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AB Science: Masitinib receives FDA and EMA authorization for confirmatory phase 3 trial in metastatic castrate-resistant prostate cancer
PRESS RELEASE MASITINIB RECEIVES FDA AND EMA AUTHORIZATION FOR CONFIRMATORY PHASE 3 TRIAL IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER, WITH BIOMARKER-DRIVEN PATIENT SELECTION TARGETING POPULATION MOST LIKELY TO BENEFIT Paris, July 4, 2025, 8am CET AB Science SA (Euronext - FR0010557264 - AB) today announced that a confirmatory phase 3 trial of masitinib in metastatic castrate resistant prostate cancer (study AB22007) has been authorized by FDA and EMA (harmonized protocol approved through step 1 of Clinical Trials Information System), with a biomarker that targets patients with less advanced metastatic disease. Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France said, 'The authorization of our confirmatory Phase 3 study by both the FDA and EMA represents a critical milestone for masitinib in metastatic castrate-resistant prostate cancer. With a validated biomarker guiding patient selection, this trial has the potential to establish the first targeted combination with docetaxel in nearly two decades for mCRPC.' Design of phase 3 study Study AB22007 is a prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to confirm the efficacy and safety of docetaxel (IV 75 mg/m² plus prednisone for up to 10 cycles) plus masitinib 6.0 mg/kg/d, versus docetaxel plus placebo in metastatic castrate resistant prostate cancer (mCRPC). The study will enroll 600 patients (randomization 1:1) with confirmed mCRPC eligible to docetaxel and with a biomarker (as measured by baseline alkaline phosphatase level) indicative of less advanced metastatic disease. The study's primary endpoint will be radiographic progression free survival (rPFS), supported by overall survival as the first secondary endpoint. Masitinib is positioned in metastatic castrate resistant prostate cancer eligible to docetaxel, a high unmet medical need Masitinib is positioned in combination with docetaxel as a treatment of mCRPC patients who are eligible to docetaxel; that is to say, it is administered directly following resistance or relapse after the metastatic hormone-sensitive prostate cancer (mHSPC) treatments. While there are numerous treatments in the mHSPC treatment space, there is currently no drug registered for use in combination with standard of care treatment docetaxel in patients who have relapsed on hormone treatments, i.e., patients with mCRPC, despite docetaxel having been approved almost 20 years ago. 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 30% [1]. Up to 20% of men who undergo state-of-the art treatment for prostate cancer will develop CRPC within 5 years, and at least 84% of these will have metastases at the time of CRPC diagnosis [2]. Practically all patients with metastatic disease become resistant to androgen-deprivation therapy. Prostate cancer is the most common cause of cancer in men, with 137.9 new cases per 100,000 men per year [2]. The estimated prevalence of people living with prostate cancer is 113 per 100,000 [3], with approximately 15% of the patients having mCRPC eligible to chemotherapy [4]. As such, the population with mCRPC eligible to chemotherapy is around 75,000 in the EU and 50,000 in the USA. Results from study AB12003 demonstrated that the biomarker Alkaline Phosphatase predicts response of masitinib in mCRPC. The combination of masitinib plus docetaxel may provide a new first-line treatment option for mCRPC patients with low metastatic involvement Primary analysis: 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 mCRPC. Eligible patients were chemo-naïve with confirmed mCRPC, 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. Masitinib (6.0 mg/kg/day) plus docetaxel confers a significant PFS benefit in mCRPC patients with ALP ≤ 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; 12, 18, and 24-month PFS rates showed 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. ALP as a biomarker: Importantly, a progressively greater masitinib treatment effect was observed for lower baseline ALP levels (less advanced metastatic disease), with a significant 47% reduced risk of progression in patients with ALP≤100 IU/L (hazard ratio=0.53, p=0.002). The efficacy and response of masitinib was in fact correlated to the level of ALP. The use of biomarker ALP for the confirmatory phase 3 study has been validated by FDA and EMA. The establishment of a biomarker predictive of the response to masitinib is a potentially important discovery. ALP measures the involvement in the bones and in the liver of metastasis. When used sufficiently early, masitinib in combination with docetaxel was able to slow down the progression of the metastatic cancer even resistant to hormone treatments. The masitinib plus docetaxel safety profile was acceptable with respect to control; consistent with the known masitinib profile and no new safety signals observed. 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. Patent protection until 2042 Based on the results from AB12003 study, AB Science filed a patent application relating to methods of treating mCRPC (i.e. a secondary medical use patent) with its lead compound masitinib. The European Patent Office has granted this patent (EP4175639). It provides protection until 2042 for masitinib and related compounds for treatment of mCRPC in the patient subpopulation with low metastatic involvement (as measured by baseline alkaline phosphatase levels), which is the patient population in the approved phase 3 study of masitinib in mCRPC. Counterpart patent applications have also been filed in other major international markets, including the United States. References : [1] Cancer stat facts: prostate cancer. National Cancer Institute/ Surveillance, Epidemiology, and End Results Program. Accessed September 10, 2021. Crawford ED, Petrylak D, Sartor O. Navigating the evolving therapeutic landscape in advanced prostate cancer. Urol Oncol. 2017 May;35S:S1-S13. doi: 10.1016/ [3] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424. [4] Scher 2015 – PLoSONE - Symptomatic mCRPC that has not been treated with or not progressed on chemotherapy 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: 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@ Attachment Authorisation Ph3 mRCPC VENG VF擷取數據時發生錯誤 登入存取你的投資組合 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤 擷取數據時發生錯誤
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Strüngmann Award Honors Araris Biotech Founding Team as 2025 Winner
The expert jury selected Dragan Grabulovski, Ph.D., Philipp Spycher, Ph.D., and Isabella Attinger-Toller, Ph.D. of Araris Biotech, from a group of outstanding life science entrepreneurs The founding team is developing a breakthrough technology to establish a new generation of targeted cancer therapies Committee representatives presented the award and the EUR 100,000 cash prize on Thursday, July 3, 2025 Munich, Germany, July 04, 2025 – The Strüngmann Award selection committee today announced that Dragan Grabulovski, Ph.D., Philipp Spycher, Ph.D., and Isabella Attinger-Toller, Ph.D., the founders of Araris Biotech, have been honored as this year's winners. The award aims to support outstanding entrepreneurial and scientific achievements, as well as ground-breaking ideas in the life sciences industry. Araris Biotech's founding team distinguished itself not only by developing of a novel technology in the antibody-drug conjugates (ADCs) field, but also by successfully validating this innovation through partnerships and a preclinical exit. This new drug class has the potential to significantly advance the development of targeted cancer therapies, thereby delivering added value for people living with cancer worldwide. 'On behalf of the award committee and this year's expert jury panel, we would like to congratulate Isabella Attinger-Toller, Dragan Grabulovski and Philipp Spycher. Together with the expert jury, we selected the founders of Araris Biotech as winners based on their combined leadership, entrepreneurial expertise and scientific excellence. Following the successful acquisition of Araris by Taiho Pharmaceuticals, we believe this award further recognizes the founding team's continued growth and positive trajectory ahead. This trio has impressively demonstrated how a new idea, a clear focus on translation and entrepreneurial boldness can come together to launch a new generation of targeted cancer therapies,' said Andreas Strüngmann, M.D., and Thomas Strüngmann, Ph.D., in a joint statement. 'It was a special privilege for us to engage with such a diverse, forward-looking group of start-ups from the DACH region. Learning more about the finalists and their impressive achievements made the final decision anything but easy.' The group of finalists selected in May comprised three companies: Araris Biotech, NovaGo Therapeutics and TOLREMO therapeutics, whose founders exemplify the entrepreneurial potential and scientific diversity that characterize the life sciences sector in the DACH region. They include an impressive variety of disciplines — spanning targeted cancer therapies, regenerative neuroscience and cancer drug resistance. Following the presentation of their entrepreneurial and scientific achievements to an expert jury, Dragan Grabulovski, Ph.D., Philipp Spycher, Ph.D., and Isabella Attinger-Toller, Ph.D., were announced today as the winning team and will receive a joint cash prize of EUR 100,000. "We feel very honored to have our vision and achievements recognized by the Strüngmann Award. As the founding team, we have always believed in the potential of our new technology and the value it may hold for patients. This award, in addition to the acquisition by Taiho Pharmaceuticals, is a validation of our commitment, shared journey and the hard work that has enabled our success story," said Dragan Grabulovski, Ph.D., CEO of Araris Biotech, on behalf of the founding team. The Araris Biotech founders, the experienced biotech entrepreneur Dragan Grabulovski, Ph.D., (CEO), the visionary scientist Philipp Spycher, Ph.D., (CSO) and the outstanding translational scientist Isabella Attinger-Toller, Ph.D., (CTO), can look back on one of the most successful Swiss biotech startups to be established in recent years. Spun out of the Paul Scherrer Institute (part of ETH domain) in 2019, the team developed a novel ADC linker-payload technology (AraLinQ™) that enables one-step payload attachment to off-the-shelf antibodies, without the need for prior antibody engineering. This innovative approach not only opens new possibilities in oncology, but also has potential for applications in other therapeutic areas. In only a few years, the Araris team raised over CHF 40 million, formed a strategic partnership with Chugai (Roche) and Johnson & Johnson, and achieved a landmark acquisition by Taiho Pharmaceutical in March 2025 for up to USD $1.14 billion. Through these achievements, the three winners exemplify the potential within the DACH region to successfully translate scientific excellence into global innovation. About the Strüngmann AwardThe award was established in 2024 to recognize outstanding entrepreneurs realizing revolutionary ideas in the DACH life science sector. The goal is to reward exceptional achievements with a prestigious prize and to further the development of the next generation of leaders in this space. The award was named to honor twin brothers Andreas Strüngmann, M.D., and Thomas Strüngmann, Ph.D., who are among the important entrepreneurs, visionaries and investors in the life science sector. As the founders of Hexal, they achieved extraordinary entrepreneurial success and as investors, they have continued to repeat that success for more than 20 years by building and developing leading companies across the industry, including Mainz-based BioNTech. Learn more at About Araris Biotech AGAraris Biotech is a leading biotech company pioneering the future of antibody-drug conjugates (ADCs) and redefining the entire paradigm of targeted cancer therapy and beyond. Araris' vision is a world without chemotherapy and its proprietary conjugation and groundbreaking multi-payload technology represents a quantum leap forward in ADC design, enabling the transformation of any antibody into an ADC with the goal of better safety and efficacy. By enabling the attachment of multiple, synergistic cancer-fighting payloads to a single antibody in an efficient one-step process, Araris is creating a new generation of smart missiles that deliver the potency of combination chemotherapy in a targeted fashion in order to tackle the persistent challenges of cancer resistance. Araris is a wholly owned subsidiary of Taiho Pharmaceutical following its acquisition in March 2025. For more information about our science and pipeline, please visit Media ContactTrophic CommunicationsStephanie May, Ph.D. and Anja HeuerPhone: +49 (0) 171 185 56 82Email: athos@ Attachment Strüngmann Award 2025 Goes To Araris BiotechSign in to access your portfolio
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European Penny Stocks: 3 Picks With Market Caps Over €10M
The European market has shown mixed performance recently, with the pan-European STOXX Europe 600 Index remaining roughly flat and major indexes like France's CAC 40 and Italy's FTSE MIB posting modest gains. In such a landscape, investors often seek opportunities in less conventional areas, including penny stocks. While the term 'penny stocks' might seem outdated, these investments can offer affordability and growth potential when backed by strong financials. Here, we explore three penny stocks that stand out for their financial strength in the current European market context. Name Share Price Market Cap Financial Health Rating Orthex Oyj (HLSE:ORTHEX) €4.51 €80.09M ★★★★★★ Maps (BIT:MAPS) €3.51 €46.62M ★★★★★★ Angler Gaming (NGM:ANGL) SEK3.60 SEK269.95M ★★★★★★ Cellularline (BIT:CELL) €2.79 €58.85M ★★★★★☆ Fondia Oyj (HLSE:FONDIA) €4.89 €18.28M ★★★★★★ Abak (WSE:ABK) PLN4.40 PLN11.86M ★★★★★★ Bredband2 i Skandinavien (OM:BRE2) SEK2.53 SEK2.42B ★★★★☆☆ Hifab Group (OM:HIFA B) SEK3.62 SEK220.24M ★★★★★★ Deceuninck (ENXTBR:DECB) €2.125 €293.39M ★★★★★★ Netgem (ENXTPA:ALNTG) €0.978 €32.98M ★★★★★★ Click here to see the full list of 324 stocks from our European Penny Stocks screener. Let's explore several standout options from the results in the screener. Simply Wall St Financial Health Rating: ★★★★★☆ Overview: Ariston Holding N.V. operates through its subsidiaries to produce and distribute hot water and space heating solutions in the Netherlands, Germany, Italy, Switzerland, and internationally, with a market cap of €1.53 billion. Operations: The company's revenue is primarily derived from its Thermal Comfort segment, which generated €2.46 billion, followed by Burners at €89.3 million and Components at €79.1 million. Market Cap: €1.53B Ariston Holding N.V., with a market cap of €1.53 billion, derives significant revenue from its Thermal Comfort segment (€2.46 billion). Despite stable weekly volatility at 7%, the stock remains highly volatile over the past three months. Its net profit margins have decreased to 0.09% from last year's 6.1%, impacted by a large one-off loss of €53.7 million in 2024 financial results. The company has high debt levels, with a net debt to equity ratio of 41.4%. However, short-term assets exceed both long-term and short-term liabilities, indicating some financial stability amidst challenges in earnings growth and profitability. Click to explore a detailed breakdown of our findings in Ariston Holding's financial health report. Understand Ariston Holding's earnings outlook by examining our growth report. Simply Wall St Financial Health Rating: ★★★★★☆ Overview: One Experience Société anonyme operates event and tourist sites, hotels, and co-working and co-living spaces, with a market cap of €16.48 million. Operations: The company generates revenue of €4.24 million from its Business Services segment. Market Cap: €16.48M One Experience Société anonyme, with a market cap of €16.48 million, faces challenges typical of penny stocks. Despite generating €4.24 million in revenue from its Business Services segment, it remains unprofitable with increasing losses over the past five years. The company's short-term assets (€3.1M) fall short of covering its short-term liabilities (€7.3M), though they exceed long-term liabilities (€16K). While debt levels have improved to a satisfactory net debt to equity ratio of 26.9%, volatility has risen significantly over the past year, reflecting ongoing financial instability amidst efforts to maintain a sufficient cash runway for future operations. Unlock comprehensive insights into our analysis of One Experience Société anonyme stock in this financial health report. Examine One Experience Société anonyme's past performance report to understand how it has performed in prior years. Simply Wall St Financial Health Rating: ★★★★★★ Overview: Biohit Oyj is a biotechnology company that produces and sells acetaldehyde-binding products, diagnostic tools, and systems for research institutions, healthcare, and industry globally with a market cap of €43.58 million. Operations: The company's revenue is primarily derived from its Diagnostic Kits and Equipment segment, totaling €14.28 million. Market Cap: €43.58M Biohit Oyj, with a market cap of €43.58 million, stands out in the biotechnology sector by achieving profitability over the past five years and growing earnings annually by 67.9%. The company's innovative GastroPanel® quick test enhances its diagnostic capabilities, offering rapid results for gastric cancer risk assessment. Despite trading below estimated fair value, Biohit maintains financial stability with no debt and adequate short-term assets (€11M) covering liabilities (€3M). Recent leadership changes may further drive growth as Vesa Silaskivi assumes the role of Chairman. Forecasts suggest continued earnings growth at 10.46% per year amidst industry competition. Jump into the full analysis health report here for a deeper understanding of Biohit Oyj. Gain insights into Biohit Oyj's outlook and expected performance with our report on the company's earnings estimates. Reveal the 324 hidden gems among our European Penny Stocks screener with a single click here. Want To Explore Some Alternatives? Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include BIT:ARIS ENXTPA:ALEXP and HLSE:BIOBV. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. 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