Abeona Therapeutics Inc., of New York and Cleveland, disclosed changes to its leadership and board, with the resignation of João Siffert from his positions as CEO, head of R&D, chief medical officer and board member, on Sept. 23. On Sept. 27, board members Brian Pereira, Stefano Buono, Stephen B. Howell, George Migausky and Shawn Tomasello all announced they had stepped down, effective immediately. No reasons for those resignations were given. Abeona said it is reviewing and exploring strategic options, including sale of some or all of its assets. The company is in phase III development with EB-101, a gene therapy for recessive dystrophic epidermolysis bullosa, which recently restarted patient enrollment following a COVID-19-related pause. Shares of Abeona (NASDAQ:ABEO) fell 41% Sept. 28 to close at $1.09.
Applied Biology Inc., of Irvine, Calif., and researchers at University Hospital Ramon y Cajal in Madrid, Spain, said results from their androgen receptor genetics study in hospitalized COVID-19 male patients, published in the Journal of the European Academy of Dermatology and Venerology, confirm an association between androgens and COVID-19 disease severity. The study demonstrated that the proportion of male patients admitted to the ICU with a longer variable genetic repeat in the androgen receptor gene variant was statistically significantly higher compared to males with a shorter variant. Similarly, the risk of ICU admissions was significantly higher among males with the longer variant. COVID-19 patients with the shorter variant experienced a shorter duration of hospitalization compared to males with the longer variant (25 days vs 47.5 days). Overall, the longer variant of the androgen receptor was associated with higher disease severity among hospitalized male COVID-19 patients.
Aqilion AB, of Helsingborg, Sweden, and Immunscape AB, of Stockholm, said they will discontinue their joint feasibility study in oncology and autoimmune diseases. “The feasibility study produced good technical results and new intangible assets, but external factors have led to declining interest in the continued commercial development of the project,” according to Sarah Fredriksson, Aqilion’s CEO.
Fibrogenesis Inc., of Houston, said it entered a manufacturing agreement with CDMO Ibiologics to supply its allogeneic fibroblast cells for Fibrogenesis’ chronic disease platform and ongoing clinical trials.
Fundación Medina, the Drugs for Neglected Diseases initiativ and Institut Pasteur Korea have been awarded a grant of €995,000 (US$1.2 million) from the Caixa Health Research 2020 program to identify natural products as potential treatments for leishmaniasis and Chagas disease. The project will use the whole-cell phenotypic screening assays of Institut Pasteur Korea, the companies said, and a new image-based assay with cell-imaging technology will be developed at Institut Pasteur Korea to identify new modes of action of novel compounds and to select the most promising compounds for further development.
Genetex Inc., of Irvine, Calif., an antibody manufacturer, said it developed a comprehensive and well-characterized catalog of SARS-CoV-2 reagents for researchers. In an effort to further optimize those antibodies, Genetex partnered with Histowiz Inc., which specializes in histopathological services. The first phase of the collaboration has established several highly validated antibodies for immunohistochemistry on human SARS-CoV-2-infected tissues, the company said.
Genfit SA, of Lille, France, and Labcorp agreed to a five-year exclusive licensing agreement for Genfit’s NIS4 technology to help identify patients with at-risk nonalcoholic steatohepatitis. As part of the agreement, Labcorp will develop and commercialize a blood-based molecular diagnostic test powered by NIS4 technology throughout the U.S. and Canada enabling widespread access to health care providers.
Iontas Inc., of Cambridge, U.K., and Fairjourney Biologics SA, of Porto, Portugal, both antibody discovery clinical research organizations, disclosed the discovery of potent SARS-CoV2 neutralizing antibodies as potential therapeutics for COVID-19. The newly identified panel of antibodies was shown to block infection at doses as low as 20 pM in pseudoviral assays and 100 pM in live coronavirus assays, surpassing or matching the best antibodies reported. This viral neutralization efficiency was independently verified by the National Institute for Biological Standards and Control, the companies said.
Kiadis Pharma NV, of Amsterdam, and Gulf Coast Regional Blood Center (GCRBC), a supplier of blood components, said they entered a collaboration in which GCRBC will supply universal donor starting material for the manufacture of Kiadis' off-the-shelf K-NK natural killer cell therapies in the U.S.
Oragenics Inc., of Tampa, Fla., said it was informed by the U.S. Biomedical Advanced Research and Development Authority (BARDA) of BARDA’s determination not to enter into negotiation with the company. While BARDA noted the company’s submission aligned with its mission, a combination of factors, including availability of funds, precluded the agency from entering into negotiations at this time. Oragenics said it remains committed to advancing its SARS-CoV-2 vaccine, Terra CoV-2, and will pursue other sources of nondilutive funding and possibly equity capital. Shares of Oragenics (NYSE American:OGEN) fell 12% to close Sept. 28 at 55 cents.
Patrys Ltd., of Melbourne, Australia, said it completed initial production and characterization of PAT-DX3, a full-sized, humanized antibody version of its dimerized antibody fragment, PAT-DX1. The full-sized version is likely to have different pharmaceutical properties and may provide opportunities for use in additional clinical applications, the company said. PAT-DX1, Patrys lead compound, is an engineered version of the mouse lupus antibody 3E10, which has been miniaturized to just contain two copies of the binding domain of 3E10 and further modified to improve its binding properties.
Sanofi SA, of Paris, said it completed its acquisition of Principia Biopharma Inc., of South San Francisco, for $100 per share in cash. The deal, valued at about $3.68 billion, brings Sanofi three clinical-stage BTK inhibitors.
Sojournix Inc., of Waltham, Mass., presented preclinical data at the North American Menopause Society meeting showing SJX-653 exhibits a potent NK3 antagonist profile across in vitro studies, in vivo models and initial clinical studies in men and postmenopausal women. SJX-653 is a highly selective NK3 antagonist in development as a non-hormonal once-daily treatment for moderate to severe vasomotor symptoms due to menopause.
Sosei Group Corp., of Tokyo, said it was notified by Pfizer Inc., of New York, that the first subject in a clinical trial was dosed with a drug nominated from the multitarget drug discovery collaboration between the two companies, triggering a milestone payment of $5 million to Sosei Heptares.
Therapeutics Solutions International Inc., of Oceanside, Calif., reported preclinical data for its Jadicell product, demonstrating superior neuroregenerative activity to other cell therapies such as mesenchymal stem cells. Using animal models, company collaborators demonstrated stimulation of stem cell proliferation that reside in parts of the brain called the dentate gyrus. Additionally, the company reported protection of neurons from inflammation associated cell death as well as reduction of inflammatory proteins produced by microglia. Jadicell is in development for treating brain injuries, including chronic traumatic encephalopathy.
Visus Therapeutics Inc., of Seattle, said it launched with a clinical development program aimed at restoring loss of near vision associated with presbyopia. Lead candidate brimochol, an eye drop formulation combining FDA-approved carbachol and brimonidine tartrate, has demonstrated statistically significant improvement in near visual acuity of a 5 Jaeger-line or greater gain, with the effect lasting at least 12 hours. Phase II trials are slated to commence in early 2021.