AB Science announced today that its Phase 2B / 3 study of masitinib (AB12003) in metastatic castration-resistant prostate cancer (mCRPC) has met its predefined primary endpoint Paris Stock Exchange: AB

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PRESS RELEASE

PHASE 2B / 3 STUDY ASSESSMENT OF MASITINIB IN IN CASTRA-RESISTANT METASTATIC PROSTATE CANCER (MCRPC) HAS MET ITS PRIMARY ENDPOINT

Paris, 29 April 2021, 7pm THIS

AB Science SA (Euronext – FR0010557264 – AB) today announced that its Phase 2B / 3 study of masitinib (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible for chemotherapy has met its predefined primary endpoint .

Patents relating to the results of Study AB12003 are pending and detailed results of Study AB12003 will be presented in a webcast with key opinion leaders that will take place as soon as the patents are filed.

About study AB12003

Study AB12003 was an international, multicenter, randomized, double-blind, placebo-controlled, 2 parallel group, phase 3 study in chemotherapy-eligible metastatic castrate-resistant prostate cancer (mCRPC). The study aimed to compare the efficacy and safety of masitinib (6.0 mg / kg / day) in combination with docetaxel versus placebo in combination with docetaxel. Docetaxel has been combined with prednisone.

The primary endpoint of the study was progression-free survival (PFS).

The target patient population consisted of adult males who had progressed to develop metastatic castration-resistant prostate cancer (mCRPC) following castration treatment (i.e. reduction in androgen / testosterone / DHT available by chemical or surgical means) and were therefore eligible for chemotherapy.

About castration resistant prostate cancer (CRPC)

The development of prostate cancer is often caused by male sex hormones called androgens, including testosterone. Castrate-resistant prostate cancer (CRPC) is defined as the progression of the disease despite androgen depletion (hormone) therapy and may present as a continuous increase in serum levels of prostate specific antigen. prostate (PSA), the progression of a pre-existing disease and / or the appearance of new metastases. Metastatic CRPC (mCRPC) occurs when cancer spreads to other parts of the body.

Prostate cancer is the most common cause of cancer in men, with 137.9 new cases per 100,000 men per year [1]. The estimated prevalence of people with prostate cancer is 113 per 100,000 [2], with approximately 15% of patients with metastatic castration-resistant prostate cancer (mCRPC) eligible for chemotherapy [3]. For example, the population with metastatic castrate-resistant prostate cancer (mCRPC) eligible for chemotherapy is approximately 75,000 in the EU and 50,000 in the US.

Prostate cancer is also the second leading cause of cancer death in men, with the highest rates in North America, Australia, and northern and central Europe. Although the overall 5-year survival rate for prostate cancer is very high, up to 20% of men who undergo advanced treatment for prostate cancer will develop CRPC within 5 years, and at least 84% of them will have metastases. at the time of CRPC diagnosis [1]. Virtually all patients with metastatic disease become resistant to androgen deprivation therapy. Median survival of people with mCRPC ranges from around 15 to 36 months in recent studies, and 5-year survival is only 28% [1].

The references
[1] Crawford ED, Petrylak D, Sartor O. Navigating the evolving therapeutic landscape of advanced prostate cancer. Urol Oncol. May 2017; 35S: S1-S13. doi: 10.1016 / j.urolonc.2017.01.020.
[2] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN Estimates of Global Incidence and Mortality for 36 Cancers in 185 Countries. CA Cancer J Clin. 2018; 68 (6): 394–424.
[3] Scher 2015 – PLoSONE – symptomatic mCRPC that has not been treated or has not progressed on chemotherapy

About masitinib
Masitinib is a novel orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, cells important for immunity, by inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a variety of conditions in oncology, inflammatory diseases, and certain diseases of the central nervous system. In oncology, because of its immunotherapeutic effect, masitinib may have an effect on survival, alone or in combination with chemotherapy. By its activity on mast cells and microglia and therefore inhibiting the activation of the inflammatory process, masitinib may have an effect on the symptoms associated with certain 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 (PKI), a class of targeted proteins whose action is essential in signaling pathways within cells. . Our programs only target diseases with high unmet medical needs, often fatal with short-term survival or rare or refractory to the previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the company’s principal compound, masitinib, has already been registered for veterinary medicine and is being developed in human medicine for oncology, neurological diseases and inflammatory diseases. The company is headquartered in Paris, France, and is listed on Euronext Paris (symbol: AB).

Further information is available on the AB Science website:
www.ab-science.com.

Forward-looking statements – AB Science
This 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 plans, objectives, intentions and expectations regarding financial results, events, operations, future services, development. of products and their potential or future performance.

These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” and other similar terms. Although AB Science believes that these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties which are difficult to predict and generally beyond the control of AB Science and which may involve the actual results and events differ materially from those expressed, implied or anticipated in the forward-looking information and statements. These risks and uncertainties include uncertainties related to the development of the Company’s products which may not be successful or to the marketing authorizations granted by the competent authorities or, more generally, any factor that may affect the marketing capacity of the products developed by the Company. AB Science, as well as those developed or identified in the public documents filed by AB Science with the Autorité des Marchés Financiers (AMF), including those listed in chapter 4 “Risk factors” of the AB Science reference document filed with of the AMF on November 22, 2016, under number R. 16-078. AB Science disclaims any obligation or commitment to update forward-looking information and statements, subject to applicable regulations, in particular Articles 223-1 and following. of the AMF general regulations.

For more information, please contact:

AB Science
Financial communication and media relations
[email protected]

Media Relations – United States

RooneyPartners
Jeffrey Freedman
[email protected]

+1 646 432 0191

Media relations – France

NewCap
Arthur Rusty
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+33 (0) 1 44 71 00 15

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