Monday, December 5, 2016 - 07:00
  • Enrollment in the first-in-human trial of IPH4102 in relapsed/refractory cutaneaous T-cell lymphomas (CTCL) is proceeding with no dose-limiting toxicities to date; Dose level 9 out of 10 is currently enrolling; Preliminary indications of objective clinical activity have already been reported in 38% of patients across all dosage levels.

  • Early data from the combination of lirilumab with azacytidine show a good safety profile in patients with relapsed acute myeloid leukemia (AML).

Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announces that clinical data for lirilumab and IPH4102 were presented in two posters at the American Society of Hematology’s (ASH) 2016 Annual Meeting (December 3-6, 2016), San Diego, CA, U.S.:

This poster presented preliminary results from the first seven dose levels of the dose-escalation part of the Phase I trial of IPH4102 (1). They showed that the drug candidate is well tolerated in patients with relapsed/refractory CTCL (2) and a preliminary global objective response rate (ORR) of 38% in the evaluable population across all dosage levels.
Explorative assessments show that clinical improvement in skin comes along with decreases of malignant cells and normalization of immune parameters in the tumor microenvironment. All responses were ongoing at the time of poster presentation.
Dose level 8 (3 mg/kg) has been completed without dose-limiting toxicity. Two further dose levels (6 and 10 mg/kg) remain to be explored in the dose-escalation part of this study.

Lirilumab is a first-in-class fully human monoclonal antibody that blocks inhibitory killer-cell immunoglobulin-like receptors (KIRs) expressed predominantly on natural killer (NK) cells to potentiate an anti-tumor immune response mediated by the latter. Lirilumab is licensed to Bristol-Myers Squibb Company by Innate Pharma.
In this Phase Ib/II study testing lirilumab in combination with azacytidine in a heavily pretreated patient population with relapsed AML, full doses of azacytidine and lirilumab (3) were well tolerated. No dose-limiting toxicities were observed. Preliminary efficacy data for 25 evaluable patients showed a response rate of 20% including two patients achieved a CR (4) or a CR with insufficient count recovery and three achieving hematologic improvement.

Preliminary results presented at ASH 2016 are encouraging, as they further reinforce the favorable safety profile of both lirilumab and IPH4102. The study of IPH4102 conducted in patients with CTCL is progressing very well and we look forward to the completion of the dose-escalation part of the trial to confirm the encouraging efficacy signal seen across dose levels to date,said Pierre Dodion, Chief Medical Officer of Innate Pharma.The good safety profile of lirilumab in combination with azacytidine in patients with relapsed AML further supports the view that lirilumab is well tolerated in numerous combinations.

Posters Details

IPH4102

The poster #1826 is available on Innate Pharma’s website.

Lirilumab

The poster #1641 is available on Innate Pharma’s website.


(1) Data were previously reported at the Third World Congress of Cutaneous Lymphomas on October 28, 2016.
(2) CTCL is an orphan disease with poor prognosis and few therapeutic options at advanced stages.
(3) 75 mg/m² and 3 mg/kg respectively
(4) Complete remission