On July 5, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported that the trial’s Independent Drug Safety Monitoring Board (DSMB) provided a positive recommendation on the continuation until its completion of the Phase 2 clinical trial of IL-7 Receptor (IL-7R) antagonist Lusvertikimab (OSE-127) in ulcerative colitis (Press release, OSE Immunotherapeutics, JUL 5, 2023, View Source [SID1234633068]).
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In parallel, the European Medicines Agency (EMA) provided a positive opinion on Orphan Drug Designation for Lusvertikimab for the treatment of Acute Lymphoblastic Leukemia (ALL).
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "After the planned DSMB review recommendation to continue the study until its completion, the Company’s primary and strategic focus remains clinical evaluation of Lusvertikimab in this ongoing ulcerative colitis Phase 2 study with end of accrual expected in the following months. In parallel, based on strong preclinical activity demonstrated by Lusvertikimab using patient’s leukemic samples, we are happy to have received a positive opinion on Orphan Drug Designation from the European Medicines Agency. Lusvertikimab orphan status for the treatment of Acute Lymphoblastic Leukemia from B or T cell precursors is opening future potential new indications in ALL, rare diseases with limited treatment options. We warmly thank our academic and clinician partners in Kiel, involved with us in this innovative research program."
ABOUT LUSVERTIKIMAB CLINICAL EVALUATION IN ULCERATIVE COLITIS (UC)
The ongoing Phase 2 clinical trial sponsored by OSE Immunotherapeutics is evaluating the efficacy and safety of Lusvertikimab (OSE-127) versus placebo in patients with moderate to severe active UC who failed or lost response or were intolerant to previous treatment(s) (CoTikiS trial: NCT04882007). A positive interim futility analysis was observed in the prespecified first 50 patients (i.e., 33% of the total patient enrollment in the study) having completed the induction phase. The upcoming major milestone for this Phase 2 clinical trial is expected in the following months with the top-line results after the induction phase (primary endpoint at week 10) and in H1 2024 for the first early assessment in maintenance after 6 months of therapy. UC is a debilitating and chronic inflammatory bowel disease which affects 3.3 million patients in US, Europe and Japan (1), representing 12.2 per 100,000 people by year (2). Despite broad available options, remission rates remain only 25-30% (3), leaving most patients without satisfactory treatments.
(1) EvaluatePharma
(2) Updated Incidence and Prevalence of Crohn’s Disease and Ulcerative Colitis in Olmsted County, Minnesota (1970-2011). Loftus EV et al. October 2014).
(3) Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572
ABOUT THE LUSVERTIKIMAB RESEARCH PROGRAM IN ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
This collaborative research program between OSE Immunotherapeutics and the University Medical Center Schleswig-Holstein in Kiel (Germany) evaluated the therapeutic potential of Lusvertikimab in targeting and blocking the high and dysregulated IL-7R expression observed in 84% of B- or T-Cell ALL (B- and T-ALL) patients. In particular, significant preclinical activity of Lusvertikimab has been demonstrated in models using leukemic samples from refractory and relapsed patients. The latest preclinical data on the use of Lusvertikimab for the treatment of B- and T-ALL and its dual anti-leukemic efficacy were presented and awarded at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2022.
In Europe, 7,000 cases of ALL are diagnosed each year (1). The condition is estimated to be affecting approximately 1.7 in 10,000 persons in the European Union (2). More globally, the number of diagnosed incident cases of ALL in Europe, US, Japan and China is estimated to achieve 26,482 cases in 2029(3).
(1) Gatta G, van der Zwan JM, Casali P, et al. Rare cancers are not so rare: The rare cancer burden in Europe. Eur. J. Cancer. 2011; 47: 2493-2511.
(2) Using epidemiological information from the European Cancer Information System (ECIS)(
(3) Global Data
ABOUT ORPHAN MEDICINAL PRODUCT DESIGNATION
Orphan designation in the European Union (EU) is granted by the European Commission after the opinion is issued by the EMA’s Committee for Orphan Medicinal Products (COMP). The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU and for which no satisfactory method of diagnosis, prevention or treatment are authorized, or, if such exists, the medicine being developed must provide significant benefit. Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives that include protocol assistance from the EMA at reduced fees during the product development phase and access to centralized authorization procedure and a 10-year period of marketing exclusivity in the EU after product approval.