AVR-118

Results indicate that EOM613 treatment mitigates cytokine release in patients with COVID-19 pulmonary vascular inflammation MONTVALE, N.J., Sept. 6, 2023 /PRNewswire/ -- EOM Pharmaceutical Holdings, Inc (OTC: IMUC) ("EOM") today announced the results of its completed clinical trial in hospitalized COVID-19 patients with severe symptoms treated with its investigational immune-regulating drug product EOM613. The trial was conducted in Brazil. This exploratory Phase 1/2a clinical trial (NCT05212532), designated RESCUE, was a proof-of-concept, open-label study evaluating the safety, tolerability, and preliminary efficacy measures, such as the effects on serum cytokines, when EOM613 was added to the standard-of-care therapy. The trial included two cohorts of patients hospitalized for COVID-19: one cohort was in the intensive care unit (ICU) and the other cohort was not (non-ICU). The study was conducted at four different medical centers in the Brazilian states of Sao Paolo and Goaia. The trial was originally designed to enroll a total of 40 patients – 20 in each cohort. The trial was redesigned, however, due to challenges in patient enrollment during the COVID-19 pandemic as a result of Brazil's successful vaccination program which led to a reduction in eligible hospitalized patients. The redesigned trial enrolled a total of 23 patients eligible for evaluation. The study's Principal Investigator was Florentino Cardoso Filho, MD, at the Casa de Saude Hospital in Campinas, Sao Paolo, and former President of the Brazilian Medical Association. Topline Results The study's topline results indicate that: EOM613, administered by subcutaneous (SC) injection was well-tolerated by hospitalized COVID-19 patients. EOM613 treatment produced a reduction in certain pro-inflammatory serum cytokine levels in line with its postulated mechanism of action of immune modulation. The non-ICU cohort was comprised of patients hospitalized for COVID-19 receiving supplemental oxygen therapy by mask or nasal prongs, corresponding to degrees 4-5 of the WHO Ordinal Clinical Scale for Disease Severity (WHO-OSDS). The ICU cohort was comprised of patients hospitalized for COVID-19 under mechanical ventilation in an ICU, corresponding to degrees 6 or 7 of WHO-OSDS. Both cohorts received the standard-of-care therapy for COVID-19 as defined by the participating hospitals, with the addition of any medications necessary for the study participant's special needs, such as diabetes, hypertension, etc., but excluding other experimental drugs and any drugs used off-label. Of the total of 23 patients enrolled in the study, 5 patients were in the non-ICU cohort and 18 patients with severe respiratory inflammation symptoms requiring mechanical ventilation support were in the ICU cohort. For the non-ICU patients, EOM613 was administered SC at a dose of 2 mL once daily (QD) for 10 days, for a total of 20 mL. The ICU cohort received EOM613 SC at a dose of 2 mL twice daily (BID) for 5 days followed by 2 mL once daily (QD) for 5 days, for a total of 30 mL. All patients were followed for 28 days. A clinical data evaluation was made of the evolution of WHO-OSDS, and laboratory exams and adverse events were compared with historic controls treated for COVID-19 at the same hospitals. The results of the trial indicate that, EOM613 administered SC at a dose level of 2 mL QD for 10 days was well tolerated in COVID-19 non-ICU patients. Study drug was discontinued for only one enrolled patient in the ICU cohort after the first day of treatment due to hemodynamic worsening (Grade 4). In ICU patients receiving a dose level of 2 mL BID for 5 days followed by 2 mL QD for 5 days, a somewhat higher frequency of adverse events (AEs) of the cardiovascular system was observed than in the non-ICU cohort as would be expected with mechanically ventilated patients, but these AEs were not deemed related to EOM613 treatment by the clinical investigators. Both treatment group regimens had no negative effect on clinical laboratory parameters (complete blood count, SMA-18 metabolic panel, biochemistry) of patients with COVID-19 infection. Post-baseline clinically significant beneficial changes were seen with EOM613 treatment for two of the blood serum cytokines involved in the cytokine storm in hospitalized COVID-19 patients, namely, soluble interleukin-2 receptor (sIL-2R) and interleukin-10 (IL-10). In the seriously affected ICU cohort, changes were also observed in other cytokines, such as TNF-α, IL-1β, IL-6 and IL-13, in line with EOM613's mechanism of action as a broad-spectrum immune regulator. For example, at screening levels of sIL-2R cytokine were meaningfully higher in the ICU cohort patients with mean values of 1721.69 (± 720.31) pg/mL (median1602.30 pg/mL). sIL-2R levels decreased during the study in both study cohorts. A statistically significant change from baseline was observed on Day 8 in the ICU cohort, i.e., a drop of -512.15 (± 698.10), median -412.80 (p = 0.0214). Similarly, in the non-ICU cohort the mean baseline value at screening on Day 28 showed mean IL-2R levels were 588.55 (± 537.76) pg/mL (median 484.60) in the non-ICU cohort and 726.96 (± 331.70) pg/mL (median 861.50) in the ICU cohort. Median changes from baseline in sIL2-R were -485.35 pg/mL and -444.90 pg/mL, respectively. Shalom Z. Hirschman, MD, Chief Medical Officer of EOM Pharmaceuticals, stated: "I am encouraged by the results of this trial indicating that EOM613 was well-tolerated even in this group of seriously affected hospitalized COVID-19 patients, as it had earlier been shown to be trials in patients with AIDS, cancer cachexia and rheumatoid arthritis. Furthermore, I am pleased that the serum cytokine measurements in COVID-19 patients validate the putative mechanism of action of EOM613 as a broad-spectrum immunomodulating agent affecting pro- and anti-inflammatory cytokine levels, as these results are consistent with previous results in cell culture in immune cells. Both sIL-2R and IL-10 cytokines have been implicated in the scientific literature as biomarkers for the progression of severe COVID-19 infection, with elevated levels of sIL-2R in particular being a predictor of hospital mortality. Thus, an agent that can be shown to diminish serum levels of this cytokine may prove beneficial. Cytokines such as sIL-2R are also associated in various other chronic inflammatory conditions such as rheumatoid arthritis in which enhanced T-cell activation is involved." "The results of this trial further elucidate EOM613's mechanism of action in patients, thus corroborating the earlier preclinical lab research, and suggesting broader potential utility. This provides an additional support for EOM's future clinical drug development in various chronic inflammatory diseases," added Irach B. Taraporewala, PhD, CEO of EOM Pharmaceuticals. "A well-tolerated broad-spectrum immune regulating agent such as EOM613 which can modulate multiple cytokines involved in disease pathogenesis could have meaningful therapeutic value. We look forward to conducting additional investigation of EOM613's potential utility." About EOM613 EOM's lead asset, EOM613, is an investigational, novel peptide-nucleic acid solution immunomodulator believed to have both anti- and pro-inflammatory broad-spectrum cytokine effects. In human cell culture studies, EOM613 demonstrated a unique "dynamic dual action" by suppressing or stimulating monocytes and macrophages depending on the activation state and environment of those key immune cells. It is hypothesized that this dynamic dual-action may overcome a limitation of many approved immunomodulators that only reduce the inflammatory state without achieving immune system balance About EOM Pharmaceutical Holdings, Inc. EOM Pharmaceutical Holdings, Inc. is a clinical-stage company focused on developing novel drugs with the potential to transform therapeutic paradigms and improve quality of life in patients suffering from debilitating and sometimes deadly diseases. The Company was founded with a specific vision to pursue innovative approaches to rescue, repair, and restore health of patients with urgent and unmet medical needs. For more information about EOM Pharmaceuticals, please visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify these statements by forward-looking words such as "may," "will," "continue," "anticipate," "intend," "could," "project," "expect" or the negative or plural of these words or similar expressions, and other similar terms. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, EOM's ability to develop and commercialize its product candidates; EOM's ability to obtain and maintain regulatory approval of product candidates; EOM's ability to operate in a competitive industry and compete successfully against competitors that have greater resources; EOM's reliance on third parties; EOM's ability to obtain and adequately protect intellectual property rights for product candidates; and the effects of COVID-19 on clinical programs and EOM's business operations. Any forward-looking statements in this press release speak only as of the date of this press release. EOM assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. SOURCE EOM Pharmaceutical Holdings

2022年6月，在生物医药领域，仅有1家公司通过IPO上市，4家公司宣布或完成与SPAC合并上市，1家公司进行反向并购上市，2家公司提交了转板上市申请。一、IPO上市6月，仅有1家医药公司采用IPO形式上市，比5月减少了2家，IPO市场陷入谷底。作为6月唯一一家IPO上市的生物医药企业，Heart Test(NASDAQ:HSCS)的IPO价格为4.25美元，发行1500万股，募集金额为6375万美元。HSCS是一家基于人工智能的心电图公司，用于筛查、护理心脏病患者，公司产品MyoVistawavECG已经获得FDA批准，是一款静息12导联心电图。HSCS的年营收规模仅为几万美元，无论是财务数据上，还是发行体量上，公司均属于质地较差的公司，股价更容易被资金左右：IPO当天，公司股价暴跌54.67%，第二天又上涨42.35%。二、SPAC上市6月，有2家SPAC公司宣布与生物医药企业合并，2家药企完成与与SPAC公司合并上市，另有2家此前计划与SPAC合并上市的医药公司，宣布终止合并。1、Alvotech(NASDAQ:ALVO)6月7日，SPAC公司Oaktree II(NYSE:OACB)完成与Alvotech合并，合并后的公司上市代码为“ALVO”。Alvotech是一家来自冰岛的生物类似药公司，主打产品是艾伯维阿达木单抗的生物类似药，Alvotech开发了一种高浓度的阿达木单抗，可以提高患者的依从性，并可能使其比其他一些已经批准的阿达木单抗生物仿制药更具竞争力，并且在美国它可能比大多数阿达木单抗生物仿制药更早上市，此前已经获得了欧盟委员会批准（2021年11月）在欧盟国家进行商业化。艾伯维的阿达木单抗专利将于2023年到期，安进、勃林格殷格翰、辉瑞等药企均准备推出生物类似药。除了阿达木单抗类似药之外，Alvotech还在就强生的Stelara和Simponi、再生元的Eylea和安进的Prolia/Xgeva开发生物类似药。Alvotech和亚洲投资人颇具渊源，公司先后接纳了日本富士、韩国新韩、新加坡淡马锡等股东，并与2018年和长春高新联合成立了长春安沃高新生物制药公司，旨在中国境内开发生物类似药。2、Senti Biosciences(NASDAQ:SNTI)6月8日，SPAC 公司Dynamics (NASDAQ:DYNS)宣布完成与Senti Biosciences合并上市，合并后公司的上市代码为“SNTI”。Senti Bio 是一家利用基因工程电路技术设计基因和细胞疗法的初创公司，由合成生物学奠基人James J. Collins及其学生卢冠达等联合创办。公司利用其专有的基因电路技术平台能够感知并治疗相关疾病，即通过合成生物学方式创建多种基因电路并编码为专有的DNA序列组合。这种基因电路能够使细胞感应到信号，并利用生物逻辑计算对疾病做出判断。Senti Bio已经开发出了三条在研管线，分别针对急性髓性白血病（AML）、肝癌和结直肠癌，均处于临床前阶段，预计到明年递交针对AML和肝癌的IND。公司独特的技术吸引了大药企的合作：公司与罗氏子公司Spark Therapeutics 合作开发针对中枢神经系统、眼部和肝脏部位的“下一代”基因疗法，还与拜耳的子公司BlueRock Therapeutics达成开发“下一代”细胞疗法合作。公司创始人卢冠达是MIT生物工程与电机工程系副教授，也是知名的连续创业者。目前，他已联合创办了8家生物技术公司，此前他联合创办的Synlogic（SYBX）、BiomX（PHGE）、Tango（TNGX）均已上市。公司在一级市场上获得了安进、拜耳、NEA、经纬中国、英特尔等知名机构的投资。此次完成合并的SPAC公司DYNS，有着资深的行业背景，DYNS的发起人包括 Omid Farokhzad、Mostafa Ronaghi等行业大牛，亦获得了ARK Investment的投资，其中：DYNS的执行主席Omid Farokhzad是蛋白质组学上市公司Seer的联合创始人兼CEO；DYNS的CEO兼董事Mostafa Ronaghi曾在Illumina担任13年CTO，也是癌症检测领域超级独角兽GRAIL的联合创始人。3、Freedom Acquisition(NASDAQ:FACT)6月21日，SPAC公司FACT宣布与Human Longevity达成合并上市的协议，合并后的公司估值约为10亿美元，预计交易在明年一季度完成。Human Longevity由基因组学领域先驱J. Craig Venter于2013年创立，通过利用基因组测序、人类微生物组、蛋白质组学和细胞疗法等技术领域的成果，计划建设最全面的人类基因型和表现型数据库。公司具体业务领域包括：基因组测序分析，先进的临床成像及机器学习、定制化的个人健康信息等。公司为用户提供名为“Health Nucleus”的健康服务，其中包括百余项健康评估的医学测试，例如全基因组测序、全身定量 MRI 和血液生物标志物检测等，用于测试癌症、阿尔茨海默氏症和心脏病等疾病的早期迹象，从而帮助人们尽早发现并对抗与衰老相关的疾病。公司曾在2016年的B轮融资中，募集了2.2亿美元的资金，成功吸引了Illumina公司，Celgene公司，GE公司等巨头的加入，公司估值也超过12亿美元。2018年，公司起诉了Venter及其同名的研究所存在分享公司机密的行为之后，导致几位管理层的离职，在2018年底，公司估值跌去了80%，导致在2019年的C轮融资中，公司仅筹集到了3000万美元。4、宣布终止合并生物医药企业的SPAC公司6月，共有2家SPAC公司宣布终止正在推进的生物医药企业合并计划：6月9日，Psychedelics药物公司Eleusis宣布终止与与SPAC 公司Spike Acquisition Corp.II（NASDAQ:SPKB）的合并上市计划；6月13日，专注于纤维化疾病的小分子药物公司Blade Therapeutics宣布终止与SPAC公司Biotech(NASDAQ:BIOT)的合并上市计划。三、反向并购上市（Reverse Merger）6月6日，中枢神经系统系统药物公司Yumanity(NASDAQ:YMTX)宣布将其在研药物YTX-7739以2600万美元的价格，出售给强生(NYSE:JNJ)，并将与未上市的生物医药公司Kineta进行换股合并，完成后，原YMTX的股东将持有合并后公司15%的股权。YMTX是本轮生物医药熊市中，研发不利药企的一个缩影，公司把出售资产的资金分配给股东，并与Kineta达成反向并购上市协议。而YMTX自身，则是在2020年8月，与Proteostasis(NASDAQ:PTI)进行反向并购上市，时间不到两年，上市公司的壳再度易手。Kineta的主要资产是KVA12.1，是一款靶向VISTA的免疫疗法，用于解决肿瘤微环境中的免疫抑制问题，拥有治疗多种癌症的潜力。 除了肿瘤免疫疗法之外，公司还有与基因泰克合作开发的管线：一款用于神经性疼痛治疗的药物。此外，YMTX与默克公司合作开发治疗肌萎缩侧索硬化症和额颞叶痴呆的在研管线也会划归合并后的上市公司。四、转板上市（Uplisting）6月，共有2家公司宣布从OTC板块，转板到纳斯达克上市，一般而言，转板上市的医药企业质地较差：Clearmind Medicine ( OTC:CMNDF )：一家致力于开发治疗暴饮暴食、酗酒等症状的迷幻药物公司，主打药物MEAI目前正处于I/IIa期临床试验。公司还在近期，与SciSparc(NASDAQ:SPRC)联合申请了治疗暴食行为药物的专利。ImmunoCellular(OTC:IMUC)：公司于今年6月递交了转板纳斯达克上市的申请，有两个进入临床二期实验的在研药物：EOM613 和 EOM147。EOM613三中是艾滋病和类风湿性关节炎，EOM147适应症是年龄相关性黄斑变性、糖尿病性视网膜病变等眼科疾病。在2021年12月，公司与EOM Pharmaceuticals合并，今年6月，提交了在纳斯达克上市的申请，股票代码拟变更为“EOM”。版权声明/免责声明本文为授权转载文章，版权归拥有者。仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。欢迎朋友们批评指正！衷心感谢！文中图片、视频为授权正版作品，或来自微信公共图片库，或取自公司官网/网络根据CC0协议使用，版权归拥有者。任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！推荐阅读2022年上半年中国新药出海成绩单！国产PD-1再次奋勇出海，百济神州和君实谁能率先成功上岸？。。。 | 药时代出海系列不出国可以用上哪些全球最新药？| 在“国九条”、“先行先试”等政策加持下，海南博鳌乐城先行区是如何“先行”的？水性凝胶贴片的机理与国外临床试验H空出世 大有可为 | CSCO-复宏汉霖肿瘤免疫高峰论坛圆满举行核酸药物“三步走”：如何从研发角度推动药物进程三款上市新药，十余项注册研究，收获期的和黄医药如何打好商业化这张牌？| 药时代专访和黄医药中国首席商务官陈洪先生出于安全考虑，赛诺菲BTK抑制剂tolebrutinib的3期临床研究被FDA部分暂停寻找「制药界董宇辉」！为中国创新代言，为优秀公司带货！——药时代直播招聘啦！“大糖盛世”下我国糖尿病市场的机遇与挑战半年收官！NMPA「官宣」批准上市9款创新药、疫苗点击这里，欢聚药时代！