The part in the dose escalation of the Phase I trial has been the subject of an oral presentation at ICML [1] in Lugano ;
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IPH4102 has been evaluated in elderly patients and heavily pretreated patients with cutaneous T cell lymphomas (LTC) advanced, of which a majority of patients with a sezary’s disease, a sub-type in a strong medical need ;
IPH4102 was well tolerated : no dose-limiting toxicities were observed and the maximum tolerated dose (MTD) was not reached ;
In patients with a sezary’s disease, the overall response rate (ORR) was 47% and the rate of disease control (DCR) of 90% ; in this population, the median progression-free survival (PFS) was 10.8 months.
Marseille, June 15, 2017, 7: 00 am CEST
Innate Pharma SA (Euronext Paris : FR0010331421 – IPH) announces today the results of the part in the dose escalation of the Phase I trial ongoing evaluating IPH4102 in patients with cutaneous T cell lymphomas (LTC), an orphan disease, relapsed or refractory. IPH4102 is an antibody humanized ” first-in-class proprietary targeting KIR3DL2 and aimed to destroy the cells of LTC.
25 patients, whose median age was 71 years, were evaluable for tolerance (10 dose levels : 0.0001 to 10 mg/kg). They received a median number of 4 lines of prior therapies. The test data indicate that IPH4102 was well tolerated, with no dose-limiting toxicities were not observed. The maximum tolerated dose (MTD) was not reached. The majority of adverse events were typical for patients with a LTC or corresponded to reactions post injection of low severity.
To 10 may 2017, 24 patients were evaluable for clinical activity. In this population, the overall response rate (ORR) was 41.7% and the rate of disease control (DCR) of 91.7%, all dose levels combined. The overall response rate and the control rate of the disease have reached to 47.4% and 89.5%, respectively, in patients with syndrome of Sézary (SS, n=19). Among the 9 patients with SS who had a clinical response, 5 complete responses have been observed at the level of the blood and 2 to the level of the skin (26% and 11%) and one patient presented a comprehensive response complete [2]. The median duration of response (DOR) was 8.2 months for all patients and has not yet been reached for patients with a SEQ., The median progression-free survival (PFS) was 9.0 months for all patients, and 10.8 months for patients with SS (from 0.9 to 17.2 months). Pruritus was significantly reduced in patients who responded clinically.
The results of the biomarkers as exploratory as the pharmacodynamics at the level of the skin and the blood or the levels of residual disease molecular is consistent with the findings of clinical activity and show a eliminating substantially all of the tumor cells in the skin and blood of patients after administration of IPH4102.
Pierre Dodion, Medical Director of Innate Pharma, commented : “The data suggest that IPH4102 is very well tolerated in patients with a LTC advanced and showed signals of clinical activity are promising. These results we are excited about, especially as the trial includes patients who have already received all the available treatments. These results allow us to be confident of the development of IPH4102. The start of the game expansion cohort of the trial at the recommended dose for Phase 2 (RP2D) is expected in the 3rd quarter of 2017. We have the will to provide the patients of this potential treatment option and it is for this purpose that we will work closely with the regulatory authorities in the course of the next few months. ”
Martine Bagot, principal Investigator of the study, Chief of the Dermatology Service at the Saint-Louis Hospital (Paris), adds : “We are delighted with the results of this part in the dose escalation trial. The profile of IPH4102 is very promising. Today, there is no satisfactory treatment for patients with LTC-to-advanced stages of the disease and IPH4102 could be a new therapeutic option for these patients with a high medical need. ”
These data were presented at the congress of the ICML in Lugano on 14 June. The presentation is available on the website of the Company, in the section IPH4102.
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A conference call to the attention of institutional investors and analysts will be held today at 15: 00 at the following numbers :
France and international : +33 (0) 1 70 77 09 37 ; United States: +1 646 722 4908
Program of the conference : acquisition of anti-C5aR (IPH5401) and data IPH4102
The presentation will be available on the website of the Society 30 minutes
before the start of the conference.
You can listen to the conference on the website of Innate Pharma.
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About the Phase I trial :
The Phase I study (NCT02593045) is a test in open, multi-centre testing IPH4102 in patients with a LTC in relapsed or refractory. It is conducted in Europe (France, the netherlands and the United Kingdom) and the United States with the participation of centres of reference : the Saint-Louis Hospital (Paris, France), the Stanford University Medical Center (Stanford, California), the Ohio State University (Columbus, Ohio), the MD Anderson Cancer Center (Houston, Texas), the Leiden University Medical Center (Leiden, the netherlands), and the Guy’s and St Thomas’ Hospital (London, The United Kingdom).
In total, 55 patients with a LTC advanced and has already received at least two lines of systemic therapy should be enrolled in this study of dose escalation followed by expansion cohort :
The part in the dose escalation, which featured 10 levels of doses, has recruited 25 patients with a CTA positive for the target KIR3DL2. The aim of this part was to identify the maximum tolerated dose and/or recommended dose for phase II, dose escalation followed a design of type 3 + 3 accelerated. Preliminary evidence of tolerability and clinical activity for the first seven dose levels were presented to the 3WCCL [3] and ASH [4] 2016. The safety data for all dose levels were presented at the ICML in June 2017.
The expansion cohort will include 2 cohorts of 15 patients with a syndrome of Ctcl or mycosis fungoides transformed. They will receive IPH4102 at the recommended dose, until progression.
The main objective of this trial is to evaluate the tolerability and safety of repeated administration of IPH4102 in this population of patients. The secondary objectives include the evaluation of the anti-tumor activity of the drug candidate. The criteria for assessment of clinical activity include the overall response rate, duration of response and progression-free survival. A large number of exploratory analyses aimed at identifying biomarkers of clinical activity are conducted.
About IPH4102 :
IPH4102 is an antibody humanized “first-in-class” inducing cytotoxicity, targeting KIR3DL2 and aimed to destroy the cells of LTC, an indication orphan. The LTC are a set of lymphoma rare T-cell affecting initially the skin. In the advanced stages of LTC, there are few therapeutic options and the prognosis is unfavorable.
KIR3DL2 is an inhibitory receptor of the family of KIR, expressed by approximately 65% of patients with a LTC, for the whole of sub-types and stages of the disease ; this rate increases up to 85% of patients with some LTC with a bad prognosis, especially Sézary syndrome and mycosis fungoides transformed. It is expressed in a limited way on the normal tissues.
IPH4102 has received orphan drug status in the European Union for the treatment of LTC.
About T-cell Lymphoma Skin (LTC) :
The cutaneous T cell lymphomas are a heterogeneous group of non-Hodgkin’s lymphoma characterized by the infiltration of T lymphocytes in malignant in the skin. The LTC constitute about 4% of non-Hodgkin lymphomas and are diagnosed at a median age of 55-65 years.
Mycosis fungoides and Sézary syndrome, its shape, leukemic, are the sub-types of LTC the most common. The overall survival rate at 5 years, which depends on the subtype of the disease, is about 10% for Sézary syndrome and less than 15% for mycosis fungoides transformed. The LTC is an orphan disease. In the advanced stages, the prognosis is unfavorable, there are few treatment options and no standard of care. The number of new cases in the United States and Europe (combined) is estimated to be approximately 6,000 per year.
About Innate Pharma :
Innate Pharma S.A., a biotechnology company in clinical phase, designs and develops novel therapeutic antibodies that exploit the innate immune system with the aim of improving cancer treatments and the clinical course of the patients.
Innate Pharma is specialized in immuno-oncology, an approach to immunotherapy innovative that changes the treatment of cancers by restoring the ability of the immune system to recognize and eliminate tumor cells.
The objective of the Company is to become a biopharmaceutical company focused on commercial in immunotherapy, focusing on indications of cancer for which there is a strong medical need. Innate Pharma is a pioneer in the discovery and development of inhibitors of the control points of immunity (PCI or checkpoint inhibitors) activating the innate immune system. Three therapeutic antibodies “first-in-class” targeting receptors of the NK cells (” Natural Killer ” or killer cells) are currently tested in the clinic and could address a large number of solid tumors and hematologic malignancies. The innovative approach of Innate Pharma has also helped to generate other candidates now in preclinical and innovative technologies. Target the receptors involved in the immune response also offers the Company the opportunity to develop therapies in the field of inflammatory diseases.
The expertise of the Company, in particular in the biology of NK cells, has allowed him to forge alliances with leading companies in the biopharmaceutical as AstraZeneca, Bristol-Myers Squibb and Sanofi.
Based in Marseille, Innate Pharma has more than 170 employees. The Company is publicly traded on Euronext Paris.
Find Innate Pharma on www.innate-pharma.com.
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