BLACKSBURG, Va.--(BUSINESS WIRE)--NImmune Biopharma, (“NImmune”), a private late-clinical-stage precision immunology biopharmaceutical company focused on the discovery and development of best-in-class biomarker-driven immunoregulatory therapeutics, led by omilancor, a Phase 3 best in class once daily oral therapy for Ulcerative Colitis, announced that it will present three abstracts, including final Phase 2 data for omilancor in active Ulcerative Colitis patients at the American College of Gastroenterology (“ACG”) 2023 Annual Scientific Meeting (“ACG 2023”), taking place at the Vancouver Convention Center in Vancouver, Canada, between October 20 and October 25, 2023..

弗吉尼亚州布莱克斯堡（BUSINESS WIRE）-NImmune Biopharma，（“NImmune”）是一家私营的晚期临床精确免疫学生物制药公司，专注于发现和开发一流的生物标志物驱动的免疫调节疗法，由omilancor领导，这是一项针对溃疡性结肠炎的3期一流的每日一次口服疗法，宣布将提交三篇摘要，包括在加拿大温哥华温哥华会议中心举行的美国胃肠病学会（“ACG”）2023年度科学会议（“ACG 2023”）活动性溃疡性结肠炎患者omilancor的最终2期数据。2023年10月25日。。

Dr. Josep Bassaganya-Riera, Founder & CEO of NImmune, said, “Final and complete Phase 2 data for omilancor in mild to severe UC patients with active disease affirms best-in-class efficacy and unrivaled safety. Omilancor is a first-in-class wholly-owned therapeutic, developed with the guidance of TITAN-X, a proprietary computational modeling and AI-powered precision medicine discovery engine that efficiently accelerates biomarker-driven immunoregulatory therapeutic development of omilancor, NIM-1324 and our other immunoregulatory therapeutics.

NImmune的创始人兼首席执行官Josep Bassaganya Riera博士说， “omilancor在轻度至重度UC活动性疾病患者中的最终和完整的第二阶段数据肯定了一流的疗效和无与伦比的安全性.omilancor是一流的国有治疗药物，在TITAN-X的指导下开发，TITAN-X是专有的计算建模和AI驱动的精准医学发现引擎，可有效加速生物标志物驱动的免疫调节omilancor，NIM-1324和我们其他免疫调节疗法的治疗发展。

Meeting the primary endpoint of clinical remission in UC patients with active disease substantially de-risks omilancor’s regulatory path to New Drug Application (NDA) and commercialization and provides clinical validation of the LANCL2 pathway as a novel mechanism of action for addressing the significant unmet clinical needs of patients with autoimmune diseases.

满足活动性疾病UC患者临床缓解的主要终点实质上降低了omilancor新药申请（NDA）和商业化的监管途径的风险，并提供了LANCL2途径的临床验证，作为解决重大未满足临床需求的新机制的自身免疫性疾病患者。

These positive clinical findings further underscore the importance of our recently announced research collaboration with the NIMML Institute and the value of its advanced computational modeling and A.I.-powered TITAN-X precision medicine platform, which efficiently accelerates biomarker-driven immunoregulatory therapeutic development of omilancor, NIM-1324 and our other immunoregulatory therapeutics.”.

这些积极的临床发现进一步强调了我们最近宣布的与NIMML研究所的研究合作的重要性，以及其先进的计算建模和A.I.-powered TITAN-X精密医学平台的价值，该平台有效地加速了omilancor的生物标志物驱动的免疫调节治疗开发，NIM-1324和我们的其他免疫调节疗法“。

“As we approach a significant milestone—the initiation of the pivotal global Phase 3 clinical program of omilancor for the treatment of UC by year-end 2023—we are pleased to present our results at ACG 2023 and encouraged by the continued scientific validation of our clinical findings and the overall momentum of omilancor’s clinical and regulatory development.

“随着我们接近一个重要的里程碑-在2023年底开始实施omilancor治疗UC的关键全球3期临床计划，我们很高兴在ACG 2023上展示我们的结果，并对我们临床研究的持续科学验证感到鼓舞。以及omilancor临床和监管发展的总体势头。

We look forward to continuing to realize the significant potential of omilancor as the first-in-class LANCL2 agonist for UC and additional autoimmune indications including Crohn’s disease and psoriasis.”.

我们期待继续认识到omilancor作为UC的一流LANCL2激动剂和其他自身免疫适应症（包括克罗恩病和牛皮癣）的巨大潜力。

Presentation Details

演示细节

Title: Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients with Ulcerative Colitis.

题目：Omilancor在溃疡性结肠炎患者的2期随机，双盲，安慰剂对照试验中的疗效和安全性。

Poster: Board Number P2216, Monday October 23, 2023, 10:30 AM – 4:15 PM

Poster: Board Number P2216, Monday October 23, 2023, 10:30 AM – 4:15 PM

Clinical remission in the approvable UC population of active disease mild to severe patients was induced in 30.4% of patients treated with omilancor relative to 3.7% of patients given placebo (Δ=26.7, P = 0.01), meeting the primary endpoint.

活动性疾病的可接受UC群体中的临床缓解相对于安慰剂组的3.7%（Δ=26.7，P=0.01），使用omilancor治疗的患者中有30.4%诱导轻度至重度患者达到主要终点。

Endoscopic and histological remission were achieved in 41.7% of omilancor given patients relative to 18.6% and 22.2%, respectively, patients in the placebo group (Δ=23.1, Δ=19.5).

安慰剂组患者的内镜和组织学缓解率分别为41.7%和18.6%和22.2%（Δ=23.1，Δ=19.5）。

Durable remission was induced in 38.5% of patients in the omilancor group versus 21.4% of patients given placebo (Δ=17.1, P = 0.05).

omilancor组38.5%的患者诱导持久缓解，安慰剂组21.4%（Δ=17.1，P=0.05）。

Endoscopic response was achieved in 73.1% of patients treated with omilancor relative to 53.6% of patients given placebo (Δ = 19.5, P = 0.02).

在接受omilancor治疗的患者中，73.1%的患者获得了内镜反应，而安慰剂组为53.6%（Δ=19.5，P=0.02）。

Omilancor exhibited statistically significant decreases in TNF-a expressing myeloid cells (p = 0.037) in the colonic mucosa and statistically significant normalization of fecal calprotectin levels (P = 0.048).

Omilancor在结肠粘膜中表达TNF-α的髓样细胞（p=0.037）显示统计学显着降低，并且粪便钙卫蛋白水平的统计学显着正常化（p=0.048）。

Oral omilancor was well-tolerated in patients with UC with no trends in AE profile observed and no dose-limiting toxicities.

UC患者口服omilancor耐受性良好，未观察到AE分布趋势，也没有剂量限制性毒性。

Pharmacokinetic analysis validated a gut-restricted profile with stable drug levels in stool over the treatment period, penetration into colonic biopsy tissue and limited systemic exposure.

药代动力学分析验证了在治疗期间粪便中具有稳定药物水平的肠限制性概况，渗透到结肠活检组织中并限制全身暴露。

Title: Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients with Crohn’s Disease.

题目：Omilancor在克罗恩病患者的2期随机，双盲，安慰剂对照试验中的疗效和安全性。

Poster: Board Number P2215, Monday October 23, 2023, 10:30 AM – 4:15 PM

Poster: Board Number P2215, Monday October 23, 2023, 10:30 AM – 4:15 PM

PRO-2 clinical remission was achieved in 41.7% of moderate to severe CD patients in the omilancor group relative to 9.1% give placebo (Δ=32.6).

在omilancor组中，41.7%的中重度CD患者获得PRO-2临床缓解，而安慰剂组为9.1%（Δ=32.6）。

Crohn’s disease activity index (CDAI) clinical remission was achieved in 25.0% of omilancor-treated patients relative to 9.1% of the placebo group (Δ=15.9).

克罗恩病活动指数（CDAI）临床缓解率为25.0%，而安慰剂组为9.1%（Δ=15.9）。

Omilancor demonstrated a promising efficacy signal in both biologic naïve and biologic-experienced moderate to severe CD patients.

Omilancor在生物学初治和生物学经验的中度至重度CD患者中均显示出有希望的疗效信号。

Normalization of fecal calprotectin was induced in 33.3% of patients treated with omilancor compared to 14.3% in the placebo group (Δ=19.0).

33.3%接受omilancor治疗的患者粪便钙卫蛋白正常化，而安慰剂组为14.3%（Δ=19.0）。

In patients with histological activity in at least one segment at baseline, omilancor induces remission in all segments in 42.9% of patients relative to 20.0% in the placebo group (Δ=22.9).

在基线至少有一个节段具有组织学活性的患者中，omilancor诱导42.9%的患者所有节段缓解，而安慰剂组为20.0%（Δ=22.9）。

Oral omilancor was well tolerated in patients with CD and displayed a benign safety profile.

CD患者口服omilancor耐受性良好，显示出良好的安全性。

Title: Transcriptional Analysis of Colonic Biopsies from Patients with Ulcerative Colitis Treated with Omilancor.

题目：Omilancor治疗溃疡性结肠炎患者结肠活检的转录分析。

Poster: Board Number P2217, Monday October 23, 2023, 10:30 AM – 4:15 PM

Poster: Board Number P2217, Monday October 23, 2023, 10:30 AM – 4:15 PM

Predictive biomarker signatures from colonic biopsies were identified by using the RandomForest A.I. algorithm within NIMML’s TITAN-X drug development platform.

通过在NIMML的TITAN-X药物开发平台内使用RandomForest A.I.算法鉴定来自结肠活组织检查的预测性生物标志物特征。

A newly identified precision immunology biomarker signature predicts omilancor responders from non-responders with 75% accuracy and patients treated with omilancor and achieving clinical remission were identified with 100% accuracy.

新鉴定的精确免疫学生物标志物签名以75%的准确度预测来自无应答者的omilancor应答者，并且以100%的准确度鉴定用omilancor治疗并达到临床缓解的患者。

Predictive modeling of gene expression changes from baseline accurately differentiated patients treated with omilancor from those given placebo with 83% accuracy.

基因表达变化的预测模型从基线准确区分接受omilancor治疗的患者与接受安慰剂治疗的患者，准确率为83%。

Biomarkers upregulated by omilancor were associated with lipid metabolism, ion balance, and known critical elements of the LANCL2 pathway.

omilancor上调的生物标志物与脂质代谢，离子平衡和LANCL2途径的已知关键元素有关。

Biomarkers downregulated by omilancor were associated with immune systems processes, mainly linked to neutrophils and leukocyte trafficking.

omilancor下调的生物标志物与免疫系统过程有关，主要与中性粒细胞和白细胞运输有关。

The posters will be available under the “Publications” section of the NIMML’s website at www.nimml.org and at the ACG 2023 ePoster Hall during and after the meeting. Additionally, the peer-reviewed accepted abstracts will be published verbatim in a special supplement to the October 2023 issue of The American Journal of Gastroenterology..

海报将在NIMML网站的“出版物”部分www.NIMML.org和会议期间和之后的ACG 2023 ePoster大厅提供。此外，同行评审接受的摘要将在2023年10月发行的“美国胃肠病学杂志”的特别补充中逐字发布。。

About Ulcerative Colitis (UC)

关于溃疡性结肠炎

UC is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation, and ulcers in the lining of the large intestine (colon) and rectum. Symptoms include abdominal pain, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss, and malnutrition. Having UC puts a patient at increased risk of developing colon cancer.

UC是一种慢性自身免疫性炎症性肠病，可引起大肠（结肠）和直肠内层的炎症，刺激和溃疡。症状包括腹痛，直肠疼痛和出血，血便，腹泻，发烧，体重减轻和营养不良。患有UC会使患者患结肠癌的风险增加。

Diagnosis typically occurs in early adulthood and the disease requires maintenance treatment for the remainder of the patient’s life. UC is estimated to affect over 900,000 patients in the United States and over 1 million patients throughout the rest of the world. With 70% of addressable patients experiencing a second flare within one year and 30% of patients in remission failing to stay in remission for more than one year, there is an unmet medical need in UC for safer and more efficacious therapeutics..

诊断通常发生在成年早期，该疾病需要在患者生命的其余时间进行维持治疗。据估计，UC影响美国90多万患者和世界其他地区超过100万患者。70%的可寻址患者在一年内出现第二次发作，30%的缓解患者未能缓解一年以上，UC对于更安全，更有效的治疗方法的医疗需求尚未得到满足。。

About Crohn’s Disease (CD)

关于克罗恩病（CD）

CD is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation and ulcers in any segment of the gastrointestinal tract. CD impacts the end of the small bowel and beginning of the colon most commonly, which in turn can lead to symptoms of abdominal pain, increased abdominal sounds, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss and malnutrition.

CD是一种慢性自身免疫性炎症性肠病，其在胃肠道的任何部分引起炎症，刺激和溃疡。CD最常影响小肠末端和结肠开始，进而导致腹痛，腹音增加，直肠疼痛和出血，血便，腹泻，发烧，体重减轻和营养不良等症状。

There are four classes of CD and treatment depends on the level of severity. Current therapeutic options for severe disease, primarily biologics, have several limitations, which include but are not limited to safety risks for malignancies and infections, limited efficacy and lack of long-term maintenance options.

CD有四类，治疗取决于严重程度。目前用于严重疾病（主要是生物制剂）的治疗选择具有若干局限性，其包括但不限于恶性肿瘤和感染的安全风险，有限的功效和缺乏长期维持选择。

There is an urgent need to establish a consensus for a first-line therapy for CD and improve upon the existing constraints in administration and efficacy..

迫切需要就CD的一线治疗达成共识，并改善现有的给药和疗效限制。。

About Omilancor

关于Omilancor

By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is a first-in-class, oral, once-daily, gut restricted therapeutic designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory functions in regulatory T cells (Treg) within the site of inflammation.

通过激活LANCL2途径并调节免疫和上皮细胞中免疫和代谢信号之间的相互作用，omilancor是一流的口服，每日一次的肠道限制性治疗药物，旨在为肠道创造有利的调节微环境，减少炎症部位内调节性T细胞（Treg）中关键炎症介质的产生和增加抗炎功能。

Omilancor has completed Phase 2 clinical testing in UC patients showing a clinical remission of 30.4% with a placebo-adjusted 12-week clinical remission rate of 26.7% (p=0.01) for the 440 mg dose. Following demonstration of a statistically significant approvable primary endpoint for clinical remission in an active disease patient population, NImmune expects to initiate a global pivotal Phase 3 program (PACIFY I and PACIFY II trials) in UC patients in the second half of 2023.

Omilancor已完成UC患者的2期临床试验，显示440 mg剂量的安慰剂调整后12周临床缓解率为26.7%（p=0.01），临床缓解率为30.4%。在活动性疾病患者群体中临床缓解的统计学显着可批准的主要终点之后，NImmune预计将在2023年下半年在UC患者中启动全球关键的3期计划（PACIFY I和PACIFY II试验）。

Omilancor's target U.S. market size is expected to be valued at $394.9 billion 2021-2030, of which a peak annual market size of $49.5 billion is expected to occur in 2030. NImmune expects peak unadjusted revenue of $12.5 billion in 2030..

Omilancor的目标美国市场规模预计将在2021-2030年达到3949亿美元，其中预计到2030年将达到495亿美元的年度峰值市场规模。NImmune预计2030年将达到125亿美元的未调整收入峰值。。

About NIM-1324

关于NIM-1324

NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes.

NIM-1324是一种口服，系统分布的小分子治疗候选药物，可激活LANCL2，LANCL2是一种表面膜相关受体，负责调节与自身免疫性疾病相关的关键细胞和分子变化。通过激活LANCL2途径，NIM-1324增加了调节性CD4+T细胞的抗炎能力和稳定性，同时也支持吞噬细胞中自噬的代谢需求。

To date, treatment with NIM-1324 has reduced the production of interferon alpha in human peripheral blood mononuclear cells (PBMCs) from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus, rheumatoid arthritis, and multiple sclerosis.

迄今为止，用NIM-1324治疗已经减少了来自系统性红斑狼疮（SLE）患者的人外周血单核细胞（PBMC）中干扰素α的产生，并且在狼疮，类风湿性关节炎的小鼠模型中提供了对临床疾病和组织病理学的保护，和多发性硬化症。

Phase 2-ready NIM-1324 completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation. NIM-1324 target U.S. market size is expected to be valued at $226.0 billion 2021-2030, of which a peak annual market size of $23.1 billion is expected to occur in 2030.

第二阶段准备好的NIM-1324完成了第一阶段的临床试验，达到了所有的终点，并且在治疗范围内血浆暴露量呈剂量比例变化，没有累积。NIM-1324目标美国市场规模预计将在2021-2030年达到2260亿美元，其中预计到2030年将达到231亿美元的年度峰值市场规模。

NImmune expects unadjusted revenue estimates from NIM-1324 therapeutics to be valued at $2.3 billion from the 2028-2030 projections..

NImmune预计NIM-1324治疗药物的未经调整的收入估计将从2028-2030年的预测中价值23亿美元。。

About NImmune Biopharma

关于NImmune Biopharma

NImmune is a late-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization.

NImmune是一家后期精密免疫学生物制药公司，开发新型一流的生物标志物驱动免疫调节疗法。NImmune的商业模式以利用先进的计算建模，a.I.和生物信息学以及生物医学研究能力为免疫调节药物开发先驱创新的发现平台为基础，使高信念候选药物的快速和资本高效临床开发成为新药申请（NDA）申请和商业化。

The lead product candidate from NImmune’s internal discovery platform is omilancor, a wholly-owned Phase 3 oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis, with fast follower potential in Crohn’s disease, Psoriasis and other autoimmune diseases. Phase 2 first-in-patient data for omilancor in UC show potential best in class efficacy and safety.

NImmune内部发现平台的领先产品候选人是omilancor，这是一家国有的3期口服，每日一次，肠道受限，一流的治疗靶向LANCL2治疗溃疡性结肠炎，在克罗恩病，牛皮癣和其他方面具有快速的追随者潜力。自身免疫性疾病。UC中omilancor的第2阶段首次住院患者数据显示潜在的一流疗效和安全性。

To learn more, visit www.NIMMUNEBIO.COM or contact media@nimmunebio.com..

欲了解更多信息，请访问www.NIMMUNEBIO.COM或联系media@nimmunebio.com..