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Advanced Biodesign announces the start of the First-In-Human Clinical Trial "ODYSSEY" targeting Acute Myeloid Leukaemia

After receiving an approval from the National Agency for Medicinal Safety and Health Products (ANSM), Advanced BioDesign announces today the enrolment of the first patient in its "ODYSSEY" (NCT05601726) First-In-Human clinical trial in acute myeloid leukemia (AML).

Lyon, 14^th November 2022 – Advanced BioDesign, a French biotechnology company specialising in the development of a new family of targeted therapies in oncology, announces that a first patient has been treated, at the Centre d'Investigation des Thérapeutiques en Oncologie et Hematologie de Lyon (CITHOL), under the supervision of Dr Maël Heiblig, with its first-in-class drug candidate, ABD-3001. Dr Maël Heiblig (Hôpital de Lyon Sud, Lyon), said he was "very enthusiastic and eager to evaluate the tolerance and efficacy of this new therapeutic approach".

This multi-centre Phase I study, called ODYSSEY, aims at evaluating the safety, pharmacokinetics and pharmacodynamics of ABD-3001 as a single agent in patients who are refractory to or have relapsed after standard therapies and for whom treatment options are limited and the prognosis is poor.

Although cancer research made significant progress in recent years, a considerable number of patients still experience treatment failure, which remains particularly prevalent for patients with acute myeloid leukaemia (AML), one of the most common and severe leukaemias in adults over 60 years. For this form of cancer, the incidence in Western countries is around 5 per 100,000 people in the population and the survival rate after 5 years does not exceed 20%, all ages combined.

The ODYSSEY study is organised according to an adaptative design. This study will involve a first part lasting 12 months with a single increasing dosage given to 6 cohorts of patients followed by a second part over an identical time scale, with a complete treatment cycle of four weeks given to 3 cohorts of patients. This design will allow for initial efficacy results and the determination of the best treatment regimen. An increase in the patient cohort for this final stage will be organised to validate the estimated effective dose (6 to 9 additional patients). Between 30 and 70 patients will be recruited in the 3 investigator centers located in Paris, Lyon and Marseille.

Prof. Régis Costello (Hôpital de la Conception, APHM, Marseille), principal investigator, will also coordinate this clinical trial in collaboration with Dr. Lina Benajiba (Hôpital Saint-Louis, AP-HP, Paris) and Dr. Maël Heiblig (Hôpital Lyon Sud, Lyon). These three highly qualified clinical centers, the largest in France in terms of number of patients, will successfully manage patient recruitment.

Ismail Ceylan, founder and CEO of Advanced BioDesign comments he is very proud and honoured "to be able to start our first clinical study. The start of enrolment and the treatment of a first patient is an important step for our company. It is a concrete expression of the excellent scientific and operational work done so far by our teams represented by Dr Mileidys Perez (CSO) and Guillaume Martin (COO). We have clearly demonstrated that our ALDH inhibitors, with DIMATE as the lead compound, constitute a family of original, truly innovative anti-cancer drugs, whose toxicity, at therapeutical doses, is limited to cancer cells without harming healthy cells and are likely to greatly reduce the risk of relapse.

He adds that the teams involved are "in the starting blocks, ready to begin the first injections in humans in order to collect safety data and very quickly gather efficacy data, with the aim of progressing towards a larger scale study to treat these patients for whom there is no other effective alternative treatment”.

Prof. Régis Costello, principal clinician (Assistance Publique des Hôpitaux de Marseille-Head of Haematology Hôpital la Conception, Marseille) comments: “It is with some emotion and great pride that we have implemented the ODYSSEY protocol in the CLIP2 Marseille (Centre Labellisé Inca Phases Précoces). This is the culmination of eight years of collaboration between the haematology and cell therapy department and Advanced BioDesign, a wonderful example of cross-disciplinary collaboration "from the laboratory benches to the patient's bed". The innovative molecule developed by Advanced BioDesign, DIMATE, appeared to us to be a therapy of the future in haematology, and in particular in the context of acute myeloid leukaemia, a very serious disease for which the outcome is fatal in more than one case out of two, despite recent advances”.

As Prof. Costello points out, "In a rather unprecedented way, the same medical team that collaborated with Advanced BioDesign in the preclinical studies will conduct the clinical trial at the Marseille University Hospital. Thanks to the data obtained during the last eight years of research, we have confidence in this Phase I clinical trial and we are already thinking about Phase II and the integration of DIMATE in future therapeutic strategies for acute myeloid leukaemia.”

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About Advanced BioDesign

Advanced BioDesign is a French biotechnology company developing an innovative therapeutic approach to treat resistant cancers, with a first indication in acute myeloid leukaemia (AML). Its lead anti-cancer compound, DIMATE, is a first-in-class suicide inhibitor of aldehyde dehydrogenases 1 (ALDH1). The ALDH enzyme allows cancer cells to detoxify themselves by recycling potentially damaging molecules. By inhibiting this enzyme, DIMATE induces apoptosis of the cancer cell without damaging healthy cells at therapeutic doses. Its clinical formulation ABD-3001 is currently being evaluated in Phase 1 clinical trials in AML. Founded in 2010 and based near Lyon (France), Advanced BioDesign is collaborating with Prof. Régis Costello at the AP-HM (Marseille) who is the principal investigator of the human study.

Advanced BioDesign is supported by the Xerys Invest fund, which has been financing its research and development programmes since 2013. To date, more than €20 million has been invested.

For more information: www.a-biodesign.com ; LinkedIn

About ABD-3001

ABD-3001 is the pharmacological form of DIMATE that targets and inhibits a detoxification system present within cancer cells. This detoxification is strongly active in most tumour or leukemic cells, enabling them to survive the inevitable metabolic disorders that occur during the cancer process. By inhibiting this cellular protection system, DIMATE poisons and kills off cancer cells, without harming healthy ones. In most cancers, there is also a population of cells, so called “cancer stem cells”, which are most often highly resistant to the cytotoxic effects of current anti-cancer drugs. This resistance to treatment appears to be the main cause of regular relapses of cancer. In studies carried out by the Advanced BioDesign team, DIMATE also destroys these cancer stem cells. Because of this specific property, which is a result of its molecular mechanism of action, DIMATE could be a particularly important drug in preventing cancers from recurring. DIMATE’s active mechanisms should enhance the anti-tumor action of all drugs and therapies activating the redox system, such as platinum salts and gamma rays, and therefore overcome primary resistance to these treatments.

 About Xerys Invest

Xerys Invest is a French investment company which primarily invests in the healthcare & Life Sciences, renewable energy and GreenTech sectors. As such, Xerys Invest supports companies in industries undergoing major transformations to address economic, environmental and societal challenges and which have great ambitions for their growth and international expansion.

In its market, Xerys Invest stands out as much for its modus operandi and the strategic and operational support it provides to portfolio companies, as for the range of à la carte investment opportunities offered to investors and for its close relations with them, or its sector-based approach. Also, Xerys Invest has considerable sector expertise, bolstered by a strategic committee made up of recognized specialists and experts in key sectors. For more information visit www.xerys.com or find us on LinkedIn.

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