BioSpace Global Roundup, Nov. 5
Minaris – Germany’s Minaris Regenerative Medicine received an investment of $63.5 million to significantly expand its facilities in Europe and Asia. The company, which is wholly owned by Showa Denko Materials Co., will use the funds to build a state-of-the-art facility in Germany dedicated to clinical and commercial manufacturing as well as development services for cell and gene therapies. The new facility is expected to be operational early 2023 and will allow for additional expansion of clean rooms according to client demand and specifications, thus more than tripling the current clean room capacity. In addition to the Germany site, Minaris will also use proceeds to expand its Japanese facility. The new site in Japan is scheduled to start operations in October 2022. Earlier this year, Minaris opened a new facility in New Jersey.
Novasep – France-based Novasep signed an agreement with Handl Therapeutics to develop an AAV-based gene therapy drug candidate for the treatment of neurodegenerative diseases. Under the terms of the agreement, Novasep will develop and manufacture AAV vectors designed for these programs and will supply drug substance and drug product to support Handl Therapeutics’ preclinical and clinical studies. Handl Therapeutics is developing multiple therapeutic adeno associated virus based programs in collaboration with the Katholieke Universiteit Leuven, with the Center for Applied Medical Research (CIMA) of the University of Navarra, Spain, and with the Biomedical Neuroscience Institute (BNI) of the University of Chile. The company is currently conducting IND-enabling preclinical studies.
Havn Life Sciences – Based in Vancouver, Havn Life partnered with the Mind Foundation on a study of depression and psilocybin. The MIND Foundation is a non-profit in Berlin that promotes psychedelic research and educates professionals and the public about psychedelic treatments, integration, evidence-based harm reduction, and human development. Their work builds on the neurobiological and psychological potential of psychedelics to improve mental health and well-being in a clinical setting. Havn Life is donating $20,000 to support this research, which will be the first psilocybin depression study in Germany since the 1970s.
Pivotal – Spain’s Pivotal has partnered with New York-based Checkpoint Therapeutics Inc. to provide clinical research services in Europe for its upcoming clinical study of its Programmed Death-Ligand 1 (PD-L1) inhibitor, cosibelimab (CK-301), in cutaneous squamous cell carcinoma (cSCC) patients. Cosibelimab is a potential, best-in-class, high affinity, fully-human IgG1 monoclonal antibody that directly binds to PD-L1 and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors to reactivate an antitumor immune response. In addition, cosibelimab has a functional Fc region that may bind and activate natural killer cells to enable cell-mediated antibody-dependent cellular cytotoxicity.
SOTIO – Czech Republic-based SOTIO and Cytune Pharma will present a late breaking poster highlighting new clinical data on SO-C101 at the Society for Immunotherapy of Cancer 35th Annual Meeting. SO-C101 is an IL-15 superagonist currently being investigated in a Phase 1 trial for the treatment of advanced solid tumors. Two additional posters will also be presented summarizing the latest preclinical data on SO-C101.
myNEO – Based in Belgium, myNEO launched its ImmunoEngine bioinformatics platform. The update includes two, one-of-a-kind machine learning algorithms, neoMS and neoIM, which enable the accurate and sensitive analyses of tumors. Specifically, the ImmunoEngine technology searches for the unique neoantigens found on the surface of cells that are different between tumor and healthy cells in each cancer patient. The myNEO ImmunoEngine technology makes it possible to detect foreign proteins on the tumor for each patient even if the tumor differs very little from normal cells.
Sobi – Stockholm-based Sobi, Swedish Orphan Biovitrum AB, announced the commercial launch of Doptelet (avatrombopag) in Europe, with the United Kingdom as the first country for launch. Doptelet is a thrombopoietin receptor agonist (TPO-RA) approved for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.
Alzinova AB – Sweden’s Alzinova AB will assess its vaccine candidate ALZ-101 in Alzheimer’s disease. The study is expected to begin in 2021 in patients with early Alzheimer’s. This is a first-in-human study, and the primary objective is to assess tolerability and any unexpected adverse effects of the ALZ-101 vaccine candidate. The study will further include analyses of the immune response i.e. levels of antibodies generated by the vaccine after repeated dosing. Pathologically, Alzheimer's disease is characterized by an aggregation of the Amyloid-β peptide (Aβ) in brain tissue, and the company's immunotherapy approach specifically targets the oligomeric, neurotoxic forms of the peptide aggregate thought to be involved in the onset and progression of the disease, according to the company. The company believes this is the first clinical study that specifically targets the toxic forms of the Aβ peptide.
XNK Therapeutics – Also based in Stockholm, XNK Therapeutics AB received Orphan Drug designation from the FDA for its lead investigational drug candidate in the treatment of multiple myeloma. XNK has already completed its first-in-human Phase I/II clinical trial (ACP-001) in multiple myeloma, with results showing a very good safety profile, and promising efficacy data. The company is continuing the clinical development in multiple myeloma in Europe and plans to initiate a Phase II clinical trial in the near future.
Enlivex Therapeutics – Israel’s Enlivex reported the Israeli Ministry of Health authorized the initiation of a proposed Company-sponsored Phase IIb clinical trial evaluating Allocetra in sepsis patients. Allocetra is also being developed for treatment of COVID-19 patients in severe and critical condition.
Fresenius Medical Care – Vifor FMC Renal Pharma and partner ChemoCentryx, Inc. of California, announced the European Medicines Agency accepted for review the Marketing Authorization Application (MAA) for avacopan for the treatment of patients with ANCA-associated vasculitis (granulomatosis with polyangitis (GPA) and microscopic polyangitis (MPA)), a group of rare and severe autoimmune diseases with high need for targeted therapies. If approved, avacopan would be the first orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis. Data from the global pivotal Phase-III ADVOCATE trial demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group.