ABD3001: Exceptional significant results observed from thebeginning of the ODYSSEY study

The National Agency for Medicines and Health Products Safety (ANSM) grants
compassionate access authorization
Lyon, June 21, 2024 – The ODYSSEY study, multicentric, is the only first-in-human phase I/II
study in France targeting a treatment for acute myeloid leukemia (AML). Started 18 months ago,
its main objective is to evaluate the tolerance of ABD-3001, but also to collect pharmacokinetic
and pharmacodynamic data in order to define a treatment regimen for future studies in patients
with AML who have limited therapeutic options and an unfavorable prognosis. This study follows
an adaptive design and includes an initial part with ascending single doses over six cohorts of
patients. We are proud to share the final results of the first phase of ascending dose
administration (SAD) of DIMATE (active principle of ABD3001).

Key points to remember:

• Solid safety profile: ABD3001 has demonstrated a favorable safety profile in patients
  with severe and recurrent forms of AML.
• Proven biological activity: At all doses tested, ABD3001 showed biological activity
  which proves target engagement ALDH (Aldehyde dehydrogenase).
• Preliminary efficacy: More than 65% of treated patients showed preliminary signs of
  efficacy. In two patients, the clinical benefit was maintained over time.
• Compassionate use approved: Based on an improvement in biological data,
  compassionate use was exceptionally approved by French authorities on June 14, 2024,
  for one patient (AAC No.: 1078995). To date, we have received an order form from StLouis hospital pharmacy where this patient will be “treated”. Our teams and those at the
  hospital have worked tirelessly so that our “ABD3001 drug” can be administered next
  June 27th.
• Very positive prospects for continuing the ODYSSEY study: We plan to accelerate
  and improve the second phase of the ODYSSEY trial with a 3-month treatment for 3
  randomized cohorts of 12 patients.
  

These results confirm the therapeutic progress potential of ABD3001 in forms of AML resistant
to all treatments. We are eager to advance all of our R&D programs to combat cancer resistance
mechanisms and relapses and enable a strategic alliance and exit under the best conditions.
Pierre Le Sourd, member of the board at Xerys Invest explains: “I am happy to share with you
the certainty that we now have at Xerys. The company ABD is developing a new family of targeted
therapy that is quite exceptional, without equivalent today, in the treatment of the most severe
cancers that are resistant or recurring. ABD was the first case I presented to the Xerys board in
2013 with the conviction that the strategy of intervening on fundamental mechanisms, still
unexploited in the regulation of cancer cells, was justified. No cancer cells, whatever their level of mutation to develop resistances, can multiply without aldehyde dehydrogenases. The exceptional results presented today confirm the quality of ABD’s scientific journey and the soundness of the financing strategy implemented by Xerys. The agreement obtained from ANSM for compassionate use can only make us optimistic for the future.”
Ismail Ceylan
CEO

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

About Xerys Invest

Xerys is a portfolio management company specializing in private equity with an approach that places
the entrepreneur’s vision at the heart of its investment philosophy.
It aims to support the managers of the companies within Xerys’ fund portfolios at every stage of their
growth, from venture capital to maturity.
Xerys therefore establishes a close, constructive, and proactive relationship with the managers of its
portfolio companies to support and advise them in their strategic decisions, arbitrations, and value
creation. With this unique approach, Xerys builds a relationship of trust with both managers and
investors, fostering shared value creation in the medium term.
More informations : www.xerys.com; LinkedIn @Xerys.