PRESS RELEASE
AB SCIENCE GRANTED
AUTHORIZATION FROM THE FRENCH
HEALTH AUTHORITY (ANSM) TO INITIATE A
STUDY OF AB8939 IN THE
TREATMENT OF ACUTE MYELOID LEUKEMIA
(AML)
SECOND
AUTHORIZATION FOR PHASE
I/II TRIAL AB18001 PERMITS PATIENT RECRUITMENT FROM STUDY SITES IN
FRANCE AND CANADA
Paris, 18 October, 2021, 6pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announces that it has been authorized by
the French Medicine Agency, ANSM, to initiate a Phase I/II study
(AB18001) evaluating AB8939 in patients with refractory and
relapsed AML and refractory myelodysplastic syndrome (MDS). This
approval comes just a few weeks after receiving similar
authorization from the Canadian Health Authority [1].
Professor Nobert Vey, MD, principal investigator
of the study and Director of Clinical Research at Institut
Paoli-Calmettes commented, “We are very excited to start the
clinical development of AB8939. This drug is based on a well-known
therapeutic class of compounds which are useful for the treatment
of various cancers, however, AB8939 has a superior potential
because it was designed to overcome common mechanisms of drug
resistance. Numerous non-clinical data generated at Institut
Paoli-Calmettes are already available suggesting that AB8939 is
particularly well-suited for treatment of relapsed/refractory
AML”.
As previously communicated [1], AB8939 is a new
generation synthetic microtubule destabilizer with the ability to
overcome multidrug resistance and the potential for broad
applicability as a potent anticancer drug. Microtubules play a
crucial role in multiple cellular functions which makes them an
important target for cancer therapy. Indeed, chemotherapies that
target microtubules, such as taxanes and vinca alkaloids, are among
the most successful anticancer therapeutics available.
Unfortunately, the development of drug resistance (for example, via
Pgp efflux pumps that transport the drugs out of the cancer cells)
often restrict their clinical efficacy.
Key characteristics of AB8939 are that it
circumvents difficulties associated with Pgp-dependent multidrug
resistance and is not deactivated by an enzyme named
myeloperoxidase, which is an advantage over existing
chemotherapies. Another advantage and distinguishing characteristic
of AB8939 is that it is a synthetic drug.
The therapeutic potential of AB8939 has been
demonstrated through a series of preclinical experiments [2–4]. 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 [2]. Ara-C is considered the
clinically most relevant cytotoxic drug for AML treatment. In
another example, cancerous tumors from patients suffering from
resistant acute megakaryoblastic leukemia (an AML subtype) were
transplanted into mice. Data showed a complete response in mice
treated with AB8939, as compared with rapid disease progression in
control animals [3]. No apparent toxicity was observed during the
time course of the treatment.
Based on these results, AB8939 was granted
orphan drug designation for AML from the U.S. Food and Drug
Administration (FDA) [5].
The first indication AB8939 is being developed
for is acute myeloid leukemia (AML), a rapid proliferating
hematological cancer that originates in the bone marrow and quickly
moves into the blood. Cytarabine (Ara-C) is the current standard
chemotherapy for AML treatment, however, drug resistance is a major
limitation to successful therapy. AB8939 therefore has strong
potential as a second or third-line treatment in AML patients who
are unfit to receive intensive chemotherapy.
The advantageous mechanistic characteristics of
AB8939 mean that it is potentially applicable to a large number of
other oncology indications currently treated by
microtubule-inhibitor drugs (such as taxanes and vinca alkaloids)
and in particular hematological cancers. The envisioned strategy is
to position AB8939 in patients with abnormal cytogenetics that make
these patients unresponsive to first-line therapy.
AB8939 was entirely discovered by the
laboratories of AB Science, which retains full ownership of
intellectual rights, and is an example of AB Science’s focus on
innovative drug development focused on improving patients’
lives.
About Study AB18001Study
AB18001, 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’, 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.
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 [6], 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.
References[1] Press release
dated September 22, 2021
[2] Goubard A, Humbert M, Mansfield C, Hermine
O, Dubreuil P, et al. In Vivo Assessment of the Next Generation
Microtubule-Destabilizing Agent AB8939 in Patient-derived Xenograft
Models of Acute Myeloid Leukemia. Blood (2019) 134
(Supplement_1): 5142.
doi.org/10.1182/blood-2019-127143
[3] Goubard A, Humbert M, Mansfield C, Hermine
O, Dubreuil P, et al. AB8939, a Microtubule-DestabilizingAgent with
Potential to Overcome Multidrug Resistance, is Active Across the
Range (M0–M7) of Acute Myeloid Leukemia Subtypes. Blood
(2019) 134 (Supplement_1): 5154.
doi.org/10.1182/blood-2019-127021
[4] Humbert M, Goubard A, Mansfield C, Hermine
O, Dubreuil P, et al. Anticancer Activity of a Highly Potent Small
Molecule Tubulin Polymerization Inhibitor, AB8939. Blood
(2019) 134 (Supplement_1): 2075.
doi.org/10.1182/blood-2019-122540
[5] Press release dated November 7, 2019
[6] National Cancer Institute
(https://seer.cancer.gov/statfacts/html/amyl.html)
About AB ScienceFounded in
2001, AB Science is a pharmaceutical company specializing in the
research, development and commercialization of protein kinase
inhibitors (PKIs), a class of targeted proteins whose action are
key in signaling pathways within cells. Our programs target only
diseases with high unmet medical needs, often lethal with short
term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and
the Company’s lead compound, masitinib, has already been registered
for veterinary medicine and is developed in human medicine in
oncology, neurological diseases, inflammatory diseases and viral
diseases. The company is headquartered in Paris, France, and listed
on Euronext Paris (ticker: AB).
Further information is available on AB Science’s website:
www.ab-science.com.
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