- Preliminary data from the dose-escalation part of an ongoing Phase I trial in elderly and heavily pretreated patients including a majority of patients with Sezary syndrome;
- IPH4102 shows good safety profile;
- Encouraging signs of clinical activity, with complete responses seen in skin and blood.
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH), today announces encouraging preliminary safety and clinical activity results from the dose-escalation part of the Phase I study testing 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.
These data are presented in a poster at the Third World Congress of Cutaneous Lymphomas (October 26-28, 2016, New-York, USA) and will be discussed by the Principal Investigator, Professor Martine Bagot, Head of the Department of Dermatology at Saint-Louis Hospital (Paris) in the Scientific Session “Endpoints & Clinical Trials” on October 28, 2016, 1:30 – 2:45 p.m. EST.
The Phase I study is currently ongoing. Data are reported for the first seven dose levels (0.0001 to 1.5 mg/kg, 16 patients) of the dose-escalation part. In this population, IPH4102 was well-tolerated with no dose-limiting toxicity reported. The majority of adverse events is typical for CTCL or reflects low grade infusion-related reactions. As of September 10, 2016, the best global response rate was 38% across all dosage levels. Complete responses appeared with increasing doses and/or duration of exposure in skin and blood (respectively 2 and 3, seen in 4 patients). All responses are ongoing at the time of the analysis, which occurred after a median duration of treatment of 126+ days (range of 41+ to 298+).
Three additional dose levels (3, 6 and 10 mg/kg) remain to be evaluated and the dose escalation part of the trial is now expected to be completed by Q2 2017 (previously expected at the end of 2017).
“These preliminary results are very encouraging and fully support the continuation of the development of the antibody candidate. By targeting KIR3DL2 on CTCL cells and triggering their killing by immune effector cells, IPH4102 has the potential to deliver a new treatment option for patients in high medical need at advanced stages of the disease,” said Pierre Dodion, Chief Medical Officer of Innate Pharma. “The development of IPH4102 benefits from long lasting collaborations with Saint Louis Hospital in Paris and reference centers, such as Stanford (US). Together we look forward to the complete safety data of the dose-escalation part of the trial and commencing cohort expansion of this new drug candidate, which is wholly-owned by Innate Pharma.”
Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris, added: “This study offers preliminary safety and efficacy results that are promising for IPH4102, in patients with CTCL subtypes that historically have been shown to be particularly difficult to treat. We are delighted with the progress that has been made with this candidate through translational research and an exceptional academic-industrial partnership.”
The study started enrolling patients in November 2015. So far, 16 patients with KIR3DL2-positive CTCL have been enrolled in seven dose-cohorts, including 13 patients with Sézary syndrome, 2 patients with mycosis fungoides and 1 patient with CD4+ CTCL. Median age was 71 years and patients had received 2 to 8 lines of prior systemic therapy for their disease.
All of the 16 patients treated with IPH4102 were evaluable for safety and clinical activity assessments.
As of September 10, 2016, patients had received up to 18 administrations of IPH4102. Treatment is ongoing in 12 patients. Preliminary results of exploratory endpoints such as pharmacodynamics in skin and blood are in line with clinical activity results (see poster #O-11), and show depletion of KIR3DL2-expressing tumor cells in skin and blood of patients after IPH4102 administrations.
Presentation/ Poster Details
The oral presentation, entitled “First-in-Human, open label, multicenter phase I study of IPH4102, first-in-class humanized anti-KIR3DL2 mAb, in relapsed/refractory CTCL: preliminary safety and clinical activity results” will take place on October 28, 2016, 1:30 – 2:45 p.m. EST. It will be available on the Company’s website, in the Product Pipeline - IPH4102 section following the session. The associated poster is displayed during the entire congress and is available on Innate Pharma’s website.
Simultaneously, poster #O-11 entitled “First-in-Human, open label, multicenter phase I study of IPH4102, first-in-class humanized anti-KIR3DL2 mAb, in relapsed/refractory CTCL: preliminary results of exploratory biomarkers” has been presented by Hélène Sicard, Anne Marie-Cardine and Maxime Battistella and is available on Innate Pharma’s website under Product Pipeline - IPH4102.
Innate Pharma hosted a conference call on November 14th, 2016, at 8:00 a.m. ET
This conference call was organized for institutional investors and sell-side analysts. During the call, the Company’s management team discussed lirilumab and IPH4102 data published at the most recent scientific meetings.
 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)