Amplia Therapeutics Limited (ASX:ATX)

Innate Immunotherapeutics Limited (ACN 165 160 841) is an Australian biotechnology company with an exciting technology that targets the human innate immune system.  The innate immune system is the body’s first line of defence against external disease causing pathogens such as bacteria and viruses, and internally caused diseases such as cancer.

Disorders of the immune system can also cause or contribute to diseases such as multiple sclerosis ("MS").  While the innate immune system is responsible for mounting the body’s initial defence against threats, it also plays a critical role in controlling the overall immune response and many for the body's reparative functions.

The Company has developed a unique, biologically derived, microparticle which can target both the regulatory/reparative functions as well as the defensive functions of the innate immune system. The first drug developed from this platform, MIS416, is showing promise in several areas, however the Company has selected secondary progressive multiple sclerosis (SPMS) as the initial indication to address with MIS416.

Innate Immunotherapeutics is conducting a Phase 2B efficacy trial of a drug candidate to treat secondary progressive multiple sclerosis (“SPMS”). There are currently no safe and effective ongoing treatments for this progressive and highly disabling form of multiple sclerosis.

Completed Phase 1B/2A trials of MIS416 have demonstrated an acceptable safety and tolerability profile. Many treated patients have self-reported a range of significant improvements to disabilities caused by their disease. In addition to trial results, SPMS patients in New Zealand have been receiving treatment for up to seven years under a compassionate use program.

On completion of this study, expected early 2017, the Company’s strategy is to partner this application of the Company’s technology with ‘big pharma’ to complete approval trials and launch sales into the worldwide unmet market for SPMS. It is expected that this is a US$4bn or greater market opportunity.

Multiple sclerosis (“MS”) is a chronic, often disabling condition, where the body’s immune system attacks the myelin sheath surrounding nerve fibers. The damaged myelin forms scar tissue which distorts or interrupts nerve impulses, disrupting the ability of parts of the nervous system to communicate properly.

This results in a wide range of symptoms, including loss of balance, muscle coordination, difficulty walking, slurred speech, tremors, stiffness, cognitive impairment, depression, fatigue and bladder problems.

There are two main forms of MS, an early “relapsing-remitting” stage of disease and a later more disabling “secondary-progressive” stage of disease. There are now 13 drugs approved to mitigate the effects of relapsing-remitting disease but no approved drugs for the effective ongoing treatment of SPMS.

Why don’t the relapsing-remitting drugs work in SPMS?  Recent evidence suggests that the damage caused to the nerve fibers in patients with SPMS arises because of the action of certain innate immune cells inside the central nervous system.  Relapsing-remitting MS drugs do not target these cells and therefore to date have not been effective in patients with SPMS.

Our competitive advantage

Our SPMS drug candidate, MIS416, has demonstrated safety both in Phase 1B/2A trials and over the seven years the Company’s New Zealand compassionate use program has been running.  Many patients who participated in the Company’s previous trial have elected to stay on the treatment as part of the compassionate use program because of continuing benefit from the drug.

There are few other drug candidates in trial for the treatment of SPMS and we believe they have less clinical experience or possibly have safety issues. 

The Company began operations in August 2000 as an unlisted New Zealand based public company. At that time the Company acquired a patented platform technology for the treatment of diseases caused by pathogens, and engaged in the research and development of new drugs based on this technology. The Company owns all patent and intellectual property rights to this technology.7

Initially the Company directed its efforts and resources towards the clinical development of an anti-HIV passive immunotherapeutic however this programme was shelved in 2008 when the Company began the preclinical evaluation of a second drug candidate, an immunomodulator referred to as MIS416.  As a result of encouraging safety and efficacy results in a number of animal models, the Company commenced a clinical development programme of MIS416 in 2010, initially targeting progressive multiple sclerosis.

To reflect the repositioning of the company around the MIS416 immunomodulator platform, the Company’s name was changed on 1 April 2009 to Innate Therapeutics Limited and on 1 August 2011 to Innate Immunotherapeutics Limited.

The Company re-incorporated in the State of Victoria in October 2013 and subsequently carried out a successful initial public offering to raise A$10 million. Innate Immunotherapeutics was admitted to the ASX on 23 December 2013.

Directors

Michael Quinn,  Independent Chairman

Liz Hopkins,  Independent Director

Andrew Sneddon,  Independent Director

Dr Robert Peach,  Independent Director

Chris Collins,  Director (and substantial shareholder)

Simon Wilkinson,  Managing Director

Management

Simon Wilkinson, CEO

Dr Gill Webster, CSO

Dr Janette Dixon, VPBD

Jeff Carter, CFO

The latest audited financial results are contained in Company's Annual Report which is available from the Company's website

The activities of the Company are subject to a number of risks and other factors which may impact its future performance.  Some of these risks can be mitigated by the use of safeguards and appropriate controls.  However, many of the risks are outside the control of the Company and cannot be mitigated.

Investors should be aware that the performance of the Company may be affected and the value of its Securities may rise or fall over any given period.  Some of the factors which investors should consider before they make a decision whether or not to apply for New Shares, but are not limited to, the risks detailed in Section 7 of the Company's IPO prospectus dated 25 November 2013. (Go to the Company website for a copy of the document)