PRESS RELEASE
AB SCIENCE RECEIVES
HEALTH CANADA APPROVAL LETTER TO
COMMENCE 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, 22 September, 2021, 6pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announced that its clinical trial with
AB8939 in adult patients with relapsed/refractory acute myeloid
leukemia (AML) has been approved by Health Canada. The ‘No
Objection Letter’ (NOL) received from Health Canada provides an
acknowledgement of AB8939’s drug candidacy and the authority to
proceed with a Phase I/II study (AB18001) in patients with
refractory and relapsed AML and refractory myelodysplastic syndrome
(MDS).
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 [1–3]. 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 [1]. 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 [2]. 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) [4].
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.
Professor Olivier Hermine, President of the
Scientific Committee of AB Science and member of the Académie des
Sciences in France said, “We believe that AB8939 could represent a
major breakthrough in the development of effective
microtubule-targeting agents, an extensively used class of cancer
treatment. Our preclinical data show that AB8939 exhibits broad
anticancer activity, with a notable advantage of it being able to
overcome common mechanisms of drug resistance. AB8939 therefore has
strong potential to be developed in numerous oncology indications,
with our initial targets being hematological cancers. We are
excited about the start of this first AB8939 study in acute myeloid
leukemia (AML), which represents a significant milestone in the
clinical program of AB Science. AB8939 seems particularly
well-suited for the treatment of relapsed or refractory AML, for
which there are very limited therapeutic options.”
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 [5], 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] 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
[2] 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
[3] 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
[4] Press release dated November 7, 2019
[5] 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.
Forward-looking Statements - AB
ScienceThis press release contains forward-looking
statements. These statements are not historical facts. These
statements include projections and estimates as well as the
assumptions on which they are based, statements based on projects,
objectives, intentions and expectations regarding financial
results, events, operations, future services, product development
and their potential or future performance.
These forward-looking statements can often be
identified by the words "expect", "anticipate", "believe",
"intend", "estimate" or "plan" as well as other similar terms.
While AB Science believes these forward-looking statements are
reasonable, investors are cautioned that these forward-looking
statements are subject to numerous risks and uncertainties that are
difficult to predict and generally beyond the control of AB Science
and which may imply that results and actual events significantly
differ from those expressed, induced or anticipated in the
forward-looking information and statements. These risks and
uncertainties include the uncertainties related to product
development of the Company which may not be successful or to the
marketing authorizations granted by competent authorities or, more
generally, any factors that may affect marketing capacity of the
products developed by AB Science, as well as those developed or
identified in the public documents published by AB Science. AB
Science disclaims any obligation or undertaking to update the
forward-looking information and statements, subject to the
applicable regulations, in particular articles 223-1 et seq. of the
AMF General Regulations.
For additional information, please contact:
AB ScienceFinancial
Communication & Media Relations investors@ab-science.com
Media Relations – USA
RooneyPartnersKate
Barrettekbarrette@rooneyco.com
+1 646 432 0191
Media Relations – France
NewCapArthur
Rouilléarouille@newcap.fr
+33 (0)1 44 71 00 15
- CP AB8939 Canada NOL VEng VF
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