With state-of-the-art fully equipped laboratories for radiolabeling, radioanalyses, handling of cells and housing of animals, Chelatec is recognized for its reliable expertise and offers a unique combination of custom radiolabeling, in vitro assays and in vivo investigations capabilities.
About the solution
Their services cover/include: – Bioconjugation – Radioactive labeling – Analytical controls (HPLC, iTLC/TLC, SDS-PAGE…) – Stability studies (storage stability, plasma stability) – In vitro assays (Binding affinity, IRF, internalization, cytotoxicity, autoradiography on tissue sections) – In vivo investigations (Pharmacokinetics, biodistribution, efficacy, dosimetry)
Cynbiose is a preclinical CRO specialized in non-human primate (NHP) translational models for biomedical research since 2008. They maintain a France-based AAALAC-accredited animal facility for toxicological studies. Their brand new state-of-the-art facility can also accommodate studies requiring biosafety environments from ABSL-1 to 3, as well as GMOs such as viral vector-based gene therapies.
About the solution
The NHP model is well suited to predict pharmacokinetic and pharmacodynamic parameters, guide the selection of a safe starting dose for FIH trials, and provide valuable data on the potential toxicity of the candidate.
Their non-GLP preclinical services include:
– Pharmacokinetics (PK, central pharmacokinetics) and pharmacodynamics (PD) profiles
– In vivo biodistribution studies: biodistribution pattern (tissues, fluids such as CSF), Kpuu determination, and non-invasive imaging technologies
Their state-of-the-art France-based animal facility has been AAALAC accredited since 2015. Their proven platform can operate studies in biosafety levels up to level 3, as well as GMOs C1-2, in a GLP-like environment.
Cynbiose combines ten years of preclinical experience and a wide range of cutting-edge capabilities to serve biopharmaceutical companies. Driven by passion and curiosity for science, their sponsors value them as trusted, reliable, flexible, and innovative partners.
THERAVIA is a European-based company dedicated to the development, marketing, and distribution of innovative and original products dedicated to serious conditions, rare diseases, and unmet medical needs. Formed in 2023 through the merger of two French companies (ADDMEDICA and CTRS), they benefit from their track records in drug development, registration, and commercialization, as well as from a strong hospital presence and a solid KOL network, especially for rare disorders. They also benefit from a robust commercial network in all countries of Western Europe.
They are supported by MERIEUX EQUITY PARTNERS as a reference shareholder to accelerate their growth in France and internationally. To expand their portfolio, they are now looking for new products with the following features:
– Designed to treat a limited number of patients
– And/or highly innovative products
– And/or addressing emerging markets with few competitors and requiring specialized sales & distribution processes
About the solution
Theravia is a leader in some rare diseases’ treatment, having, for example, marketed a safe and easy-to-dose form of hydroxyurea called « Siklos » in Europe, the US (https://siklosusa.com/), and other territories to treat sickle cell disease. They invest in large clinical trials to advance the knowledge of the disease and its treatment. For instance, they are conducting ESCORT-HU, a Phase IV observational cohort study that includes more than 2,000 patients.
HTL Biotechnology is a French biotech company and world leader in the development and responsible bioproduction of pharmaceutical-grade biopolymers. These biopolymers are used by healthcare companies for the development of treatments in a wide range of leading therapeutic areas such as ophthalmology, dermatology, medical aesthetics, and rheumatology.
For over 30 years, HTL Biotechnology has been a driving force for innovation in the sector, collaborating with research entities and biotech companies to address tomorrow’s medical needs (regenerative medicine, drug delivery, etc.). HTL Biotechnology is a fast-growing international company, exporting nearly 80% of its production to over 30 countries. To meet these growing global needs for biopolymers, HTL Biotechnology has also established subsidiaries in Singapore and the United States, including the construction of a production unit for a neuromodulator. Historically based in Javené (Brittany), the company consolidates production, innovation, research and development, and quality activities on-site. HTL Biotechnology employs nearly 300 collaborators worldwide.
About the solution
Biopolymers are at the heart of today’s and tomorrow’s therapeutic innovations, HTL Biotechnology offers:
Quality is essential, and HTL guarantees that all its products comply with the highest quality standards and good manufacturing practices (GMP-compliant). Our commitment to safety and excellence is proven: no batch recalls in three decades, auditing and certification by regulatory bodies such as the FDA (USA). – Innovation portfolio: heparosan, oligo-HA – Biopolymer platform service: HTL offers expert advice and support to companies wishing to embark on the industrial production of a modified hyaluronic acid compound.
Crossject SA is an emerging specialty pharma company based in France and the U.S. It is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it was awarded a $60 million contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA). ZEPIZURE® is based on the Company’s award-winning needle-free autoinjector ZENEO®, designed to enable patients and untrained caregivers to easily and instantly deliver emergency medication via intramuscular injection on bare skin or even through clothing. The Company’s other products in development include rescue therapies for allergic shocks, adrenal insufficiencies, opioid overdose and asthma attacks.
About the solution
ZENEO is a pre-set in factory needle free device, it enables the easy and safe injection of a drug in only two steps, press and push into the injection site, even through clothing if necessary.
ZENEO has demonstrated through several Human Factors studies that it can be used easily and quickly even by naïve users even during an emergency situation.
There is no needle, which is a real advantage in terms of risk of laceration during injection and/or potential cross-contamination for the rescuer, or further down the disposal chain.
ALTEVAX was founded in 2016 by Professor Antoine Carpentier, neuro-oncologist and Head of the Neurology Department at Saint-Louis Hospital in Paris (AP-HP). His research on biological nanoparticles and melanin’s potential as adjuvant for vaccines resulted in a patented antigen-melanin platform technology.
Since 2016, the research team at ALTEVAX has demonstrated melanin’s ability to shield antigens from degradation and transport them to the lymph nodes, where they induce a robust and specific immune response involving CD4 and CD8. ALTEVAX technology is protected by two families of general patents and can be used in a wide range of new vaccines depending on the antigens selected.
ALTEVAX lead product, a therapeutic vaccine against Glioblastoma, based on the tumor-associated antigen TERT (from the telomerase complex), has completed the final stage of preclinical development, and will enter a Phase 1/2a clinical trial in newly diagnosed glioblastoma in Q3 2024.
About the solution
ALTEVAX technology, peptide-based vaccines using melanin as adjuvant triggers a specific immune response, involving CD4+ and CD8+ lymphocytes, against self-antigens that is more effective and faster than current vaccine technology using emulsions, RNA (primarily producing antibodies and few CD8+), or DNA as messenger vectors. Laboratory experiments confirmed its superior efficacy.
Melanin induces an immune reaction similar to the reaction by the human body when defending against pathogenic aggressions. It is a natural, non-toxic product and offers an excellent benefit-to-risk ratio.
ALTEVAX mastered the production process for synthetic melanin and its combination with peptides. Its vaccines will be administered subcutaneously, simplifying administration, and reducing costs.
Netris Pharma is a clinical-stage company developing innovative therapeutics to improve treatment outcome for cancer patients, targeting resistance to both chemotherapy and immunotherapy.
About the solution
Their lead asset, NP137, is a first-in-class anti-Netrin1 monoclonal antibody currently investigated in a randomized phase II in Endometrial and Cervical cancers as well as in 5 exploratory trials.
Alzprotect, established in 2007 in Lille, France, focuses on creating therapies to slow or halt neurodegenerative diseases and rejuvenate brain function. Alzprotect is dedicated to innovating in the neurodegenerative field. The company holds 4 international patent families for its developed drugs and their global indications.
About the solution
Alzprotect is making strides with AZP2006 (EZEPROGIND), a novel oral synthetic molecule aimed at enhancing lysosome homeostasis by regulating Progranulin and its chaperone protein, Prosaposin. Unlike traditional treatments that target symptoms like amyloid peptides or Tau protein, AZP2006 focuses on the root processes of neurodegeneration. It has shown promising results in reducing amyloid peptide secretion, lowering hyperphosphorylated Tau protein levels, and decreasing neuroinflammation, thus offering a comprehensive treatment approach. Granted « orphan drug » status in Europe and the US for Progressive Supranuclear Palsy (PSP), its safety and efficacy have been proven in human trials, paving the way for Phase 2B/3 trials for PSP and future applications in Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis.
BIOPHTA is a French preclinical-stage biotech company (FDA pre-IND) transforming ophthalmology to relieve patients in the treatment of their eye diseases. They develop a new standard of care to replace topical eye-drops as well as invasive intra-ocular injections for the retina.
Their technology is based on an innovative family of biopolymers that allow a one-week continuous treatment of the eye. They overcome efficacy issues of daily eyedrops as well as the high cost and invasiveness of ocular injections. It’s the first time a therapy displays such innovative technological features to disrupt both front-of-the-eye as well as retina treatments.
About the solution
They improve the efficacy of eye treatments by leveraging the first 7-day continuous microdosing pharmaceutical form. This topical mucoadhesive ophthalmic insert is self-applied directly onto the eye surface by the patient and instantly jellifies. Their hydrogel strongly adheres to the eye surface for 7 days, allowing a one-week drug delivery to the eye of a controlled dose. It is the first topical and non-invasive therapy offering a continuous sustained release treatment of the retina.
