Tularemia

HALIFAX, Nova Scotia, March 12, 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 biodefense products, today announced a publication in the journal Frontiers in Bacteriology on the prevention of tularemia. Appili’s Director of Non-Clinical Research, Dr. Carl Gelhaus, Ph.D., together with medical doctors from the United States Uniformed Services University of the Health Sciences and Ukrainian researchers published a perspective manuscript “Considerations for prevention of and emergency response to tularemia outbreaks in Ukraine: vaccine involvement”. “Appili has been developing ATI-1701, a biodefense vaccine, to protect warfighters from tularemia.” said Carl Gelhaus, Ph.D., Director of Non-Clinical Research of Appili Therapeutics. “With the help of our Ukrainian colleagues and U.S. Army physicians, we have assessed the potential risk for tularemia outbreaks in Ukraine, by reviewing the literature of previous wartime outbreaks in Eastern Europe. Many of the conditions for tularemia outbreaks now exist in Ukraine, and their warfighters need protection. We suspected that rodent populations would explode and carry tularemia into war-affected areas. Even as we were preparing the manuscript, “Mouse fever”, an infection of unknown etiology, was reported in news outlets, underscoring the urgency of making sure Ukrainians are protected from the risk of many infectious diseases, including tularemia. The acceptance and publication of this perspective article recognizes that the epidemiological, medical, military, and scientific tularemia experts should prepare to prevent and respond to tularemia outbreaks in wartime Ukraine.” The perspective manuscript explores the current war in Ukraine and the increased risk for outbreaks of tularemia. Several wartime tularemia outbreaks have been documented, as far back as the Siege of Stalingrad in WWII. Furthermore, F. tularensis was weaponized and stockpiled as an offensive agent, and experts consider tularemia to have a high potential use in a biological weapons attack. Russia administers its own tularemia vaccine, but that vaccine is not available in Ukraine. Furthermore, the legacy Russian vaccine is unlikely to meet the rigorous FDA and EMEA standards for safety and efficacy. ATI-1701 is the Company’s potential first-in-class vaccine candidate for the prevention of infection with F. tularensis. Since it is a highly infectious pathogen capable of causing severe illness, medical counter measures for F. tularensis are a top biodefense priority for governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets, strengthening ATI-1701’s position as a potentially valuable vaccine that is urgently needed on the market. Appili is working hard to develop our ATI-1701 vaccine that could potentially help protect the Ukrainian people living in what United Nations Secretary-General Antionio Guterres described as “an epicenter of unbearable heartache and pain”. Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili adds “At Appili, we hope that our products can alleviate that kind of human suffering”. About ATI-1701 ATI-1701 is a novel, live-attenuated vaccine for F. tularensis, which causes tularemia, a Category A pathogen which can be aerosolized and is over 1,000 times more infectious than anthrax. Since it is a highly infectious pathogen capable of causing severe illness, medical counter measures for F. tularensis are a top biodefense priority for the United States and governments around the world. There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets. Appili secured a US$14M funding commitment for ATI-1701 from the United States Air Force Academy (“USAFA”), who is working in partnership with the Defense Threat Reduction Agency. These funds along with other potential funding sources, are anticipated to continue to advance the ATI-1701 program toward an IND submission to the FDA in 2025. About Appili Therapeutics Appili 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 a vaccine candidate to eliminate a serious biological weapon threat, a topical antiparasitic for the treatment of a disfiguring disease, and a novel easy to use, liquid oral formulation targeting parasitic and anaerobic infections. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit . Forward looking statements This news release contains “forward-looking statements”, including with respect to any potential outbreak of tularemia in the Ukraine, the funding commitment from USAFA, further anticipated milestones and the timing thereof and the Company’s development plans with respect to ATI-1701. 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, the risk that ATI-1701 may never become an approved vaccine for the prevention or treatment of tularemia, and the other risks listed in the annual information form of the Company dated June 22, 2023, and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at ). 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. Media Contact: Jenna McNeil, Communications Manager Appili Therapeutics E: JMcNeil@AppiliTherapeutics.com Investor Relations Contact: Don Cilla, President and CEO Appili Therapeutics E: Info@AppiliTherapeutics.com

Emergex has entered into an agreement with DEKA Research & Development (‘DEKA’) to assess the compatibility of Emergex’s T cell-priming set-point immunotherapeutic candidates with DEKA’s Intradermal Therapeutic Applicator. The collaboration builds on previous data showing satisfactory loading and stability of Emergex’s therapeutic candidates when incorporated with the Intradermal Therapeutic Applicator. The collaboration also covers completion of a preclinical study to compare the pharmacokinetics of [i] Emergex’s Dengue treatment candidate by syringe-based microneedle technology, which have been used in previous preclinical and clinical Emergex studies, with [ii] DEKA’s Intradermal Therapeutic Applicator. Pending preclinical study results, the agreement allows for the possibility of advancing the Intradermal Therapeutic Applicator as an administration device for Emergex’s pipeline of treatments for viral diseases. ABINGDON, United Kingdom, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of synthetic T cell-priming set-point immunotherapy-based treatment candidates, today announced that the Company has entered into an agreement with DEKA to assess the compatibility of Emergex’s immunotherapeutic candidates with the DEKA Intradermal Therapeutic Applicator. The Intradermal Therapeutic Applicator incorporates hollow microneedle technology into a convenient self-administration device. This agreement builds on previous data showing satisfactory loading and stability of Emergex’s product candidates when incorporated into the Intradermal Therapeutic Applicator. Laurens Rademacher, Chief Technology Officer at Emergex, added: “We are delighted to announce this important collaboration with DEKA. Intradermal/Epidermal delivery is critical to the mechanism of our T cell-priming product platform. The use of microneedles, which have been utilized in all our previous preclinical and clinical work, paired with the ease-of-use of the Intradermal Therapeutic Applicator is a perfect complement to our own technologies.” The agreement covers completion of a preclinical pharmacokinetic study to compare the delivery of Emergex’s DengueTcP1 product candidate by syringe-based microneedle technology versus the DEKA Intradermal Therapeutic Applicator. Pending completion, if promising data is obtained, the agreement allows for the possibility of advancing DEKA’s Intradermal Therapeutic Applicator as a device for administration of Emergex’s T cell-priming set-point immunotherapeutic product candidates in the pipeline. Dean Kamen, Founder and President, of DEKA Research & Development, commented: “The partnership with Emergex is a meaningful step forward in patient therapeutic delivery. The combined technologies of our novel intradermal therapeutic delivery platform along with Emergex’s products can open a new route to intradermal drug administration in a patient friendly, easy-to-use, painless way. We are excited by the potential of our combined technologies in saving numerous lives.” About DEKA Intradermal Therapeutic ApplicatorDEKA’s technology leverages hollow microneedles that offer a unique design with flexible features for efficient therapeutic delivery, self-administration and minimal pain. With a simple push of the top button on the device, the petal design spreads outward, thereby stretching the skin and enabling a consistent insertion of the microneedles into the skin. The continued downward motion then activates the trigger that applies pressure to the reservoir to expel the therapeutic agent into the intradermal region. Numerous advantages of this device include self-administration​, dose-sparing and less overall waste than conventional needles​. About DEKA Research and DevelopmentBased in Manchester, NH, DEKA Research & Development Corp. is a technology development organization. The company was founded in 1982 by Dean Kamen. Find out more online at www.dekaresearch.com.Visit our LinkedIn page for updates. About Emergex Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic the body’s natural T cell 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. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases. Find out more online at www.emergexvaccines.com.Visit our LinkedIn page or Twitter account for updates. For further information, please contact: EmergexStorme Moore-Thornicroft, Executive DirectorPhone: +44 (0) 1235 527589Email: smt@emergexvaccines.comMedia InquiriesRachelle Babb, Senior Account ExecutivePhone: +1 (929) 325-7559Email: rachelle.babb@russopartnersllc.com 1 Trademark application submitted A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1fc26fd8-c29e-41b9-8d86-6564c43f916c

Emergex received authorisation from the Philippines FDA to launch a Phase I-II clinical trial of CoronaTcP, its T cell-priming immune set-point candidate against Betacoronaviruses. Emergex is progressing trial initiation plans, with an anticipated start date in Q2 2024. ABINGDON, United Kingdom, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic T cell-priming immune set-point candidates, today announced that the Philippines Food & Drug Administration has authorised the initiation of a Phase I-II clinical trial of CoronaTcP™1, Emergex’s T cell-priming set-point product, designed to be broadly effective against disease caused by Betacoronaviruses, including SARS-CoV-1, as well as known and emerging variants of SARS-CoV-2. The naNO-COVID 2 trial (NCT05633446) is a randomized, double-blind, placebo-controlled Phase I-II trial in the Philippines, which will investigate the safety and immunogenicity of CoronaTcP. The study is expected to enrol 110 healthy volunteers (18–75 years of age), who will each receive either one or two doses of CoronaTcP or placebo. All participants will be followed up for six months. This study follows completion of the naNO-COVID trial (NCT05113862), a Phase I clinical trial in Switzerland which demonstrated that CoronaTcP had a favourable safety pro successfully induced virus-specific CD8+ memory subsets. Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, commented: “We thank the Philippines FDA for rapidly approving this trial after a successful Phase I clinical trial in Switzerland. Coronaviruses are susceptible to high mutation rates, and cellular immunity is critical for long-lasting protection. We look forward to evaluating our T cell-based approach, which has the potential to improve any previous immune status. Emergex is rapidly moving forward with plans for the trial, and we expect to start enrolling volunteers in Q2 2024.” The naNO-COVID 2 trial The naNO-COVID 2 trial (NCT05633446) is a Phase I-II, double-blind, randomized, placebo-controlled study investigating the safety and immunogenicity of a T cell-priming immune set-point candidate for coronavirus disease in healthy adults. The clinical study will enrol 110 participants, who will be randomized into the following groups: Group 1: one vaccination on Day 0 (n=55): 44 CoronaTcP + 11 placebo; Group 2: two vaccinations on Day 0 and Day 21 (n=55): 44 CoronaTcP + 11 placebo. Overall, 88 participants will receive CoronaTcP (7.5 nmol peptide per dose) and 22 will receive placebo (water for injection). Safety and immunogenicity of CoronaTcP (cellular and humoral immune responses) during the six-month post-vaccination period will be evaluated. About Emergex Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic the body’s natural T cell 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. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases. Find out more online at . Visit our LinkedIn page or Twitter account for updates.