Final results of the dose-escalation part from the Phase I trial evaluating IPH4102 in patients with advanced cutaneous T-cell lymphomas presented at the EORTC CLTF meeting
Marseille, France, October 16, 2017, 7:00 AM CEST
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH) announces that final results of the dose-escalation part of the ongoing Phase I study investigating IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL), an orphan disease, were presented by Pr Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris, in an oral presentation at the EORTC CLTF [1] Meeting in London on October 15, 2017.
These data confirm the good safety profile and promising activity of IPH4102 in this elderly and heavily pretreated patients population (n=25). The objective response rate in the 20 patients with Sézary syndrome was 50%; the ORR4 [2] was 40%, the disease control rate (DCR), 90%, the median duration of response (DOR), 9.9 months and the median progression free survival (PFS), 10.8 months, respectively. Data on pruritus were reported for the first time and show substantial improvement in patients having a global clinical response but also in patients with stable disease. The Recommended Phase 2 Dose (RP2D) has been identified at 750 mg, a fixed dose equivalent to 10 mg/kg.
Expansion cohorts started, including 2 cohorts of 15 patients each in two CTCL subtypes: Sézary syndrome and transformed mycosis fungoides.
Biomarker results were presented in an oral presentation by Dr Maxime Battistella, Assistant Professor Pathology and Dermatopathology at St Louis Hospital and Université L. Diderot. The presentation and poster are available in the IPH4102 section on Innate Pharma's website .
About the IPH4102 Phase I trial:
The Phase I trial (NCT02593045) is an open label, multicenter study of IPH4102 in patients with relapsed/refractory CTCL which is performed in Europe (France, Netherlands and United Kingdom) and in the US. Participating institutions include several hospitals with internationally recognized expertise: the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, CA), the Ohio State University (Columbus, OH), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Leiden, Netherlands), and the Guy's and St Thomas' Hospital (London, United Kingdom). 55 patients with advanced CTCL having received at least two prior lines of systemic therapy were to be enrolled in two sequential study parts:
- 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 MTD and/or the RP2D; the dose-escalation followed an accelerated 3+3 design. The safety and clinical activity data of all dose levels were presented at the EORTC CLTF meeting on October 15, 2017.
- The cohort expansion part is accruing 2 cohorts of 15 patients each in 2 CTCL subtypes (Sézary syndrome and transformed mycosis fungoides) receiving IPH4102 at the RP2D of 750 mg (fixed dose equivalent to 10 mg/kg) 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.
About IPH4102:
IPH4102 is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, designed for treatment of CTCL, an orphan disease. This group of rare cutaneous lymphomas of T lymphocytes has a poor prognosis with 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 them with certain aggressive CTCL subtypes, in particular, Sézary Syndrome and transformed mycosis fungoides. It 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.
About Cutaneous T-Cell Lymphoma ("CTCL"):
CTCL is a heterogeneous group of non-Hodgkin's lymphomas which arise primarily in the skin and are characterized by the presence of malignant clonal mature T-cells. CTCL accounts for approximately 4% of all non-Hodgkin's lymphomas and has a median age at diagnosis of 55-65 years.
Mycosis fungoides, and Sézary Syndrome, its leukemic variant, are the most common CTCL subtypes. The overall 5-year survival rate, which depends in part on disease subtype, is approximately 10% for Sézary Syndrome and less than 15% for transformed mycosis fungoides. CTCL is an orphan disease and patients with advanced CTCL have a poor prognosis with few therapeutic options and no standard of care. There are approximately 6,000 new CTCL cases in Europe and the United States per year.
About Innate Pharma:
Innate Pharma S.A. is a clinical-stage biotechnology company dedicated to improving cancer treatment and clinical outcomes for patients through first-in-class therapeutic antibodies that harness the innate immunity.
Innate Pharma specializes in immuno-oncology, a new therapeutic field that is changing cancer treatment by mobilizing the power of the body's immune system to recognize and kill cancer cells.
The Company's broad pipeline includes four first-in-class clinical stage antibodies as well as preclinical candidates and technologies that have the potential to address a broad range of cancer indications with high unmet medical needs.
Innate Pharma has pioneered the discovery and development of checkpoint inhibitors, with a unique expertise and understanding of Natural Killer cell biology. This innovative approach has resulted in major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb, Novo Nordisk A/S and Sanofi. Innate Pharma is building the foundations to become a fully-integrated biopharmaceutical company.
Based in Marseille, France, Innate Pharma has more than 170 employees and is listed on Euronext Paris.
Learn more about Innate Pharma at www.innate-pharma.com
Information about Innate Pharma shares:
| ISIN code Ticker code | FR0010331421 IPH |
Disclaimer:
This press release contains certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference prospectus filed with the AMF, which is available on the AMF website www.amf-france.org or on Innate Pharma's website.
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For additional information, please contact:
| Investors Innate Pharma Dr Markus Metzger / Jérôme Marino Investor relations Tel.: +33 (0)4 30 30 30 30 investors@innate-pharma.com | International Media Consilium Strategic Communications Mary-Jane Elliott / Jessica Hodgson / Philippa Gardner Tel.: +44 (0)20 3709 5700 InnatePharma@consilium-comms.com |
| French Media ATCG Press Marie Puvieux Mob: +33 (0)6 10 54 36 72 presse@atcg-partners.com |
[1] European Organisation for Research and Treatment of Cancer, Cutaneous Lymphoma Task Force
[2] Rate of responses lasting at least more than 4 months
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