Core Viewpoint - AB Science has received regulatory approval from several European countries to initiate the third stage of its Phase I/II study combining AB8939 with venetoclax for treating acute myeloid leukemia (AML), indicating potential advancements in treatment options for patients with relapsed/refractory AML [1][4]. Group 1: Study Details - The third stage of the study has been approved in France, Germany, Spain, and Greece, focusing on determining the maximum tolerated dose (MTD) of AB8939 [2]. - The first two stages of the Phase I study involved 28 and 13 patients, respectively, establishing the MTD of AB8939 at 21.3 mg/m² after both 3 and 14 consecutive days of treatment [3]. - The current stage will evaluate the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax, a standard treatment for AML [3][6]. Group 2: Treatment Rationale - The combination of AB8939 and venetoclax is expected to have low hematologic toxicity, potentially making it less toxic than the current standard treatment of azacitidine plus venetoclax [5]. - Both compounds target different mechanisms in cancer cells, which may lead to additive or synergistic effects in efficacy [5][9]. - AB8939 destabilizes microtubules, preventing cancer cell division, while venetoclax inhibits BCL2, promoting apoptosis in cancer cells, thus addressing resistance mechanisms [7][13]. Group 3: Market Potential - The estimated market potential for AML treatments exceeds €2 billion annually, with significant addressable markets in the United States, Europe, and Asia-Pacific [11][12]. - The total incidence of AML in the United States, Europe, and Asia-Pacific is approximately 79,100 cases, with a significant portion being poor responders to standard therapies [12][15]. Group 4: Intellectual Property and Regulatory Status - AB8939 is protected by patents until 2026, with potential extensions and additional protections for specific uses in AML, extending to 2044 for certain chromosomal abnormalities [16][18]. - The drug has received orphan drug designation from both the EMA and FDA, granting it marketing exclusivity for 10 years in Europe and 7 years in the US [19].

Core Points - AB Science has announced the issuance of a Canadian patent for AB8939, which protects its composition and use in treating acute myeloid leukemia (AML) until 2036 [1] - The patent completes the intellectual property coverage for AB8939 across all key geographic areas, including Europe, USA, China, Japan, South Korea, India, Israel, Latin America, and Australia [2] - AB8939 is a novel microtubule destabilizer currently in early phase clinical trials for AML, with the first phase focusing on determining the maximum tolerated dose [3] - The drug is also eligible for regulatory data protection in Canada, preventing generic competition for 8 years post-approval, and has received orphan drug designation from EMA and FDA, providing additional market exclusivity [4] - A separate patent application has been filed to protect AB8939 for treating AML with specific chromosomal abnormalities, potentially extending protection until 2044 [5] - AB8939 targets cancer cells by destabilizing microtubules and inhibiting enzymes essential for cancer stem cell survival [6] - AB Science specializes in developing protein kinase inhibitors for diseases with high unmet medical needs and has a portfolio of molecules including masitinib [7][8]

Core Insights - AB Science's lead compound, masitinib, is highlighted as a potential breakthrough treatment for progressive multiple sclerosis (MS) due to its unique mechanism of action targeting mast cells and microglia [1][2][3] - Professor Patrick Vermersch, a prominent neurologist, emphasizes the significant role of neuroinflammation in neurodegenerative disorders, including MS, and the importance of addressing the pro-inflammatory activity of mast and microglial cells [1][2] - Phase IIB/III trials of masitinib have shown promising results in reducing neuroinflammation and slowing disease progression, with further phase III data expected to clarify which patient groups may benefit most [3] Company Overview - AB Science, founded in 2001, specializes in the research, development, and commercialization of protein kinase inhibitors (PKIs) targeting diseases with high unmet medical needs [5][6] - The company is headquartered in Paris, France, and is listed on Euronext Paris under the ticker AB [6] - Masitinib has been registered for veterinary medicine and is being developed for human medicine in various fields, including oncology and neurological diseases [6]