Cystic Fibrosis

Study to evaluate the safety and tolerability of KIT2014, an inhaled peptide therapy designed to enhance Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function, act as a bronchodilator, and reduce inflammation KIT2014 is being developed as a CFTR enhancer, acting as an add-on treatment to existing CFTR modulators, targeting improved lung function and reduced inflammation in Cystic Fibrosis patients TURIN, Italy, Oct. 30, 2024 /PRNewswire/ -- Kither Biotech, a clinical-stage biotech company focused on innovative therapies for respiratory diseases, today announced the start of a Phase 1 clinical study of KIT2014, a novel inhaled peptide therapy for Cystic Fibrosis (CF). KIT2014 is designed as an add-on therapy to existing CFTR modulators and works by enhancing CFTR gating, promoting bronchodilation, and reducing inflammation through PDE3/4 inhibition. "The initiation of this Phase 1 study marks a significant step forward for Kither Biotech and the CF community," said Dr. Dimitrios Goundis, CEO of Kither Biotech. "KIT2014 addresses mucus obstruction, chronic inflammation, and bronchoconstriction-three critical challenges that affect CF patients even with current CFTR modulators. We are excited to begin assessing the potential of KIT2014 to improve treatment outcomes." About the KIT2014 Study This Phase 1 double-blind, placebo-controlled study will primarily evaluate the safety and tolerability of single and multiple doses of KIT2014 in healthy adult volunteers, followed by an assessment of pharmacokinetics. For more information, visit clinicaltrials.gov (NCT06659757). About Cystic Fibrosis Cystic fibrosis is a life-limiting genetic disease that affects approximately 130,000 people worldwide. It is caused by mutations in the CFTR gene, which lead to defective chloride ion transport across cell membranes, resulting in the buildup of thick, sticky mucus in the lungs. This mucus impairs mucociliary clearance, promotes chronic bacterial infections, and triggers persistent inflammation, leading to progressive lung damage. Unmet Medical Need for KIT2014 Despite significant advances from CFTR modulators, many CF patients continue to experience persistent inflammation and recurring infections, severely impacting lung function and overall health. Neutrophil-driven inflammation, marked by elevated levels of neutrophil elastase, remains a major contributor to lung damage in CF patients. KIT2014 addresses these issues with an innovative solution that directly targets this inflammation, reduces neutrophil activation, and provides an additional therapeutic benefit that complements existing CF treatments. KIT2014 has the potential to improve significantly long-term outcomes for CF patients. Mechanism of Action of KIT2014 KIT2014 is a peptide-based therapy designed to target these fundamental issues by acting on multiple pathways in CF lung disease. Delivered through inhalation, it allows direct targeting of the lungs. By inhibiting phosphodiesterase 3/4 (PDE3/4), it elevates cyclic adenosine monophosphate (cAMP) levels. In bronchial epithelial cells, this mechanism enhances CFTR gating and improves chloride ion transport, while in airway smooth muscle cells, it acts as a bronchodilator. Additionally, KIT2014 reduces neutrophil-driven inflammation through PDE3/4 inhibition. Together, these mechanisms position KIT2014 as a promising add-on to existing CFTR modulator therapies. About Kither Biotech Kither Biotech is a clinical-stage biotech company focused on developing innovative therapies for respiratory diseases. Kither Biotech's lead program, KIT2014, is an innovative inhaled peptide therapy aimed at enhancing CFTR function, providing bronchodilation, and reducing inflammation in CF patients. By targeting multiple pathways in CF lung disease, Kither Biotech is committed to addressing unmet medical needs and improving the quality of life for patients suffering from severe respiratory conditions. The company has successfully raised $26 million to date from investors including Claris Ventures, 2Invest, 3B Future Health, CDP Venture Capital, Italian Angels for Growth, Club degli Investitori, Ersel and ACE Venture. For more information, please visit and follow us on LinkedIn. SOURCE Kither Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Publication describes the structure of phage Pa193, a top candidate for inclusion into Armata's multi-phage anti-Pseudomonas clinical products LOS ANGELES, Oct. 30, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced a paper in Communications Biology, published by Nature Portfolio. The publication, titled, "Cryo-EM analysis of Pseudomonas phage Pa193 structural components," describes the structure of phage Pa193. Pa193 is representative of a family of phages present in Armata's multi-phage clinical candidate, AP-PA02, which the company is developing to treat chronic Pseudomonas aeruginosa infections in patients with cystic fibrosis (CF) or non-cystic fibrosis bronchiectasis (NCFB). "We are very pleased to simultaneously advance the fundamental understanding of phage structure while remaining laser focused on phage function in full clinical development. One of our phage clinical candidates contributed to the important learnings from this study," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "As we continue to advance our proprietary development programs, which are founded on uncompromising science and rigorously designed clinical trials, this study furthers our understanding of phage structural components and how changes in phage biology may expand their clinical utility to other dangerous pathogens beyond P. aeruginosa, potentially informing future development plans." Dr. Gino Cingolani, Anderson Family Endowed Chair in Medical Education, Research & Patient Care and Professor in the Department of Biochemistry and Molecular Genetics, The University of Alabama at Birmingham, and co-author of the paper, stated, "This research highlights our ability to decipher a whole virus at the single atom resolution. Leveraging cryogenic electron microscopy, proteomics and bioinformatic analysis, we are now able to take a complete inventory of all structural components of a large macromolecular assembly, such as Pa193. The opportunities are endless. From a basic-science standpoint, understanding both the architecture and design principles of Pa193 provides valuable insight into its stability and mechanisms of genome-delivery. These findings can be generalized to other members of the Pa193 phage family and aid in structure prediction and protein engineering, valuable to using phages as biomedicines for therapeutic applications." The full publication can be found here: About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing. Forward Looking Statements This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant current Good Manufacturing Practices; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2024, and in its subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Media Contacts: At Armata: Pierre Kyme Armata Pharmaceuticals, Inc. [email protected] 310-665-2928 x234 Investor Relations: Joyce Allaire LifeSci Advisors, LLC [email protected] 212-915-2569 SOURCE Armata Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ViaNautis Bio Signs Strategic Collaboration Agreement with Lilly to leverage its polyNaut® platform to develop novel products delivering genetic medicines Multi-year collaboration will use ViaNautis’ non-immunogenic polyNaut® nanovesicles that precisely target specific tissues and cell types Cambridge, UK, 28 October, 2024 – ViaNautis Bio ("ViaNautis" or the "Company"), a groundbreaking biotechnology company at the forefront of delivering targeted genetic nanomedicines, today announces a collaboration with Eli Lilly and Company (“Lilly”). Under the terms of the agreement, ViaNautis will receive an initial upfront payment from Lilly, with the short-term potential for additional payments including research-based milestones. Further milestones and royalties would be due should specific cargo-loaded polyNaut®-based products enter the clinic and reach commercialisation. This collaboration will leverage ViaNautis’ platform for precise delivery of genetic cargos to prioritised tissues to address significant unmet medical needs. ViaNautis' proprietary polyNaut® nanovesicles are designed to deliver genetic materials with precise targeting of specific tissues and cell types. This technology aims to improve current genetic medicine delivery, potentially transforming treatment options for various diseases. Dr Francesca Crawford, co-founder of ViaNautis, commented: "This collaboration with Lilly is a testament to our polyNaut® platform, which is also driving a highly differentiated emerging pipeline for severe life-limiting diseases. Combining our scientific know-how to precisely deliver genetic nanomedicines targeting difficult-to-reach sites, with Lilly's extensive drug development and commercialization expertise will accelerate the creation of novel therapies to improve patient outcomes." Dr Adi Hoess, Chief Executive Officer of ViaNautis, said: “I am very excited about our collaboration with Lilly to develop novel genetic medicines for patients in need. I want to thank Fran and the team for their hard work in getting to this key milestone and I look forward to working with Lilly to accelerate our shared vision of delivering targeted genetic medicines.” *ENDS* For further information on the Company please visit www.vianautis.com or contact: ViaNautis:Dr Adi Hoess, CEO Email: adi.hoess@vianautis.com ICR Healthcare:Amber Fennell, Namrata Taak, Kris LamEmail: vianautis@consilium-comms.comTel: +44 (0)20 3709 5700 About ViaNautis ViaNautis, was founded in 2018 as a spin-off from UCL. The company’s core mission is to exploit the unique capabilities of the revolutionary polyNaut® technology. PolyNaut® is a versatile nano-engineered polymer technology designed for targeted intracellular delivery. This innovative technology enables polymer nanoparticles to deliver a wide range of payloads from small molecules to genetic materials creating 'a bionic nanoparticle.' The highly adaptable polymer structure of polyNaut® can be formulated to encapsulate a wide array of genetic cargoes, with sizes exceeding current standards for viral and non-viral delivery. Notably, it enables therapeutic efficacy of encapsulated molecules through direct delivery to the cell cytoplasm, facilitated by GOTO® technology for intracellular shuttling. PolyNaut® is set apart from conventional non-viral delivery technologies through its remarkable ability to target specific cells and penetrate biological barriers, including the challenging blood-brain barrier. PolyNaut® nanoparticles, when functionalised for CNS delivery through transcytosis, exhibit exceptional brain uptake. Deploying its state-of-the-art polyNaut® platform, ViaNautis is at the forefront of pioneering new therapies for CNS diseases and cystic fibrosis. The company is actively building an internal pipeline and collaborating with leading pharmaceutical and biotech companies to unlock the potential of promising genetic molecules as well as new therapeutic platforms. For more information, connect with us on https://www.linkedin.com/company/vianautis/ and visit www.vianautis.com.