The European Commission approved Dublin-based Allergan Inc.’s divestiture of brazikumab, an IL-23 inhibitor being developed to treat autoimmune diseases, to Cambridge, U.K.-based Astrazeneca plc. The commission’s approval of North Chicago, Ill.-based Abbvie Inc.’s acquisition of Allergan was conditional upon brazikumab’s sale. Brazikumab is in a phase IIb/III study of Crohn’s disease and a phase IIb trial in ulcerative colitis. While the FTC reviews the transaction, Abbvie and Allergan entered a timing agreement with FTC staff that could enable a decision during the second quarter of 2020. Closing the transaction is also subject to Irish High Court approval.
Astrazeneca plc, of Cambridge, U.K., will fund three National Comprehensive Cancer Network oncology research programs designed to improve health care provider performance and/or health care quality, focusing on enhancing patient care and outcomes for people with advanced non-small-cell lung cancer. Research begins in the third quarter of 2020 and continues for two years.
Avectas Ltd., of Dublin, and CCRM, a Canadian not-for-profit organization funded by the Canadian government, will collaborate to accelerate the translation of Avectas’ nonviral cell engineering platform to develop therapies for immune-oncology and gene editing. The platform can be used with mRNA, DNA and proteins, including gene-editing tools such as CRISPR.
Celldex Therapeutics Inc., of Hampton, N.J., said it expects to receive a $1.7 million payment related to a 2013 agreement with Rockefeller University to perform manufacturing and development services for the institution’s portfolio of broadly neutralizing antibodies, or bNAbs, against HIV, including clinical-stage candidates 3-BNC-117 and 10-1074. In January, Gilead Sciences Inc., of Foster City, Calif., licensed the portfolio from Rockefeller, entitling Celldex to the up-front payment along with potential development milestone payments and sales royalties.
Cytokinetics Inc., of South San Francisco, said preclinical data on selective cardiac troponin activator AMG-594, discovered under a joint research program with Amgen Inc., of Thousand Oaks, Calif., characterized its mechanism of action and effect to increase cardiac contractility. In vitro studies suggested that AMG-594 selectively increased the calcium sensitivity of the troponin complex in cardiac muscle. In bovine cardiac myofibrils, AMG-594 increased activation by calcium in a concentration-dependent manner. In experiments using a reconstituted hybrid sarcomere, the compound selectively targeted the cardiac troponin complex over the fast or slow skeletal muscle troponin complex and, in intact cardiac muscle fibers, AMG-594 increased calcium sensitivity and maximal isometric tension in a concentration-dependent manner. Additionally, in vivo studies suggested a pharmacodynamic window associated with increases in cardiac contractility. Echocardiographic assessments in healthy rats, myocardial infarcted rats and healthy dogs showed that an intravenous infusion of an escalating dose was associated with exposure-dependent increases in measures of fractional shortening and ejection fraction that were driven primarily by a reduction in left ventricular end systolic dimensions. The data were presented at the Keystone Symposium, Charting a New Course for Heart Failure: From Discovery to Data, in Keystone, Colo.
Cytoo SA, of Grenoble France, said it inked a research collaboration with Asklepios Biopharmaceutical Inc., of Research Triangle Park, N.C., aimed at selecting a gene therapy candidate for a rare muscle disorder. The companies plan to cooperate on development of an AAV-based screening platform derived from patient cells with the goal of screening and selecting a preclinical candidate capable of restoring a healthy phenotype from patient cells cultured in vitro. Financial terms were not disclosed.
Domain Therapeutics SA, of Strasbourg, France, said it acquired the shares of Prestwick Chemical SASU and Neurofit SAS, both former French subsidiaries of Bionomics Ltd., of Adelaide, Australia, to expand its programs targeting G protein-coupled receptors, or GPCRs, by enabling larger collaborations with pharma partners and supporting Domain’s asset-centric affiliates. Prestwick’s acquisition will double Domain’s medicinal chemistry resources, while Neurofit will continue to pursue service-based activities and supply Domain with an animal pharmacology platform for neurological diseases. By absorbing the liabilities of both units, Domain said the acquisition constituted an accounting neutral operation, without initial investment.
Heat Biologics Inc., of Durham, N.C., said it launched a program within wholly owned subsidiary Zolovax Inc. to develop a vaccine using its immune-activating gp96 platform to treat or prevent infection from the SARS-CoV-2 coronavirus, which causes COVID-19. The company also filed a corresponding provisional patent for use of its platform to target the coronavirus.
Iktos SAS, of Paris, and SRI International, of Menlo Park, Calif., said they entered a collaboration agreement designed to accelerate discovery and development of antiviral therapies. Under the collaboration, Iktos’ generative modeling technology will be combined with SRI’s Synfini, a fully automated end-to-end synthetic chemistry system, to design optimized compounds and accelerate the identification of drug candidates to treat multiple viruses, including influenza and the Wuhan coronavirus (COVID-19).
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., said it accelerated the timeline to develop its DNA vaccine, INO-4800, to address COVID-19. The company shared data from preclinical testing and small-scale manufacture with public and private partners and, in March 2020, plans to prepare 3,000 human trial doses. A first-in-human trial in 30 healthy volunteers is expected to begin in the U.S. in April, with additional trials to follow soon afterward in China and South Korea. Inovio said it plans to present or publish initial findings around the third quarter of 2020 and, by year-end, to manufacture 1 million doses of its INO-4800 COVID-19 DNA for additional trials or emergency use.
Mediwound Ltd., of Yavne, Israel, said the U.S. Biomedical Advanced Research and Development Authority (BARDA) expanded its contract with the company, providing supplemental funding of $5.5 million to support emergency readiness to deploy Nexobrid (bromelain gel) in a mass casualty situation. Under the modified contract, including the supplemental amount, BARDA will provide technical assistance and $82 million in total funding to advance Nexobrid toward FDA approval.
Nanosurface Biomedical Inc., of Seattle, said it received $1.9 million in new funding in 2019 from the NIH to support accelerated development of its human induced pluripotent stem cell (iPSC)-based platforms for drug discovery and safety screening. The funding announcement brings the total nondilutive Small Business Innovative Research funding Nanosurface has received from the NIH to $3.1 million. Funds will be used to develop Nanosurface’s iPSC platform for modeling and assessing human cardiac function on-a-chip.
Ocugen Inc., of Malvern, Pa., said Nature Gene Therapy published preclinical data on use of its NR2E3 gene stimulator, OCU-400 (NR2E3-AAV), as a genetic modifier and therapeutic agent to treat multiple retinal degenerative diseases. The publication detailed efficacy results in five mouse models of retinitis pigmentosa (RP) – rd1 (PDE6-beta-associated), Rho-/- and RhoP23H (Rhodopsin-associated), rd16 (Leber congenital amaurosis) and rd7 (enhanced S-cone syndrome) – following administration of the preclinical candidate by subretinal injection. Findings suggested that modifier gene therapy was sufficiently potent to elicit broad-spectrum therapeutic benefits in early and intermediate stages of RP.
Pluristem Therapeutics Inc., of Haifa, Israel, said it was notified that the U.S. Biomedical Advanced Research and Development Authority (BARDA) declined to fund a proposal the company submitted for a study seeking to show the superiority of PLX-R18 (PLX stem cell therapy) vs. current standard of care to treat acute radiation syndrome. Pluristem said the decision was based on BARDA’s technical considerations as well as strategic needs, availability of funds and resources and the goal of balancing the agency’s portfolio. On March 3, Pluristem’s shares (NASDAQ:PSTI) lost 36 cents, closing at $3.60.
Siga Technologies Inc., of New York, said it agreed to provide its oral antipoxviral drug, Tpoxx (tecovirimat), for use in the SKV vaccinia oncolytic immunotherapy platform in development by Turnstone Biologics Inc., of Toronto. The platform uses vaccinia viruses engineered for increased selectivity and safety along with high-potency immune stimulation and allows delivery of multiple therapeutic agents directly to tumors. Financial terms of the deal were not disclosed.
Xphyto Therapeutics Corp., of Vancouver, British Columbia, said its wholly owned German subsidiary, Vektor Pharma TF GmbH, plans to initiate R&D programs related to infectious disease, including COVID-19. The programs include an in vitro study of thin film delivery of cannabigerol and quercetin for potential antibacterial and antiviral treatments, respectively, and development of point-of-care sensor-film infectious disease detection products.