AB Science SA, of Paris, said it signed an exclusive licensing agreement with the University of Chicago to research prevention and treatment of nidoviruses, coronaviruses and picornaviruses. The collaboration follows the discovery by the university that masitinib inhibits the main protease, 3CLpro, necessary for the SARS-CoV-2 viral replication cycle. AB Science will supply masitinib and more than 130 other AB Science drugs that have demonstrated activity against SARS-CoV-2 main protease 3CL-Pro via virtual screening methodology.
Having received European Commission market authorization for cardiovascular risk reduction in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics, Amarin Corp. plc, of Bridgewater, N.J., and Dublin, said it planned to launch Vazkepa (icosapent ethyl) in Germany before the end of the third quarter of 2021. Amarin said it expects to grow its staffing in Europe to approximately 300 people by the end of 2021, with increases planned as market access is expanded in various countries. Vascepa capsules are composed solely of the active ingredient icosapent ethyl, a form of eicosapentaenoic acid.
New preclinical data from Ampio Pharmaceuticals Inc., of Englewood, Colo., suggested Ampion's suitability for addressing kidney diseases and provides further evidence it is a platform biologic for treatment of inflammatory and autoimmune diseases, the company said. The study evaluated Ampion’s ability to suppress TLR7 signaling in order reduce the pro-inflammatory chemokine, CXCL10. Toll-like receptors are a mechanism for innate immune cells to detect and respond to microbial infection. Ampion is a stem cell antigen-1 inhibitor.
ANI Pharmaceuticals Inc., of Baudette, Minn., said it acquired NDAs for Oxistat Lotion, Veregen Ointment and Pandel Cream and the ANDA for Apexicon E Cream from Sandoz Inc., a unit of Novartis AG, of Basel, Switzerland. Pandel Cream will be transitioned later upon receiving requisite approvals. Collectively, the products generated net revenues of $13.2 million in 2020, the company added. The acquisition was funded through the company’s revolver credit facility.
Bavarian Nordic A/S, of Copenhagen, said it received a new supply order from Janssen Pharmaceutica NV, part of New Brunswick, N.J.-based Johnson & Johnson, valued at approximately $28 million. Bavarian Nordic will manufacture and deliver bulk drug substance of MVA-BN Filo vaccine, licensed to Janssen as part of its Ebola vaccine regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN Filo), which was approved by the European Commission in 2020. Manufacturing of the bulk drug substance will commence in May, and delivery is expected to take place in the second half of 2021.
Hoth Therapeutics Inc., of New York, said it engaged the CRO Worldwide Clinical Trials for a phase IIa dose-ranging trial of HT-001 for treating cutaneous toxicities associated with EGFR inhibitor therapy for cancer patients. The study is an investigation of the efficacy and safety of varying dose strengths of HT-001 compared to placebo for treating cutaneous disorders (skin, nails and scalp) associated with EGFR inhibitor therapy. The study will be conducted in cancer patients receiving EGFR inhibitors, inclusive of both small-molecule and biologic drug classes.
Kuros Biosciences Inc., of Schlieren, Switzerland, said it will receive a $2 million milestone payment from Checkmate Pharmaceuticals Inc., of Cambridge, Mass., for dosing the first melanoma patient in a phase II study with vidutolimod (CMP-001, formerly CYT-003). Checkmate is investigating vidutolimod, a Toll-like receptor 9 agonist, across multiple tumor types in combination with checkpoint inhibitor immunotherapies. Vidutolimod was licensed from Kuros in 2015. Kuros stands to receive up to $56 million in development and regulatory milestone payments related to vidutolimod. In addition, Kuros will receive royalties of high single-digit to low-teens percentages on future annual net sales of products covered by a licensed patent.
Maxwell Biosciences Inc., of Austin, Texas, said Pharmaceuticals published a paper co-authored by scientific advisory board member Gill Diamond of the University of Louisville and collaborators showing that peptoids MXB-4 and MXB-9 exhibited in vitro antiviral activity against SARS-CoV-2. When incubated with virus for one hour at 37°C at increasing concentrations, the researchers observed virus inactivation with IC50 values of 20 µg/mL and 7 µg/mL, respectively. Visualization by Cryo-EM confirmed direct disruption of the viral membrane, as previously shown with HSV-1. The researchers also assayed peptoid cytotoxicity against cultured human cells and observed tolerability up to 500 µg/mL, suggesting a good therapeutic window.
Moderna Inc., of Cambridge, Mass., and Catalent Inc., of Somerset, N.J., said they expanded their strategic collaboration by dedicating a high-speed vial filling line to manufacture Moderna’s COVID-19 vaccine (mRNA-1273) and, potentially, other programs from Moderna’s pipeline at Catalent’s biologics facility in Bloomington, Ind. The high-speed line will be dedicated to Moderna’s use through June 2023. Catalent also will provide inspection, labeling, placement in cartons and final packaging for the programs.
Mybiotics Pharma Ltd., of Rehovot, Israel, and the Hadasit Medical Research Services and Development Ltd., part of Hadassah Medical Center, entered a research collaboration and licensing agreement to identify microbiome-based therapeutics for enhancing the response to and reduce adverse effects of anti-PD-1 and anti-PD-L1 in melanoma patients. The research will aim to assess the composition of the gut microbiome and secondary metabolites in up to 100 melanoma patients treated with PD-1/PD-L1 checkpoint inhibitors, some of which already exhibited long-term response to treatment. Stool and blood samples will be collected at various time points along treatment to identify microbiome components.
Oryzon Genomics SA, of Madrid, Spain, said it initiated a preclinical collaboration on autism with researchers from the Seaver Autism Center for Research and Treatment at the Icahn School of Medicine at Mount Sinai, under the direction of Joseph Buxbaum. The effort will explore the effects of vafidemstat, Oryzon’s phase II lysine specific histone demethylase 1 inhibitor and MAO B inhibitor, in models of autism in Shank3 deficient mice models developed and characterized at Seaver by Buxbaum’s team.
Ose Immunotherapeutics SA, of Nantes, France, said a peer-reviewed publication on OSE-230, its preclinical chemokine receptor-like 1 agonist targeting chronic and severe inflammation, was published in Science Advances. The paper showed that the monoclonal antibody reduced tissue neutrophil accumulation and triggered resolution of chronic inflammation of the G protein-coupled receptor that is overexpressed in the inflamed tissues of people who fail to respond to anti-TNF-alpha or anti-alpha-4 beta-7 therapies. The research team observed reduction of fibrosis in inflamed tissues and reduction in development of inflammation-driven tumors. The collaboration included Ose staff and scientific partners at Ambiotis, a French contract research organization; Mabsilico, a French biotech specializing in artificial intelligence; and the Center for Research in Transplantation and Immunology, based at the University Hospital of Nantes.
Oxford Biomedica plc, of Oxford, U.K., said it agreed to a three-year development and supply agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, covering the manufacture and supply of viral vectors. Oxford plans to manufacture GMP batches to support Boehringer’s development of viral vectors and may manufacture and supply viral vector products in the future.
Progenity Inc., of San Diego, said it concluded an agreement with Ionis Pharmaceuticals Inc., of Carlsbad, Calif., to evaluate the safety, tolerability and performance of Progenity’s oral biotherapeutics delivery system (OBDS) for oral systemic delivery of antisense oligonucleotides developed and manufactured by Ionis. The OBDS is an ingestible capsule based on needle-free technology designed by Progenity that enables delivery of a drug formulated in solution directly into the tissues of the small intestine, where it can be absorbed systemically. Initially, the companies plan to evaluate the OBDS in conjunction with an Ionis drug in a preclinical canine model to assess in vitro compatibility and performance as well as in vivo safety, tolerability and performance.
Rational Vaccines Inc., of Cambridge, Mass., said it executed a license agreement with Louisiana State University covering work conducted by virologist Konstantin “Gus” Kousoulas from LSU’s School of Veterinary Medicine in the Division of Biotechnology and Molecular Medicine that expands Rational's core mission to eliminate the herpes virus. In animal models, the vaccine technology, known as VC2, showed potential to treat herpes simplex virus 1 and 2 as well as facial and ocular herpes. VC2 is a live-attenuated, engineered version of HSV-1 that prevents HSV from entering neurons of the body.
Sound Pharmaceuticals Inc. (SPI), of Seattle, said it was awarded a $3.1 million cooperative grant from the National Center for Advancing Translational Sciences at the U.S. NIH to support testing of SPI-1005 in two phase II trials involving 120 adults with moderate or severe COVID-19. The oral capsule contains ebselen, a COVID-19 replicase polyprotein 1a/1ab inhibitor and glutathione peroxidase stimulator, in development for neurotologic, neuropsychiatric and respiratory indications. In addition to assessing clinical outcomes, SPI will examine whether the body's inflammatory and cellular immune response to COVID-19 infection will improve with SPI-1005 treatment.
Valeo Pharma Inc., of Montreal, said it inked a letter of intent following negotiations with the pan-Canadian Pharmaceutical Alliance for coverage of Redesca and Redesca HP (low molecular weight heparin biosimilar) to prevent and treat thromboembolic disorders. The agreement enables Valeo to ensure coverage under publicly funded drug plans in Canada.
Yumanity Therapeutics Inc., of Boston, said an in vivo efficacy study of YTX-7739 in a mouse model of glioblastoma multiforme (GMB) showed increased overall survival. The study, conducted by researchers at the Massachusetts General Hospital and presented virtually at the Society for NeuroOncology/NCI Joint Symposium: Targeting CNS Tumor Metabolism, showed the oral stearoyl CoA desaturase-1 (SCD) inhibitor, administered alone or with temozolomide (TMZ), and YTX-9184, a second SCD inhibitor in development by Yumanity, each increased median survival as a monotherapy and showed synergy with TMZ in both aggressive and slow-growing tumors. YTX-7739 is in development by Yumanity to treat Parkinson’s disease.