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OSE Immunotherapeutics announces publication of preclinical studies

Posted on by angelo

OSE Immunotherapeutics Announces Publication of Lusvertikimab Preclinical Efficacy Results in
Acute lymphoblastic leukemia in the journal “Blood”

Nantes, France – July 1st2024 – 7:30 a.m. CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Ticker: OSE) announced today the publication of a paper on the latest preclinical efficacy data on the use of its anti-IL-7 receptor (IL-7R)

Antagonist A&io) Lusvertikimab (OSE-127) for the treatment of B- and T-cell acute lymphoblastic leukemia (B- and T-ALL) in “Blood,” a peer-reviewed medical journal published by the American Society of Hematology.

The preclinical data on Lusvertikimab published in ‘Blood’ were generated from a collaborative research program between OSE Immunotherapeutics and the University Medical Center Schleswig-Holstein in Kiel (Germany). This collaboration uses patient-derived samples and in vivo xenograft models to evaluate the therapeutic potential of Lusvertikimab, an anti-IL-7R antagonist, to target and block the elevated and dysregulated expression of IL-7R observed in nearly 85% of patients with acute lymphoblastic leukemia (ALL ) End.

Prof. Denis Schewe (newly appointed Head of Pediatric Hematology/Oncology, University Hospital Dresden and National Center for Tumor Diseases, partner site Dresden, and formerly of the University Medical Center Schleswig-Holstein Kiel) and Dr Lennart Lenk (Department of Pediatrics I, Christian-Albrechts University Kiel and University Medical Center Schleswig-Holstein, Kiel), leading the research program in collaboration with OSE Immunotherapeutics, comment: “Treatment options for T-ALL remain very limited and there is an urgent need for new immunotherapy approaches to reduce toxicity and target relapsed or refractory disease in ALL patients. Thanks to its dual mode of action including both blocking of IL-7R signaling and induction of antibody-dependent cellular phagocytosis, Lusvertikimab could represent a promising new immunotherapy option for patients with of CD127-positive ALL, particularly in combination with standard polychemotherapy. Once applied clinically, Lusvertikimab could significantly improve ALL treatment and relapsed/refractory disease outcomes.

Nicolas Poirier, Managing Director of OSE Immunotherapeutics, concludes: “We are very pleased with this publication on Lusvertikimab in “Blood”, a high-level journal in the field of hematology whose manuscripts are reviewed by eminent specialists. “New targeted immunotherapy options are urgently needed for patients with B-ALL and T-ALL and we are pleased to collaborate with hematology research leaders at Kiel University to address this challenge clinical. »

The summary, titled: “IL-7R Antagonist Lusvertikimab Reduces Leukemic Burden in Xenografted ALL via Antibody-Dependent Cellular Phagocytosis” reported that IL-7R immunotherapy with Lusvertikimab shows significant results in vivo efficacy in preclinical models using B-ALL and T-ALL samples. Mechanistically, Lusvertikimab targeted ALL cells via a dual mode:

  • On the one hand, it blocks IL-7 receptor signaling and thus blocks proliferative and pro-survival signals induced by interleukin-7.
  • In parallel, it induces the elimination of leukemic cells by macrophages (antibody-dependent phagocytosis), notably with a strong correlation with the level of surface expression of IL-7R on leukemic cells.

About acute lymphoblastic leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is a heterogeneous group of lymphoid disorders resulting from clonal proliferation of immature lymphocytes of B (85%) or T (15%) cell lineages. (3) in the blood, bone marrow and other lymphoid organs.
Although it is one of the most common cancers in children, accounting for approximately 25% of all childhood cancer diagnoses in children under 15 years of age (4)adults can also develop ALL. Approximately 40% of diagnosed ALL cases occur in adults, and of these, approximately 50% have refractory disease or relapse under current conventional therapies. (4).

The American Cancer Society estimates that nearly 6,660 new cases of ALL will be diagnosed in the United States in 2022.(5)In Europe, 7,000 cases of ALL are diagnosed each year (6)The number of patients in Japan was estimated at around 5,000 in a survey conducted by the Japanese Ministry of Health and Welfare in 2017. The number of incident cases diagnosed with acute lymphocytic leukemia (ALL) in Europe, the United States, Japan and China is expected to reach 26,482 cases by 2029.(7).

(1) ASH Publication – Blood (2022) 140 (Supplement 1): 1045 – 1047
(2) Dr Lennart Lenk, Dr Irène Baccelli, Dr Dorothee Winterberg, Dr Anna Dietterle, Dr Frédérique Corallo, Julien Taurelle, Emma Narbeburu*Anna Laqua, Ph.D., Beat Bornhauser, Ph.D., Jean-Pierre Bourquin, MD, Ph.D., Fotini Vogiatzi, Ph.D., Martin Schrappe, MD, Gunnar Cario, Monika Brüggemann, MD, Nicolas Poirier, Ph. D. and Denis Martin Schewe, MD
(3) DeVita, Jr. VT, Hellman S, Rosenberg SA, eds. ; Cancer: principles and practice of oncology, 10th ed. ; Lippincott-Raven, Philadelphia, Pennsylvania; 2014.
(4) Treatment of childhood acute lymphoblastic leukemia (PDQ®) – Healthcare professional version, accessed October 2022
(5) American Cancer Society. 2022 Key Statistics on Acute Lymphocytic Leukemia (ALL). Available at: https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html#references., accessed in October 2022
(6) Gatta G, van der Zwan JM, Casali P, et al. Rare cancers are not so rare: the burden of rare cancer in Europe. Eur. J.Cancer. 2011; 47:2493-2511.
(7) Global data

ABOUT OSE IMMUNOTHERAPEUTICS

OSE Immunotherapeutics is a biotechnology company dedicated to the development of first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I).
The Company’s current well-balanced clinical pipeline includes:

  • Tedopi® (commercially available neoepitope-based immunotherapy activating tumor-specific T cells): this cancer vaccine is the Company’s most advanced product; positive results from the phase 3 trial (Atalante 1) in non-small cell lung cancer patients with secondary resistance after failure of checkpoint inhibitors. Other phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are underway in solid tumors.
  • OSE-279 (anti-PD1): first positive results in the ongoing phase 1/2 in solid tumors.
  • OSE-127 – lusvertikimab (humanized monoclonal antibody antagonist of the IL-7 receptor); phase 2 underway in ulcerative colitis (sponsor OSE Immunotherapeutics); preclinical research underway in leukemia (OSE Immunotherapeutics).
  • FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; Phase 1/2 underway in kidney transplantation (sponsored by Nantes University Hospital); Phase 1 successful in the United States (sponsor Veloxis Pharmaceuticals, Inc.).
  • Anti-SIRPα monoclonal antibody developed in partnership with Boehringer Ingelheim in advanced solid tumors and cardiovascular-renal-metabolic (CRM) diseases; positive phase 1 dose escalation results in monotherapy and in combination; Phase 2 in CRM diseases is expected to be launched in late 2024.
  • ABBV-230 (Agonist mAb ChemR23) developed in partnership with AbbVie in chronic inflammation.

OSE Immunotherapeutics plans to generate significant additional value from its three proprietary drug discovery platforms, which are central to its ambitious goal of delivering next-generation, best-in-class immunotherapies:

  • mAb pro-resolving platform focused on targeting and improving resolution of inflammation and optimizing the therapeutic potential of targeting neutrophils and macrophages in I&I. ABBV-230 (licensed by AbbVie) is the first candidate generated by the platform, additional discovery programs are underway on new pro-resolving GPCRs.
  • Myeloid Checkpoint Platform focused on optimizing the therapeutic potential of myeloid cells in IO by targeting immunoregulatory receptors expressed by macrophages and dendritic cells. BI 765063 And BI 770371 (licensed by Boehringer Ingelheim) are the most advanced candidates generated by the platform. Complementary discovery programs in progress, including positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs.
  • BiCKI® Platform is a bifunctional fusion protein platform built on the key component of anti-PD1 combined with a novel immunotherapy target to increase antitumor efficacy by “cis-potentiating” tumor-specific T cells. A first program was acquired by Boehringer Ingelheim.
  • mRNA therapeutic platform enables local delivery into the inflammatory site of innovative RNA-encoded immunotherapies to locally control and/or suppress immune responses and inflammation.

Additional information on OSE Immunotherapeutics’ assets is available on the Company’s website: www.ose-immuno.com
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Forward-Looking Statements
This press release contains, implicitly or expressly, information and statements that may be deemed to be forward-looking information and statements regarding OSE Immunotherapeutics. They do not constitute historically proven facts. This information and statements include financial projections based on assumptions or assumptions made by the management of OSE Immunotherapeutics in light of their experience and their perception of historical trends, current economic and industry conditions, future developments and other factors that they consider appropriate.
These forward-looking statements include statements generally using the conditional and containing verbs such as “expect,” “anticipate,” “believe,” “target,” “plan,” or “estimate,” their declensions and conjugations and words of similar import. Although OSE Immunotherapeutics’ management believes that the forward-looking statements and information are reasonable, OSE Immunotherapeutics’ shareholders and other investors are cautioned that the realization of these expectations is inherently subject to various risks, known and unknown, and uncertainties that are difficult to predict and generally beyond OSE Immunotherapeutics’ control. These risks could cause actual results and developments to differ materially from those expressed, implied or projected by the forward-looking statements. These risks include those discussed or identified in the public documents filed by OSE Immunotherapeutics with the AMF. These forward-looking statements are not guarantees of future performance. This press release contains summary information only and should be read in conjunction with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for fiscal year 2023, available on the OSE Immunotherapeutics website. Except as required by applicable law, OSE Immunotherapeutics is publishing this press release as of the date hereof and undertakes no obligation to update or revise any forward-looking information or statements.