BLACKSBURG, Va.--(BUSINESS WIRE)--NImmune Biopharma ('NImmune”), a private late-clinical-stage precision inflammation and immunology (“I&I”) biopharmaceutical company developing novel biomarker-driven immunoregulatory therapeutics, today announced the acquisition of development and commercialization rights for omilancor in Asia.

弗吉尼亚州布莱克斯堡（商业新闻短讯）--NImmune Biopharma（“NImmune”）是一家私人临床晚期精确炎症和免疫学（“I＆I”）生物制药公司，开发新型生物标志物驱动的免疫调节疗法，今天宣布收购omilancor在亚洲的开发和商业化权利。

Covered markets include China, Macau, Hong Kong, Taiwan, Thailand, Singapore, South Korea, Cambodia, Indonesia, Myanmar, the Philippines, Thailand, and Vietnam. Upon closing of this transaction, NImmune will wholly own global rights to omilancor and the entire LANCL2 portfolio of immunoregulatory therapeutics.

涵盖的市场包括中国、澳门、香港、台湾、泰国、新加坡、韩国、柬埔寨、印度尼西亚、缅甸、菲律宾、泰国和越南。交易结束后，尼姆将完全拥有奥米兰科和整个LANCL2免疫调节治疗组合的全球权利。

Omilancor is a once-daily, oral, best- and first-in-class therapy in Phase 3 clinical development for ulcerative colitis (UC) and Phase 2 for Crohn’s disease (CD), with multiple I&I indications planned..

Omilancor是溃疡性结肠炎（UC）的3期临床开发和克罗恩病（CD）的2期临床开发中的一种每日一次的口服最佳一流疗法，计划有多种I＆I适应症。。

“The wind-down of LianBio, announced on February 13, 2024, provided an unprecedented opportunity to consolidate global rights to omilancor in NImmune and capture significant additional value for shareholders. We are very excited to continue late-stage development of omilancor and bring the best- and first-in-class potential of an oral therapeutic to patients with ulcerative colitis and Crohn’s disease,” said Dr.

“LianBio于2024年2月13日宣布停产，为巩固尼姆内奥米兰科的全球权利提供了前所未有的机会，并为股东带来了巨大的附加价值。我们非常高兴继续奥米兰科的后期开发，并为溃疡性结肠炎和克罗恩病患者带来最佳和一流的口服治疗潜力，”Dr。

Josep Bassaganya-Riera, Founder & CEO of NImmune. “The timing of this transaction could not have been more ideal as we launch the global Phase 3 program of omilancor in UC. We now look forward to completing ongoing discussions with potential global and regional strategic partners that can help to further accelerate Phase 3 timelines and bring the best-in-class potential of omilancor to address the unmet needs of millions of IBD patients in the U.S.

Josep Bassaganya Riera，NImmune的创始人兼首席执行官。“随着我们在坎特伯雷大学启动奥米兰科全球第三阶段项目，这笔交易的时机再理想不过了。我们现在期待着与潜在的全球和区域战略合作伙伴完成正在进行的讨论，这将有助于进一步加快第三阶段的时间表，并发挥奥米兰科同类最佳的潜力，以解决美国数百万IBD患者未满足的需求。

and worldwide.”.

以及全世界。”。

By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators such as TNF, increasing anti-inflammatory functions in regulatory T cells (Treg) and phagocytes within the site of inflammation while decreasing excessive or pathogenic effector immune responses such as Th1 and Th17.

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被设计用于在肠道中创造有利的调节微环境，减少关键炎症介质如TNF的产生，增加炎症部位内调节性T细胞（Treg）和吞噬细胞的抗炎功能，同时减少过度或致病性效应免疫反应，如Th1和Th17。

LANCL2 activation enhances the anti-inflammatory functions of Treg cells by amplifying IL-2 signaling and promoting metabolic reprogramming resulting in enhanced mitochondrial metabolism. Over 90% of downregulated genes in IBD are related to mitochondrial metabolism. Activation of LANCL2 with omilancor reverses this downregulation..

LANCL2激活通过扩增IL-2信号传导和促进代谢重编程来增强Treg细胞的抗炎功能，从而增强线粒体代谢。IBD中超过90%的下调基因与线粒体代谢有关。用omilancor激活LANCL2可以逆转这种下调。。

In a Phase 2 double-blind, randomized, placebo-controlled trial, oral once daily omilancor induced clinical remission in 30.4% of patients with active UC (78% w/ baseline MES of 3) or, a placebo-adjusted 26.7% (P = 0.01) with no identified treatment related adverse events. Ongoing development of a precision biomarker signature intended to serve as a companion diagnostic to omilancor may help to more precisely identify responders and maximize enduring clinical remission.

在一项2期双盲，随机，安慰剂对照试验中，30.4%的活动性UC患者（78%w/基线MES为3）或安慰剂调整后的26.7%（P=0.01）每天口服一次奥米兰科诱导临床缓解，没有发现与治疗相关的不良事件。正在进行的精确生物标志物签名的开发旨在作为奥米兰科的伴随诊断，可能有助于更准确地识别应答者并最大程度地延长临床缓解期。

Omilancor’s predictive biomarkers were developed with the guidance of the NIMML Institute’s TITAN-X platform, a proprietary advanced computational modeling and AI-powered precision medicine discovery engine that efficiently accelerates biomarker-driven I&I therapeutic development..

Omilancor的预测性生物标志物是在NIMML研究所的TITAN-X平台的指导下开发的，该平台是一种专有的先进计算建模和人工智能驱动的精密医学发现引擎，可有效加速生物标志物驱动的I＆I治疗开发。。

About NImmune Biopharma

关于NImmune生物制药

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是一家晚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的免疫调节疗法。NImmune的商业模式以一个发现平台为基础，该平台利用先进的计算建模，人工智能和生物信息学以及生物医学研究能力来开创免疫调节药物开发的创新，使高信念候选药物的快速和资本高效的临床开发成为新药申请（NDA）申请和商业化。

The lead product candidate from NImmune’s discovery platform is omilancor, a wholly owned oral, once-daily, gut-restricted, first-in-class therapeutic currently in Phase 3 clinical development, which targets LANCL2 for ulcerative colitis and Crohn’s disease. Published, final and complete Phase 2 proof-of-concept data for omilancor show potential best-in-class efficacy and safety.

NImmune发现平台的主要候选产品是omilancor，这是一家全资拥有的口服，每日一次，肠道受限，目前处于3期临床开发阶段的一流治疗药物，针对溃疡性结肠炎和克罗恩病的LANCL2。omilancor的已发布、最终和完整的第二阶段概念验证数据显示出潜在的同类最佳疗效和安全性。

For more information, please visit www.NIMMUNEBIO.COM or contact media@nimmunebio.com..

有关更多信息，请访问www.NIMMUNEBIO.COM或联系media@nimmunebio.com..