Category Archives: Biotech Companies France

Medincell Enters Into Strategic Co-development and Licensing Agreement with AbbVie to Develop Next-generation Long-acting Injectable Therapies

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Medincell will receive an upfront payment of $35 million and is eligible for up to $1.9 billion in potential development and commercial milestones, plus royalties on worldwide sales.

Medincell and AbbVie will co-develop, and AbbVie will commercialize up to six cutting-edge long-acting injectables (LAI).

The first LAI program candidate has been selected and formulation activities are underway.

This pivotal alliance leverages Medincell’s commercial-stage LAI technology and development know-how, and AbbVie’s extensive clinical development and commercialization expertise, to deliver innovative therapeutic solutions to patients globally.

MONTPELLIER, France–(BUSINESS WIRE)–Medincell (Paris:MEDCL) today announced a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications. Medincell will use its commercial-stage long-acting injectable technology platform to formulate innovative therapies. Medincell will conduct formulation activities and preclinical studies, including supportive CMC work to advance candidates into clinical trials. AbbVie will finance and conduct the clinical development for each program and will be responsible for regulatory approval, manufacturing, and commercialization.

Christophe Douat, Medincell’s CEO said: “This will be an exciting partnership with one of the most innovative and successful pharmaceutical companies. Medincell has entered a new period of growth following the FDA approval of the first product using our technology in April 2023. The full potential of long-acting injectable therapies is getting increasingly recognized.”

Sébastien Enault, Medincell’s Chief Business Officer added: “Our business development is accelerating following FDA approval of our first product. Our technology can help harvest the full potential of many known or yet untapped drugs. We are ready to make this exciting partnership very successful.”

Under the terms of the co-development and licensing agreement covering up to 6 programs, Medincell will receive a $35 million upfront payment and is eligible to receive up to $1.9 billion in development and commercial milestones ($315 million for each program). Medincell is also eligible to receive mid-single to low-double-digit royalties on net sales.

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.

UZED® and SteadyTeq™ are trademarks of Teva Pharmaceuticals

www.medincell.com

Contacts

David Heuzé
Head of Corporate and Financial Communications, and ESG

david.heuze@medincell.com / +33 (0)6 83 25 21 86

Grace Kim
Head of US Financial Strategy & IR

grace.kim@medincell.com / +1 (646) 991-4023

Nicolas Mérigeau
Media Relations

medincell@newcap.eu / +33 (0)1 44 71 94 94

Louis-Victor Delouvrier/Alban Dufumier
Investor Relations France

medincell@newcap.eu / +33 (0)1 44 71 94 94

MaaT Pharma Announces Positive Review from the DSMB on the Ongoing Phase 1 Clinical Trial Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS)

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  • Independent Data Safety and Monitoring Board (DSMB) recommended that the trial proceeds as planned without modifications.
  • MaaT033 has shown a good safety profile and was generally well tolerated in the first 8 patients with ALS treated with MaaT033 used in a chronic setting.

    • MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today announced that the DSMB reviewed safety data in the first 8 patients with Amyotrophic Lateral Sclerosis (ALS) treated with MaaT033 in the IASO clinical trial. The DSMB recommended that the trial continue without modifications.

    The DSMB, composed of 4 independent experts, including an ALS patient association representative, concluded that safety was good. More precisely, it should be noted that no serious or severe adverse events were observed, and no infectious events could be related to MaaT033. The preliminary results reinforce confidence in the safety of MaaT033, a drug candidate produced by combining the microbiota from multiple donors using a “pooling” process.

    MaaT033 is currently evaluated, in a chronic setting, in a Phase 1b pilot study (NCT05889572) in ALS (also known as Lou Gehrig’s disease in the US and Charcot’s disease in French-speaking countries). The Company has developed the clinical trial with the French academic experts FILSLAN/ ACT4ALS-MND and in collaboration with the French patients’ association Tous en Selles contre la SLA. Data readout is now expected in early H2 2024. MaaT033 is also being evaluated in the Phase 2b trial PHOEBUS (NCT05762211), the largest one to date in Europe for a microbiome therapy in oncology, dedicated to improving survival of patients with blood cancers receiving allogeneic hematopoietic stem cell transplantation (HSCT).

    About MaaT033

    MaaT033, a donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

    About MaaT Pharma

    MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, MaaT Pharma launched, in March 2022, an open-label, single arm, phase 3 clinical trial in patients with acute GvHD (aGvHD), following the achievement of its proof of concept in a phase 2 trial. Its powerful discovery and analysis platform, gutPrint®, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company’s Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice. MaaT Pharma is listed on Euronext Paris (ticker: MAAT).

    Forward-looking Statements

    All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

    Contacts

    MaaT Pharma – Investor Relations
    Guilhaume DEBROAS, Ph.D.

    Head of Investor Relations

    +33 6 16 48 92 50

    invest@maat-pharma.com

    MaaT Pharma – Media Relations
    Pauline RICHAUD

    Senior PR & Corporate Communications Manager

    +33 6 14 06 45 92

    media@maat-pharma.com

    Trophic Communications
    Stephanie MAY or

    Priscillia PERRIN

    +49 171 185 56 82

    maat@trophic.eu

    Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

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    Autophagy is a catabolic process which degrades a cellular own component through the lysosomal machinery. The lysosome, at the heart of the autophagy sytem is important in various processes (cancer, infection…).

    Genoscience Pharma - new approaches disrupting cancer cell lysosomal functions

    In Cancer, they are required in tumor cells for cellular adhesion, motility and signaling, exocytosis, angiogenesis and overall survival, growth, aggressiveness, metastatic potential and drug resistance. Because of their high metabolic rates, rapidly dividing and invasive cancer cells require increased new biomass production to survive. The lysosome is also important for adaptation to nutrient stress as it contains hydrolytic enzymes that play a major role in the degradation of intracellular macromolecules and catabolic (such as autophagy) and anabolic growth. This busy lysosomal behavior leads to alterations in lysosomal structure and function, which, paradoxically, renders cancer cells more sensitive to lysosomal destabilization. In addition, lysosomal enzyme activity is elevated in many tumors compared to adjacent normal tissue, and several reports suggest that lysosomes in tumor cells are more fragile than normal lysosomes. Therefore, lysosome seems to be a target of interest in the fight against cancers. Targeting lysosomes triggers apoptotic and lysosomal cell death pathways.

    Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

    In virology, It has been shown that autophagy is activated during virus and bacterial infection and that some viruses can use the autophagy system to facilitate their own replication . Some viruses, such as Coronaviruses are single stranded, positive sense RNA viruses, which induce the rearrangement of cellular membranes upon infection of a host cell. This provides the virus with a platform for the assembly of viral replication complexes, improving efficiency of RNA synthesis. Genoscience Pharma focuses on new approaches disrupting cancer cell lysosomal functions.

    Genoscience Pharma was founded in 2001 by Pr Philippe Halfon, a world renowned medical expert on viral diseases, especially on Human Immunodeficient Virus (HIV) and Hepatitis C Virus (HCV). The company was initially focused on the development of anti-HCV agents. Two protease inhibitors were thus developed and out-licensed to BioLineRX. A new scientific direction was taken in 2012 after the discovery of a new chemical family: autophagy inhibitors. Following promising preliminary in vitro and in vivo results from these small molecules, including against cancer stem cells, Genoscience Pharma has decided to take the opportunity to make the difference in Oncology, especially in cancers where medical needs are still unmet. Now, Genoscience Pharma is a clinical stage biopharmaceutical company focused on translating novel scientific insights into medicines for patients with cancer.

    Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

    More info: https://www.genosciencepharma.com/

    Keywords : lysosomal functions , cancer, oncology , Genoscience Pharma , lysosomes , infectious diseases  , virus , Covid19, leukemia , pancreatic cancer , hepatocarcinoma , small molecules

    Cell-Easy – reducing stem cells manufacturing cost for cell therapies

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    Cell-Easy is a cell therapy Contract Development and Manufacturing Organization (CDMO) for preclinical and clinical drug development projects.

    Cell-Easy’s aspiration is to dramatically reduce stem cell manufacturing cost, starting with ASC (historical and local strong expertise), to change the affordability challenge currently met by Cell Therapies. Its ASC production process was designed using QbD approach and economical study (Manufacturing Cost model simulation) to ensure cell quality, scalability, compatibility with GMP requirements and economic viability for the entire clinical development INCLUDING the commercialization.

    European leading CDMO company specialized in large volume industrialized production of GMP approved cell products

    Cell-Easy’s team is committed to its customers to develop & produce ATMPs for clinical advanced therapies. Its ambition combines analytical and process innovations to provide cGMP cells with extended characterization (safety, identity, and performance). Cell-Easy’s experience in stem cells has grown from its original ambition: to make cell therapy accessible to as many patients as possible, by combining an allogeneic approach with a high-performance culture process. Its MSC production process has been designed using a QbD approach and an economic study (simulation of the manufacturing cost model) to ensure cell quality, scalability, compatibility with GMP requirements and economic viability for the entire clinical development, including commercialization.

    Analytics-driven Contract Development and Manufacturing Organization (CDMO) specialized in Cell Therapy, Cell-Easy offers customized process development, GMP manufacturing and unique analytical services for adult stem cells (MSCs, iPSCs and Exosome) and immune cells (engineered CAR-T,-NK…cells, and non-engineered cells) in Regenerative Medicine and Immuno-oncology fields.

    Cell-Easy facilities comprise 350 sqm of qualified controlled environment suites optimized to develop Manufacturing and Analytical Process, proceed to environmental and material Quality Control and execute cGMP Manufacturing, Fill&Finish, long-term Storage of ATMPs compliant with all the requirements of Regulatory Standards and cGMP guidelines.

    Cell-Easy is a recent and fast-growing biotech startup based in Toulouse, France. The Cell-Easy Management team and all collaborators have a strong expertise in the Development and Manufacturing of innovative cell-based therapies.

    More info : https://www.cell-easy.com/

    Biophytis – therapeutics to slow down the degenerative processes associated with aging

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    Biophytis is a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratoy failure in patients suffering from COVID-19.

    Biophytis - therapeutics to slow down the degenerative processes associated with aging

    Biophytis SA, founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, Biophytis has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical needs. Specifically, the company is advancing two proprietary drug candidates into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The business model of BIOPHYTIS is to ensure the conduct of the project until clinical activity in the patient is proven, then to license the technologies in order to continue the development in partnership with a pharmaceutical laboratory. The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and collaborates with scientists at the Institute of Myology, and the Vision Institute

    Its lead drug candidate, Sarconeos (BIO101), is an orally administered small molecule in development for the treatment of neuromuscular diseases, including sarcopenia and Duchenne muscular dystrophy (DMD). Our second drug candidate, Macuneos (BIO201), is an orally administered small molecule in development for the treatment of retinal diseases, including dry AMD and Stargardt disease.

    Biophytis also has preclinical efficacy data for Sarconeos (BIO101) in Spinal Muscular Atrophy (SMA), a rare neuromuscular disease. Spinal Muscular Atrophy is a rare progressive neurodegenerative disease that robs an individual of the ability to walk, eat and breathe. SMA is the leading genetic cause of death in infants. Symptoms may appear in the first 6 months of life (type 1, the most severe and common), in infancy (types 2 and 3) or in adulthood (type 4, the least common form). SMA affects 1 in 11,000 births in the United States each year, and about 1 in 50 Americans is a genetic carrier.

    More info : www.biophytis.com

    Keywords for Biophytis :

    neuromuscular diseases, dry age-related macular degeneration, AMD, ophthalmology, infectious diseases, COVID19, Asthma, COPD, small molecule, sarcopenia, Stargardt disease, Duchenne muscular dystrophy , DMD, preclinical stage pharma company, clinical stage pharma company , Spinal Muscular Atrophy , rare diseases , aging

    Cytoo – next generation HCS with physiologically relevant cellular models

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    Cytoo - next generation HCS with physiologically relevant cellular models

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    AgileBio – collaborative tools that enhance research productivity

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    AgileBio – collaborative tools that enhance research productivity

    agilebio

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    DDI-Predictor – predict drug drug interactions mediated by cytochromes

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    DDI-Predictor – predict drug drug interactions mediated by cytochromes

    ddi-predictor

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    Kromaton – centrifugal partition chromatography

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    KROMATON is an innovating firm pioneer in Centrifugal Partition Chromatography (CPC), or Countercurrent Chromatography (CCC), a liquid/liquid preparative chromatography technique.

    Kromaton – centrifugal partition chromatography

    Kromaton

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    IDD Biotech – differentiated therapeutic MAbs

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    IDD biotech aims to improve the life of patients by developing differentiated therapeutic MAbs for the pharmaceutical market with a pipeline of internally discovered product candidates and strategic collaborations with research institutes and pharmaceutical companies.

    IDD Biotech – differentiated therapeutic MAbs

    IDD Biotech

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