Innate Pharma from Marseille (France) has dosed it’s first super-rare skin cancer patient with a phase I immuno-oncology trial set to take place across the US, Netherlands, France and the UK.
The CEO of Innate Pharma, Hervé Brailly (whom we interviewed on Labiotech Tour), explained that this was a big deal for the biotech, seeing as this candidate is their first cytotoxic antibody, aimed to deplete KIR3DL2 expressing cells cancer.
KIR3DL2 in an inhibitor receptor found in a very low concentrations on NK Killer cells, which tumor cells use to mask their identity and prevent attack from the immune response. KIR3DL2 can therefore serve as a tumor biomarker, particularly for subtypes of Cutaneous T-cell Lymphomas (CTCL).
CTCL is a group of super rare cutaneous lymphomas, the most prevalent examples being Mycosis fungoides, which accounts for 55-60% of CTCL cases, followed by Sézary syndrome. These blood cancers have a very poor prognosis and few therapeutic options at advanced stages.
The candidate in question (IPH4102) has therefore been granted orphan drug designation for CTCL in the EU. It works as a monoclonal antibody which selectively binds to KIR3DL2, and so ‘reveal’ the cancer cells to the immune system. Indeed, this antibody has demonstrated a high level of efficacy in various pre-clinical models.
The KIR3DL2 targeting candidate will be trialed with 60 patients who have relapsed/refractory cutaneous T-cell lymphomas with a primary objective of testing the safety and tolerability of the candidate. This phase I trial is therefore expected to deliver data at the end of 2017 (for the dose escalation) and 2018 (for the cohort expansion).
The study will take place across multiple centres spanning many key academic and health institutions. Those involved include the Saint-Louis Hospital (Paris, France), the MD Anderson Cancer Center (Houston, Texas), the Stanford University Medical Center (California), the Ohio State University (Columbus, OH), the Leiden University Medical Center (Netherlands), and the Guy’s and St Thomas’ Hospital (UK).
Brailly also went on to comment on how developing this candidate in a targeted patient population with an associated biomarker actually points to a very straightforward path to regulatory approval. Innate Pharma would therefore be keen to retain full rights to develop IPH4102 to market it as their own..
Generally, this French biotech has been progressing very well in its immuno-oncology research pipeline, which also includes as phase II monoclonal antibody combo-trial (lirilumab) for patients with relapsed/refractory or high-risk untreated Chronic Lymphocytic Leukemia (CLL).
They recently recieved the first €5M downpayment of their ‘Monster Deal’ with Bristol Myers-Squibb (the leader in the field) on this indication, which ammounts to €408M ($465M). It is encouraging to see the US Cancer Giant, MD Anderson, on board with Innate Pharma, which is surely a good sign for this phase I trial for patients with these super rare types of cancer.
Indeed, this is the 3rd antibody developed by Innate Pharma with their first-in-class platform and therefore this makes this milestone even more significant.