NANTES, France I April 05, 2017 I OSE Immunotherapeutics SA (ISIN:FR0012127173) (Mnémo:OSE) announced today that the Company presented significant results at the AACR* meeting in the very promising field of myeloid/macrophage suppressive cells, an abundant immune cell type infiltrating many tumors and often associated with a poor prognosis.

OSE-172 (Effi-DEM) is a first-in-class checkpoint inhibitor that blocks these suppressive cells, allowing parallel mobilization of T cells and produces dramatic anti-tumorigenic results in monotherapy and in combination with other immunotherapies as T checkpoint inhibitors.

OSE-172 is a selective SIRP-alpha antagonist monoclonal antibody. SIRP-alpha is expressed on myeloid suppressive cells (primarily on Myeloid Derived Suppressor Cells (MDSC) and Tumor Associated Macrophages (TAM)). The main ligand of SIRP-alpha is CD47, which is ubiquitously expressed in various cells and overexpressed in tumors.

The preclinical safety of OSE-172 was first established without any binding to or potential interaction with human red blood cells and platelets while CD47 is expressed on these hematological cells. Furthermore, CD47 interacts with several other ligands and physiological functions, such as the CD47/SIRP-gamma axis, another member of the SIRP family, which has been observed to play a role in human T cell proliferation. OSE-172, as selective antagonist of SIRP-alpha, is not a binder of SIRP-gamma, thus avoiding a deleterious impact on T cell immune response and allowing for a strong human effector T cell proliferation, a key advantage of this mechanism of action.

Furthermore, the efficacy of this myeloid checkpoint inhibitor has been established alone and in combination with immunotherapies as T checkpoint inhibitors. OSE-172 has demonstrated its impact on the Tumor Micro-Environment by switching M2 pro-tumorigenic macrophages into M1 anti-tumorigenic macrophages whilst increasing effector memory CD8 T cells.

When OSE-172 was combined with other immunotherapies, T memory cells transmitted efficacy against a new tumor re-challenge.

“These new data demonstrate OSE-172 as having a differentiated safety and selective pharmacological profile which provides us with the opportunity to open various potential indications in the immuno-oncology field for our new myeloid checkpoint inhibitor. We are currently actively preparing the next steps of its development towards clinical stage,” said Bernard Vanhove, Chief Operating Officer of OSE Immunotherapeutics, in charge of R&D and International Scientific Collaborations.

*American Association for Cancer Research, Washington April -1-5th, 2017
The poster presented was entitled: “Selective targeting of SIRP alpha induces potent memory anti-tumor immune responses without presenting hematological toxicity” and is available on the AACR website.

ABOUT OSE IMMUNOTHERAPEUTICS
Our ambition is to become a world leader in activation and regulation immunotherapies
OSE Immunotherapeutics is a biotechnology company focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology, auto-immune diseases and transplantation. The company has a balanced portfolio of first-in-class products with a diversified risk profile ranging from clinical phase 3 registration trials to R&D:

In immuno-oncology:

  • Tedopi® (OSE-2101), a combination of 10 optimized neo-epitopes to induce specific T activation in immuno-oncology – Currently in registration Phase 3 trial advanced NSCLC HLA A2+ patients EU /US – Orphan Status in the US – Registration expected in 2019 – A Phase 2 with Tedopi® in combination with a checkpoint inhibitor in NSCLC is considered in 2017.
  • OSE-172 (Effi-DEM), new generation checkpoint inhibitor targeting the SIRP-α receptor – In preclinical development for several cancer models.

In auto-immune diseases and transplantation:

  • FR104, CD28-antagonist in immunotherapy – Phase 1 trial completed – For the treatment of autoimmune diseases and for use with transplantation – Licensed to Janssen Biotech Inc. to pursue clinical development.
  • OSE-127 (Effi-7), interleukin receptor-7 antagonist – In preclinical development for inflammatory bowel diseases and other autoimmune diseases. License option agreement with Servier for the development and commercialization.

The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter global agreements at different stages of development with major pharmaceutical players.

Immunotherapy is a highly promising and growing market. By 2023 Immunotherapy of cancer could represent nearly 60% of treatments against less than 3% at present * and the projected market is estimated at $67 billion in 2018 **.

There are more than 80 autoimmune diseases that represent a significant market including major players in the pharmaceutical industry with sales towards $10 billion for the main products. The medical need is largely unmet and requires the provision of new innovative products involved in the regulation of the immune system.

*Citi Research Equity
**BCC Research

SOURCE: OSE Immunotherapeutics