacokinetics and pharmacodynamics of ABD-3001 (NCT05601726) as a stand-alone treatment in patients who are unresponsive to or have relapsed on standard therapies, and for whom therapeutic options are limited and prognosis unfavourable.
The compound of interest, DIMATE, is an aldehyde dehydrogenase 1 inhibitor considered to be an important marker of cancer stem cells and functional regulators of tumour growth, immune evasion and drug resistance.
Aligning with the government’s priorities, particularly as part of the France 2030 plan, the maturity of the ‘ODYSSEY’ project and its innovative nature have enabled it to stand out from the crowd. The project has also been approved by the technical group of LyonBiopôle, a competitiveness hub based in Lyon.

Ismail Ceylan, CEO of Advanced BioDesign, comments: « I would like to thank the Government and Bpifrance for this recognition and invaluable support. It is partly thanks to public investment and the calls for projects that pharmaceutical research and development programmes such as ours can come to fruition. I’m proud to see our ODYSSEY project continuing its development and making progress with trials for patients with AML.”

This financial aid, of more than 3 million, will be paid in several instalments, and will enable us to accelerate our expansion, which has so far been financed by Xerys Funds, Advanced BioDesign’s long-standing shareholders. Firstly, it will enable Advanced BioDesign to continue its multicentre clinical trial, for which recruitment for the phase I study began last November in 3 research centres: Hôpital St-Louis – APHP in Paris, Hôpital Lyon Sud – HCL and Hôpital La Conception – APHM located in Marseille.
This funding will specifically support the development of the SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) phases, the cohort extension phase to confirm the RP2D (Recommended Phase 2 Dose) and preparation for phase II.
Running from February 2023 to February 2026 (i.e. over a period of 36 months), the project is currently at the stage 3 of dosage out of six and has already been given to 9 patients. The ODYSSEY study is organised around a design incorporating an initial 12-month rising single-dose phase in 6 patient cohorts, followed by a second phase of the same length, in which 3 patient cohorts will receive a full four-week treatment cycle. This design will provide initial efficacy results and determine the best treatment procedure.

Virginie Fontaine, Head of Bpifrance’s Healthcare innovation sector, says: « We are delighted to support Advanced BioDesign’s ODYSSEY project. This high-quality clinical programme brings together recognised national players and meets a major medical need. This innovation in the field of oncology treatments, and in particular AML, is fully in line with the French government’s priorities in the field of healthcare.”