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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

NIAID will be conducting and sponsoring clinical trials to accelerate and to streamline the rapid development of next-generation COVID-19 vaccinesABINGDON, United Kingdom, Oct. 02, 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 vaccine candidates, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (Bethesda, MD, USA), has selected Emergex for inclusion in its Project NextGen. Through Project NextGen, NIAID is conducting early phase clinical trials on select next-generation SARS-CoV-2 vaccine candidates covering a broad range of platforms, including T cell vaccines. The objective of Emergex’s T cell-based platform is to generate a protective cellular immune response, specifically the generation of tissue-resident memory CD8 +T cells and, in the case of SARS-CoV-2, can provide a rapid recall response locally in the respiratory tract leading to an abortive infection. Induction of variant agnostic and long-lasting cell-mediated protection will limit the need for frequent boosters. The Emergex vaccine, CoronaTcP, is designed to be broadly effective against Betacoronavirus infections, including SARS-CoV-1, as well as known and emerging variants of SARS-CoV-2. Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, said “We are thrilled that our immunotherapy candidate for Betacoronaviruses, which has already demonstrated an excellent safety profile and shown to be capable of eliciting targeted CD8 T cell immune memory, has been selected as part of the Project NextGen initiative. Our T cell-based platform technology has the potential to address current and future coronavirus challenges and thereby strengthen preparedness for future pandemics, through harnessing the natural course of cellular immunity by ensuring rapid, targeted and robust immune responses against emerging infectious threats.” Emergex’s CoronaTcP candidate has demonstrated in a completed Phase I clinical trial in Switzerland to have a favorable safety profile and to successfully induce epitope-specific CD8+ memory subsets, which are critical for long-lasting protection against Betacoronaviruses in the face of high mutation rates and continuous emergence of new variants of those viruses. The Company also employs a variety of microneedle devices to achieve transdermal administration of its vaccines, which are 100% synthetic, and to facilitate development of both systemic and tissue-resident CD8 T cell memory responses. In addition, this delivery approach can overcome logistical constraints of traditional vaccines which require cold-chain measures during shipping, manufacturing, and conventional administration by healthcare professionals, all of which elements can significantly restrict global accessibility. Emergex looks forward to this important next step in the development of its novel T cell-priming Betacoronavirus candidate. NIAID is projected to cover the full cost of the Phase I clinical trial, including operations and related analyses. Emergex will be responsible for providing clinical trial materials and documentation required for an investigational new drug (IND) submission. About Project NextGen Project NextGen is a $5 billion initiative to accelerate and to streamline the rapid development of next generation vaccines, drugs and treatments through public-private collaborations. Led by NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), Project NextGen is a coordinated effort between the US Federal Government and private sector to advance the pipeline of innovative vaccines, drugs and therapeutics from labs into clinical trials, with the intent to transition to the private sector in later stage development and proceed to potential US Food and Drug Administration (FDA) authorization, approval, and then commercial availability. About Emergex Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, Oxon, UK, with an operating subsidiary in Doylestown, Pennsylvania, a microneedle manufacturing facility in Fremont, CA, USA and GMP production vaccine facility in Milton Park, UK. The Company is pioneering the development of 100% synthetic T cell-priming vaccine candidates designed to mimic the body’s natural T cell immune response to destroy and clear pathogen-infected cells, in order to protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel microneedles 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 Pandemic Influenza candidates, as well as [ii] intracellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative immunotherapy candidates with the 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 (X) account for updates. For further information, please contact: EmergexStorme Moore-Thornicroft, Executive Director & Chief Operating OfficerPhone: +44 (0) 1235 527589Email: smt@emergexvaccines.com Media InquiriesRachelle Babb, Senior Account ExecutivePhone: +1 (929) 325-7559Email: rachelle.babb@russopartnersllc.com

VANCOUVER, Canada I August 22, 2024 I BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF ) (“BioVaxys” or the “Company”) highlights the potential of its novel lipid-in-oil delivery platform, DPX™, across multiple infectious disease studies and announces its plans for partnering and further development. BioVaxys’ DPX™ technology (“DPX”) is a patented delivery platform that can incorporate a range of bioactive molecules to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease. Key findings demonstrated in completed infectious disease studies, which are discussed in more detail below include: BioVaxys President and Chief Operating Officer Kenneth Kovan says “With data so compelling and supportive of the value of DPX-based vaccines for infectious diseases, we are seeking various off-balance sheet avenues to support development.  The significant cargo capacity of DPX and the proven ability to package diverse antigens such as that shown with our DPX-SurMAGE multi-antigen cancer vaccine, could also greatly benefit potential partnerships for developing more effective viral vaccines, such as a multivalent mRNA DTP vaccine to address the recognized problem of immunity to the Bordetella pertussis waning over time, or for emerging global diseases such as MPox, where a DPX-mRNA formulation could have significant advantage. This fits well with our strategy of expanding development partnerships with DPX beyond oncology.” 100% of Subjects in a Phase 1 Study Treated with a DPX-based RSV Vaccine Developed Antibodies with Persistent Immune Response DPX™+RSV(A) “DPX-RSV” is BioVaxys’ vaccine candidate targeting the respiratory syncytial virus (RSV) based on a DPX formulation of the SHe peptide of group A RSV.  Results of a Phase 1 study showed that more than nine months after the last vaccination, 15 of 16 participants (93%) who received DPX-RSV demonstrated antigen-specific immune responses. This study evaluated the safety and immune response profile of two doses of DPX-RSV in 40 healthy older adult volunteers (aged 50-64 years) and was well tolerated amongst all study participants, with no SAEs reported.  One of the two doses of DPX+RSV(A) was tested out to one year and 100% of older adults (7/7 immune responders) maintained antigen-specific immune responses one year after receiving a booster dose. After one year, their antibody levels measured were still at peak with no sign of decrease. RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older. Currently available RSV vaccines including GSK’s Arexvy, Moderna’s mResvia, and Pfizer’s Abrysvo target either the F or G proteins of the virus and provide protection by neutralizing the RSV virus. Clinical measures of efficacy focus on the amount of neutralizing antibodies in the bloodstream. DPX-RSV works differently; it targets the SH viral ectodomain of the RSV virus and, instead of neutralizing the virus, it enables the immune system to recognize and destroy infected cells. BioVaxys has exclusive worldwide licenses on applications that target the SH ectodomain antigen in RSV. The Company is exploring opportunities to out-license this product to potential partners. Animal challenge studies with DPX-Based Anthrax Vaccine Demonstrated 100% Immunity from Single Injection The promise and versatility of the DPX platform for infectious disease applications has been additionally supported by in vivo studies of a DPX formulation targeting anthrax, with a DPX Anthrax vaccine formulation exhibiting 100% immunity following a single injection. In a preclinical study led by the National Institutes of Health, a single intramuscular injection of recombinant B. anthracis -protective antigen (rPA) formulated in the Company’s DPX platform (“DPX-rPA”) was compared in animal models to rPA in alum, and to Biothrax® (anthrax vaccine adsorbed (AVA)), a US Food and Drug Administration approved vaccine that requires five administrations over 12 months with annual boosting to maintain pre-exposure prophylaxis.  Serological analysis of anti-rPA immunoglobulin G and toxin neutralization activity demonstrated higher responses induced by DPX-rPA when compared to rPA in alum.  In rabbit and non-human primate (“NHP”) studies, the DPX-rPA formulation generated an immune response in as little as 14 days after a single immunization, whereas AVA required two immunizations. In the rabbit study, a single injection of DPX-rPA or two injections of AVA conferred 100% protection from a lethal anthrax challenge. Furthermore, in the NHP study, single-dose DPX-rPA was 100% protective against challenge, whereas one primate in the two-dose AVA group and all saline-administered animals succumbed to infection. Anthrax, caused by exposure to aerosolized spores of Bacillus anthracis , remains a very serious biological threat, and is categorized by the Centers for Disease Control and Prevention (CDC) as a Category A biothreat agent, along with botulism, plague, smallpox, tularemia, and viral hemorrhagic fevers posing the greatest risk to national security.  At-risk populations for non-weaponized occupational exposure include those working with infected animals, contaminated animal products or environments such as farmers, veterinarians, livestock handlers, diagnostic laboratory workers, agriculture and wildlife workers, and workers who butcher animals or process meat, hides, hair and wool. The ideal anthrax vaccine would provide rapid protection with a single dose, generate a durable immune response, and have enhanced stability for stockpiling purposes. An anthrax vaccine formulated in DPX™ is expected to provide these characteristics. There are currently no approved anthrax vaccines that can provide single dose, rapid protection. Currently approved anthrax vaccines include Biothrax, which requires multiple doses over the span of a year, and more recently, Cyfendus, which is intended for people with suspected or confirmed inhalational exposure to anthrax and is given in two intramuscular doses over two weeks and must be given together with antibiotics. As the efficacy of Cyfendus for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax, BioVaxys is exploring potential advancement of DPX-rPA with its current preclinical data with the US Dept of Defense, Battelle and other organizations. DPX-rHA for Influenza Achieves Higher Antibody Levels than Alum rHA Vaccine and Protects Against Multiple Flu Strains Most recently, in preclinical influenza studies in a murine model, a single dose of DPX formulated with recombinant hemagglutinin (rHA) was shown to exhibit higher and more durable levels of HA antibodies than Alum+rHA. Alum is the market-standard adjuvant that can increase the immunogenicity of recombinant hemagglutinin (rHA) in influenza vaccines. When combined with rHA, alum can generate anti-HA titers that are 10 times higher than without the alum adjuvant. Additional in vivo studies compared two different strains (Puerto Rico H1N1 and Hong Kong H3N2) of heat inactivated whole influenza virus packaged in DPX (DPX+FLU) compared to Alum + heat inactivated whole influenza virus (Alum+FLU).  One month post vaccination the mice were challenged with both live influenza strains, with the animals that received DPX+FLU having an almost 100% survival 10 days post challenge to both the Puerto Rico H1N1 and Hong Kong H3N2 strains, compared to ~70% survival for mice challenged with Puerto Rico H1N1and receiving Alum+FLU, and <20% survival for mice challenged with Hong Kong H3N2 strain and receiving Alum+FLU. BioVaxys is planning further preclinical studies to evaluate a quadrivalent (four flu strains) DPX formulation. BioVaxys Technology Corp . ( www.biovaxys.com ), registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© “neoantigen” tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company’s clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX™ platform, and is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© “neoantigen” tumor cell construct platform for refractive late-stage ovarian cancer. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF ). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn. SOURCE: BioVaxys Technology