4basebio AG, of Heidelberg, Germany, said the management board plans to convene an extraordinary general meeting Nov. 3 and to propose a consolidation of shares at a ratio of 9 to 1. That will be implemented after the completion of the spin-off of its DNA business.
Acacia Pharma Group plc, of Cambridge, U.K., said the U.S. Drug Enforcement Administration (DEA) designated its procedural sedative Byfavo (remimazolam injection) as a schedule IV medicine, which is for drugs with a low potential for abuse and low risk of dependence. The scheduling is consistent with that granted to many other benzodiazepine drugs, the company said. Byfavo was approved by the FDA on July 2, for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Scheduling by the DEA represents the final requirement, and the drug’s launch is expected by the end of 2020.
Aim Immunotech Inc., of Ocala, Fla., said it received institutional review board (IRB) approval to expand the AMP-511 expanded access program (EAP) of its Toll-like receptor 3 modulator, Ampligen (rintatolimod), to include individuals previously diagnosed with COVID-19 who still show chronic fatigue-like symptoms, commonly referred to as post-COVID-19 long haulers. Under the amendment to the AMP-511 EAP protocol, previously focused on individuals with myalgic encephalomyelitis or chronic fatigue syndrome, up to 20 of 100 active participants can be COVID-19 long haulers. AIM is preparing the IRB-approved protocol for submission to the FDA.
Akari Therapeutics plc, of New York, said it made further progress in its COVID-19 pneumonia program with nomacopan in the U.S. and Brazil. The company’s initial proof-of-principle studies have demonstrated that the 45-mg standard dose of nomacopan can be used to treat patients with COVID-19 pneumonia without the need for up-dosing. The studies showed rapid onset of action of nomacopan, as well as no reported adverse safety signals. Both studies, involving more than 60 patients each, have a primary endpoint of time to oxygen normalization and hospital discharge. The secondary endpoints will include the need for intubation and mortality. Treatment is for up to 14 days, with study monitoring and completion after two months.
Argenx SE, of Breda, the Netherlands, and Ghent, Belgium, said it will partner with Chugai Pharmaceutical Co. Ltd., a subsidiary of Basel, Switzerland-based Roche Holding AG, and the Clayton Foundation for Research to increase its technological capabilities in antibody Fc engineering. Argenx entered a research license and option agreement with Chugai and a nonexclusive research agreement to use Clayton’s DHS mutations for extending the serum half-life of therapeutic antibodies. Argenx also said it is collaborating with Halozyme Therapeutics Inc., of San Diego, to enable subcutaneous delivery of three current or future Argenx product candidates.
Applied Biomath LLC, of Concord, Mass., said it entered a two-year strategic partnership with Xilio Therapeutics Inc., of Waltham, Mass., to provide a variety of services related to mathematical modeling, simulation, analysis and visualization, which include systems pharmacology, quantitative systems pharmacology, experiment prioritization and design and traditional and mechanistic pharmacokinetic/ pharmacodynamic modeling in support of Xilio's preclinical and clinical drug development projects. Xilio is developing immunotherapies for treating cancer.
Aro Biotherapeutics Co., of Philadelphia, said Ionis Pharmaceuticals Inc., of Carlsbad, Calif., has exercised an option to acquire a license to an undisclosed antisense oligonucleotide (ASO)-Centyrin drug conjugate. In December 2019, Aro and Ionis entered a licensing and collaboration agreement to advance a defined number of ASO-Centyrin drug conjugates. Ionis is leveraging Aro’s technology to enhance the activity of ASOs via tissue-specific delivery to inhibit disease-causing RNAs and proteins.
ATCC, of Manassas, Va., said it received an indefinite delivery/indefinite quantity contract award with a ceiling value of $250 million from the U.S. Biomedical Advanced Research and Development Authority to join its Clinical Studies Network and provide a biological specimen and investigational product storage facility with centralized services. The contract supplements ATCC’s participation in the U.S. government’s COVID-19 pandemic response.
Atomwise Inc., of San Francisco, said it received $2.3 million in grant funding for AI-based discovery of antimalarial and antituberculosis therapies from the Bill & Melinda Gates Foundation. The grant will be used to discover compounds that can advance the development of novel antimalarial and antituberculosis small-molecule therapies in collaboration with the Gates Foundation’s global network of partners and funded investigators.
Bioatla Inc., of San Diego, and Beigene Ltd., of Beijing, said they revised their previous global co-development and commercialization agreement for Bioatla’s investigational CAB CTLA-4 antibody, BA-3071. The previous agreement from April 2019 now becomes a global licensing agreement for BA-3071, which was designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors, such as Beigene’s anti-PD-1 antibody, tislelizumab. Beigene will hold an exclusive global license to BA-3071 and will be solely responsible for its global clinical development and commercialization and have the right to receive all profits on any future sales net of royalty payments to Bioatla. In addition to the up-front payment Bioatla received upon execution of the original agreement, Bioatla is eligible to receive near-term development and regulatory milestone payments together with increased tiered royalties on worldwide sales. Additional terms of the amended agreement were not disclosed.
Derm-Biome Pharmaceuticals Inc., of Vancouver, British Columbia, said one of its topical drugs produced significant and dose-dependent inhibitory effects in a mouse model of psoriasis. The company said that in the trial it observed significant inhibitory effects in a dose-dependent manner in all concentration ranges tested. Used as a positive control, Long Beach, Calif.-based Dermavant Sciences Inc.’s psoriasis drug, tapinarof, also showed significant antipsoriatic activity in a preclinical trial using the same mouse model. Derm-Biome said its drug showed comparable inhibitory effects to tapinarof over a similar range of concentrations. Derm-Biome’s compound inhibits pro-inflammatory cytokine production, up-regulates anti-inflammatory mediators, including interferons and other anti-inflammatory cytokines, and enhances expression of proteins key to maintaining an effective skin barrier.
Eisai Co. Ltd., of Tokyo, signed a joint research agreement with four research organizations – Kan Research Institute, National Center for Global Health and Medicine, Nagasaki University and Yokohama City University in Japan – concerning the development of therapeutics to prevent the aggravation of COVID-19. The project was adopted for the second public call by the Japan Agency for Medical Research and Development. A nonclinical animal model of SARS-CoV-2 infection will be constructed. A Toll-like receptor 4 antagonist, eritoran, discovered by Eisai, and an anti-fractalkine antibody, E-6011, discovered by Eisai’s research subsidiary Kan, will be evaluated.
GT Biopharma Inc., of Beverly Hills, Calif., signed a partnership agreement with Cytovance Biologics Inc., a U.S.-based contract development and manufacturing organization and a subsidiary of the Shenzhen Hepalink Pharmaceutical Group Co. Ltd., of Shenzhen, China. Cytovance will be the exclusive GMP manufacturer for three of the company's TriKE therapeutic product candidates. Cytovance will use its Keystone bacterial or mammalian expression systems. Subject to the completion of certain milestones by Cytovance, GT has the option to pay Cytovance up to $6 million for its manufacturing services in either cash or in shares of the company's common stock valued at the time Cytovance achieves each of several milestones over the next 12 months.
Hemogenyx Pharmaceuticals plc, of London, provided an update on its CDX bispecific antibody in acute myeloid leukemia (AML). The compound may be able to treat AML directly and provide a benign conditioning regimen for blood stem cell replacement therapy. The company has constructed and successfully tested in vivo CAR T cells, called HEMO-CAR-T cells, and has introduced and tested in vitro a safety switch within the HEMO-CAR to modulate the activity of HEMO-CAR-T cells.
ILC Therapeutics Ltd., of Scotland, U.K., launched a research partnership with the University of St. Andrews. The parties aim to move a COVID-19 therapy toward clinical trials. The startup is working with the university’s Catherine Adamson from the School of Biology, specifically looking at the role that its drug, Alfacyte, can play in preventing COVID-19-induced acute respiratory distress syndrome.
Imbio Inc., of Minneapolis, entered a partnership with Genentech, part of Basel, Switzerland-based Roche Holding AG, to develop quantitative imaging diagnostics for lung diseases. The multiyear agreement deploys Imbio’s artificial intelligence know-how to build and deploy such technology for use in research, clinical trials and clinical practice. Imbio will continue to develop and market its portfolio of quantitative imaging algorithms for lung and cardiothoracic diseases outside of the partnership.
Kaleido Biosciences Inc., of Lexington, Mass., offered an update to its ongoing COVID-19 clinical development program evaluating KB-109 when added to supportive self-care in outpatients with mild to moderate COVID-19 disease. New projections for enrollment of the multicenter K031 study in about 350 patients indicate that top-line data will be available in the first quarter of 2021. Previous projections had targeted the fourth quarter of this year.
Molecular Partners AG, of Zurich-Schlieren, Switzerland, disclosed supportive preclinical data from in vivo assessments of its DARPin candidates targeting COVID-19. The candidates show robust activity in an aggressive viral challenge hamster model, supporting potential efficacy as therapeutic options in patients with late-stage disease. First-in-human studies for the candidate called MP-0420 are anticipated to begin in November, and clinical studies for the second antiviral prospect, MP-0423, are expected to initiate in the first half of 2021.
Moleculin Biotech Inc., of Houston, reported preliminary findings from its research collaboration with the Rega Institute in Leuven, Belgium, that demonstrate its drug candidates, WP-1096 and WP-1097, are showing significant in vitro activity in a range of infectious diseases. In addition to activity against SARS-CoV-2, antiviral activity has now been documented for HIV, Zika and dengue fever.
Mustang Bio Inc., of Worcester, Mass., and Sirion Biotech GmbH, of Martinsried, Germany, said they entered a licensing agreement under which Mustang acquired rights to Sirion’s Lentiboost technology for the development of MB-207, a lentiviral gene therapy in development for treating X-linked severe combined immunodeficiency patients who have been previously treated with a hematopoietic stem cell transplantation and for whom retreatment is indicated. Lentiboost is Sirion’s noncytotoxic transduction enhancer for lentiviral vectors. Under the terms, Sirion will receive an undisclosed up-front payment and development and sales milestones, as well as royalties on future product sales.
Ocugen Inc., of Malvern, Pa., said it entered an agreement with Kemwell Biopharma Pvt. Ltd., of Bangalore, India, to manufacture OCU-200, Ocugen’s biologic candidate in preclinical development for treating diseases such as diabetic macular edema (DME), diabetic retinopathy and wet age-related macular degeneration. Under the agreement, Kemwell will manage all CMC and clinical manufacturing activities as well as provide OCU-200 supplies for IND-enabling toxicology studies and phase I/IIa trials. Ocugen is planning to initiate IND-enabling studies, including GLP toxicology studies next year, with DME as the first targeted indication.
Oncimmune Holdings plc, of Nottingham, U.K., said it was awarded funding from the U.K. Research and Innovation Ideas to Address COVID-19 program, which will support a joint collaboration between Oncimmune and Medicines Discovery Catapult to deliver the IMPACTT (immunity profiling of patients with COVID-19 for therapy and triage) program.
Oxford Biomedica plc, of Oxford, U.K., said it has approval from the U.K.’s Medicines and Healthcare products Regulatory Agency for a fourth manufacturing suite within the company’s Oxbox manufacturing facility that will be used to develop a potential COVID-19 vaccine.
Respirerx Inc., of Glen Rock, N.J., said studies published in Experimental Neurology describe the ability of CX-717, one of the company’s lead ampakines, to improve motor nerve function in an animal model of spinal cord injury. CX-717 improved the electrical activity of the phrenic motor nerve when recorded below the site of the spinal injury, an effect which increased over the course of eight weeks.
Taysha Gene Therapies Inc., of Dallas, said it partnered with medical genetics firm Invitae Corp., of San Francisco, to support the latter’s Detect Lysosomal Storage Diseases (LDS) and Behind the Seizure programs. Detect LDS enables the rapid diagnosis of lysosomal storage disorders, including GM2 gangliosidosis (also known as Tay-Sachs and Sandhoff disease). Behind the Seizure is a cross-company collaboration designed to support faster diagnosis for children with epilepsy.
Transgene SA, of Strasbourg, France, NEC Corp., of Tokyo, and Bostongene Corp., of Waltham, Mass., said they are collaborating on two ongoing phase I trials of TG-4050, an individualized therapeutic vaccine for ovarian and head and neck cancers based on Transgene’s Myvac platform and NEC’s AI-driven Neoantigen Prediction System in Europe and the U.S. As part of the collaboration, Bostongene will conduct genomic and transcriptomic analyses of primary patient tumors collected from patients enrolled in those two clinical trials to identify predictors of response to TG-4050 and the cancer cell-intrinsic and -extrinsic factors that may mediate each patient’s response to the vaccine.