Antibiotic resistant 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

VE303 high dose associated with reduction in antibiotic resistance genes (ARGs) High VE303 strain colonization also associated with reduced ARGs Presence of ARGs increases the risk of drug-resistant infections Pivotal Phase 3 trial, RESTORATiVE303, underway CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vedanta Biosciences , a late clinical-stage company developing defined bacterial consortia as oral therapies with an initial focus on gastrointestinal diseases, today announced the oral presentation of additional analyses from its completed Phase 2 CONSORTIUM study of VE303, an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent Clostridioides difficile infection (rCDI). These analyses document the positive impact of VE303 treatment on the levels of antibiotic resistance genes (ARG) in the gut microbiomes of patients enrolled in the CONSORTIUM study, revealing associations between higher dosage and colonization of VE303 strains with lower levels of ARGs. The late-breaking oral presentation will be given this Friday October 18, in Los Angeles, CA, as part of Infectious Diseases Week (IDWeek) 2024. “The intestinal tract is ordinarily an important line of defense against antibiotic-resistant organisms. A gut microbiome that is disrupted by multiple courses of antibiotics can become a reservoir for these potentially dangerous organisms, which could lead to development of a hard-to-treat infection elsewhere in the body,” said Jeffrey L. Silber, M.D., Chief Medical Officer of Vedanta Biosciences. “By helping to restore a healthier, more diverse gut microbiome, administration of VE303 appears to reduce the prevalence of organisms carrying these resistance genes. The analyses we are presenting at IDWeek document an additional dimension to VE303’s therapeutic profile, in addition to its ability to prevent further recurrence of CDI.” In the Phase 2 CONSORTIUM Study, VE303 was well tolerated, reduced the odds of CDI recurrence by >80% compared with placebo, colonized the gut well, and led to early restoration of healthy, diverse, native gut bacteria. The results of the study were published in the Journal of the American Medical Association in 2023. During the study, serial stool samples were analyzed for the presence of ARGs over time, beginning at the completion of antibiotic treatment for the most recent CDI episode. Compared with pre-treatment baseline samples, when study participants across the treatment groups were carrying an average of almost 60 ARGs, receipt of the VE303 high dose resulted in significantly fewer ARGs overall (p<0.005) and fewer ARGs carried by Proteobacteria (p<0.005), including Klebsiella , which can cause potentially serious infections. These significant reductions were seen by the end of treatment on Day 14 and were observed through Day 28 (the final timepoint in this analysis). In contrast, recipients of the VE303 low dose or placebo did not have a reduction in ARGs. Vedanta’s late-breaking oral presentation is titled “Impact of VE303, a Defined Bacterial Consortium, on Antimicrobial Resistant Gene Prevalence in Patients with Clostridioides difficile Infection (CDI)” and will be presented at 1:45pm PDT on Friday October 18 by Dr. Rajita Menon, Vedanta’s Director of Modeling & Statistics. About the RESTORATiVE303 Study RESTORATiVE303 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the safety and efficacy of VE303 in patients at high risk for recurrence of CDI after completing a course of antibiotics for a prior CDI episode. The trial is being conducted at approximately 200 sites in 23 countries, across five continents. The primary endpoint is the comparison of CDI recurrence rates at eight weeks in the VE303 and placebo groups. The Phase 3 study design and VE303 dosing regimen are based on the completed Phase 2 trial, in which VE303 met its primary endpoint for preventing CDI recurrence at eight weeks and was observed to be generally well-tolerated. For more information on RESTORATiVE303 ( NCT06237452 ), please visit clinicaltrials.gov. About VE303 VE303 is a potential first-in-class Live Biotherapeutic Product candidate for the prevention of recurrent Clostridioides difficile infection (rCDI). It consists of an orally administered defined bacterial consortium composed of eight strains that were selected using Vedanta’s product discovery engine. VE303 is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypass the need to rely on direct sourcing of donor fecal material of inconsistent composition. Vedanta published positive results in JAMA in April 2023 from the Phase 2 CONSORTIUM trial, in which VE303 met its primary endpoint of preventing C. difficile infection recurrence at eight weeks. Vedanta is currently enrolling patients into a registrational Phase 3 study, RESTORATiVE303, for the prevention of recurrent C. difficile infection. Vedanta Biosciences received a $5.4 million research grant from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) in 2017 and a contract for up to $114 million from Biomedical Advanced Research and Development Authority (BARDA) to support clinical studies of VE303. The U.S. Food and Drug Administration (FDA) granted VE303 Orphan Drug Designation in 2017 and Fast Track designation in 2023 for the prevention of recurrent CDI. About IDWeek 2024 IDWeek 2024 TM is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). With the theme “Advancing Science, Improving Care,” IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2024™ takes place Oct. 16-19 at the Los Angeles Convention Center (1201 S Figueroa St) in Los Angeles, CA. For more information, visit . About Vedanta Biosciences Vedanta Biosciences is a late clinical-stage company developing defined bacterial consortia as oral therapies with an initial focus on gastrointestinal diseases. The company’s lead assets are potential first-in-class oral therapies: VE303, in a Phase 3 registrational trial for prevention of recurrent C. difficile infection, and VE202, in a Phase 2 trial for treatment of ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria. The product engine, supported by broad foundational intellectual property, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale. Contacts Media Tom Donovan TBCVedanta@tenbridgecommunications.com Investors Chris Brinzey +1 617-835-9304 Chris.Brinzey@westwicke.com