CERENIS to Present New Data Validating HDL Targeted Drug Delivery in the Field of Oncology and Immuno-Oncology at the 30th EORTC/NCI/AACR1 Symposium

Regulatory News:

Cerenis Therapeutics (FR0012616852 – CEREN – PEA-PME eligible) (Paris:CEREN), an international biopharmaceutical company dedicated to the discovery and development of HDL-based innovative therapies for treating cardiovascular and metabolic diseases, as well as new HDL-based vectors for targeted drug delivery in the field of oncology, today announced that the company will present new data on its ongoing activities for chemotherapy and immuno-oncology at the 30^th EORTC/AACR/NCI symposium, organized by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR), being held November 13-16, 2018, in Dublin, Ireland.

HDLs are Nature’s universal targeting delivery systems able to deliver small molecules, proteins, antigens, and nucleic acids directly to the cell cytoplasm reaching the appropriate targets and avoiding the lysosomal degradation of particle cargo. They offer full biocompatibility, access to the relevant blood and lymph compartment, and specific targeting with Apolipoprotein A-I (apoA-I), the HDL protein, interacting specifically with HDL receptors known to be over-expressed in cancer cells.

Poster presentations will feature new data in validated preclinical models highlighting the multiple unique advantages of the HDL technologies developed by CERENIS in oncology and Immuno-oncology.

Poster Presentation Details:

Multimeric apoA-I, called Cargomers® are novel proprietary nanoparticles of few nanometers that have the unique ability to rapidly enter the lymphatic circulation to carry neoantigen peptides and nucleic acids in order to present tumor neoantigens capable of eliciting a strong and specific cellular immune response against melanoma tumor cells. The ease of the loading of the Cargomers®, the size and the biocompatibility of these nanoparticles make this a novel and relevant platform for immuno-oncology and personalized medicines.

CER-001, a recombinant human apoA-I discoidal HDL mimetic loaded with paclitaxel (a chemotherapy drug) was demonstrated to be very effective for intra tumor drug delivery and thus able to show marked inhibition of breast cancer tumor cell growth.

These results for HDL and Cargomers® targeted drug delivery, combined with the preliminary positive results of Cerenis' TARGET PHASE II clinical study published on June 25^th 2018 demonstrate the value of this unique platform to target tumors in patients. Combined, these data strongly support the development of the HDL drug delivery platform as Cerenis prepares to launch two programs (CER-320 and CER- 350) in immuno-oncology.

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About CERENIS: www.cerenis.com
Founded in 2005, Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of HDL-based innovative therapies.

CERENIS’ expertise has translated into a rich portfolio of programs for the treatment of cardiovascular disease and associated metabolic diseases such as NAFLD and NASH as well as a HDL targeted drug delivery platform in oncology, more specifically in immuno-oncology and chemotherapy.

CERENIS is well positioned to become one of the leaders in the HDL therapeutic market, with a broad portfolio of programs in development and several products in clinical phases.

About CER-001
CER-001 is a bio-engineered complex of recombinant human apoA-I, the major structural protein of HDL, and phospholipids. It has been designed to mimic the structure and function of natural, nascent HDL, also known as pre-beta HDL. Its mechanism of action is to increase apoA-I and the number of HDL particles. SAMBA, the clinical Phase 2 study in patients with hypoalphalipoproteinemia due to genetic defects, has provided important data demonstrating the efficacy of CER-001 in regressing atherosclerosis in several distinct vascular beds, and leading to the TANGO study. The totality of the data to date indicates that CER-001 performs all of the functions of natural pre-beta HDL particles and has the potential to be the best-in-class HDL mimetic on the market.

About Targeted HDL Drug Delivery
HDL particles, loaded with an active agent, hold the promise to target and selectively kill malignant cells while sparing healthy ones. A wide variety of drugs can be embedded in these particles targeting markers specific to cancer cells and bring these potent drugs to their intended site of action, with lowered systemic toxicity. CERENIS intends to develop the first HDL-based targeting drug delivery platform dedicated to the oncology market, including immuno-oncology and chemotherapy.

¹ : European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR), Dublin from November 13^th to 16^th, 2018

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