Abbvie Inc., of North Chicago, joined the Dementia Consortium, a global early stage drug discovery collaboration that previously included MRC Technology; Alzheimer's Research UK; Astex Pharmaceuticals, a unit of Otsuka Pharmaceutical Co. Ltd., of Tokyo; Eisai Inc., of Woodcliff Lake, N.J.; and Eli Lilly and Co., of Indianapolis. (See BioWorld Today, Dec. 11, 2013.)
Argen-x NV, of Breda, the Netherlands, opened three clinical trial sites in South Korea for the recruitment of MET-amplified cancer patients for the phase I safety expansion cohort of the experiment with ARGX-111, described as a MET-targeting human monoclonal "Simple Antibody" from the firm's platform that modulates all known mechanisms of action of the receptor.
Daiichi Sankyo Co. Ltd., of Tokyo, was the subject of an $8.2 million monetary settlement plus court-ordered hiring reforms as a result of a civil-rights lawsuit by the San Francisco law firm of Sanford Heisler Kimpel LLP. The nearly 1,600 female plaintiffs were represented in the class action by the law firm's chairman David Sanford, San Francisco managing partner Felicia Medina and associates Yonina Alexander and Danielle Fuschetti. According to the complaint, Daiichi Sankyo historically paid its female sales employees less than male employees for doing the same work; promoted or advanced female sales employees at slower rates than male sales employees and treated pregnant employees and working mothers of young children adversely compared to non-pregnant employees, male employees, or non-caregivers. Plaintiff Sara Wellens and five other named plaintiffs filed the complaint on behalf of female sales professionals at the company in 2013.
Dilaforette AB, of Stockholm, signed a collaboration agreement with Manama, Bahrain-based Arabian Gulf University (AGU) for a phase II proof-of-concept trial of sevuparin in patients with sickle cell disease experiencing acute vaso-occlusive crisis. AGU will provide up to $1.2 million in nondilutive funding for the study and will assist with patient recruitment in return for royalties on future product revenues, capped at twice the financial support provided to the randomized phase II study, which is enrolling patients at sites in the Middle East and Europe. Results are expected in the second half of the year.
Eisai Ltd., of Hatfield, U.K., and Charles River Laboratories International Inc., of Wilmington, Mass., said they signed a collaboration agreement, which will involve Charles River supporting Eisai scientists from Japan, the U.S. and the U.K. on a range of synthetic and medicinal chemistry projects, including those seeking treatments for neurological diseases. Scientists from Charles River will also participate in a medicinal chemistry project to discover new antimalarial drugs with activity against drug-resistant strains of disease. This work is in collaboration with the Global Health Innovative Technology Fund and Medicines for Malaria Venture, and builds upon earlier research by Eisai, which has focused on malaria and neglected diseases to improve access to medicines in developing countries.
Glaxosmithkline plc, of London, said its majority-owned HIV company, Viiv Healthcare, completed two transactions to acquire late-stage HIV R&D assets and a portfolio of preclinical and discovery-stage HIV research assets from New York-based Bristol-Myers Squibb Co. Viiv's other shareholders include New York-based Pfizer Inc. and Shionogi Co. Ltd., of Osaka, Japan. (See BioWorld Today, Dec. 21, 2015.)
Helsinn Group, of Lugano, Switzerland, said it entered distribution, license and supply agreements with Mundipharma International Corp. Ltd., of Singapore, and its network of independent associated companies granting exclusive rights to anamorelin in Norway, Finland, Sweden, Denmark and Iceland. Under the terms of the new agreements, Helsinn retains all development rights as well as regulatory and clinical development activities in those countries and the supply of anamorelin to Mundipharma for commercial use. Anamorelin is a once-daily, orally active ghrelin receptor agonist in development for the treatment of cancer anorexia-cachexia in patients suffering from non-small-cell lung cancer.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., said that preclinical testing of its synthetic vaccine for the Zika virus induced robust and durable immune responses and resulted in seroconversion in all vaccinated mice, demonstrating the potential for a Syncon vaccine to prevent and treat infections from the pathogen. Inovio is developing its Zika vaccine with Geneone Life Science Inc., of Seoul, South Korea, and academic collaborators, with plans to initiate a phase I study by year-end. (See BioWorld Today, Jan. 25, 2016.)
JHL Biotech Inc., of Hsinchu, Taiwan, said it received authorization from the U.K.'s Medicines and Healthcare Products Regulatory Agency to begin a clinical trial for JHL1101, a rituximab biosimilar developed and manufactured by its Taiwanese subsidiary to treat rheumatoid arthritis (RA). JHL said it is the first company from the Greater China region to receive European approval for clinical trial of a monoclonal antibody biosimilar. The randomized, double-blind, multinational phase I trial will compare the similarity of JHL1101 with its reference product, Basel, Switzerland-based Roche AG's Mabthera. About 150 patients with severe RA will participate in the study, enrollment of which is beginning this year. (See BioWorld Today, May 13, 2015.)
Living Cell Technologies Ltd., of Auckland, New Zealand, has completed the placement of 54.6 million shares at $0.05063 raising $2.76 million. These funds will be used as working capital to carry out a phase IIb trial of their lead product Ntcell in Parkinson's disease and to apply for provisional consent to treat paying patients in New Zealand in 2017. The company is also announcing a share purchase plan to give eligible LCT shareholders the opportunity to further participate in the success of the company.
Middle East respiratory syndrome coronavirus (MERS-CoV) has been chased from the headlines by other viruses, but with a fatality rate of around 30 percent and the potential ability to spread from person to person, it remains a threat to global heath in the eyes of the World Health Organization. Now, researchers from the Navy Medical Research Center have reported using transchromosomal cows to generate polyclonal antibodies that could rapidly reduce the viral load in the lungs of MERS-CoV-infected mice. Passive immunization with polyclonal antibodies is one strategy against emerging infectious diseases, but getting sufficient amounts of antibodies to treat as necessary can be a challenge, as sufficient numbers of human volunteers can be hard to find and animal antibodies can lead to severe immune reactions, especially with repeated administration. In their work, the authors used cows that are genetically engineered to produce fully human antibodies, and vaccinated them with two different vaccinations against MERS-CoV. Antibodies purified from their sera rapidly reduced viral levels in mice, even if they were administered up to two days after infection. The authors concluded that although more extensive safety studies are necessary, their cows, which can produce up to a pound of antibody per month each, "potentially offer a platform to rapidly produce a therapeutic to prevent and/or treat MERS-CoV infection and/or other emerging infectious diseases." The findings appeared in the Feb. 17, 2016, issue of Science Translational Medicine.
OBI Pharma Inc., of Taipei, Taiwan, reported top-line results from the phase II/III study of immunotherapy candidate OBI-822/821 (formerly OPT822/OPT821) in patients with metastatic breast cancer, with data available to date showing the trial did not meet the primary efficacy end point of progression-free survival (PFS). However, the company said patients who demonstrated an immune response (IgG or IgM) showed highly significant improvement in PFS and the secondary endpoint of overall survival is trending toward statistical significance. OBI plans to use those data to develop a phase III study. OBI-822/821, a synthetic glycoprotein comprising tumor-associated carbohydrate Globo H covalent-bonded to carrier protein KLH, was generally well tolerated with no major safety concerns.
Rockwell Medical Inc., of Wixom, Mich., said it signed exclusive licensing and manufacturing supply agreements with Wanbang Biopharmaceutical Co. Ltd., a subsidiary of China's Shanghai Fosun Pharmaceutical (Group) Co. Ltd., for the rights to commercialize Rockwell's end-stage renal disease products Triferic (soluble ferric pyrophosphate) for anemia and Calcitriol (active form of vitamin D) for secondary hyperparathyroidism in dialysis patients. Under the terms, Wanbang becomes the exclusive distributor in China for an initial term of 10 years in exchange for an up-front fee plus regulatory and revenue milestone payments totaling $39 million. Wanbang is required to achieve annual minimum purchase requirements to retain exclusive commercialization rights. It also has exclusive rights to develop and commercialize Triferic for new therapeutic indications in the Chinese market.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said Health Canada accepted the new drug submission for ixazomib for priority review. The application seeks approval of the oral proteasome inhibitor for patients with relapsed and/or refractory multiple myeloma.
There is clear evidence that the microbiome influences the risk of colorectal cancer, and probiotics and the anti-inflammatory effects they mediate can lower the risk. However, less is known about whether the gut microbiome also affects the risk of cancers in locations outside of the gut. Now, researchers from the University of Hong Kong have shown that probiotics influenced the course of liver cancer in mice. The authors showed that preventive treatment with a commercial probiotic mixture reduced the growth of hepatocellular carcinomas by roughly 40 percent. "Our results revealed that the probiotics' beneficial effect is closely related with the abundance of certain beneficial bacteria that produce anti-inflammatory metabolites, which subsequently regulate the pro-inflammatory immune cell population via the crosstalk between gut and tumor. We believe that our study highlights the extraordinary potential of probiotics in extraintestine cancers and can be adapted to the study of other cancers." They published their study in the Feb. 15, 2016, online issue of the Proceedings of the National Academy of Sciences.
Scientists from the University of Melbourne and Monash University, both in Australia, have shown that the mosquito Aedes aegypti could be infected with two strains of Wolbachia parasite, and that doubly infected mosquitoes could outcompete single strain-infected animals in the field. Though they are not a natural host, A. aegypti can be infected with genetically engineered Wolbachia strains, and such infections make them resistant to dengue virus, and other viruses such as Zika virus. Resistance, however, is as much of a concern as it is with any anti-infective strategy. In their experiments, the authors showed that A. aegypti mosquitoes already infected with one Wolbachia strain could be infected with a second, and that such a superinfection could spread among a mosquito population. "This represents a potential mechanism for resistance management in regions where single infections have already been deployed," the authors concluded. Their work appeared in the Feb. 18, 2016, issue of PLoS Pathogens.