Avance Clinical Congratulates Client Tetherex Pharmaceuticals on Initiation of Dosing in a Phase 1 Clinical Study Using a Novel Single-Cycle Adenovirus Vaccine Strategy in Australia

The largest Australian full-service CRO for international biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical today congratulated client Tetherex Pharmaceuticals on first patient dosing for its Phase 1 vaccine clinical trial.
Tetherex Pharmaceuticals, Inc. is a privately held, clinical stage biopharmaceutical company focused on development of selectin inhibitor therapeutics for the treatment of a broad range of inflammatory diseases and single-cycle adenovirus vaccines for multiple infectious diseases and cancer indications.

Avance Clinical Chief Scientific Officer Dr Gabriel Kremmidiotis said:

“The exciting aspect of the Tetherex product is the potential to vaccinate using a nasal spray. Administering the vaccine via the same route that the virus uses to get into our bodies, may result in more effective protection compared to the first generation Covid-19 vaccine products currently being administered as injectables. Commencement of dosing with the Tetherex Covid-19 vaccine product constitutes a major achievement for the Avance Clinical team who played a key role in supporting Tetherex in gaining regulatory approval to conduct the First-in-Human trial with their exciting vaccine candidate.”

According to Tetherex Pharmaceutical’s announcement:

Tetherex Pharmaceuticals has executed an exclusive worldwide license with Mayo Clinic for the development and commercialization of a novel single-cycle adenovirus vaccine platform. The platform will be used to target multiple infectious diseases, beginning with a Phase 1 clinical study investigating a vaccine for COVID-19. Dosing of the initial cohort of the Phase 1 study is underway in Australia.

“Current adenovirus vaccines under investigation for COVID-19 and other infectious diseases are highly restricted in the amount of vaccine antigen they can deliver to cells,” said Dr. Russell Rother, President and Chief Operating Officer of Tetherex. “The single-cycle adenovirus platform allows one round of robust vaccine antigen expression to occur without the generation of infectious virus particles which, in preclinical models, translates to a marked improvement in the ensuing immune response.”

About the Single Cycle Adenovirus Vaccine Platform

The single-cycle adenovirus platform was developed to enhance the expression of target antigens, amplifying immune responses to infectious disease targets. Preclinical studies have demonstrated that the single-cycle adenovirus can increase target antigen expression up to 100-fold over currently utilized replication defective adenovirus vaccines. Intranasal administration of single-cycle vaccine elicits both systemic and mucosal immune responses. A mucosal response allows the immune system to encounter respiratory viruses like SARS-CoV-2 at the site of entry while the viral titers are lower. The platform also provides a robust manufacturing and supply chain paradigm relative to other vaccine platforms, such as mRNA.

Tetherex’s Phase 1 open label study, designed to assess safety, reactogenicity and immunogenicity of the single-cycle adenovirus vaccine, is expected to recruit a total of approximately 80 healthy volunteers and includes both a single ascending dose group and a multiple dose group. Subjects will receive the vaccine via either intramuscular or intranasal administration.

The study site is Nucleus Network in Brisbane, and Dr Paul Griffin Nucleus Network’s Principal Investigator said:

“The covid 19 global pandemic continues to impact lives around the world. We are very fortunate to have developed a number of vaccines for Covid-19 already that are safe and highly effective. These vaccines are beginning to give us the capacity to start to reduce the impact of this viral infection, however it’s clear there are certain properties of these vaccines that we would ideally like to improve upon such as having a vaccine that could be given via a route other than needle and syringe and perhaps a vaccine that could further reduce the ability for a vaccinated individual to become infected in the first place, a so called transmission blocking vaccine. A vaccine given intranasally has the potential to achieve some of these objects hence I am very excited to be the principal Investigator on the Tetherex clinical trial.”

“The addition of this novel vaccine platform to the Tetherex portfolio significantly expands our ability to leverage our scientific and clinical development expertise and broadens our overall technology base. This reduces risk to our investors while providing the potential of significant upside,” said Dr. Scott Rollins, Chairman and Chief Executive Officer of Tetherex. “The platform will be utilized to target multiple infectious diseases which allows Tetherex to seek partnerships and alliances for the ever-expanding infectious disease marketplace.”

About Avance Clinical

Avance Clinical is the largest full-service Australian CRO focussed on delivering quality clinical trials in Australia and New Zealand for international biotechs. Avance Clinical has been delivering CRO services in the region for the past 24 years. Avance is accredited by the office of the gene technology regulator (OGTR) and has experience with the level of complexity involved in the granting of licenses from OGTR. This accreditation allows Avance to take responsibility, on behalf of clients, for the execution of trials which involve genetically modified organism products.

The company’s clients are international biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. Avance Clinical delivers customised solutions designed around specific client needs rather than a one size fits all approach. As a company Avance Clinical has focused on state-of-the-art technology and systems across all functional areas to provide clients with the most effective processes.

Medidata, Oracle, and Medrio are just some of our technology partners. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of candidates who demonstrate passion and expertise in their chosen field. Visit http://www.avancecro.com for more information.

Recent Awards:
Excellence in Business Award 2021
Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

Clinical Advances of RNAi Therapy Discussed at Oligonucleotide Therapeutics and Delivery Conference 2021

From optimizing particle size to choosing the right nanocarrier systems, Oligonucleotide Therapeutics and Delivery conference will address delivery to non-hepatocyte cells such as cancerous tissues and overview the most successful platforms.

Download a copy of your brochure to find out who will be speaking at the upcoming conference in September www.oligonucleotide.co.uk/PRCOMpr4

Clinical Advances of RNAi Therapy

Treating diseases with antibody oligonucleotide conjugates: Combining the selectivity of antibodies with the specificity of oligonucleotide drugs

– Antibody oligonucleotide conjugates utilize the selectivity of antibody delivery and the specificity of oligonucleotide therapeutics to treat diseases

– AOC1001 is designed to treat myotonic dystrophy type 1

– Other AOCs are in development to address muscle disease and other disorders

Arthur A Levin, Chief Scientific Officer, Avidity Biosciences Inc

Delivery of Novel siRNA constructs for treating cancer

– Creating siRNA payloads for cancer treatment

– Understanding the challenges of cell-specific delivery: how to get size and efficacy right?

– Choosing the appropriate delivery system

– Presenting success and future steps

David Evans, Chief Scientific Officer, Sirnaomics, Inc

Recent clinical progress with RNAi loaded KRAS-LODER for pancreatic tumour

– Introducing the RNAi loaded KRAS-LODER for targeting KRAS mutations

– Overviewing recent clinical success in phase II trials

– Presenting phase II clinical trials results including primary and secondary endpoints

– Outlining next steps of programme

Amotz Shemi, CEO, Silenseed

INT-1B3 (miR-193a-3p mimic): from bench-to-bedside

– Focus on microRNA R&D

– Success (bench-to-bedside) story for Oncology therapeutic intervention

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Michel Janicot, CDO, InteRNA Technologies BV

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Japan – Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-Abeta Protofibril Antibody, in the peer-reviewed journal Alzheimer’s Research and Therapy. The manuscript describes results from Study 201, a Phase 2b proof- of-concept clinical trial that explored the impact of treatment with lecanemab (BAN2401) on reducing brain amyloid beta (Abeta) and clinical decline. The manuscript concluded that the pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the Phase 3 clinical trial Clarity AD aims to confirm. The results of Study 201 were presented at the Alzheimer’s Association International Conference and Clinical Trials on Alzheimer’s Disease in 2018.

The lecanemab Clarity AD Phase 3 clinical trial completed enrollment last month with 1,795 symptomatic patients with early Alzheimer’s disease (AD). Clarity AD is a placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase designed to confirm safety and efficacy of lecanemab in subjects with early AD. Additionally, the Phase 3 AHEAD 3-45 clinical study is currently exploring lecanemab in individuals with preclinical AD, defined as patients that are clinically asymptomatic, but have intermediate or elevated brain Aβ levels.

“Amyloid beta aggregates are thought to be more toxic than monomers, and we hypothesized that reducing these could represent an effective treatment approach in early stages of Alzheimer’s disease,” said Jeffrey Cummings, M.D., ScD, lecanemab manuscript author and director at the Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas. “These results from lecanemab’s Phase 2b clinical trial are encouraging and the scientific community is looking forward to learning more in the Phase 3 studies, Clarity AD and AHEAD 3-45, currently underway.”

“These supportive findings from the lecanemab Phase 2b study and the initiation of two Phase 3 studies are exciting for the field and provide the opportunity to further explore the key role of the amyloid beta pathway in the pathophysiology of Alzheimer’s disease,” said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. “Eisai’s precision pipeline approach envisions an Alzheimer’s disease treatment paradigm based on a person’s pathophysiological biomarker profile along the disease continuum. We are working to advance lecanemab and our other targeted investigational compounds as quickly as possible in our commitment to bringing solutions to patients and their families.”

For more information, visit https://www.eisai.com/news/2021/pdf/enews202128pdf.pdf.

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