The Durham, N.C.-based Antibacterial Resistance Leadership Group, a research network for which the Duke Clinical Research Institute acts as a coordinating center, received a federal award worth up to $102.5 million over seven years. The funds will support its mission to prioritize, design, and execute clinical research to reduce the public health threat of antibacterial resistance.
Bavarian Nordic A/S, of Copenhagen, has received antitrust clearance in the U.S., Spain and Portugal of its planned acquisition from Glaxosmithkline plc of two commercial vaccines, Rabipur/RabAvert and Encepur for rabies and tick-borne encephalitis, in return for €301 million (US$336 million) up front and up to €495 million in milestones. The two products are forecast to attain combined revenues of €175 million this year. With these clearances, and the recent approval from the company’s shareholders of a rights issue to fund part of the acquisition, the transaction will now proceed toward closing, expected to occur by the end of the year.
Bioaegis Therapeutics Inc., of Morristown, N.J., reported the publication, in F1000Research, of new research findings with recombinant human plasma gelsolin in influenza that demonstrates that the therapy dramatically improves survival in a highly lethal influenza animal model. Studies conducted in collaboration with investigators at the Harvard T.H. Chan School of Public Health demonstrated clinical improvement in mice infected with lethal doses of influenza when administering gelsolin after a clinically relevant delay. The current FDA-approved antivirals target the flu virus, but do not address the severe later stage morbidity and mortality that that are the focus of plasma gelsolin (rhu-pGSN) therapy, the company noted.
Effepharm Co. Ltd., of Shanghai, said it acquired two biopharmaceutical companies, Dendrimer Co. and Folvo Co., that have enhanced its R&D capability in anti-aging and energy metabolism. In addition, the company plans to augment its R&D resources with a $5 million investment in a R&D center in the G60 science and innovation corridor in Shanghai.
Equillium Inc., of La Jolla, Calif., and Biocon Ltd., of Bengaluru, India, said they have expanded their collaboration and license agreement for itolizumab, a first-in-class humanized anti-CD6 monoclonal antibody, which Biocon developed and launched in India, under the brand name Alzumab, to treat moderate to severe plaque psoriasis in 2013. Equillium now receives the exclusive rights for developing and commercializing the drug in Australia and New Zealand as well as the U.S. and Canada markets covered by a 2017 agreement between the companies. Equillium is conducting phase Ib proof-of-concept trials of itolizumab for the treatment of acute graft-versus-host disease and lupus nephritis.
Horizon Discovery Group plc, of Cambridge, U.K., said it entered a strategic collaboration with Mammoth Biosciences Inc., of South San Francisco, to develop new CRISPR tools to provide the next generation of engineered cell lines. They will collaborate to identify and optimize the company’s novel proteins for use under license by Horizon that will have exclusive rights to use this approach to bioproduction and will also be able to sublicense it to partners intent on modifying their own proprietary cell lines. Horizon will pay an undisclosed consideration and issue warrants to Mammoth for the exclusive rights being licensed. The warrants will be issued within 30 days and will give Mammoth the right to subscribe for ordinary shares in Horizon equivalent to 0.5% of the issued share capital of the company.
In a phase I/II clinical trial slated to begin early next year, Iteos Therapeutics SA, of Gosselies, Belgium, and MSD, a subsidiary of Kenilworth, N.J.’s Merck & Co., will evaluate the safety and efficacy of EOS-100850, Iteos’ non-brain penetrant A2A receptor antagonist, combined with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for patients with solid tumors. EOS-100850, Iteos’ lead compound, is currently in a phase I/Ib study as a monotherapy. There is a growing pile of preclinical evidence, and a recent trickle of clinical data, indicating the anti-inflammatory effects of adenosine are critical to tumor immunosuppression and that this is a potential cause of resistance to anti-PD-1 and anti-PD-L1 immune checkpoint inhibitors.
Matinas Biopharma Holdings Inc., of Bedminster, N.J., entered a feasibility evaluation with Genentech Inc. to develop oral formulations using Matinas’ lipid nanocrystal platform for designing intracellular drug delivery. No financial details were disclosed. Matinas’ lead candidate, MAT-9001, an omega-3 fatty acid-based composition, is being developed to treat hypertriglyceridemia.
Mölnlycke Health Care AB, of Gothenburg, Sweden, said that a controlled evaluation of 100 U.K. National Health Service patients demonstrated savings in chronic wound care costs with the use of the hemoglobin-based topical oxygen therapy spray, Granulox, a product it added to its portfolio with its 2018 acquisition of the German wound care products company Sastomed GmbH.
Oncolytics Biotech Inc., of San Diego, regained Nasdaq compliance by resolving the company’s minimum bid price deficiency. On Sept. 17, Nasdaq told Oncolytics it was out of compliance because the company’s stock (NASDAQ:ONCY) hadn’t hit the closing bid price of $1 or more for 30 consecutive business days. To resolve the issue, Oncolytics maintained the minimum closing bid price of $1 or more for at least 10 consecutive days. Oncolytics is developing pelareorep, an intravenously delivered immune-oncolytic virus for treating cancers.
Opiant Pharmaceuticals Inc., of Santa Monica, Calif., was awarded $2.4 million from the HHS’s Biomedical Advanced Research and Development Authority to develop OPNT-003 (nasal nalmefene), an opioid antagonist for treating opioid overdose. The funding is the second half of the authority’s original award payment. Opiant plans to submit an NDA for OPNT-003 and its intranasal delivery device combination in the fourth quarter of 2020.
Sanbio Co. Ltd., of Tokyo, and Osaka’s Sumitomo Dainippon Pharma Co. severed their joint development of SB-623, a regenerative cell medicine for treating chronic stroke, in the U.S. and Canada. The two also terminated the joint development and license agreement between Sanbio’s U.S. subsidiary, Sanbio Inc., and Sumitomo created in 2014. SB-623’s North American rights return to the Sanbio Group, which includes Sanbio and Sanbio Inc. There will be no payment or receipt of development cooperation fees or monetary remittance at milestones or otherwise between the two companies.
Theranexus SAS, of Lyon, France, received the worldwide exclusive license to develop and commercialize the Beyond Batten Disease Foundation’s BBDF-101 for treating Batten disease, a rare, fatal, inherited pediatric CNS disorder. Theranexus will pay fixed sums on signing, approval, and achievement of commercial objectives post-approval. The agreement provides for royalty payments based on net sales once BBDF-101 is marketed by Theranexus. A clinical trial assessing safety and pharmacokinetics begins in 2020.
New results from preclinical in vitro and in vivo experiments by Montreal’s Theratechnologies Inc. show that TH-1902 (docetaxel conjugated to the company’s investigational peptide TH-19P01) for treating triple-negative breast cancer (TNBC) improves efficacy and tolerability compared to docetaxel alone. The data show a sustained inhibition of TNBC tumor growth in mice treated with TH-1902 when using equimolar doses of TH-1902 and docetaxel. The study also found a significantly improved efficacy over a full dose of docetaxel, even with the conjugate administered at a quarter of the dose of docetaxel. Theratechnologies plans to begin a phase I trial of TH-1902 for treating TNBC in 2020.
Vertex Pharmaceuticals Inc., of Boston, negotiated an agreement with the Health Service Executive in the Republic of Ireland to expand the existing long-term cystic fibrosis reimbursement agreement to include the triple combination regimen (elexacaftor, tezacaftor and ivacaftor), which is under review and pending approval by the EMA, for all eligible patients ages 12 and older in line with the potential future licensed indication. Vertex submitted an MAA for the triplet on Oct. 31.