Tularemia

THURSDAY, Jan. 2, 2025 -- Cases of a bacterial infection called “rabbit fever” have been increasing during the past decade. Cases of tularemia increased by 56% during the 2010s compared to the previous decade, researchers report in the CDC’s Morbidity and Mortality Weekly Report . Half of all the nearly 2,500 reported cases between 2011 and 2022 came from four states: Arkansas, Missouri, Kansas and Oklahoma. However, cases have been reported in 47 states. “The case fatality rate of tularemia is typically less than 2% but can be as high as 24%,” the research team led by CDC epidemiologist Kiersten Kugeler noted. The disease is caused by the bacterium Francisella tularensis , “an organism that has been designated a tier-1 select agent based on its potential for misuse as a bioweapon,” the researchers wrote. People can become infected by tick or deer fly bites, drinking water contaminated with the bacteria, or coming into contact with infected animals like rabbits or rodents, the CDC says. Tularemia is treatable with antibiotics, but can develop into pneumonia if not addressed, researchers said. Symptoms can include skin ulcers, eye infections, sore throat, cough, difficulty breathing, and swollen lymph glands, depending how the bacteria passed into a person’s body. American Indian/Alaskan Native people are particularly at risk, with a tularemia infection rate about five times that among whites, researchers said. Incidence was highest among children 5 to 9 years old, as well as senior men 65 and older. Researchers noted that the findings might reflect an actual increase in human infections, or improved detection of new cases thanks to better lab tests. People can protect themselves against tularemia by using insect repellant and wearing long pants, long sleeves and long socks to ward off ticks and deer flies, the CDC says. They also should avoid sick animals, not mow over dead animals, and wear gloves when handling wild animals, the CDC said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Overwhelming shareholder support in favour of take-private transaction with Aditxt Studies presented at IDWeek 2024™ demonstrate ATI-1701 provides full protection against lethal tularemia in animal models after one year Alignment with U.S. Food and Drug Administration on development requirements for ATI-1801 NDA Submission HALIFAX, Nova Scotia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, today announced its financial and operational results for the second quarter of its fiscal year 2025, which ended on September 30, 2024. All figures are stated in Canadian dollars unless otherwise stated. “During fiscal year 2025, Appili shareholders voted overwhelmingly in favor of the transaction with Aditxt, facilitating our access to capital and activating promising opportunities for Appili,” said Dr. Don Cilla, President and CEO of Appili. “The shareholder vote is an important milestone for Appili and brings us one step closer to ‘Making Promising Innovations Possible Together’ through Aditxt’s social incubator platform.” ATI-1701, Biodefense Vaccine Candidate with Strong U.S. Air Force Academy Funding Commitments ATI-1701, a novel live-attenuated vaccine for preventing F. tularensis, has previously secured US$14 million in awards from the United States Air Force Academy (“USAFA”). Under the cooperative agreement with USAFA, Appili manages a comprehensive development program, including nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities supporting an IND submission in 2025. Recent data presented by Appili's scientific team at the Military Health System Research Symposium and IDWeek 2024™ demonstrated strong efficacy results. Studies showed that a single dose of ATI-1701 provided full protection against lethal tularemia in animal models, with protection for one year after vaccination. Additional research highlighted the heightened risk of tularemia outbreaks in conflict zones and positioned ATI-1701 as a potentially valuable tool in protecting warfighters. Appili has recently had positive interactions with the United States Food and Drug Administration (“FDA”) in the form of a pre-IND meeting, confirming the development pathway for the majority of Appili’s proposed development plan. Appili is currently in the process of implementing suggested changes in its development effort. ATI-1801, Demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies ATI-1801, a novel topical formulation of paromomycin (15% w/w), is under advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally. In a recent response to Appili’s Type B meeting request, the FDA agreed with the Company’s proposed strategy to establish a scientific bridge between previous clinical trial material and new drug product batches. The approach enables Appili to leverage key results from the clinical dossier for ATI-1801 licensed from U.S. Army Medical Materiel Development Activity, including the successful results of a Phase 3 study, and allows the completion of an New Drug Application much sooner than if additional clinical data were required. ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. The company is evaluating ATI-1801’s eligibility for a priority review voucher (“PRV”), which, if confirmed, would make it the second PRV-eligible program at Appili, alongside ATI-1701, which is potentially eligible for a PRV pending renewal of certain U.S. legislation. LIKMEZ™ (ATI-1501), FDA Approved Liquid Oral Reformulation of the Antibiotic Metronidazole In September 2023, Appili, together with its U.S. partner, Saptalis Pharmaceuticals LLC., announced the approval by the FDA of LIKMEZ™ (ATI-1501), LIKMEZ® is the first and only FDA-approved liquid formulation of metronidazole providing a novel prescribing option for patients with difficulty swallowing or experiencing taste-related hurdles. LIKMEZ, with patent coverage through 2039, addresses the unmet need in patients with dysphagia to avoid risks associated with drug compounding, and discontinuation related anti-microbial resistance. In November 2023, Saptalis, through a commercialization partner, launched LIKMEZ in the U.S. and the product is now available to patients and doctors. Appili earned milestone payments from Saptalis and is entitled to receive additional sales-based milestone payments and royalties from Saptalis based on sale of the product. Saptalis is currently in the process of identifying an alternative commercialization partner. Aditxt Arrangement On November 6, 2024, shareholders of the Company overwhelmingly voted in favour of a special resolution approving a plan of arrangement pursuant to which Aditxt Inc. (NASDAQ:ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir, Inc. will acquire all of the issued and outstanding Class A common shares of the Company by way of a court-approved plan of arrangement under the Business Corporations Act (Ontario) (the “Transaction”). Approximately 29.50% of the outstanding Appili Shares were voted by shareholders and the Transaction was approved by 99.79% of the votes cast. For further details regarding the Transaction, please see Appili’s press release dated April 2, 2024 and Appili’s management information circular (the “Circular”) dated October 4, 2024, a copy of which is available under Appili’s profile on SEDAR+ (sedarplus.ca). Appili and Aditxt are in the process of satisfying the remaining closing conditions, which include: (1) the Company obtaining final court approval for the Transaction, and (2) Aditxt securing sufficient financing to complete the Transaction. Subject to satisfaction or waiver of the remaining closing conditions, Appili expects the Transaction to close in December 2024. Financial Results The Company prepares its financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook–Accounting. All figures are stated in Canadian dollars unless otherwise stated. The net loss and comprehensive loss of $0.8 million or $0.01 loss per share for the three months ended September 30, 2024, was $0.2 million lower than the net loss and comprehensive loss of $1 million or $0.01 loss per share during the three months ended September 30, 2023. This relates mainly to an increase in research and development expenses of $1 million, an increase in financing costs of $0.1 million and a decrease in revenue of $0.3 million. This increase was offset by a decrease in general and administrative expenses by $0.1 million, an increase in government assistance of $1.3 million, and an increase of $0.2 million in foreign exchange gain. As of September 30, 2024, the Company had cash of $0.7 million, compared to $0.1 million on March 31, 2024. As of November 13, 2024, the Company had 121,266,120 issued and outstanding Common Shares, 11,520,281 stock options, and 41,356,874 warrants outstanding. This press release should be read in conjunction with the Company’s unaudited interim condensed consolidated financial statements for the second quarter of the 2025 fiscal year and the related MD&A, copies of which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca. About Appili TherapeuticsAppili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. The Company is currently advancing a diverse range of anti-infectives, including an FDA approved ready-made suspension of metronidazole for the treatment of antimicrobial infections, a vaccine candidate to eliminate a serious biological weapon threat, and a topical antiparasitic for the treatment of a disfiguring disease. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com. Forward looking statementsThis news release contains “forward-looking statements”, including with respect to the funding commitment from USAFA and expected timing of invoice payment, advancing program towards IND, further anticipated milestones and the timing thereof, the Company’s development plans and timelines with respect to ATI-1501, ATI-1701 and ATI-1801, the timing of any milestone and/or royalty payments in respect of ATI-1501, consideration to be received by shareholders in connection with the proposed Transaction, the expected timing and process to complete the Transaction, and the Company’s expectations with respect to its ability to operate as a going concern and satisfy its ongoing working capital requirements. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in (i) the annual information form of the Company dated June 25, 2024, (ii) the Cicular, and (iii) the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law. All statements included in this press release relating to the Arrangement are qualified by reference to the “Forward Looking Statements” section included in the Arrangement Press Release. Media Contact:Jenna McNeil, Communications ManagerAppili Therapeutics E: JMcNeil@AppiliTherapeutics.com Investor Relations Contact:Don Cilla, President and CEOAppili TherapeuticsE: Info@AppiliTherapeutics.com

ABINGDON, United Kingdom, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Emergex Vaccines Holding Limited, a clinical-stage biotechnology company that is addressing major global infectious diseases through the development of synthetic T cell-priming vaccine and immunotherapy candidates, today announced that the Company has changed its name to Gylden Pharma Limited (‘Gylden’ or the ‘Company’). The name change reflects the Company’s expanded product pipeline – that along with a focus on infectious disease prophylactic vaccines and advanced proprietary core technologies, includes advanced delivery and R&D assets acquired via the purchase of Zosano Pharma in October 2022. The Company’s broadened core technologies (that include not only a nanoparticle-based delivery platform but also microneedle array patch and immunoproteomics/multi-omics technologies, as well as in-house cGMP nanomedicine manufacturing capabilities) have enabled the restructure of its overall product pipeline, allowing for the expansion into other disease indications. The name, “Gylden” comes from the Old English word for “golden”, and is a metaphoric nod to the Company’s flagship technology platform which utilises gold nanoparticles to deliver vaccines/immunotherapeutics consisting of targeted synthetic peptides to the skin-resident immune system to elicit a robust T cell immune response. The parent company, headquartered in the UK shall henceforth be named Gylden Pharma Limited. The main US subsidiary name is Gylden USA Corporation and it owns Zosano Pharma in Fremont, CA. The corporate logo remains unchanged. Professor Thomas Rademacher, Co-Founder and CEO at Gylden Pharma, commented: “The name “Gylden” is a reflection of the technology-driven nature of our unique nanoparticle-based platform to deliver innovative vaccines and immunotherapies. Our core nanotechnology enables the delivery of immunologically-relevant pathogen peptides essential to generating targeted, robust T cellular immune responses protective against emerging viral and bacterial threats. Viral epidemics pose a serious threat to human health worldwide. Gylden’s highly versatile technology platform is designed not only to facilitate rapid and scalable manufacturing of these vaccines/immunotherapies against many different infectious pathogens but also, owing to their long shelf-life characteristics and absence of cold-chain logistics, to distribute these products to hard-to-reach geographies with significant medical need. The expansion of our core technologies also allows us to generate product candidates in commercial markets additional to infectious diseases, namely cardiometabolic and cancer.” The Company has already undergone significant expansion of its technology invention and clinical efforts, and anticipates its continued growth as a technology-driven organization. Achievements to date include successfully demonstrating the safety of, and proof of concept for, its technology platform with first-in-human clinical trials of T cell-priming vaccine candidates against Dengue and Betacoronavirus diseases (formal names: naNO-DENGUE and naNO-COVID, respectively, described here and here). The Company’s acquired Zosano microneedle array patch-based [MAP] technology (announced here) are advancing in various stages of clinical development, with one Zosano product (a migraine treatment) in process to be the granted FDA marketing authorization. Prior preliminary studies completed, which combined Zosano’s MAP technology with its T cell-priming candidates consolidate the Zosano platform’s potential and support the development of our many T cell-priming candidates. The Company has also initiated another immunotherapy programme, in personalized pancreatic cancer treatment, with potential for expansion into other cancer types. The Company has focused on strategic global partnerships with government health authorities to support further clinical development and thus ensure that its product candidates can reach territories where those infectious diseases strike the hardest. Importantly, following the Manufacturing and Import Authorisation (MIA) Investigational Medicinal product (IMP) license and cGMP accreditation received by the Company earlier in 2024 (issued by the UK’s Medicines and Healthcare Products Regulatory Agency [MHRA]), the new Company name further reflects those hard-earned capabilities. About Gylden Pharma Gylden is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and R&D and cGMP manufacturing facilities in Milton Park, Oxfordshire, UK, and Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming vaccines/immunotherapies designed to mimic the body’s natural cellular immune response to destroy and to clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Gylden’s first indications pursued are against infectious diseases: [i] including core candidates for Betacoronaviruses, Dengue Fever and Universal Influenza (including Pandemic Influenza), as well as [ii] intra-cellular bacterial infectious disease, such as tularemia, caused by Francisella tularensis. Additional products include MAP-based products for a number of metabolic and other indications, as well as a cancer immunotherapy. Gylden has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention of RNA viral infections and immunotherapy in other therapeutic categories. Find out more online at www.gyldenpharma.com Visit our LinkedIn page or Twitter (X) account for updates. For further information, please contact: GyldenMedia Inquiries Storme Moore-Thornicroft, Executive Director Phone: +44 (0) 1235 527589 Email: S.MThornicroft@gyldenpharma.com Rachelle Babb, Senior Account Executive Phone: +1 (929) 325-7559 Email: rachelle.babb@russopartnersllc.com