KRT18

GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced today the details of its poster presentation at the Vaccines Summit 2022, being held from October 11-13 in Washington D.C. Bio-Thera will present research and preclinical results of a highly thermal stable recombinant bivalent nanoparticle vaccine containing spikes of SARS-CoV-2 Omicron and Delta, showing high immunogenicity and potentially offering broad cross-protection against ever evolving Covid-19 variants. Preclinical studies showed that the candidate vaccine was highly immunogenic in both mice and rats, could elicit robust broadly cross-reactive neutralizing antibodies against all major SARS-Cov-2 variants. The candidate vaccine protected all the K18-hACE2 transgenic mice challenged with lethal dose of Omicron variant from body weight loss and death, with undetectable live virus in their lung tissues. This vaccine candidate leverages the self-assembled stable nanoparticles, is formulated with Bio-Thera’s proprietary formulation platform, and is highly stable across a broad range of temperature from freezing to over 40-degree Celsius. This vaccine candidate thus could be a valuable strategy for vaccination against the ever-changing SARS-CoV-2, especially for the remote and low-income regions in the globe. Details of the presentation are as follows: Presentation Title: Highly Thermal Stable Recombinant Bivalent Nanoparticle Vaccine Containing Spikes of SARS-CoV-2 Omicron and Delta Shows High Immunogenicity and Potentially Offers Broad Cross-Protection Session Title: Poster presentation session Session Date and Time: Tuesday, October 11, from 6:00 PM – 7:00 PM EDT Location: Sheraton Reston Hotel, 11810 Sunrise Valley Dr, Reston, VA 20191 at Foyer area Poster Board Number: P-011 About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and has two approved products, QLETLI® and POBEVCY® in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on immuno-oncology, ADC targeted therapies, autoimmune diseases, and other severe and emerging unmet medical needs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to the aforementioned vaccine candidate or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.

The growing incidence of a potentially cancer-causing liver disease in children is associated with prenatal exposure to several endocrine-disrupting chemicals, researchers report. The growing incidence of a potentially cancer-causing liver disease in children is associated with prenatal exposure to several endocrine-disrupting chemicals, Mount Sinai researchers report. It is the first comprehensive study on the association of prenatal exposure and mixtures of these chemicals and non-alcoholic fatty liver disease. The researchers used cytokeratin-18 as a novel marker for the disease in children. The findings, reported in JAMA Network Open in July, underline the importance of understanding prenatal exposure to environmental chemicals as a risk factor for non-alcoholic fatty liver disease, which is a rapidly growing issue in children that can lead to severe chronic liver disease and liver cancer in adulthood. "These findings can inform more efficient early-life prevention and intervention strategies to address the current non-alcoholic fatty liver disease epidemic," said Vishal Midya, PhD, first author and postdoctoral researcher in the Department of Environmental Medicine and Public Health and a member of the Mount Sinai Institute for Exposomic Research at the Icahn School of Medicine at Mount Sinai. Damaskini Valvi, MD, PhD, MPH, senior author, Assistant Professor of Environmental Medicine and Public Health, and a member of the Mount Sinai Institute for Exposomic Research at Icahn Mount Sinai, added, "We are all daily exposed to these chemicals through the food we eat, the water we drink, and the use of consumer products. This is a serious public health problem. These findings show that early life exposure to many endocrine-disrupting chemicals is a risk factor for pediatric non-alcoholic fatty liver disease, and draw attention for additional investigation needed to elucidate how environmental chemical exposures may interact with genetic and lifestyle factors in the pathogenesis of liver disease." Non-alcoholic fatty liver disease is one of the most common liver diseases worldwide and is increasingly diagnosed in childhood -- affecting 6 percent to 10 percent of the general pediatric population and approximately 34 percent of children with obesity. Endocrine-disrupting chemicals are a wide class of environmental pollutants that include several pesticides, plastics, flame retardants, and toxic metals. Examples include perfluoroalkyl substances (PFAS), also known as "forever chemicals" used in nonstick cookware and food packaging, and polybrominated diphenyl ethers (PBDEs) used as flame retardants in furniture and infant products. Endocrine-disrupting chemicals interfere with hormone and metabolic systems in people. Several experimental studies have shown that exposures to these chemicals can lead to liver injury and non-alcoholic fatty liver disease; however, until now, the potential effects of prenatal mixture exposures to these chemicals have not been studied in humans. In this study, researchers measured 45 chemicals in the blood or urine of 1,108 pregnant women from 2003 to 2010. The chemicals included endocrine-disrupting chemicals such as PFAS, organochlorine and organophosphate pesticides, plasticizers (phenols, phthalates), PBDEs, and parabens. When the children reached the ages of 6 to 11 years old, scientists measured the levels of enzymes and cytokeratin-18 that indicate risk for liver disease in the children's blood, finding elevated levels of those biomarkers in children who had been more highly exposed to environmental chemicals during pregnancy. "By understanding the environmental factors that accelerate fatty liver disease, we can reduce people's risk by giving them actionable information to make informed choices that reduce the risk or impact of the disease," said Robert Wright, MD, MPH, Ethel H. Wise Chair of the Department of Environmental Medicine and Public Health and Co-Director of the Institute for Exposomic Research at Icahn Mount Sinai. "Exposomics is the wave of the future because once you've sequenced the human genome, which has been done, there isn't much more you can do in genomics alone. The missing piece of the puzzle for us to understand different diseases is to measure their environmental causes, and exposomics is a way to accelerate our knowledge of how the environment is affecting our health." The study participants were enrolled in the Human Early-Life Exposome project, a collaborative network of six ongoing population-based prospective birth cohort studies from six European countries -- France, Greece, Lithuania, Norway, Spain, and Britain. Limitations of this study include the inability to conduct a liver biopsy, considered the gold-standard to establish a causal link with non-alcoholic fatty liver disease, because of the risk and ethical limitations due to the children's age. This research was funded by the National Institute of Environmental Health Science (NIEHS) and the European Community's Seventh Framework Programme.