AB Science receives Notice of Allowance for European patent
covering masitinib in the treatment of metastatic castrate
refractory prostate cancer (mCRPC)
PRESS RELEASE
AB SCIENCE
RECEIVES NOTICE OF ALLOWANCE
FOR EUROPEAN PATENT
COVERING MASITINIB IN
THE TREATMENT OF METASTATIC
CASTRATE REFRACTORY PROSTATE CANCER
(mCRPC),
STRENGTHENING THE COMPANY’S INTELLECTUAL PROPERTY POSITION
UNTIL 2042
Paris, 26 June, 2023, 6pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announced that the European Patent Office
has issued a Notice of Allowance for a patent relating to methods
of treating (mCRPC) with its lead compound masitinib, based on
findings from study AB12003 [1]. This new European patent provides
intellectual property protection for masitinib in the treatment of
mCRPC until 2042.
Masitinib is positioned in combination with
docetaxel as a treatment of mCRPC patients who are eligible to
chemotherapy; that is to say, it is administered directly following
the metastatic hormone-sensitive prostate cancer (mHSPC) treatment
space.
Although there are numerous treatments in the
mHSPC treatment space, there is currently no drug registered for
use in combination with docetaxel in patients with mCRPC, despite
docetaxel having been approved almost 20 years ago. Historically,
there has been a high failure rate of trials studying combinations
of docetaxel and new targeted agents, with study AB12003 being a
rare example of a phase 3 clinical trial that showed improvement in
progression-free survival (PFS) for masitinib in combination with
docetaxel.
The Notice of Allowance (NOA) means that the
European Patent Office intends to grant the patent application,
EP4175639A1, after the completion of certain formal procedural
steps. Once granted, the patent can be kept in force until May
2042. A European NOA is issued after an examiner determines that a
patent application satisfies all requirements for patentability
under the European Patent Convention.
More specifically, this patent provides
protection of masitinib and related compounds for treatment of
mCRPC in a patient subpopulation with low metastatic involvement
(as measured by baseline alkaline phosphatase levels). This patient
population is fully consistent with results from masitinib study
AB12003 [1] and the on-going clinical development program of
masitinib in mCRPC.
As a reminder, key results from study AB12003
include:
- Masitinib (6.0 mg/kg/day) plus
docetaxel conferred a significant progression-free survival (PFS)
benefit in mCRPC patients with baseline alkaline phosphatase levels
(ALP) less than or equal to 250 IU/L; hazard ratio of 0.79
[0.64,0.97] (p=0.0087), corresponding to a 21% reduction in risk of
progression relative to control.
- Assessment of PFS rates was
convergent with this primary outcome, with 12, 18, and 24-month PFS
rates showing significant improvement in favor of masitinib plus
docetaxel relative to control: 1.6-fold (p=0.0035), 1.9-fold
(p=0.0001) and 1.9-fold (p=0.0028), respectively.
- A progressively greater masitinib
treatment effect was observed for lower baseline ALP levels (i.e.,
less advanced metastatic disease), with a significant 47% reduced
risk of progression in patients with ALP less than or equal to 100
IU/L (hazard ratio=0.53, p=0.002).
- The masitinib plus docetaxel safety
profile was acceptable, consistent with the known masitinib profile
and with no new safety signals observed.
Although localized disease is associated with
high survival rates, metastatic prostate cancer still represents an
unmet medical need with a 5-years survival rate of about 32%
[2].
References
[1] Pavic, Michel; Hermine, Olivier; Spaeth, Dominique
LBA02-11 Masitinib plus docetaxel as first-line treatment of
metastatic castrate refractory prostate cancer: results from study
AB12003, Journal of Urology: September 2021 - Volume 206 - Issue
Supplement 3. doi: 10.1097/JU.0000000000002149.11
[2] American Cancer Society. Cancer Facts & Figures 2023.
Atlanta: American Cancer Society; 2023. Accessed June 2023.
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2023/2023-cancer-facts-and-figures.pdf
About study
AB12003
Study AB12003 was a prospective, placebo
controlled, double blind, randomized, phase 3 trial, evaluating
masitinib (6.0 mg/kg/d) in combination with docetaxel (IV 75 mg/m²
plus prednisone for up to 10 cycles) as a first-line treatment of
metastatic castrate resistant prostate cancer (mCRPC). Eligible
patients were chemo-naïve with confirmed mCRCP, who had progressed
on previous abiraterone treatment or were indicated for docetaxel
treatment, and had a ECOG ≤1. Primary analysis was performed on a
pre-specified targeted subgroup, defined as patients with baseline
alkaline phosphatase levels (ALP) ≤250 IU/L, and on the overall
population. Primary endpoint was progression free survival (PFS)
(PCWG2 definition). The study was successful if improvement in
median PFS relative to control reached a 3.9% level of significance
for the target subgroup (alpha split with fallback procedure to
conserve overall type-I error at 5% for the overall study cohort).
Primary analysis was based on 450 patients in the targeted subgroup
(ALP ≤ 250 IU/L). There was a total of 712 patients in the overall
study cohort.
About masitinib
Masitinib is a orally administered tyrosine
kinase inhibitor that targets mast cells and macrophages, important
cells for immunity, through inhibiting a limited number of kinases.
Based on its unique mechanism of action, masitinib can be developed
in a large number of conditions in oncology, in inflammatory
diseases, and in certain diseases of the central nervous system. In
oncology due to its immunotherapy effect, masitinib can have an
effect on survival, alone or in combination with chemotherapy.
Through its activity on mast cells and microglia and consequently
the inhibition of the activation of the inflammatory process,
masitinib can have an effect on the symptoms associated with some
inflammatory and central nervous system diseases and the
degeneration of these diseases.
About AB Science
Founded 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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