We are developing an off-the-shelf immunomodulation and adaptive cell therapy, based on WJ-MSC, to tackle the full complexity of an inflammatory disease as a first indication: septic shock. The 1st large-scale GMP production unit, ensuring affordable treatment is on its way
StemInov is a clinical stage company, spin-off from Nancy’s Teaching Hospital and Lorraine Region’s Uni. We develop an off-the-shelf, allogenic cell therapy treatment, in the field of inflammatory pathologies, with a focus on critical care. More than a new compound, our proprietary Wharton jelly (WJ-MSC) Stem cells, from the umbilical cord, “WhartSep”, is a new concept in immunomodulation and adaptive medicine. Our first indication is the patented treatment of septic shock and ARDS. Based on a robust preclinical data and on largely admitted safety, StemInov is preparing a phase I/II efficacity trial on pneumonia patients, developing septic shock or ARDS.
Septic shock is a medical emergency: 50% of mortality rate and growing incidence, 1st cause of death in US Intensive Care Units with an incidence of 19/100 000, 42.1% of infected patients suffer from intense respiratory issues. Today, there is no specific treatment for sepsis, leading to a huge unmet medical need. Sepsis is propitious for the development of innovative drugs, with high valuation perspectives. Sepsis’ impact on hospital expenses is $16.7Bn in US and €7.6Bn in Europe (Surviving Sepsis Campaign).
WhartSep will address this market, estimated to be between €4Bn and €5.5Bn, with an innovative and disruptive cell therapy to tackle the full complexity of septic shock. WhartSep’s uniqueness is to show three complementary actions: antibacterial effect, inflammatory and immunity modulation, and lung preservation. StemInov is now reaching readiness to lead a Phase I/II clinical trial. A research program is aiming at enlarging WhartSep’s indications and patents’ portfolio.
While the current production capability of StemInov is fitted for early phase clinical trials, larger batches of WhartSep, now need to be produced. Internal competencies are being leveraged to set up the first 3D production European WJ-MSC production unit.
TECHNOLOGY & COMPETITIVE ADVANTAGES
WhartSep is fitting hospital’s constraints, providing “off-the-shelf” cells that can be stored frozen for years prior to being injected to patients.
The product is classified as an ATMP (Advanced-Therapy Medicinal Product) by the EMA (European Medicines Agency).
Today, treatments in development, such as mAbs/NCEs are facing similar limitations: 1 drug, 1 mode of action, for multiple combined effects pathology.
On the contrary, WhartSep’s biological features show unique advantages, tackling the complexity of septic shock and ARDS, acting on various aspects of the pathology and adapting to the patient’s needs.
WhartSep has 3 different actions:
Ability to migrate to damaged organs and tropism for lungs
Direct and indirect antibacterial effect
Pro- or anti-inflammatory action, depending on the environment
Our ATMP is safe and in-vivo efficacy has been shown in a peritonitis model both in mice & pigs, in double-blind randomized study.
WhartSep’s raw material is easily accessible, in a non-invasive way. Production batches are homogeneous. Our production costs are low.
To supply WhartSep’ for our Phase I/II clinical trials, we have developed the specific know-how on WhartSep’s 3D production. A proof of concept in GMP-like conditions showed homogeneous and repeatable cells expansion in bioreactors, enabling to optimize each batch release as well as to guarantee a production cost.
Our industrial process combines several innovative approaches: online controls with captors, live monitoring involving machine learning, feedback solution with QbD approach, process modeling with digital twins. This enables higher yield, high cell viability and cost optimization.
Patent 1: Use of WJ-CSM in sepsis
Patent 2: Umbilical cord cutting automation
Steminov aims to patent new class of stem cells based on specific characteristics in relation with specific therapeutic interest. Other avenues are being explored to expand the IP portfolio.
Julie HUTIN (MS), CEO & Co-founder: Industry career within Eurofins Genomics. Academics as Engineer, Central School-Lyon, EM-Lyon and HEC-Paris business school
Pr. Danièle BENSOUSSAN, Co-founder, Board member & CSO: University Prof., Hospital Practitioner, Head of Department of the Cell Therapy and Tissue Bank Unit.
Eric HALIOUA, Strategy consultant, Board Member: Serial entrepreneur with strong strategic, technological, and managerial experiences with proven track record in deal-making and fund-raising. CEO of PDC line pharma.
Claude DEDRY (Industrial Pharmacist), Consultant of Pharmaceutical operations & Quality: Owner of CMDL Consulting (Belgium). Former COO of Promethera Biosciences, QA director of GSK vaccines with >25-year experiences in bioproduction and cell therapy.
Pr. Pierre Emmanuel CHARLES (Professor of Intensive Care Unit) – Clinical Medical Advisor: expert in WJ-MSC in respiratory diseases.
Roland GORDON BERESFORD – Regulatory Consultant: Owner of RGBIO regulatory consulting company. Expert in regulatory affair and IP with a previous experience in ATMP (NOVADIP).
LAST 24-MONTH ACHIEVEMENTS
Potency Test (on going): StemInov is setting up the potency test for its drug candidate. This functional test will be adapted to the application of septic shock. It will verify the adaptive capacities of WhartSep at the end of the bioproduction process to regulate in pro-inflammatory or in immunosuppressive context. Protocol design validated and first cells lines produced
Strong pre-clinical data showing safety and efficiency
Synopsis of a Phase I/II randomized clinical study has been defined, for start in 2024 and finish in 2026.
Set-up of the R&D laboratory in GMP-like condition
Cell amplification proof of concept in bioreactors in GMP-like condition
Set-up of the logistic umbilical cord supply for the production unit
First master cell bank on-going
Pre-Industrial Process Plan validated
Submission of patents. Patent 1 granted in EU.