On December 12, 2022 OSE Immunotherapeutics reported the latest preclinical data on the use of its anti-IL-7 receptor (IL-7R) antagonist OSE-127 for the treatment of B- and T-Cell Acute Lymphoblastic Leukemia (B- and T-ALL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting (1) on December 11, 2022 (New Orleans, Louisiana) (Press release, OSE Immunotherapeutics, DEC 12, 2022, View Source [SID1234646949]). This oral presentation has received the meritbased "Abstract Achievement Award" from the peer-review committee.

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The preclinical data on OSE-127 presented at ASH (Free ASH Whitepaper) was generated from a collaborative research program between OSE Immunotherapeutics and the University Medical Center Schleswig-Holstein in Kiel (Germany). This collaboration is using patient-derived samples and in-vivo xenograft models to evaluate the therapeutic potential of anti-IL-7R antagonist OSE-127 in targeting and blocking the high and dysregulated IL-7R-expression observed in 84% of B- or T-Acute Lymphoblastic Leukemia (ALL) patients.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased to share our collaborative research on OSE-127 in B-ALL and T-ALL with the international scientific hematology research community. By targeting the oncogenic IL-7 pathway and simultaneously triggering leukemia clearance through macrophage-driven phagocytosis, OSE-127 demonstrated great therapeutic potential in both B-ALL and T-ALL patient-derived xenograft experiments to address a significant unmet need for a wide spectrum of leukemia subtypes".

Pr. Denis Schewe (Head of the Pediatrics Department, Otto-von-Guericke-University, Magdeburg and formerly from the University Medical Center Schleswig-Holstein of 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, state: "Treatment options for T-ALL remain very limited and there is an urgent need for novel immunotherapy approaches to reduce toxicity and to target relapsed or refractory disease in ALL patients. Due to its dual mode of action comprising both antibody-dependent cellular phagocytosis induction and IL-7R-pathway blockade, OSE-127 may represent a promising novel immunotherapy option for ALL patients, including cases with dysregulated IL-7R signaling, particularly in combination with standard of care polychemotherapy. When translated into the clinic, OSE-127 could significantly improve ALL-therapy and the outcome of relapsed/refractory disease."

The 2022 ASH (Free ASH Whitepaper) presentation, entitled "The IL7R-Antagonist OSE-127 Blocks Acute Lymphoblastic Leukemia Development Via a Dual Mode of Action" (2) , reported on the preclinical efficacy of OSE-127 in ALL and on the mechanism of action underlying its anti-leukemic efficacy:

• In a large prospective ALL patient cohort, IL-7R positivity was detected in more than 84% of cases.

• Mechanistically, OSE-127 efficiently targeted leukemic cells not only via its IL-7R antagonist activity but also through macrophage-mediated antibody dependent phagocytosis (ADCP).

• In vivo efficacy of OSE-127 treatment correlated with IL-7R expression levels on patient leukemic cells, independently of IL-7R pathway activity, highlighting IL-7R as a potential predictive biomarker for OSE-127 efficacy in ALL.

• High preclinical efficacy has been observed both in minimal residual disease (MRD) as well as in overt-leukemia patient derived xenograft (PDX) models.

• OSE-127 demonstrated preclinical in vivo efficacy as monotherapy in 96% of tested B- and T-ALL Patient Derived Xenografts (PDXs), including samples from relapse and refractory patients.

• Standard of Care (SOC) poly-chemotherapy synergized with OSE-127 treatment, resulting in increased survival in overt-
leukemia settings, with clearance of the disease in 56% of SOC + OSE127 treated cases.

Additional patent applications were filed in 2021 and 2022 to strengthen the global intellectual property of OSE-127 by covering the use of anti-IL-7R antagonist antibodies with macrophageredirected phagocytic activity for the targeted treatment of IL-7R-positive cancers.