TARGETED ANTI-INFECTIVE TECHNOLOGY - fixed … · patented, anti-infective technology based on...

TARGETED ANTI-INFECTIVE TECHNOLOGYHARNESSING MICROBIOLOGY

(C) 2017 FIXED PHAGE ALL RIGHTS RESERVED | CONFIDENTIAL

FIXED PHAGE ECOMPANY OVERVIEW

• Fixed Phage (FP) is a biotechnology company developing and commercialising a unique, patented, anti-infective technology based on bacteriophage immobilisation and stabilisation.

• Based in Glasgow in Scotland.

• Bacteriophages (“phages”) are naturally occurring, organic microbes and potent anti-infectives that target and destroy specific bacteria but are harmless to humans, plants and animals.

• FP is focussing it’s Technology in three markets; that of 1. Animal Health (Aqua and Land)2. Food Packaging3. Agriscience

• There is a clear need within these markets for natural anti-infectives that address current infection issues.

• FP has ongoing licensing and development contracts with major multinational, household name organisations in both food packaging and aquaculture. This gives FP access to major consumer market opportunities in the US, Europe and Asia.

• The FP patent portfolio covers the base science of phage immobilisation, Field of Use applications and products. Aquaculture ponds - South East Asia


Antimicrobial Food Packaging to extend shelf life

Phages are everywhere on the planet, and are in balanced equilibrium with bacteria.

• 1030 bacteria on the planet. • 1031 phages on the planet. • 108 phages in every litre of water.

BACTERIA, PHAGES AND MICROBIOLOGYMicrobiology

Algae

Fungi

Bacteria

Viruses

Bacteriophages

A type of microbe. The name derives from the Greek word phagein, "to devour”. Discovered in 1915 by Frederick Twort, and Felix d’Herelle.

Potent anti-infectives that target and destroy specific bacteria but are harmless to plants, animals and humans.


LIMITATIONS EXISTING LIQUID BASED BACTERIOPHAGESMicrobiology

The antimicrobial properties of bacteriophages are now widely known. However, to date liquid FREE phages have suffered from critical issues:

It is difficult to target and fix liquid phages to sites where they are needed to combat infection.

It is inherently difficult to combine hard products with liquid phage solutions. Also, adding liquid phages at the point of use, is not always practical.

Existing solutions often rely on polymer binders, which can add cost and complexity.

Liquid bacteriophages are highly susceptible to environmental stress, particularly drying.

In commercially relevant temperatures such as room temperature or higher, typical phage solution may last from hours to weeks.

Commercial products therefore need to be refrigerated and/or transported quickly to point of use.


1

2

Electrode.Can be easily

deployed in existing manufacturing sites.

ValueFIXED PHAGE TECHNOLOGY KEY BENEFITSATTACHMENT AND IMMOBILISATION MASSIVELY ENHANCED STABILITY OF PHAGES

Phages Immobilised to Substrate

• Phages retain their antimicrobial efficacy.

• Phages can be easily dried and processed.

• Now: Phages now retain commercially relevant stability. Fixed Phage has many studies showing years of stability.

• Crucially, the resulting product now has inherent anti-bacterial properties.

• FP Technology transforms the business model and supply chain for phage based products.


Corona. Electrical discharge

brought on by ionised gas such as air.

Substrate. Rotated through corona which activates surface. Phage solution is then

applied.

Phages irreversibly and covalently bound to

substrate.

1

2

3

4

Uniquely, with FP Technology, phages can be immobilised onto powders then used

individually or formulated into gels, creams or liquids.

Key Value FIXED PHAGE KEY TECHNOLOGYATTACHMENT AND IMMOBILISATION OF PHAGES TO A WIDE VARIETY OF SUBSTRATES

Phages can be immobilised onto a wide range of materials to create active

antimicrobial packaging.

Planar Surfaces

Phages can be immobilised onto pellets which can in turn be added to animal feed.

Beads and Pellets Powders


Shrimp EMS

• Early Mortality Syndrome (EMS) is caused by a bacterial pathogen in the shrimp gut. The pathogen is Vibrio Parahaemalyticus.

• Vibrio infection began in fish farms in South East Asia but is now a huge global problem. In some countries, EMS has wiped out half of the predicted annual shrimp harvest* and costs the industry circa $1Bn per year.

• Fixed Phage has spent the last 2 years working with a multi-national corporation to address Shrimp EMS.

• FP has isolated phages that are able to kill Vibrio Parahaemalyticus and then immobilised these phages onto shrimp feed. The cocktail then treats the Vibrio infection in vivo in the shrimp gut.

• Results generated in Thailand and Arizona as part of this project have conclusively shown a significant reduction in mortality in shrimp infected with Vibrio Parahaemalyticus.

• Results have also shown that feeds with phages immobilised onto them have commercially relevant shelf life when stored at 30C.

TECHNOLOGY EXAMPLE PHAGE DELIVERED VIA FEED

P. Vannamei shrimp from Vietnam showing signs of EMS

Aquaculture ponds - South East Asia

(C) 2017 FIXED PHAGE ALL RIGHTS RESERVED | CONFIDENTIAL* Intrafish - The Global Shrimp Report 2016

Results

ATTACHMENT OF PHAGES TO SHRIMP FEED - TACKLING BACTERIAL DISEASE


• Strong statistically significant data validating the efficacy of the Fixed Phage Technology, conclusively demonstrating that phage based feeds can treat bacterial diseases in vivo.

Source: FP data, 2016

IMMOBILISATION TECHNOLOGY PHAGE STABILITY


Results

• Strong statistically significant data validating; 1) The phage stabilising properties of the FP Technology and 2) The commercially relevant shelf life with products produced with the FP Technology.

Source: FP data, 2016

FIXED PHAGE REGULATORY POSITIONINGRegulatory

• In the US, several phage products have gone to market using a regulatory route known as “Generally Regarded as Safe” (GRAS).

• There are established GRAS pathways for both human food and animal feed. Both are very similar and there should therefore be a clear, relatively well-defined pathway through the process for phages incorporated into animal feeds.

• Phages added to human foods (e.g. processed meats) have fallen under GRAS regulations and there are currently 6 GRAS applications from 3 different companies on file: • GRAS 198 (Listeria on Cheese), • GRAS 218 (Listeria on food), • GRAS 435 (Salmonella on food), • GRAS 468 (Salmonella on food), • GRAS 528 (Listeria monocytogenes on food) and • GRAS 603 (Salmonella enterica on food).

• Currently, there are no GRAS applications relating to phage additives in animal feed. However, the 7 steps for submitting a feed application are largely to food additives and available at https://www.gpo.gov/fdsys/granule/CFR-2010-title21-vol6/CFR-2010-title21-vol6-part570

• Process is typically months to build dossier.


https://www.gpo.gov/fdsys/granule/CFR-2010-title21-vol6/CFR-2010-title21-vol6-part570

https://www.gpo.gov/fdsys/granule/CFR-2010-title21-vol6/CFR-2010-title21-vol6-part570

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