15 June 2017
DOSE-ESCALATION DATA SHOW favorable SAFETY PROFILE AND PROMISING CLINICAL ACTIVITY FOR IPH4102
Oral presentation on the dose-escalation part of a Phase I trial at the International Conference on Malignant Lymphoma (ICML) in Lugano;
IPH4102 was evaluated in elderly and heavily pretreated patients with advanced cutaneous T-cell lymphomas (CTCL), mostly with Sézary syndrome, a subtype with high unmet medical need;
IPH4102 was well tolerated: no dose-limiting toxicity was reported and the maximum tolerated dose (MTD) was not reached;
In patients with Sézary syndrome, best global response rate (ORR) was 47% and disease control rate (DCR) was 90%; this population achieved a median progression free survival (PFS) of 10.8 months.
Marseille, France, June 15, 2017, 7:00 AM CEST
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH), today announces results from the dose-escalation part of the ongoing Phase I study of IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL), an orphan disease. IPH4102 is Innate Pharma’s wholly-owned, first-in-class anti-KIR3DL2 humanized therapeutic antibody, designed to trigger immune cell-mediated killing of CTCL cancer cells.
25 patients, with a median age of 71 years old and a median number of four prior systemic treatments, were evaluable for safety (10 dose levels: 0.0001 to 10 mg/kg). The data from the trial indicate that IPH4102 was well tolerated with no dose-limiting toxicity. The maximum tolerated dose (MTD) was not reached. The majority of adverse events reported was typical for CTCL or reflected low grade infusion-related reactions.
As of May 10, 2017, 24 patients were evaluable for clinical activity. In this population, best global overall response rate (ORR) was 41.7% and disease control rate (DCR) was 91.7% across all dose levels. Best global ORR and DCR reached 47.4% and 89.5% respectively in patients with Sézary syndrome (SS, n=19). Among the 9 patients with SS who achieved clinical responses, one had a global complete response. 5 complete responses were seen in blood and 2 in skin (resp. 26% and 11%). Median duration of response (DOR) was 8.2 months in all patients and not reached in patients with SS. Median progression free survival (PFS) was 9.0 months in all patients and 10.8 months in patients with SS (range from 0.9 to 17.2). Pruritus was significantly decreased in patients with clinical response.
Pharmacodynamic endpoints and molecular residual disease results are consistent with clinical activity results and show substantial elimination of neoplastic cells in skin and in blood.
 In CTCL, global clinical response assessment is a composite of response evaluation in all organs involved with tumor cells, such as skin, blood, lymph nodes and viscera (E. Olsen et al, JCO 2011).
“The data reported suggest that IPH4102 is very well tolerated in patients with advanced CTCL and shows promising signs of clinical activity. We are thrilled by these results, given that the trial included patients who had received all available treatment options. They give us confidence for the next steps of the development plan of IPH4102; the cohort expansion part of the trial is planned to start in Q3 2017 at the recommended Phase II dose. We are committed to bringing this potential new therapeutic option to patients and will be focused on working closely with the regulatory authorities during the coming months toward this goal.”
Pierre DodionChief Medical Officer of Innate Pharma
“We are very pleased with the results of the dose-escalation part of the trial. The profile of IPH4102 is very promising. Today, there is no satisfactory treatment and IPH4102 could be a new therapeutic option for CTCL patients in high medical need at advanced stages of the disease.”
Martine BagotPrincipal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris
These data were presented in an oral presentation at the International Conference on Malignant Lymphoma (ICML) in Lugano on June 14. The presentation is available on the Company’s website, in the Product Pipeline - IPH4102 section.
A conference call for institutional investors and sell-side analysts
will be held today at 3:00pm CEST.
Dial in numbers: USA: +1 646 722 4908; France and international: +33 1 70 77 09 37
During this conference call, the management team will discuss
the acquisition of the anti-C5aR antibody as well as IPH4102 data.
The presentation will be made available on the Company’s website 30 minutes
before the conference call begins.
A replay will be available on Innate Pharma’s website after the conference call.
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. Preliminary safety and clinical activity results for the first seven dose levels from the dose-escalation part were presented at the 3WCCL and ASH in 2016; the safety data of all dose levels were presented at the ICML meeting on June 14, 2017.
- The cohort expansion part will consist of 2 cohorts of 15 patients each in 2 CTCL subtypes (transformed mycosis fungoides and Sézary syndrome) 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.
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 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 with a focus on discovering and developing first-in-class therapeutic antibodies that harness the innate immune system to improve cancer treatment and clinical outcomes for patients.
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 aim is to become a fully-integrated biopharmaceutical company in the area of immunotherapy and focused on serious unmet medical needs in cancer. Innate Pharma has pioneered the discovery and development of checkpoint inhibitors to activate the innate immune system. Innate Pharma's innovative approach has resulted in three first-in-class, clinical-stage antibodies targeting natural killer cell receptors that may address a broad range of solid and hematological cancer indications as well as additional preclinical product candidates and technologies. Targeting receptors involved in innate immunity also creates opportunities for the Company to develop therapies for inflammatory diseases.
The Company's expertise and understanding of natural killer cell biology have enabled it to enter into major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb and Sanofi.
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:
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 (http://www.amf-france.org) or on Innate Pharma’s website.
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.
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 Third World Congress of Cutaneous Lymphomas
 American Society of Hematology