Many infectious diseases in developing countries are arthropod-borne viruses (Aboviruses). Live attenuated viruses are an effective technology to develop vaccines, but poor stability of these vaccines limits their distribution and use to remote areas of the world where the vaccines are needed most. This project is aimed at determining the major degradation pathways during storage and to developing stable liquid formulations of a Chikungunya vaccine, using a live attenuated vaccine and Arecor’s proprietary formulation technology to address the principal pathways of degradation that lead to loss of structural integrity and biological activity. Specific goals of the project include developing liquid formulations capable of a shelf-life of 2 years at 2-8°C, stability during repeated freeze-thaw cycles, and minimum of 3 month stability at 25°C to allow for short term storage and distribution.

AT247, a novel formulation of insulin with an ultra-rapid glucose lowering action, can transform diabetes care by enabling the development of a fully closed loop artificial pancreas (AP) system. The AT247 formulation was developed using Arecor's proprietary formulation technology and is based on a unique mixture of two ingredients. The first results in significant acceleration of insulin absorption from the injection site and the second ensures excellent stability of insulin in the pump. The ultra-rapid action of AT247 has already been demonstrated in a Phase I clinical trial where the onset and offset of exposure was superior to that of Fiasp, currently the fastest acting, commercially available insulin. The objective of the proposed Phase II trial is to compare the glycaemic control, safety and tolerability of AT247 with Fiasp when administered by insulin pump over a period of 6 weeks. Continuous glucose monitoring will allow the assessment of time spent with blood glucose (BG) level in a healthy range (TIR), a key metric for measuring episodes of hyper- and hypo- glycaemia as well as influencing long term health outcomes for people with Type I diabetes (T1D). Despite significant advances in treatment options, only 6% of people with T1D are considered to be under good BG control. It has been shown that TIR is significantly improved when patients are using an automated insulin delivery system (AP), where BG is continuously measured, an algorithm calculates insulin requirements based on real-time BG which is then automatically delivered by a pump. Current best-in-class insulins are not fast enough acting to control BG within an AP system around meal-times (when BG rises rapidly) and the patient must manually intervene (hybrid closed loop, HCL). The challenge is to develop an ultra-rapid acting insulin that enables a fully closed loop AP system. This will be transformative for T1D patients, improving quality of life and health outcomes. In addition, a true AP system will ultimately greatly reduce the wider burden of T1D on health care systems.

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There is a recognised unmet medical need to develop insulin products with a significantly faster onset of action compared with the current state-of-the-art prandial insulin products (Novolog, Humalog, Fiasp). Prandial insulin is used by diabetics to control blood glucose rises after meals. To ensure effective blood glucose management and the best patient outcomes it is essential that, once injected, insulin begins to act as rapidly as possible. In a healthy individual insulin is released very quickly in response to a rise in blood sugar reaching half maximal concentration in 16- 18 min which is approximately twice as quickly as state-of-the-art injectable rapid acting insulins. There is evidence to demonstrate that for Type 1 and Type 2 diabetics, an even faster acting insulin (Superfast) will lead to better control of blood glucose rises after meals and greater treatment flexibility. Superfast insulin is also a key component required for the development of efficient closed-loop pump systems that would enable automatic glucose control, continuous glucose measurement and smart algorithms to control how much superfast insulin to deliver via an integrated insulin pump. The primary output from this project will be a safe and stable Superfast acting insulin that closely mimics physiological release of insulin, ultimately reducing complications and improving patient outcomes. The effectiveness and safety of the developed technology will be evaluated in model systems to ensure the desired profile is met and generating a tangible asset for partnering with key Pharma companies under a well validated licensing model. Further value is added via the development and implementation of drug product manufacturing. Superfast acting insulin represents a considerable scientific innovation over the current state-of-the-art and a significant commercial opportunity to develop a superior therapeutic product for the management of diabetes. Almost 80% of diabetes treatment costs are spent on disease complications. With an ~14bn p.a. direct cost of diabetes to the NHS there is an excellent opportunity to benefit the U.K. in terms of both socio-economic factors and scientific innovation.

There is an unmet need to develop advanced therapies that combine two or more therapeutic products in one dose to improve patient convenience. This leads to better compliance, improved health outcomes and a better patient experience. However, it is often impossible to develop these co-formulations due to very different formulation conditions required to stabilise individual pharmaceutical ingredients in the same aqueous environment. Highly innovative formulation platforms are therefore essential to enable many of these commercially attractive combination products. Arecor has developed and successfully commercialised a proprietary formulation technology that delivers superior stability of therapeutic proteins compared with coventional formulation optimisation. To date the technology has only been successfully applied to single pharmaceutical ingredients, and the purpose of this project is to adapt the technology to overcome additional issues associated with co-formulations. Issues such as drug-drug interactions, in-vivo bioequivalence, stabilisation under non-optimal conditions, device compatibility and toxicological safety will all be evaluated under this preclinical platform. To ensure efficiency a validated state-of-the-art robotic liquid handling and multivariate design combined with high throughput analytics will be employed. Whilst the primary objective is to adapt and validate an innovative pre-clinical platform, co-formulations with high commercial potential will be a secondary output.

Availability of low cost insulin products, particularly products that can be distributed and used outside the cold chain is critical to developing an effective healthcare system that can deal with the rapidly increasing incidence of diabetes. This project will combine the expertise and technologies of Arecor and Cadila Pharmaceuticals to develop a innovative, low cost basal insulin product that can be distributed and used outside the cold chain. In addition validated technology will be employed to extend the duration of action of insulin glargine with beneficial consequences to the control of hypoglycaemia. The scope of the project will allow formulation development and optimisation, stability testing and pre-clinical development. Following successful completion of the project, the project partners will progress the asset into clinical development and commercialisation. The final product, which will draw on Arecor’s proprietary formulation technologies and Cadila’s excellent track record in therapeutic development and commercialisation, will represent an attractive commercial opportunity as well as having a strong positive impact on the economic development and social welfare in India.

Arecor is a world leader in developing stable formulations of therapeutics, with in-house development programmes aimed at differentiated product concepts in diabetes. Arecor has solid plans for developing those product concepts to Phase I clinical proof-of-concept and subsequent licensing of the assets. One of the product concepts is liquid glucagon, both for emergency use and as a critical component for a bihormonal pump. Arecor has developed prototype liquid formulations of glucagon showing sufficient stability for a viable commercial product. With the critical support from InnovateUK, Arecor is progressing this asset through pre-clinical development by performing further optimisation to ensure compatibility with a selected delivery device, toxicology studies, formal stability studies and validated pharmacokinetic studies. Following this study, Arecor will be ready to move into Phase I human trial. Stable liquid glucagon product will transform the way glucagon is used for emergency treatment of severe hypoglycaemia episodes by removing the need for a complex reconstitution of the currently marketed lyophilised products. In addition, there is a recognised need for liquid glucagon as a critical component of bihormonal pumps that will also be addressed by this product.

This project represents a unique opportunity to translate British technology and expertise from the human health sector into livestock disease control in the developing world context. The project focuses on East Coast Fever (ECF), a major constraint on small-holder cattle production in East, Central and Southern Africa. An effective vaccine, ECF-ITM, currently exists for the disease but it has a number of important drawbacks that affects its use in the field. This project will trial the use of novel formulations as a replacement for the ECF-ITM vaccine diluent. Success in the project will deliver important ECF-ITM vaccine product enhancements, notably vaccine stability. This will afford far greater mobility and flexibility to ECF vaccinators resulting in an estimated 300,000 additional cattle being effectively immunised per year. This will be a notable development in the sustainable intensification of small- holder cattle production in the region. Finance summary table To assist the applicant with the Finance Section of this application form please refer to the Guidance for Applicants. It will

The aim of the project is to use innovative formulation technology to develop a proof-ofconcept for insulin product with a consistent, ultra-long release profile. Formulations will first be validated with the use of an in vitro model before demonstrating the ultra-long release profile in a relevant animal model. Arecor is a biotherapeutic formulation company with a technology that has the ability to elongate the time action profile of insulin whilst maintaining a product stability profile suitable for commercialisation. The duration of action for currently marketed products is less than 24 hours in at least a third of patients, which increases the risk of severe life-threatening hypoglycaemic episodes. A consistent, elongated release profile will offer reduced hypoglycaemic risk, whilst in turn improving dose flexibility resulting in improved patient compliance, health benefits and savings for the healthcare provider.

The aim of this project is to provide new formulations that bring about a step change in biopharmaceutical yield and quality by improving product stability through the most protein degradation sensitive/impactful areas of downstream processing (DSP). This is a novel approach to improving process efficiency as currently protein products have comparatively limited stability in the existing default DSP buffers. To develop a new platform of formulations and formulation strategies this collaborative project will bring together the formulation expertise of Arecor with the DSP expertise at Fujifilm Diosynth Biotechnologies (FDB) and The Centre for Process Innovation (CPI). The platform of formulations and the formulations strategies developed can then be applied to reduce production cost of all biologics to pharma and ultimately cost to healthcare providers. These new formulations may also enable the production of biotherapeutics that are currently very difficult/impossible to manufacture.

A growing number of drugs that are being developed to combat infection and disease are protein based "biotherapeutics". The supply of these vital biotherapeutics is limited only to areas where there is a sufficient cold-chain i.e. fridges/freezers. Arecor is a biotherapeutic formulation company that has developed technology to stabilise liquid formulations to improve their shelf life. In collaboration with Manchester University's Centre of Excellence in Biopharmaceuticals, Arecor will use the TSB formulated product grant to fund the development of the next generation liquid biotherapeutic formulations that are room temperature stable starting with a new room temperature stable formulation of fast acting insulin. These new biotherapeutic formulations can be shipped to any part of the world without the need for cold-chain storage. Unilever, Lilly and PrismTC will all assist in the development of this new technology that will improve healthcare provision to the third world and reduce the environmental burden of cold-chain provision.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

The 3 human influenza pandemics in the 20th century killed tens of millions of people worldwide. Sporadic human infections by avian H5N1 virus in the past few years have led the scientific community to believe that a virulent virus may emerge as the result of re-assortment between H5N1 virus and seasonal influenza virus, causing another pandemic. There is universal consensus that vaccines are a key tool to prevent and intervene in an influenza pandemic. Pandemic influenza preparedness, as detailed in the Implementation Plan for the National Strategy for Pandemic Influenza, focuses extensively on the establishment of influenza vaccines and on the rapid immunization of citizens. FluGen’s replication deficient M2SR live attenuated vaccine candidate has shown in animal and in vitro models that it has superior properties relative to currently marketed vaccines particularly in the elderly. FluGen’s studies have demonstrated that influenza viruses lacking a portion of their genome replicate well in cell culture but are attenuated in mice and ferrets. This vaccine confers protection against multiple strains of Influenza and can be rapidly produced, due to its cell based production method. The key deliverable of this project is to develop stable liquid formulation of the M2SR vaccine, which is currently stored at -80°C, with critical quality attributes acceptable for use in intranasal products. We will use the replication deficient Flu vaccine for formulation development, which will use FDA approved excipients, using Arestat™ stabilisation technologies. Arestat™ is a proprietary formulation technology allowing the design of novel liquid formulations of biologics with superior stability. The technology has been validated on a wide range of recombinant proteins and other biologics in collaboration with major pharma companies. The aim is to develop a formulation that allows for storage of the vaccine at 2-8°C with allowances for excursions outside of this temperature range.

Drug formulation has the power to move a product from a hospital setting directly to the home, empowering the patient to control their own treatment. High concentration formulations of antibodies have the potential to shift the burden of outpatient intravenous infusions in the clinic to the use of a ready-to-use autoinjector. Novel chemicals designed at Arecor have the potential to allow such a shift. Arecor has generated proof of concept data showing their ability to dramatically increase the stability of concentrated antibodies. The stability achieved is measured in not months, but years at elevated temperatures. The objective of this project is to examine a wide range of non-clinical toxicology assays of the novel excipients, the effect on further antibody models and to address the problem of viscosity. The aim is to produce a data package for regulatory approval in injectables and facilitate partnerships to allow this technology to reach the market.