MELBOURNE, Australia, Dec. 17, 2020 /PRNewswire/ -- Open Care (https://open.care) have announced the progress of their early-stage development of their potential COVID-19 Immunisation, ImmubioCV, based on Nanobiologics, a new approach centered on nanoparticles, water coherent domains and ultra dilutions that allows for the preparation of potentially safe, effective and readily scalable immunisations using a novel patent pending process.
Open Care, the biotech company behind Immubio, an immunisation development and delivery platform designed to produce immunisations that are highly effective at modulating the immune response, has taken a multidisciplinary approach to disease prevention. With their formulation design complete, the company is now preparing for pre-clinical studies ahead of clinical trials.
Immubio has the potential to deliver oral liquid immunisations that are inherently safe, adaptable to strain mutation, can be stored and distributed at room temperature and rapidly scaled to billions of doses at a significantly lowered cost to traditional vaccines.
The company has revealed a breakthrough in nanoparticle science - the Immubio platform that combines ultra-diluted, patent pending antigen called Nantigen and Moleculebase, a framework for specific molecule selection to safely prime targeted mechanisms. The Immubio platform development offers potential in positive physiological outcomes to target and prevent infectious diseases.
Wesley Cooke, Open Care's Founder and Chief Executive Officer, has described the Immubio platform and Nanobiologics as an "incredibly exciting field of nanoparticle science that could rewrite how we approach and protect the world from infectious diseases like SARS-COV-2, the novel coronavirus."
Pending completion of trials and approval by regulatory authorities, ImmubioCV could supply billions of doses by late 2021 given its composition and use of nanoparticles which could provide a much-needed solution to the current accessibility and affordability crisis.
Mr Cooke added: "This is a completely novel approach to immunity that holds great promise for the billions of people globally currently disadvantaged because of the COVID-19 pandemic. What we are dealing with now is an issue regarding affordability and equitable access for the world's poorest."
In terms of targeting the virus and working differently to traditional vaccines, the aim of ImmubioCV is to prime and prepare the immune system safely. It is expected this will help the body to stop the disease from progressing and enable it to develop an appropriate immune response.
"Based on this platform, a careful and comprehensive analysis of scientific evidence on pathogenesis, immune response and clinical observations from a particular disease allows us to link a broad spectrum of reactions occurring during the course of the disease to specific known pathways that contribute to, and are part of, the homeostatic mechanisms." Chief Immubio Scientist, Dr Gustavo Bracho has said.
Open Care are also optimistic that this potential break-through in nanoparticle science will not only be successful in severely reducing the incidence of infectious disease but could lead to "complete control of epidemics".
Marco Stacke, Open Care's Chief Operations Officer, has said that "due to its unique speed to market and the immediate response to a new pathogen, Immubio could greatly reduce the human and economic costs of a pandemic."
The manufacturing and distribution of ImmubioCV is planned to take place in Germany through strategic partnerships designed to establish a manufacturing facility dedicated to Open Care's technology, including a state-of-the-art Research and Development lab.
Open Care are currently finalising initial partnerships and are seeking additional international collaboration to secure the remaining materials required to complete their formula to begin their pre-clinical studies.
The company is in early-stage discussions with leading Contract Research Organisations to implement a global trial across multiple countries. The company plans to begin Phase 1 of their human trials in Q2 of 2021 for ImmubioCV after the pre-clinical phase has finalised.
The team at Open Care will also be developing a digital health app and immunisation certificate program. The company is in the process of relocating their head office to Switzerland in order to be closer to their planned manufacturing facilities in Germany, and have signed engagement letters with leading life science firms including legal and regulatory to enable the transition and commercialisation of the Immubio platform.
Patent protection has been applied for with the European Patent Office for their novel platform and processes. The company is now seeking investment and is open for their first round of funding to commercialise ImmubioCV with details available on their website.
ABOUT OPEN CARE
Open Care is a biotech company that focuses on disease prevention and is currently developing ImmubioTM, an immunisation development and delivery platform based on NanobiologicsTM.
Open Care's breakthrough in nanoparticle science combines ultra-diluted, patent-pending antigen called NantigenTM and MoleculebaseTM, a framework for specific molecule selection to safely prime targeted mechanisms leading to beneficial physiological outcomes for target diseases that will empower humanity to fight modern disease.
The platform is designed to produce immunisations that are effective at reducing disease burden, that provide a high level of safety and are less costly than traditional immunisations.
For more information, please visit https://www.open.care.
DISCLAIMER AND FORWARD-LOOKING STATEMENT
This forward-looking statement may include, but may not be limited to, statements concerning: Open Care's efforts to combat COVID-19; the collaboration to develop nanoparticle technology to fight COVID-19; Open Care´s expectations regarding the potential characteristics of ImmubioCV; the expected timepoint for additional readouts on efficacy data of ImmubioCV; the nature of any current or future clinical data, which will be subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or emergency use authorization; the timing for submission of manufacturing data to regulatory agencies; Open Care´s envisioned storage and distribution plan, including estimated immunisation shelf life at different temperatures; and the ability of Open Care to supply the quantities of ImmubioCV to support clinical development and, if approved, market demand.
Any forward-looking statements in this press release are based on Open Care's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.
Risks and uncertainties include, among other things, the uncertainties inherent in the biotech fields of research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, including the possibility of unfavourable new preclinical or clinical trial data and further analysis of existing preclinical or clinical trial data; the ability to produce comparable clinical or other results; risks related to the availability of raw materials to manufacture ImmubioCV; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved technology; uncertainties regarding the ability to obtain recommendations from technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and failure to protect and enforce our data, intellectual property and other proprietary rights and the risks and uncertainties relating to intellectual property claims and challenges.
Open Care assumes no obligation to update forward-looking statements contained in this release, dated as of December 17, 2020, as the result of new information or future events or developments. Open Care undertakes no duty to update this information unless required by law.
SOURCE Open Care Pty Ltd
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