VALUES

We have been collaborating with SMALTIS since 2014 as part of our Pseudomonas Elastase Inhibitors project. This project aims to develop an inhalation drug used in combination with antibiotic therapy to reduce the frequency and severity of Pseudomonas aeruginosa infections in cystic fibrosis patients. Thanks to its tools and technical skills, SMALTIS has designed tailor-made Pseudomonas aeruginosa mutants that have enabled us to make decisive progress. Caring and always attentive, SMALTIS team is also a true scientific partner by being a source of proposals and sharing its extensive knowledge on antibiotic resistance mechanisms.

As part of the development of our candidate EB8018 designed to block bacteria expressing virulence factor FimH (a key inducer of the inflammatory cascade of the intestine, particularly in patients with Crohn disease), we have successively called upon the services of SMALTIS. In the preclinical phase, they first quantified in vitro the adhesion and invasion capacities of a collection of strains isolated from patients on a model of intestinal cell infection and then evaluated the impact of our molecule on these strains. The quality of the work performed, the level of expertise of the team combined with the ability to listen and adapt, led us to include SMALTIS as a service provider in our Phase 1B clinical study. The team developed a customized procedure to isolate and dissociate bacteria called "adherent" and "invasive" in intestinal biopsies, and then demonstrated the action of our EB8018 compound on these strains. SMALTIS continues to support the development of EB8018 in a phase 2a clinical trial.

During our program to develop and industrialize the production of our Kinoïdes® vaccines, SMALTIS has proven to be a partner of choice for optimizing one of our cytokine production systems. Its service consisted in optimizing the genetic heritage of the host bacterium by excising DNA from exogenous sequences. Very attentive and with a rare expertise in microbiology, SMALTIS team has always been benevolent and has never hesitated to guide us by providing sound advice. It is with pleasure that we will again call upon the services of SMALTIS to help meet our next challenges.

We use Escherichia coli strains to manufacture our Uro-Vaxom® product for the prevention of recurrent lower urinary tract infections and co-treatment of acute urinary tract infections and, in accordance with regulatory requirements, we must demonstrate the stability of our strains. We therefore asked SMALTIS to develop a tailor-made quality control method. In addition to their ability to listen to customer needs and propose new ideas, the SMALTIS team has also distinguished itself by the quality and accuracy of its analysis reports. At present, the partnership established with SMALTIS is a real asset for OM Pharma.

As part of the Oncobax®-AK project and the development of Live Biotherapeutic Products to potentiate the efficacy of cancer immunotherapies, we called upon Smaltis' services to characterize one of our candidate bacterial strains. The objective was to provide a complete file to the regulatory authorities regarding the characteristics of the strain, before initiating clinical studies. The Smaltis team worked hard to develop the protocols and test conditions necessary to determine the specificities of the strain of interest. The rigor shown by Smaltis' researchers, the quality and detail of the data transmitted, as well as the scientific relevance of the various characterization tests, allowed us to meet the regulatory requirements and to initiate the clinical trials with confidence. We are delighted to have collaborated with Smaltis.