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Advanced BioDesign joins forces with GTP Bioways to start manufacturing of its innovative treatment for Acute Myeloid Leukemia (AML)

  • This partnership has been granted support from the Plan Innovation Santé 2030, a part of the France 2030 government program.
  • ABD-3001 drug candidate is currently in phase I/II clinical development (ODYSSEY study) in relapsed patients with limited therapeutic options.

Lyon, Toulouse (France), March 27, 2024 – Advanced BioDesign, a biotech company specializing in the development of new therapeutic approaches to resistant cancers, and GTP Bioways, a CDMO (Contract Development Manufacturing Organisation) specializing in the manufacture of innovative therapies, today announced their collaboration to meet the crucial needs of the first-in-human ODYSSEY study, aimed at treating acute myeloid leukemia (AML) with the drug candidate ABD-3001. These two companies, financially backed by the French government through the France 2030 plan and supported by Bpifrance, have joined forces to develop and produce a novel therapeutic approach.

The objective of this collaboration is to develop and produce the drug candidate ABD-3001, currently being tested in the ODYSSEY clinical program (NCT05601726). This clinical trial, which has been underway for 15 months, aims at treating patients with acute myeloid leukemia (AML) who are resistant to standard treatments, and for whom no therapeutic option is available.

“This 100% French collaboration has enabled us to meet a number of technical and industrial challenges. Our teams were able to provide Advanced BioDesign with the expertise and production capacity it needed to launch and carry out its clinical trial under the best possible conditions”, said Alain Sainsot, President of GTP Bioways.

In line with the government’s priorities, and in particular as part of the France 2030 plan, the ODYSSEY project’s maturity as well as its innovative nature had enabled it to stand out and win the i-DEMO call for projects in 2023. The ODYSSEY study aims to develop a new treatment for acute myeloid leukemia (AML), which could meet the needs of 100,000 patients a year worldwide who are currently at a therapeutic impasse.

This multicenter clinical trial is the only Phase I/II first-in-human study in Europe targeting the treatment of AML. Its main aim is to assess the safety of ABD-3001, and also to gather initial efficacy data as a single agent in patients with limited therapeutic options and a poor prognosis.

Ismail Ceylan, CEO of Advanced BioDesign, commented: “I’m delighted to be working with GTP Bioways. The skills deployed by the teams led by Alain Sainsot have enabled us to recruit 15 patients to date, without any disruption in the supply of our drug candidate. Our innovative formulation requires know-how and expertise which we have found in GTP Bioways’ teams in Toulouse”.

Patient recruitment for the ODYSSEY study began in November 2022, under the coordination of Pr Régis Costello, principal investigator at APHM, as well as at HCL in Lyon and APHP – St-Louis in Paris. “We are very excited to continue the clinical development of ABD-3001. We are currently completing the first part of our Phase 1 study, with a very favorable safety profile. Our ambition for the second part of the trial will be to establish a bolder treatment protocol that would potentially allow ABD-3001 to be introduced directly as an alternative therapy for AML patients who, all too often, have only limited therapeutic options”, added Ismail Ceylan.

Bruno Bonnell, Secretary General for Investment, in charge of France 2030, declared: “We’re delighted with this collaboration, which brings us a step closer to the ambition we’re pursuing with the Innovation Santé 2030 plan, the healthcare component of France 2030. Carrying out more clinical trials and including patients means giving ourselves the maximum chance of ensuring that French patients benefit from the most innovative treatments. This first-in-human trial represents hope for patients suffering from acute myeloid leukemia.”

Paul-François Fournier, Executive Director of Innovation at Bpifrance, concluded: “We are delighted to support an ambitious and innovative project involving two French companies. The combined know-how and expertise of each will enable us to develop and produce a new therapeutic approach in the field of oncology, where there is a strong medical need.”

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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.

Following an adaptive design, the study integrates an ascending single-dose first part, on six patient cohorts, followed by a second part, during which three patient cohorts will receive full four-week treatment cycles, enabling 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).

About GTP Bioways CDMO

GTP Bioways is a Contract Development and Manufacturing Organisation (CDMO) offering comprehensive manufacturing services to support biopharmaceutical companies from pre-clinical trials to commercial production of their innovative therapies.

GTP Bioways’ expertise and capabilities include process development and manufacturing of biological molecules (in mammalian and microbial systems), antibody-drug conjugates and nanomedicines. Drawing on their expertise in solving customer challenges, GTP Bioways strives to offer a tailor-made approach, finely tuned to meet each specific challenge.

GTP Bioways operates four sites in France and employs 150 people. The company expects to generate sales of 23.7 million euros in 2024.

For further information: www.gtp-bioways.com | Linkedin: @GTP-Bioways-CDMO

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

About Bpifrance

Bpifrance finances companies – at every stage of their development – with credit, guarantees and equity capital. Bpifrance supports them in their innovation and international projects. Bpifrance now also supports their export activities through a wide range of products. Consulting, university, networking and acceleration programs for startups, SMEs and ETIs are also part of the range of services offered to entrepreneurs. Thanks to Bpifrance and its 50 regional offices, entrepreneurs benefit from a single, close and efficient contact to help them meet their challenges.

For further information: www.bpifrance.frwww.presse.bpifrance.fr/ Follow us on X (Ex-Twitter): @BpifrancePresse @Bpifrance

 

 

Contacts :

GTP Bioways

Laurence Padiolleau / laurence.padiolleau@gtp-bioways.com / +33 (0) 771 186 473

Advanced BioDesign

Ulysse Communication – Press Relation

Bruno Arabian / barabian@ulysse-communication.com / +33 (0) 6 87 88 47 26

Pierre-Louis Germain / plgermain@ulysse-communication.com / +33 (0) 6 64 79 97 51

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