Gastrointestinal Diseases

– Webcast to be Held at 8:00 am ET on November 7, 2024 – NEW YORK, Oct. 31, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that the company will release its financial results for the third quarter ended September 30, 2024, including a corporate update, on Thursday, November 7, 2024, before the opening of the U.S. financial markets. A webcast will follow at 8:00 am ET. To participate in the webcast, please register in advance at: or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access. An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; and the company's expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BOSTON, Oct. 31, 2024 /PRNewswire/ -- In a remarkable development for cancer research, patients with advanced-stage cancer have benefited from SUPLEXA, a personalized treatment that trains the patient's own immune cells to fight cancer. "Cancer often gains the upper hand by suppressing the immune system. Our approach flips the script: we isolate immune cells from this suppressive environment, we reactivate their inherent cancer-fighting abilities in a laboratory, and return them back to the patient", said Dr Frank Borriello, Founder and CEO of Boston-based Alloplex Biotherapeutics[1]. While the science behind SUPLEXA is sophisticated, the process for patients and clinicians is surprisingly straight-forward. A single 50 mL blood draw from the patient is all it takes to develop a complete course of SUPLEXA therapy. With nothing more than standard lab equipment, the patient's white blood cells are isolated and 'trained' outside the body (ex vivo) using Alloplex's proprietary ENLIST immune cell training technology. About a month later, the enhanced blood cells are infused into the patient, where they not only seek out and destroy rogue cancer cells — that had, until then, evaded the immune system — but improve the overall immune health of the patient. Full results of the first-in-human trial[2] will be released at the 2024 SITC conference in November. The Australian study showed no treatment-related serious adverse events — unsurprising, given that SUPLEXA is made from the patients' own immune cells that have simply undergone a training process to improve their functionality before being reintroduced to the patient. Remarkably, and in addition to its strong safety profile, SUPLEXA transformed the lives of patients with various cancer types. Its most striking results were observed in patients with a specific type of advanced colorectal cancer (CRC) and renal cell carcinoma (RCC). Three CRC patients derived significant clinical benefit: one achieved a complete response (CR), another a partial response (PR) and another stable disease (SD). "Many of these patients sustained a strong clinical response for up to two years," said Dr. Borriello. Of the ten RCC patients, one achieved a partial response (PR) and six achieved stable disease (SD) while only 3 had progressive disease (PD). Patients with other solid tumors, including melanoma, breast and lung cancer, also demonstrated long-term SD with SUPLEXA. While quality of life assessments were not formally captured in this study, patients reported improvements in their well-being, a reduction in pain and improved symptom control. For the participating patients who had exhausted all standard treatment options, "SUPLEXA has been a remarkable experience," said Principal Investigator, Assoc. Professor Rohit Joshi[3], who led the first-in-human study across three sites in Australia[4]. "It's also allowed them to continue with their normal lives, have a vacation, take up new hobbies and spend more time with family and friends," said Assoc. Prof. Rohit Joshi. FDA Opens Door to Proceed With encouragement from the FDA to proceed with an Investigational New Drug (IND) submission, Alloplex Biotherapeutics plans to initiate Phase 2 clinical trials of SUPLEXA in early 2025. The trial will combine SUPLEXA with immune checkpoint inhibitors (ICIs) in patients with a specific type of colorectal cancer. The goal is to test, in a controlled clinical setting, whether SUPLEXA's complementary mechanisms can enhance patient outcomes by amplifying the effectiveness of ICIs, which are the standard of care for this type of cancer. Notes: Alloplex Biotherapeutics is a private Boston-based company founded in 2016 with a singular focus on developing its ENLIST immune cell training platform for cancer. SUPLEXA cells represent the first candidate to emerge from this platform that harnesses and amplifies the innate capabilities of the immune system, Full clinical and scientific results of the trial will be presented at the Society for Immunotherapy of Cancer 'SITC' meeting in Houston, Texas in early November 2024. Abstracts #378 and #678 will be presented in the Immune Engineering Workshop and at the Annual Meeting. Assoc. Professor Rohit Joshi, MBBS, MD, FRACP, FACP, FRCP, is a highly published and renowned medical oncology consultant. He is an Associate Professor at the University of South Australia and University of Adelaide; and Director of Cancer Research SA ('CRSA'). The company's first-in-human clinical trial enrolled 35 patients with a variety of advanced cancer types. It was an open label, single-agent, basket study across three clinical sites in Australia and concluded in June 2024. The three sites in Australia where the SUPLEXA trial was carried out are: (1) Cancer Research SA ('CRSA') in Adelaide, South Australia; (2) Southern Oncology Research United ('SOCRU') in Adelaide, South Australia, and (3) Greenslopes Private Hospital / Gallipoli Medical Research Foundation, in Brisbane, Queensland. Full Media Kit: An extensive library of backgrounders, Q&As, images (including headshots) and videos is available at Media Contact Email: [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引言 肠道菌群与人体的健康有着密切的关系，涉及免疫、营养以及多种疾病的调控。它们通过与人体的共生作用，影响着免疫系统的发育和功能，增强人体对病原体的抵抗力。此外，肠道菌群还参与了营养物质的代谢，帮助消化食物中的复杂碳水化合物，产生对人体有益的代谢物，如短链脂肪酸。同时，肠道菌群的失衡与肥胖、糖尿病、炎症性肠病等多种慢性疾病的发生密切相关。这些肠道菌的作用，主要是通过它们对肠道化学环境的调控来完成的。目前肠道菌群中哪些菌有具体的哪些化学调控能力还有很大的空白。 2024 年 10 月 25 日，美国圣路易斯华盛顿大学医学院Jeff Gordon团队的程基业教授在 Science 期刊发表题为：A human gut Faecalibacterium prausnitzii fatty acid amide hydrolase的研究论文。该研究发现了一类新的细菌蛋白酶可以调控人体肠道中的內源性大麻素，为理解肠道菌群如何通过化学调控来和人体对话提供了更新的视角。 研究使用了来自孟加拉儿童的13或14种基因组测序肠道菌株组成的微生物群落，将它们引入无菌小鼠体内。结果显示，含有Faecalibacterium prausnitzii  (F.prausnitzii) 的群落的小鼠体内，N-酰基乙醇胺（NAEs）的水平显著降低，尤其是油酰乙醇胺（OEA）。这表明F.prausnitzii可能通过其特异性的酶来调控NAEs的降解。N-酰基乙醇胺（NAEs）在人体中扮演着重要的生理角色，对代谢调节、食欲控制、炎症反应和疼痛管理等方面具有重要作用。OEA是一种饱腹感因子，通过激活特定的受体来减少食物摄入，从而有助于调节体重。在体内，N-酰基乙醇胺（NAEs）的水平和活性主要受到一种叫做脂肪酸酰胺水解酶（FAAH, Fatty Acid Amide Hydrolase）的酶的调控。此前还从未发现过细菌有此类似的FAAH能够调控NAEs。 （Credit: Science） 研究者通过运用现代生物信息学和传统生物化学手段，对F.prausnitzii的蛋白分离和基因分析，发现了一个候选基因，该基因在大肠杆菌中表达后，纯化的蛋白能够合成并水解多种N-酰基化合物，此结果确认并首次发现了微生物脂肪酸酰胺水解酶（FAAH）。微生物FAAH的蛋白序列和二级结构与人体FAAH都截然不同。在功能上和人体FAAH相比，微生物FAAH展现出了更广泛的水解能力，能水解包括对人体具有毒性的群体感应代谢物。微生物FAAH还展现出双向催化活性，能与不同多种脂肪酸和胺类化合物合成脂肪酸酰胺，表现出独特的合成和水解功能。 模式图（Credit: Science） 精氨酸是这种微生物FAAH酶在合成活性中最偏爱的胺类底物，合成产物油酰精氨酸从未报道过的全新化合物，通过细胞模型实验，研究发现油酰精氨酸和油酰组氨酸，能够激活特定的核激素和G蛋白偶联受体。向无菌小鼠口服这些N-酰基氨基酸，结果显示肠道免疫相关通路的表达水平显著降低。 进一步分析孟加拉营养不良儿童的粪便样本，发现接受MDCF-2治疗后的OEA水平显著降低，与F.prausnitzii菌FAAH基因的表达呈负相关。这些结果表明，F.prausnitzii菌FAAH在肠道中对活性N-酰基化合物的调控具有重要作用。 这个研究开启了一个新的微生物肪酸酰胺酶FAAH的研究方向，增添了肠道中N-酰基乙醇胺人体与肠道菌共治的证据。调控肠道微生物FAAH的合成或水解活性，可能对包括营养不良在内的多种疾病的治疗具有潜在的应用价值。 参考文献 http://doi.org.libproxy1.nus.edu.sg/10.1126/science.ado6828 责编|探索君 排版|探索君 来源|BioArt End 往期精选 围观 一文读透细胞死亡(Cell Death) | 24年Cell重磅综述（长文收藏版） 热文 Cell | 是什么决定了细胞的大小？ 热文 Nature | 2024年值得关注的七项技术 热文 Nature | 自身免疫性疾病能被治愈吗？科学家们终于看到了希望 热文 CRISPR技术进化史 | 24年Cell综述