Amarillo Biosciences Inc., of Amarillo, Texas, said its China licensing partner, Xiamen Weiyang Pharmaceutical Co. Ltd., began initiating the sharing of proprietary clinical research information with health officials in China to potentially explore the effect of ABI’s low-dose oral interferon in combating the spread of the COVID-19 coronavirus, along with other related viral indications such as influenza. Xiamen Weiyang will focus on seeking appropriate regulatory channels in which to either fast track formalized clinical research trials for low-dose oral IFN-α, or at the very least expedite the development process with Chinese health authorities to pave the way for proactive studies in preparation of future similar viral outbreaks. Xiamen Weiyang will work in conjunction with ABI’s subsidiary branch office in Taiwan.
Aptorum Group Ltd., of Hong Kong, reported further positive data from its current IND-enabling studies for ALS-4, a small-molecule candidate indicated for the treatment of infections caused by Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus, based on a novel antivirulence nonbactericidal approach. Subject to completion of the current studies, Aptorum is planning to submit an IND for ALS-4 in the second half of this year and start a phase I trial. ALS-4 inhibits dehydrosqualene desaturase of S. aureus, an enzyme that is critically involved in the biosynthesis of staphyloxanthin, believed to be primarily responsible for the bacteria's defense mechanism against the attack from reactive oxygen species deployed by phagocytic cells and neutrophils.
CNS Pharmaceuticals Inc., of Houston, and Vancouver, British Columbia’s WPD Pharmaceuticals Inc. are collaborating on a phase I trial for treating brain cancer with CNS’ chemotherapy candidate, berubicin. The study, to be conducted at Children’s Memorial Health Institute in Warsaw, Poland, is an investigation of an anthracycline, berubicin, and topoisomerase II inhibitor for treating pediatric brain tumors. In a $2 million deal last November, CNS granted berubicin-related patent rights to WPD in Eastern Europe and Central Asia.
Codagenix Inc., of Farmingdale, N.Y., said it will collaborate with the Serum Institute of India to rapidly co-develop a live-attenuated vaccine against the emergent coronavirus COVID-19. Codagenix said its technology allows for the rapid generation of multiple vaccine candidates against emerging viruses, starting with only the digital sequence of the viral genome. It has already designed multiple nCoV vaccine candidate genomes using its deoptimization technology. The vaccine viruses will then be grown and tested in vivo by contracted laboratories suitable for containment, prior to testing in clinical trials. The Serum Institute of India, a vaccine manufacturer, will then scale-up the manufacture of the vaccine. The two parties said they are pursuing an accelerated development pathway with built-in redundancies to increase speed and likelihood of success.
Cytodyn Inc., of Vancouver, Wash., signed a letter of intent with Long Jian International Group, of Hong Kong, to develop and license leronlimab in China. The companies plan to explore opportunities to test the monoclonal antibody targeting the CCR5 receptor as a treatment for the COVID-19 coronavirus and cancer.
Dr. Reddy’s Laboratories Ltd., of Hyderabad, India, is acquiring divisions selling branded generics in India, Nepal, Sri Lanka, Bhutan and Maldives from Wockhardt Ltd., of Mumbai, India, for Rs1,850 crore (US$259 million). Through the deal, which is expected to close during the first quarter of the fiscal 2020-2021 year, Dr. Reddy's will get 62 brands, as well as a manufacturing plant in Baddi, India.
Investigators at Jianjin University Haihe Hospital have discovered that autophagy played a role in the regeneration of alveolar epithelial cells after lung injury. Autophagy is a general cellular response to nutrient stress, and it is thought to promote cellular health by breaking down misfolded or damaged proteins, prompting the authors to investigate its effects in lung repair. They showed that in response to lung injury, autophagy furthered a switch from lipid to glucose metabolism, enabling the proliferation of alveolar epithelial cells and tissue repair. “Autophagy switches lipid metabolism to glucose metabolism to secure epithelial regeneration after injury,” the authors wrote. “Our results elucidate an important link between autophagy, metabolism, and alveolar progenitor cell function, and could provide a clue to better understand lung homeostasis and injury repair.” They reported their findings in the Feb. 11, 2020, issue of Stem Cell Reports.
Johnson & Johnson, of New Brunswick, N.J., is collaborating with the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine against the COVID-19 coronavirus. BARDA will provide funding of a vaccine candidate into phase I studies and have the option for additional funding. J&J's Janssen Pharmaceutical Co. unit will upscale production and manufacturing capacities to meet public health needs.
Luye Pharma Group, of Hong Kong, signed an exclusive distribution and marketing service agreement with a subsidiary of Cipla Ltd., of Mumbai, India, for Seroquel (quetiapine fumarate, immediate-release) and Seroquel XR (extended-release formulation) in South Africa, Namibia and Botswana. The drugs are atypical antipsychotic medicines with antidepressant properties. The main indications for Seroquel are the treatment of schizophrenia and bipolar disorder. Seroquel XR is also approved in some markets for major depressive disorder and generalized anxiety disorder. Terms were not disclosed.
M8 Pharmaceuticals Inc., of Berwin, Pa., and Daewoong Pharmaceutical Co. Ltd., of Hwaseong, South Korea, signed an exclusive licensing agreement whereby M8 will have the rights to commercialize and promote Fexuprazan in the Mexican market. The new drug is described a potassium-competitive acid blocker, in the class regarded as the next-generation treatments to replace proton pump inhibitors, often used for gastroesophageal reflux disease. Terms were not disclosed.
Researchers at Monash University have demonstrated that although neutrophils were recruited to the site of skin penetration during hookworm infection, the worms were able to degrade the neutrophil extracellular traps (NETs) that are one of neutrophils’ major weapons against invaders. NETs are made of DNA and histones, and neutrophils use them to entrap pathogens that are too large to be eaten. The authors demonstrated that in mice, hookworm larvae secreted the DNA-degrading enzyme Nb-DNAse II, which destroyed the backbone of the NETs. In vitro, neutrophils were better able to kill worms in the presence of an Nb-DNAse II inhibitor. “Homologs of Nb-DNase II are present in other [worms], including the human hookworm, Necator americanus, which also evaded NETs in vitro,” the authors noted. “These findings highlight the importance of neutrophils in hookworm infection and a potential conserved mechanism of immune evasion.” Their work appeared in the Feb. 12, 2020, issue of Cell Host & Microbe.
Recce Pharmaceuticals Ltd., of Sydney, disclosed positive efficacy data in a rat infection model for its Recce-327 antibiotic in the treatment of kidney and urinary tract infections caused by Escherichia coli, which often progresses to sepsis. The new data demonstrate the potential of the treatment in new indications to form part of a broader anti-infective treatment model in pre-sepsis. The findings also expand Recce-327’s patent protection and claims, the company noted.
Synergy Pharmaceuticals Inc., of New South Wales, Australia, performed a study that investigated a new approach to breaking down the herpes viral envelope by employing specific T cells generated through an amino-acid formula. The treatment consisted of five immunotherapeutic core compounds (5CC) comprising rhodiola, tribulus, astragalus, lysine and a proprietary mix of amino acids. The 5CCs are effective inhibitors of herpes viral DNA synthesis and interferon-induced cellular antiviral response and were found to neutralize antiviral reproduction by blocking cell-to-cell infection, the company said. The study was able to validate that for some participants there was a noted progression from a positive antibody serology to a negative one. This was the first time evidence has documented a cure for the herpes simplex virus, Synergy said.
Vir Biotechnology Inc., of San Francisco, has identified two monoclonal antibodies that bind to SARS-CoV-2 (previously known as 2019-nCoV), which were originally found because they bind and neutralize the original SARS-CoV. The antibodies target the SARS-CoV-2 spike protein in the region that the virus uses to enter cells through the cellular receptor ACE2. Infection with SARS-CoV-2 causes the newly named disease, COVID-19, or the coronavirus.