Prosthetic joint infection

Nodenza Venture Partners invests in Trellis Bioscience Lead product TRL1068 targets biofilm, estimated to cause 60-70% of antibiotic resistant infections New York, October 22, 2024 – Nodenza Venture Partners (“Nodenza”), today announces its investment in Trellis Bioscience (“Trellis”), a clinical-stage company focused on discovering and developing native human monoclonal antibodies to treat and prevent drug-resistant, life-threatening infectious diseases. Trellis has developed a patented, proprietary technology (CellSpot) to clone genes of rare fully-human therapeutic monoclonal antibodies (mAbs) from memory B-cells of the blood of individual human donors. CellSpot has identified a high-affinity, broad-spectrum native human antibody, TRL1068, which targets and disrupts bacterial biofilm, a physiological factor promoting drug resistance in most clinically relevant multi-drug-resistant bacteria species, both gram positive and gram negative. TRL1068 is being developed for the treatment of chronic prosthetic joint infection (“PJI”), a chronic infection which requires, as standard of the care, the surgical removal of the prostheses with an estimated cost to the US health system of more than $10bn a year. In addition to PJI, it is estimated that biofilm is the cause of 60-70% of antibiotic resistant infections. TRL1068 has been granted Fast Track and QIDP designations and orphan drug designation for PJI and infective endocarditis by the U.S. Food and Drug Administration (FDA). Chronic PJI always forms biofilms on the prosthesis, thereby shielding the bacteria from eradication by antibiotics, being the reason for PJI to be a difficult-to-treat disease. As biofilm cannot be removed by antibiotics or any other non-invasive treatment, the current standard treatment of chronic PJI is a complex two-stage surgical procedure consisting of removal and replacement of the infected prosthesis. This costly and invasive two-stage process substantially and adversely affects quality of life, with increased immobility and morbidity in addition to decreased 5-year survival rates in patients with PJI when compared with non-infected patients that receive a prosthetic joint replacement. In a clinical proof-of-concept trial, published in a peer-reviewed article in the prestigious AAC Journal, TRL1068 has demonstrated the ability to disrupt the bacterial biofilm barrier to antibiotic access, allowing antibiotics to be efficacious without surgical intervention: In 25% of TRL1068-treated patients, biofilm was removed below the limit of detection after only 7 days of treatment, a finding that has never been observed in this patient population.64% of chronic PJI patients treated with an infusion of a single dose of TRL1068 and standard antibiotics had a bacterial biofilm burden below 100 CFU/mL sonication fluid after only 7 days of treatment. Although the sample size is small (n=11), a favourable comparison to historical data where only 15% of PJI patients are below that mark, suggesting that a treatment period 8 times longer, as planned in a Phase 2 study, will be highly efficacious.TRL1068 was well-tolerated across all three dose groups with no drug-related adverse events.The results of this initial exploratory study have provided strong evidence of efficacy across a diverse set of bacterial species, safety, and pharmacokinetic data to guide the design of a pivotal clinical study of TRL1068 for PJI with the goal to treat the infection without the need for a complex replacement surgery. Ross Morton, Managing Partner of Nodenza Venture Partners, said: “Antibiotic resistance is a significant and growing global threat, with insufficient investment to identify urgently needed new approaches. Trellis stands out with its truly novel and innovative approach to address antibiotic resistance. Through the application of its unique CellSpot technology, Trellis has the potential to be at the forefront of innovation in this critical field. CellSpot and TRL1068 align perfectly with Nodenza Venture Partners’ strategy of identifying and investing in disruptive technologies and therapies with the potential to deliver exceptional benefits to patients. We believe that Trellis has the potential to generate a multi-fold return on for Nodenza.” Stefan Ryser, Ph.D, President & CEO of Trellis Bioscience, commented: “Nodenza’s deep expertise of the pharmaceutical and biotech industry, and their recognition of the novelty of biofilm disruption, makes it an ideal investment partner for Trellis Bioscience as we prepare to advance TRL1068 rapidly through the clinic. The positive data generated to date give us confidence in the potential for a successful clinical study that may result in early FDA marketing authorisation given the five times higher mortality of the PJI standard of care surgery versus an aseptic prostheses replacement as well as the lack of new mechanisms to tackle the specific challenges of prosthetic joint infection. Nodenza has also recognized the enormous potential of TRL1068 beyond PJI as it addresses the broader global threat of antibiotic resistance.” Contacts: Nodenza Venture Partners Ross Morton, Managing Partnerinfo@nodenza.com Mo Advisory PRmo@mopradvisory.comMo Noonan / Jonathan Birt Notes to Editors About Nodenza Venture PartnersNodenza Venture Partners provides financial and operational support to early-stage and pre-commercial biotech and medtech companies and products designed to bring exceptional patient benefit. Our bi-modal investment strategy combines early-stage opportunities – advancing new treatment modalities through active IND to phase 2 - with pre-commercial targets supporting their transition from scientific to commercial companies delivering strong upside potential. Established by a team of experienced life sciences entrepreneurs, founders and leaders, our approach leverages Nodenza’s extensive expertise in the creation and growth of new companies, as well as late-stage product development and launch. For more information visit us at https://www.nodenza.com Trellis BioscienceTrellis Bioscience is a clinical-stage company focused on discovering and developing native human monoclonal antibodies to treat and prevent drug-resistant, life-threatening infectious diseases. Antibodies are the immune system's most potent natural weapon against disease. Trellis's innovative proprietary technology CellSpot™ overcomes technical obstacles that have long hindered exploiting the full human antibody repertoire. This ideal source of drugs focuses on the selection of elite antibodies that bind highly conserved target epitopes with high affinity. To learn more, visit trellisbio.com. Attachment Nodenza Trellis Investment Final

SUZHOU, China, Oct. 16, 2024 /PRNewswire/ -- TenNor Therapeutics, a clinical stage company dedicated to developing new therapies to address unmet needs in infectious diseases, announced today the initial closing of a Series E financing round for more than 300 million RMB. New investor AMR Action Fund joined Zhongshan Venture Capital and other existing investors in the round. The proceeds will be used to support the development and to seek regulatory approval in China of rifasutenizol, which could become the first new drug developed specifically for Helicobacter pylori infection in more than 30 years. "We are extremely glad to have the financial support from AMR Action Fund, Zhongshan Venture Capital, and other existing investors," said Dr. Zhenkun Ma, Founder and CEO of TenNor Therapeutics. "TenNor is dedicated to addressing the challenges of drug-resistant infections in China and around the world by innovating solutions for diseases currently without adequate therapies. With the additional funding, TenNor is well positioned to seek regulatory approval and bring to market rifasutenizol, a novel therapy for Helicobacter pylori infections, while also advancing a second product that will target prosthetic joint infections and similar infections associated with medical devices." "The global burden of drug-resistant bacterial infections is staggering and only getting worse, with recent data in The Lancet indicating that nearly 40 million people will die from antimicrobial resistance by 2050," said AMR Action Fund Chief Executive Officer Henry Skinnner, PhD. "We are pleased to support the team at TenNor as they advance the development of novel antibiotics that could save the lives of patients around the world and significantly reduce the suffering associated with these intractable infections." "TenNor is a leading company with multiple assets in late-stage of clinical development for the treatment of diseases associated with bacterial infections and metabolism," said Cheng Zhang, Chairman of Zhongshan Venture Capital, "TenNor adopts a first-line strategy to address major unmet needs in China. The products TenNor is developing has significant market potential in China and around the world. We are very glad to support this round of investment together with AMR Action Fund, a global leader in the antimicrobial space." TenNor develops differentiated products for diseases associated with bacterial infections and metabolism that currently lack adequate therapeutic options. The company adopts a business strategy to develop first-line therapies for indications with clear unmet medical needs and major market potential to ensure commercial success. TNP-2198 (rifasutenizol) is a novel multi-targeting drug candidate with a synergistic mechanism of action against anaerobic and microaerophile bacteria. It has potential to become the first new drug developed specifically for Helicobacter pylori infection in more than 30 years. TNP-2198 could play an important role in supporting the large-scale screening-and-eradication strategy to prevent gastric cancers in regions with high gastric cancer rate. TenNor is completing a phase 3 clinical trial of TNP-2198 in China and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). TNP-2092 (rifaquizinone) is a novel triple targeting drug candidate designed to address the dual challenges of antimicrobial resistance and persistence associated with medical device infections. TenNor has completed six phase 1 and phase 2 clinical trials for TNP-2092 for injection and is planning for a phase 3 multiregional clinical trial for the treatment of prosthetic joint infections. TNP-2092 has received QIDP, Fast Track and Orphan Drug designations from the U.S. FDA. About TenNor Therapeutics TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products against diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology platform and a strong new drug development portfolio with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address the unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. For more information please visit: . SOURCE TenNor Therapeutics (Suzhou) Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

▎药明康德内容团队报道 今日（10月16日），丹诺医药宣布完成逾3亿人民币E轮融资的首批交割。这轮融资由中山投控旗下中山创投和AMR Action Fund (AMR基金) 共同领投，所获资金用于支持核心新药研发管线，包括治疗幽门螺杆菌感染新药候选物TNP-2198和治疗植入医疗器械感染新药候选物TNP-2092的后期临床试验和商业化。 “我们非常高兴获得中山创投和AMR基金的支持，” 丹诺医药创始人、董事长和首席执行官马振坤博士表示。“丹诺医药致力于解决细菌耐药和耐受带来的双重挑战，为尚缺乏合理治疗手段的细菌感染和菌群代谢相关疾病提供解决方案。这轮融资将支持丹诺医药加速推进治疗幽门螺杆菌感染新药候选物TNP-2198的商业化，以及治疗植入医疗器械感染新药候选物TNP-2092的后期临床试验。” “丹诺医药专注于细菌感染和菌群代谢相关疾病领域新药研发，治疗幽门螺杆菌感染的首创新药产品TNP-2198已经完成III期临床实验，并且多个在研新药候选物也已经进入后期临床试验阶段，”中山创投董事长张程表示。“丹诺医药采取差异化的产品开发策略，以解决国内外市场未满足需求，具有广阔的市场前景。我们很高兴有机会与全球抗感染领域的头部投资机构AMR基金合作，共同参与这轮投资。” “目前全球抗生素耐药细菌感染的状况令人震惊，并且日趋严重。《柳叶刀》发表的最新数据表明，到 2050 年全球将有近 4000 万人死于抗生素耐药细菌的感染，”AMR 基金首席执行官 Henry Skinner 博士表示。“我们非常高兴为丹诺医药提供资金支持，丹诺团队正在快速推进新型抗菌药物的研发，这些新药产品有希望挽救全球无数患者的生命，并减少耐药细菌感染带来的痛苦。”  丹诺医药专注细菌感染和菌群代谢相关疾病，聚焦在尚缺乏合理治疗手段、并具有巨大市场前景的适应症，目前已经有多个新药候选物进入后期临床试验阶段。丹诺医药采取一线疗法的新药研发策略，以确保商业化成功。 TNP-2198 (利福特尼唑) 是一个对微需氧菌和厌氧菌具有独特多靶点协同作用机制的新药候选物，有望成为30多年以来全球第一个针对幽门螺杆菌感染开发的新药产品，以应对在胃癌高发地区开展幽门螺杆菌感染筛查-根除、预防胃癌策略的需求。丹诺医药已经在中国完成 TNP-2198 的5项1期和2期临床试验，目前3期临床试验已经接近尾声。丹诺医药已经获得美国 FDA 对TNP-2198合格感染性疾病产品（QIDP）和快速通道资格。 TNP-2092 (利福喹酮) 是一个具有独特三靶点协同作用机制的新药候选物，用于应对植入医疗器械感染中抗生素耐药和耐受所带来的双重挑战。丹诺医药已经在中美完成 TNP-2092 注射剂的6项 I期和 II期临床试验，并准备开展一项治疗人工关节感染的国际多中心 III 期临床试验。丹诺医药已经获得美国FDA 对TNP-2092的 QIDP、快速通道资格和孤儿药资格。 参考资料： [1] 丹诺医药新闻稿. 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。