Vitamin E Deficiency

Obesity, due to its associated chronic, systemic inflammation, increases the risk for metabolic diseases, atherosclerosis, various malignant tumors, and numerous immune-mediated disorders.With weight loss, less inflammation is expected, but adipose tissue inflammation can persist long after weight loss. One study showed that immediately after weight loss fat breakdown releases fatty acids triggering an increase in adipose tissue (AT) proinflammatory macrophages and inflammation. Over time, there is a gradual decline in inflammatory processes.The NLRP3 inflammasome and its release of pro-inflammatory cytokines, IL-1β and IL-18, by AT macrophages is essential in development of obesity-related complications. NLRP3 inhibition in a DIO mouse model protected against cardiovascular complications and fatty liver disease.Data from this review article support ZyVersa’s development of Inflammasome ASC Inhibitor IC 100 for obesity with associated comorbidities to be used as an add-on to incretin therapy. WESTON, Fla., Oct. 29, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, highlights data from a review article published in the peer-reviewed journal, Life. The article summarizes data from 345 publications on the role of inflammasome-induced inflammation in obesity and its comorbidities, and it reinforces the need for therapeutic options to better address the inflammation. “Strong evidence that obesity treatment needs to go beyond weight loss and address the damaging inflammation leading to life-altering comorbidities is driving ZyVersa and other biopharma companies to invest in development of drugs to be used along with incretin therapy to treat inflammation,” said Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “Studies documenting the key role of inflammasomes in triggering obesity-associated inflammation led ZyVersa to focus on this area for development of Inflammasome ASC Inhibitor IC 100. We are excited about the potential of IC 100 to effectively control the inflammation of obesity. Unlike the NLRP3 inhibitors in development, IC 100 targets ASC to inhibit multiple inflammasomes, including NLRP3 and AIM2, which are associated with obesity. More importantly, IC 100 uniquely disrupts the function of ASC specks to attenuate chronic, systemic inflammation leading to obesity comorbidities. We look forward to progressing IC 100’s obesity development program into phase 1 around mid-2025.” In the review article titled, The Interplay between Obesity and Inflammation, the authors concluded: Development of adipose tissue inflammation triggers subsequent cardiovascular events and therefore represents a major reason for the treatment of obesity.The interplay between obesity and inflammation is complex, involving a variety of cellular and humoral factors, and due to the complexity and particular features of the adipose tissue, the inflammation within may persist for long periods of time.Macrophages are the main cellular component driving adipose tissue chronic inflammation. Modulation of macrophages and their release of proinflammatory cytokines, such as NLRP3-driven IL-Iβ and IL-18, can be a key factor in medical intervention in obese patients.Understanding the pathophysiological changes in adipose tissue and the interplay with chronic inflammation can assist in the design of future studies and reveal opportunities for the development of more efficient therapies for obesity. About Inflammasome ASC Inhibitor IC 100 IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, and Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here. About ZyVersa Therapeutics, Inc. ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced proprietary technologies to develop first-in-class drugs for patients with inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux MediatorTM VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. For more information, please visit www.zyversa.com. Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. Corporate, Media, and IR Contact:Karen CashmereChief Commercial Officerkcashmere@zyversa.com786-251-9641

MAX BioPharma is Pursuing Strategic Partnerships and Series A Financing LOS ANGELES, Oct. 24, 2024 /PRNewswire/ -- MAX BioPharma, Inc. ( ) recently published an article demonstrating the anti-atherosclerotic, anti-inflammatory, and cholesterol-lowering effects of its orally bioavailable oxysterol lead compound, Oxy210, in the peer-reviewed journal, Cells. Oxy210 is derived from the Company's Oxysterol Therapeutics® platform of proprietary small molecule oxysterols that has enabled discovery of diverse oxysterol-based drug candidates in different therapeutic areas, such as bone regeneration, viral and bacterial infection, cancer, pathologic fibrosis, and chronic inflammation. Oxy210 displays unique mechanisms of action that mediate its anti-inflammatory and anti-fibrotic effects based on multipronged targeting of not just one, but multiple cellular signaling pathways. When dysregulated, these vital signals are known to drive the progression of complex diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and its comorbidity, atherosclerosis, which is the leading cause of death in people with MASH. Continue Reading During previous research conducted at the David Geffen School of Medicine at the University of California, Los Angeles and directed by Principal Investigator Dr. Jake Lusis, Professor of Medicine, and Dr. Simon Hui, Project Scientist, Oxy210 was found to significantly inhibit the development of fibrosis in a humanized mouse model of MASH that involves progressive inflammation, fat deposition, and fibrosis in the livers of these mice. The inhibition of fibrosis by Oxy210 was associated with reduced hepatic lipid deposition and the inhibited expression of pro-fibrotic and pro-inflammatory factors including transforming growth factor beta (TGF-β), NLRP3 inflammasome, interleukin-6 (IL-6), tumor necrosis alpha (TNF-α), interleukin-1 beta (IL-1β) and monocyte chemotactic protein 1 (MCP-1). Moreover, Oxy210 inhibited adipose tissue inflammation, suggesting its anti-inflammatory potential that reaches beyond the liver. In their recently published article, the investigators report on significant inhibition of atherosclerosis, a chronic inflammatory disease, in addition to parallel inhibition of MASH. Treatment with Oxy210 was associated with lowering circulating cholesterol levels and reducing macrophage proliferation and content in the artery wall. Together with the in vitro findings of the anti-inflammatory effects of Oxy210 in aortic endothelial cells and macrophages, it appears that Oxy210 could be a promising drug candidate for targeting MASH, atherosclerosis, and perhaps other chronic inflammatory diseases associated with metabolic dysfunction. An anti-inflammatory, anti-fibrotic, cholesterol-lowering oxysterol drug candidate targeting MASH and atherosclerosis Post this "There is an urgent need for therapies to treat fatty liver disease and its more advanced form, MASH, and I find the results of our studies with MAX BioPharma quite exciting" states Dr. Lusis. "Our humanized hyperlipidemic mouse model of MASH reflects the natural history of metabolic dysfunction-associated steatotic liver disease (MASLD) progression in humans and reproduces the salient features of human MASH. Attenuation of hepatic fibrosis and inflammation, as well as anti-atherosclerotic effects suggest that Oxy210 should be further explored as a therapeutic candidate for targeting both conditions " explains Dr. Hui." Dr. Frank Stappenbeck, Director of Chemistry at MAX BioPharma, comments: "Oxysterol-based molecules have been our treasure-trove, driving the Company's drug discovery efforts across several therapeutic indications", adding that "Surprisingly, Oxy210 acts a bit like a Swiss-army knife by combining anti-inflammatory, anti-fibrotic, and lipid-lowering effects, a rare combination of helpful properties". Additional pre-clinical studies required by the FDA for clinical development of Oxy210 are currently underway at MAX BioPharma and the Company is seeking strategic partnerships with biotechnology and pharmaceutical companies with the expertise and resources to further the development of oxysterol-based molecules towards FDA approval and commercialization. In addition, MAX BioPharma is in the process of raising a series A tranche financing round to support the advancement of its therapeutic development programs. "We are very excited and hopeful that our efforts will result in an effective and safe therapy for MASH, a condition with currently only one FDA-approved treatment, indicated for non-cirrhotic MASH and apparently effective in less than 30% of patients. Nevertheless, with dozens of failed clinical drug candidate in this field, this first ever FDA-approved drug reintroduced some degree of hope for people suffering with this condition, once considered untreatable" says Dr. Farhad Parhami, Founder, President and CEO of MAX BioPharma, adding "we hope to continue the advancement of MASH therapeutics with our novel drug candidate". About MAX BioPharma, Inc. MAX BioPharma is a privately held preclinical stage California-based biopharmaceutical company developing novel small molecule lipids as drug candidates for intervention in debilitating and fatal human diseases. The company will be a leader in a new field of Oxysterol Therapeutics® by leveraging a robust and growing intellectual property portfolio that will lead to treatments for numerous indications. MAX BioPharma's first success based on small molecule lipids has contributed to the discovery of novel osteogenic oxysterol compounds that target multipotent mesenchymal cells, including mesenchymal stem cells, to induce the formation of bone-forming osteoblasts and bone. The company is translating this technology into the next generation of therapeutic agents for stimulation of bone formation, locally and systemically, in indications such as spinal fusion, non-union fractures, and osteoporosis. MAX BioPharma is also pursuing the development of small molecule oxysterols that function as anti-tumorigenic Hedgehog and TGF-b pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung and pancreatic cancer, and hematologic malignancies, as well as fibrotic diseases of liver, lung, and kidney among others. For more information, please visit us at Media Contact: Farhad Parhami [email protected] SOURCE MAX BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

呼吸道合胞病毒（RSV）疫苗是新冠疫情之后，全球创新疫苗研发领域竞争最激烈的产品。因其拥有百亿美元级别的蓝海市场空间，全球已有数十家疫苗研发企业布局，其中包括十余家中国企业。苏州艾棣维欣生物的ADV110是目前我国企业中RSV疫苗研发进展最快的产品。 近日，艾棣维欣（证券代码: 874055.NQ）发布公告，RSV疫苗ADV110的II期临床试验完成并取得总结报告，该临床试验成功达到了所有主要临床终点，临床研究的安全性、耐受性和免疫原性数据支持该疫苗进一步的III期临床研发。临床研究评价了60-80岁成年人群接种不同剂量及剂次RSV疫苗ADV110的安全性，耐受性及免疫原性。结果显示，各剂量组均表现出良好的安全性和耐受性；接种ADV110可在60-80岁成人群体内产生高水平免疫反应，展现出良好的量效关系。 RSV感染的现状 呼吸道合胞病毒（RSV）是一种导致呼吸系统疾病的主要病原体，可引发各年龄段人群的下呼吸道感染（LRTI），对于婴幼儿、老人及患有基础性疾病人群来讲，RSV病毒的威胁可谓是致命的。 RSV感染是全世界五岁以下儿童住院和死亡的主要原因。据《柳叶刀》估计，2019年全球5岁以下儿童中约有3,300万RSV-ALRTI（RSV病毒感染伴随急性下呼吸道感染症状）病例，并导致其中约360万儿童住院以及10万儿童死亡。 根据灼识咨询预计，2032年全球5岁以下儿童RSV严重感染发病人数将达到3,707万人，其中中国儿童病例约有290万人，2022年至2032年全球5岁以下儿童RSV严重感染发病人数复合年增长率预计为1.1%。即使在症状轻微的儿童中，未经治疗的RSV感染也可能发展成慢性呼吸道疾病，如喘息和哮喘，并影响儿童长久的生长发育。 对于老年人，RSV病毒感染会引起或加重慢性阻塞性肺疾病（COPD）、慢性心力衰竭等疾病，导致了相当数量患者住院治疗、重症甚至死亡，带来极大的负担。RSV感染导致疾病的情况在新冠疫情之后更为明显。 RSV疫苗开发行业格局 RSV预防性疫苗的研发历程超过60年，主要的瓶颈在于疫苗的安全性以及保护力问题。这个瓶颈于2023年开始被打破，2023年5月，葛兰素史克（GSK）公司宣布旗下呼吸道合胞病毒疫苗 Arexvy 获美国FDA批准上市，用于预防 60 岁及以上人群由 RSV 引起的下呼吸道疾病，成为全球首款获批的RSV疫苗。紧随其后，辉瑞公司的无佐剂二价RSV疫苗Abrysvo也获得了FDA的批准。在2024年6月，美国Moderna的RSV疫苗mResvia亦成功获批，用于60岁以上老年人群体，成为了第三款获批的RSV疫苗。 根据国际卫生组织PATH于2024年4月更新的全球RSV疫苗与抗体药物研发概览图，紧随其后的项目包括中国艾棣维欣生物、日本第一三共、美国Icosavax的三款重组蛋白疫苗，以及法国赛诺菲的mRNA疫苗和美国Meissa开发的减毒活疫苗。 2024年6月底，美国疾病控制与预防中心（CDC）的独立疫苗顾问免疫实践咨询委员会（ACIP）建议，老年人RSV接种范围为75岁成年人以及60-74岁的高风险群体。缩小接种年龄范围的原因可能与辉瑞和GSK的疫苗非常罕见地导致的吉兰-巴利综合征（GBS）副作用有关。已上市的RSV疫苗仍然不够完美，仍具备改良的空间。另外，目前针对儿童群体的RSV疫苗仍是空白，这是较老年人RSV疫苗更大的市场。 艾棣维欣RSV疫苗ADV110 艾棣维欣的ADV110是一款含有新型佐剂AE011的RSV重组蛋白亚单位疫苗，用于预防RSV引起的呼吸道疾病。根据已发表的ADV110研究论文，其II期临床试验是在澳大利亚进行的一项随机双盲、安慰剂对照、剂量探索临床试验，受试者为60-80岁的成年人，旨在评估疫苗的安全性、耐受性及免疫原性，进而在I期临床试验的基础上积累更多受试人群的安全性和免疫原性数据，并评估后续临床研究的剂量，其临床方案如下图所示。 图片来源：medRxiv（2023） 试验分为三组进行，低剂量和高剂量两次免疫组，以及高剂量加强免疫组。该试验共有125名临床受试参与者进入试验列队，其中124名参与者(99.2%)完成所有给药计划，125名参与者(100%)全部完成最后一次给药四周后的随访。安全性数据显示，不同剂量的ADV110疫苗均具有良好的安全性和耐受性，所有组在试验中均没有SAE发生，TRAE的发生率没有随疫苗剂量或频率的增加而升高。在免疫原性评估中，数据显示在接种ADV110疫苗后，与免疫前的基线水平相比，所有组的抗原特异性抗体几何平均浓度(GMC)都有所增加，且各组反应率均超过80%。相对于低剂量ADV110(10µg)两次免疫组，给予高剂量ADV110(20µg)两次免疫组，可在后续观察期持续产生抗体，表现出更强的免疫反应，且统计学显著。额外第三次免疫加强会诱导抗体水平进一步增加，在所有观察时间点抗体产生水平均显著高于初始基线测量值。数据证明了ADV110从低剂量到高剂量队列与剂量相关的抗体增强特性，多次免疫在抗体应答中也呈现出重要作用，显示了良好的免疫原性与量效关系。 据论文介绍，RSV疫苗ADV110的设计初衷是产品既能具有良好的免疫原性且同时能够抑制与VED风险相关的过度的T细胞反应。避免VED风险是用于儿童预防性RSV疫苗的一个决定性因素。本次RSV疫苗ADV110的II期临床试验成功达到了所有主要临床终点，临床研究的安全性、耐受性和免疫原性数据支持该疫苗进一步的III期临床研发。艾棣维欣的ADV110具备开发为一款优秀的老年人和儿童RSV疫苗的潜力。采用重组蛋白与新佐剂技术的ADV110，其研发进度继续保持中国领先，成为中国RSV疫苗领域与跨国企业竞争的明星选手。 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。