About this program

IPH4102 is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, designed for treatment of T-cell lymphomas.

Cutaneous T-cell lymphomas (CTCL), an orphan disease, is a group of rare cutaneous lymphomas of T lymphocytes with poor prognosis and few therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up to 85% of certain agressive CTCL subtypes, in particular, Sézary syndrome and transformed mycosis fungoides (tMF). KIR3DL2 has a restricted expression on normal tissues.

IPH4102 was granted orphan drug status in the European Union and in the United States for the treatment of CTCL.

Innate Pharma expects to initiate a global Phase II study (“TELLOMAK”) in different subtypes of T-cell lymphomas in the first half of 2019.

    Mechanism of action of anti-KIR3DL2

    The Phase I trial is an open label and multicenter study. It is performed in Europe (France, Netherlands, United Kingdom) and in the US. Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the MD Anderson Cancer Center (Houston, Texas), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the Leiden University Medical Center (Leiden, Netherlands), and the Guy’s and St Thomas’ Hospital (London, United Kingdom).

    • The dose-escalation part has accrued 25 KIR3DL2-positive CTCL patients in 10 dose levels. The objective was to characterize IPH4102 safety profile, identify the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D); the dose escalation followed an accelerated 3+3 design. Results of the dose-escalation were presented at the EORTC CLTF meeting in October 2017
    • The cohort expansion enrolled 15 patients with Sézary Syndrome and 4 tMF receiving IPH4102 at the RP2D until progression.

    The primary objective of this trial is to evaluate the safety and tolerability of repeated administrations of single agent IPH4102 in this patient population. The secondary objectives include assessment of the drug’s antitumor activity. Clinical endpoints include global objective response rate, response duration and progression-free survival. Exploratory analyses are aimed at identifying biomarkers of clinical activity.

    In a presentation at EORTC CLTF meeting in September 2018 , IPH4102 showed encouraging clinical activity, demonstrated by high response rate and long progression-free survival.

    Following updated results presented at the 2018 ASH Annual Meeting, Innate Pharma expects to initiate a global Phase II study (“TELLOMAK”) in different subtypes of T-cell lymphomas in the first half of 2019.

    Documents: 

    AttachmentSize
    ASH 2018: IPH4102, an anti-KIR3DL2 mAb in refractory Sézary syndrome: results from a multicenter international phase 1 trial1.43 MB
    EORTC CLTF 2018: IPH4102 results of the Phase 1 study in refractory CTCL863.07 KB
    EORTC CLTF 2017: IPH4102 is safe and clinically active in advanced CTCL patients, results from the dose-escalation part664.71 KB
    EORTC CLTF 2017: Biomarkers of pharmacological and clinical activity of IPH4102890.56 KB
    ICML 2017: Dose-escalation safety, biomarker and clinical activity results (Phase I in relapsed/refractory CTCL)813.6 KB
    ASH 2016: First-in-Human, Multicenter Phase I Study of IPH4102, First-in-Class Humanized Anti-KIR3DL2 Monoclonal Antibody1.49 MB
    3WCCL: Presentation at the Scientific Session “Endpoints & Clinical Trials” with Pr Martine Bagot567.32 KB
    Poster presented at the 3WCCL by Pr Martine Bagot731.18 KB
    Poster presented at the 3WCCL by Hélène Sicard, Anne Marie-Cardine and Maxime Battistella628 KB
    Poster presented at the 3WCCL by Maxime Battistella731.18 KB
    Poster on IPH4102 presented at ASCO2016234.18 KB
    Pr Martin Bagot presentation - Paris, Dec 2, 2015 - WARNING: some images may offend the sensibilities1.68 MB
    Dr Youn H. Kim presentation, Key Opinion Leader luncheon to discuss Cutaneous T-cell Lymphoma2.52 MB
    Pr Martin Bagot presentation at EORTC cutaneous lymphoma task force meeting - Torino sept. 2015 7.04 MB
    Poster on IPH4102 presented at T-Cell Lymphoma Forum 2015160.66 KB
    Poster on IPH4102 presented at T-Cell Lymphoma Forum 20142.65 MB
    Poster on IPH4102 presented at AACR Annual Meeting 2013 1.06 MB