Clinical Trials

Date: 2014-11-03

Type of information: Publication of results in a medical journal

phase: preclinical

Announcement: publication of results in Cancer Research

Company: Innate Pharma (France)

Product: IPH4102

Action mechanism:

monoclonal antibody. KIR3DL2 is an inhibitory receptor of the KIR family, normally expressed on a subset of normal NK cells and specifically expressed in most subtypes of the orphan indication of CTCL. CTCL is a group of rare cutaneous lymphomas of T lymphocytes with poor prognosis and few therapeutic options at advanced stages, such as the Sezary Syndrome and Transformed Mycosis Fungoides.
IPH4102 is a first-in-class anti-KIR3DL2 humanized cytotoxic antibody, designed to selectively deplete CTCL cancer cells. IND-enabling studies with IPH4102 are currently ongoing and a Phase I trial is expected to start in 2015. IPH4102 was recently granted orphan drug status in the European Union for the treatment of CTCL. Biomarker tools are being developed in parallel to monitor KIR3DL2 expression in patients.

Disease: cutaneous T-cell lymphomas, and especially their aggressive forms: Sezary Syndrome and Transformed Mycosis Fungoides

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• On November 3, 2014, Innate Pharma, the innate immunity company developing first-in-class therapeutic antibodies for cancer and inflammatory diseases, announced that a peer-reviewed scientific article describing IPH4102 and results of preclinical efficacy studies was published online in Cancer Research, a journal of the American Association for Cancer Research. The article published is entitled “IPH4102, a humanized KIR3DL2 antibody with potent activity against cutaneous T-cell lymphoma”. Professor Martine Bagot, Head of the Dermatology Department at the Saint-Louis Hospital in Paris, France, and co-author of the study, said: “This study offers a preclinical proof of concept for clinical development of IPH4102, a novel monoclonal antibody therapy that targets KIR3DL2, one of the most relevant tumor antigens of cutaneous T-cell lymphoma, where there remains a high unmet medical need”. Potent antitumor properties of IPH4102 were shown against human cutaneous T-cell lymphoma (CTCL) cells in vitro and in vivo in a mouse model of KIR3DL2+ tumors, in which IPH4102 reduced tumor growth and improved survival. The efficacy of IPH4102 was further evaluated in laboratory assays using the patients’ own natural killer (NK) cells against their primary tumor samples in presence of IPH4102. These latter studies were performed in patients with Sézary Syndrome, the leukemic form of CTCL with the worst prognosis. In these experiments, IPH4102 selectively and efficiently induced killing of the patients’ CTCL cells. Together, these results provide preclinical proof of concept supporting the clinical development of IPH4102 to treat advanced CTCL patients.
• On November 8, 2013, Innate Pharma has announced that it had selected and qualified the IPH4102 drug candidate for further development. IND-enabling studies and industrial production of the molecule have begun. The IND application is expected to be submitted in late 2014.

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