GlobeNewswire Inc | Nov 22, 2021 12:21PM EST

November 22, 2021

PRESS RELEASE

AB SCIENCE RECEIVES U.S. FOOD AND DRUG ADMINISTRATION (FDA) AUTHORIZATION TO INITIATE PHASE I/II TRIAL OF AB8939 IN THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML)

AB8939 IS A NEW GENERATION SYNTHETIC MICROTUBULE DESTABILIZER WITH THE ABILITY TO OVERCOME MULTIDRUG RESISTANCE AND HAS BROAD APPLICABILITY AS A POTENT ANTICANCER DRUG

Paris, November22, 2021, 6pm CET

AB Science SA (Euronext - FR0010557264 - AB) today announces that its Phase I/II study (AB18001) evaluating AB8939 in patients with refractory and relapsed AML and refractory myelodysplastic syndrome (MDS) has received Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA).

Study AB18001 is titled A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia. The study has a multi-stage design. The first part is a dose escalation study that aims to determine the safety and tolerability of intravenous AB8939 in patients with refractory or relapsed AML or patients with refractory MDS, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy (response rate) assessment of AB8939.

Study AB18001 has also been approved in France and in Canada.

AB8939 is a new synthetic microtubule-destabilizing drug. Preclinical data show that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has strong potential to be developed in numerous oncology indications.

The first indication AB8939 is being developed for is acute myeloid leukemia (AML). Cytarabine (Ara-C) and azacytidine are standard chemotherapies for AML treatment, however, drug resistance is a major limitation to successful therapy. In vivo data from a highly resistant Ara-C patient derived xenograft (PDX) mouse model showed that AB8939, administered alone or in combination with Ara-C, increased survival relative to single agent Ara-C, with an accompanying significant reduction of blasts in blood and decrease in tumor growth. Further evidence of therapeutic potential was demonstrated using an azacytidine resistant PDX model with AB8939, administered alone or in combination with azacytidine, showing a significant reduction of blasts relative to single agent azacytidine. Moreover, while azacytidine was associated with strong treatment related hematotoxicity, AB8939 did not induce hematotoxicity throughout its 4-week treatment period.

AB8939 was granted orphan drug designation for AML from the U.S. Food and Drug Administration (FDA).

AB8939 was entirely discovered by the laboratories of AB Science, which retains full ownership of intellectual rights, and is an example of AB Sciences focus on innovative drug development focused on improving patients lives.

About acute myeloid leukemia (AML)Acute myeloid leukemia (AML) is a serious, life-threating condition and the most common cause of leukemia-related mortality, with a majority of patients facing a highly unsatisfactory prognosis. As such, AML represents an unmet medical need, with limited therapeutic options for patients who are refractory or too frail to benefit from potentially curative but highly toxic treatment, or for those patients that have relapsed following a first complete response. The prevalence of AML in western countries is around 1 per 5,000 persons, corresponding to around 100,000 cases in Europe and 60,000 in the USA. Among AML patients, it is estimated that approximately 50% of the patients will not have stem cell transplantation and will relapse. Therefore, the estimated targeted population of AB8938 in AML is around 80,000 people in Europe and the US.

propos d'AB ScienceFonde en 2001, AB Science est une socit pharmaceutique spcialise dans la recherche, le dveloppement, et la commercialisation d'inhibiteurs de protines kinases (IPK), une classe de protines cibles dont l'action est dterminante dans la signalisation cellulaire. Nos programmes ne ciblent que des pathologies fort besoin mdical, souvent mortelles avec un faible taux de survie, rares, ou rsistantes une premire ligne de traitement.AB Science a dvelopp en propre un portefeuille de molcules et la molcule phare d'AB Science, le masitinib, a dj fait l'objet d'un enregistrement en mdecine vtrinaire et est dveloppe chez lhomme en oncologie, dans les maladies neurodgnratives, dans les maladies inflammatoires et dans les maladies virales. La Socit a son sige Paris et est cote sur Euronext Paris (Ticker : AB).

Plus d'informations sur la Socit sur le site Internet : www.ab-science.com

Dclarations prospectives AB ScienceCe communiqu contient des dclarations prospectives. Ces dclarations ne constituent pas des faits historiques. Ces dclarations comprennent des projections et des estimations ainsi que les hypothses sur lesquelles celles-ci reposent, des dclarations portant sur des projets, des objectifs, des intentions et des attentes concernant des rsultats financiers, des vnements, des oprations, des services futurs, le dveloppement de produits et leur potentiel ou les performances futures. Ces dclarations prospectives peuvent souvent tre identifies par les mots s'attendre , anticiper , croire , avoir l'intention de , estimer ou planifier , ainsi que par d'autres termes similaires. Bien quAB Science estime que ces dclarations prospectives sont raisonnables, les investisseurs sont alerts sur le fait que ces dclarations prospectives sont soumises de nombreux risques et incertitudes, difficilement prvisibles et gnralement en dehors du contrle dAB Science qui peuvent impliquer que les rsultats et vnements effectifs raliss diffrent significativement de ceux qui sont exprims, induits ou prvus dans les informations et dclarations prospectives. Ces risques et incertitudes comprennent notamment les incertitudes inhrentes aux dveloppements des produits de la Socit, qui pourraient ne pas aboutir, ou la dlivrance par les autorits comptentes des autorisations de mise sur le march ou plus gnralement tous facteurs qui peuvent affecter la capacit de commercialisation des produits dvelopps par AB Science ainsi que ceux qui sont dvelopps ou identifis dans les documents publics publis par AB Science. AB Science ne prend aucun engagement de mettre jour les informations et dclarations prospectives sous rserve de la rglementation applicable notamment les articles 223-1 et suivants du rglement gnral de lAMF.

Pour tout renseignement complmentaire, merci de contacter :

AB Science

Communication financireinvestors@ab-science.com

Relations Mdias FranceNewCapArthur Rouillarouill@newcap.fr+33 (0)1 44 71 00 15

Relations Mdias Etats-UnisRooneyPartnersKate Barrettekbarrette@rooneypartners.com

+1212223 0561

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