Abbvie Inc., of North Chicago, and Allergan plc, of Dublin, said they signed a consent decree with the FTC related to Abbvie's pending acquisition of Allergan. The companies agreed to divest brazikumab, an IL-23 inhibitor in development to treat autoimmune diseases, to Astrazeneca plc, of Cambridge, U.K., and Zenpep (pancrelipase replacement therapy), an approved treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, to Nestle SA, of Vevey, Switzerland, which also is set to acquire the pancreatic enzyme preparation Viokace (pancrelipase) as part of the transaction. The deals are expected to close in May 2020, subject to the FTC’s additional review and approval of the consent decree.
The Cystic Fibrosis Foundation said it awarded up to $5 million in research funding to Armata Pharmaceuticals Inc., of Marina Del Rey, Calif., to conduct a phase Ib/II trial to test the safety and tolerability of bacteriophage in Pseudomonas aeruginosa infections in individuals with cystic fibrosis (CF). The foundation said the randomized, controlled trial will become the first in the U.S. to study phage in CF outside the FDA’s emergency IND process.
Arrowhead Pharmaceuticals Inc., of Pasadena, Calif., said it adopted precautionary measures involving ongoing studies of its drug candidates but does not expect a material effect on projected development timelines. Participants enrolled in the phase II/III Sequoia (AROAAT2001) or phase II AROAAT2002 studies of the RNAi-based liver-targeted therapeutic, ARO-AAT, to treat alpha-1 liver disease will continue on study per protocol. Home health care visits, where available, and other options, along with use of local laboratories, as needed, are expected to facilitate compliance with the schedule of study assessments. Based on CDC recommendations to avoid the risk of exposure to COVID-19, Arrowhead is pausing new patient screening in those studies for at least four weeks but continues to complete the startup process at additional clinical sites.
Asklepios Biopharmaceutical Inc., of Research Triangle Park, N.C., said it formed a research collaboration and licensing agreement with the University of North Carolina (UNC) at Chapel Hill to develop and commercialize a gene therapy for Angelman syndrome based on preclinical findings from a UNC School of Medicine team. Additional details and financial terms were not disclosed.
Axim Biotech Inc., of New York, said it completed the acquisition of Sapphire Biotech Inc., which it is operating as a wholly owned subsidiary. Sapphire is focused on developing therapeutics to inhibit cancer growth and metastasis and is developing a line of diagnostics products.
Cannabics Pharmaceuticals Inc., of Bethesda, Md., said it offered its high-throughput screening facility to assist efforts in Israel to conduct research on the SARS-CoV-2 virus, including the establishment and operation of a diagnostic platform and the screening of libraries of potentially relevant compounds, such as cannabinoids, combinations of FDA antiviral approved drugs and natural products. Financial terms were not disclosed.
Yissum, the technology transfer company of The Hebrew University of Jerusalem, said it formed a strategic collaboration with Cytovia Therapeutics Inc., of New York, to develop precision medicines for blood cancers and solid tumors. Cytovia will sponsor a research program to develop multispecific antibodies targeting both natural killer (NK) cells and tumor antigen. The research will be led by Ofer Mandelboim, a professor in the Lautenberg Center for Immunology and Cancer Research at Hebrew University’s Faculty of Medicine, whose team previously showed that the NK activating receptor, NKp46, influences FN1 expression by tumors, ultimately affecting their metastatic ability. Financial terms were not disclosed.
Eusa Pharma Inc., of Hemel Hempstead, U.K., started an observational case-control study of siltuximab, an interleukin-6-targeted monoclonal antibody, in patients with COVID-19 who have developed serious respiratory complications. The study will test hospitalized patients prior to admission to an intensive care unit as well as patients already requiring intensive care. Ergomed plc, of Guildford, U.K., will provide clinical research services for the study at the Papa Giovanni XXIII Hospital in Bergamo, Italy.
Fujifilm Corp., of Tokyo plans to invest approximately ¥9 billion (US$83 million) to expand the microbial production capacity of Fujifilm Diosynth Biotechnologies' U.K. site. The expansion, which is scheduled to be operational after 2022, will triple the production capacity at the site.
Geovax Labs Inc., of Atlanta, which is using its GV-MVA-VLP vaccine platform to design and construct vaccine candidates using genetic sequences from the virus responsible for the ongoing COVID-19 outbreak, said it has designed, constructed and conducted in vitro characterization on three candidates, which it will now narrow down to one based on safety, immunogenicity and protective efficacy in upcoming animal studies. The final candidate will proceed to manufacturing and initial human testing, the company said.
Horama SA, of Paris, licensed the global rights to HORA-001, a gene therapy program for inherited retinal dystrophy associated with CRB1 gene mutations, from the Leiden University Medical Center. Horama will pay an undisclosed up-front payment, milestone payments and royalties on net sales of the therapy. A phase I/II study is planned for 2023.
Ibio Inc., of New York, has created SARS-CoV-2 Virus-Like Particle as a vaccine for preventing infection from the SARS-CoV-2 virus that causes COVID-19. The company has filed four provisional patent applications with the U.S. Patent and Trademark Office.
Ideaya Biosciences Inc., of South San Francisco, and Pfizer Inc., of New York, are collaborating to test Ideaya's protein kinase C inhibitor, IDE-196, with Pfizer's MEK inhibitor, binimetinib, in patients with solid tumors that harbor GNAQ or GNA11 hotspot mutations. The study, which will be sponsored by Ideaya, is scheduled to start in mid-2020.
IMV Inc., of Dartmouth, Nova Scotia, is developing a vaccine candidate to prevent COVID-19 using its PDX platform, a lipid-based delivery platform.
Mateon Therapeutics Inc., of Agoura Hills, Calif., said an independent laboratory found its TGF-beta antisense drug, OT-101, had a 50% effective concentration of 7.6 µg/mL in an in vitro antiviral assay. The company plans to talk with the FDA about clinical testing as soon as preclinical work is completed.
Newlink Genetics Corp., of Ames, Iowa, and Lumos Pharma Inc., of Austin, Texas, will complete their merger shortly. An overwhelming majority of Newlink Genetics’ stockholders voted to approve the issuance of shares in connection with the merger. The new company will assume the Lumos Pharma Inc. name and trade on Nasdaq under the ticker LUMO.
Oxford Biomedica plc, of Oxford, U.K., signed a license and clinical supply agreement with Juno Therapeutics, a unit of New York-based Bristol Myers Squibb Co. The agreement gives Juno a nonexclusive license to Oxford Biomedica's Lentivector platform for Juno's application in CAR T and TCR-T programs in oncology and other indications. Oxford will supply the vector for five years, which may be extended further. Oxford will receive $10 million up front with the possibility of up to $86 million in development and regulatory milestones and up to $131 million in sales-based milestone payments, as well as an undisclosed royalty on net sales of products using the Lentivector platform.
Vaxart Inc., of South San Francisco, signed an agreement with Emergent Biosolutions Inc., of Gaithersburg, Md., for contract development and manufacturing services to help develop and manufacture Vaxart’s oral vaccine candidate to prevent COVID-19. Emergent will produce clinical material for a phase I trial scheduled to start early in the second half of 2020. Financial terms of the deal weren't disclosed.
Versatope Therapeutics Inc., of Lowell, Mass., selected VT-105 for clinical development as a universal influenza vaccine. The vaccine is based on the matrix-2 protein ion channel of the influenza virus.