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Investor Services - Frequently Asked Questions

What is an antibody?
What is a domain antibody?
What is TNF?

Commercial FAQ
What is a Patent?
What is the Patent process?
What is a Divisional Patent?
What is an Opposition?
Can I learn anything about a patent application from patent office web sites?
Where can I learn more about Arana's corporate partnerships?
Where are Arana securities listed?

 

What is an antibody?

Antibodies are an essential part of the body’s immune system. They are large proteins naturally produced by our white blood cells. Their function is to protect us by targeting and removing “foreign” materials such as bacteria or viruses.

Antibodies home in on targets on the surface of a cell. These targets may be the access points for infection by a virus, or the sites at which growth factors stimulate cell multiplication, as in cancer. Attached antibody blocks access to the target by virus or a growth factor. 

Each individual has the capability of producing millions of different antibodies. Each antibody is highly specific for its target (antigen), meaning it is capable of singling it out from amongst thousands of other, often similar, targets. Once the target antigen is recognised, the antibody binds to it tightly and (in the case of a virus or bacteria) aids its elimination from the body. Other therapeutic targets might be blocked from causing disease by the continuing attachment of the antibody.

Antibodies are natural proteins that traditionally remain for a long time in the bloodstream and are predictable in their effects. These properties and their high level of specificity make antibodies a very attractive proposition as potential drugs.

Antibodies have been known for a long time – why are they only now succeeding as drugs?

In the 1970s, breakthrough science made possible reliable production of monoclonal antibodies (that is antibodies recognizing a single target antigen). These antibodies were hailed as potential 'magic bullets' for treating diseases because of their exquisite target specificity and lack of toxicity, and were soon being developed as possible therapeutic agents.

However, monoclonal antibodies were initially produced from mice. When administered to humans, the mouse antibodies were rejected as “foreign” and rapidly became ineffective. As a result, most of these early efforts aimed at developing monoclonal antibodies as therapeutics were unsuccessful.

Further technological breakthroughs were needed to solve this problem. The focus was on making the mouse antibodies appear more “human-like” by producing, firstly, chimaeric antibodies (a mixture of mouse and human antibody components) and then antibodies that were 'humanised' by grafting binding sites from a mouse antibody onto a human antibody structure ('CDR grafted').

 

What is a domain antibody?

A domain antibody (formerly referred to as a single domain) is the smallest known sub-component of an antibody that retains functions of an antibody. The small size of domain antibodies relative to 'full' antibodies (about one-tenth the size) offers potential advantages including being cheaper to produce, having greater ability to penetrate through the body, and greater ease of administration.

 

What is TNF?

TNF is a key immune system hormone involved in multiple defence functions. When produced in inappropriate amounts it can contribute to the progression of diseases such as rheumatoid arthritis and Crohn's disease (an inflammatory disease of the bowel).

Therapeutic antibodies are often described as chimeric, humanised or human - what does this mean?

These terms relate to the proportion of the antibody that is made up of human protein (the remainder usually being mouse protein). In general, more 'human' proteins are considered better because they are less likely to be rejected by the body as being foreign.

  % human protein Degree of 'foreign-ness' Examples: Anti-TNF antibodies
Chimeric
Approximately 70
Low Remicade (Centocor)
Humanized Greater than 90 Very Low CDP870 (Celltech/Pharmacia)
Human 100 Nil Humira (Abbott)

 

Commercial FAQ

What is a Patent?

A patent is a temporary monopoly in a technological innovation, which provides the patent owner with the right to exclusively exploit the invention for the life of the patent (generally 20 years). The idea or invention claimed must be novel, non-obvious, and have a real utility.

 

What is the Patent process?

Under the Patent Co-operation Treaty (PCT), the process and timetable is as follows:

File provisional patent [Day 0 - Priority Date]

Up to 12 months later - Complete filing as PCT application. A PCT application automatically ensures submission of the patent in all countries that are parties to the treaty

About 16 months from Day 0 - International Search Report (looking for prior art etc) issues

18 months from Priority Date - Publication of PCT application. This is the first occasion that the existence of the patent application reaches the public domain

20 - 21 months from Priority Date - Entry into National Phase. At this time costs can be limited by reducing the number of countries in which the patent application is examined be examined

After this, each country will examine the patent application according to their own internal timetables and practices, which in the case of Japan can take several years. It is common for there to be a number of rounds of written and verbal discussions between the applicant and the Examiner, directed to specific questions or issues.

 

What is a Divisional Patent?

In the US, the practice is to allow one "invention" or novel idea, per patent. If the patent office considers there is more than one invention in the PCT application, they will divide the patent into a number of separate applications, or divisionals, each with the same title as the original PCT but with different application numbers. These divisionals will then normally be examined separately.

 

What is an Opposition?

In certain countries (excluding the USA), any party who feels that a patent should not be granted has a period of time (which varies up to six months) after a patent office publishes a notice that it intends to grant a patent, to object to the granting of that patent. Both parties then argue their case before the patent office or a specific court, and a decision is made in favour of one of the parties.

 

Can I learn anything about a patent application from patent office web sites?

Generally, no. The US Patent and Trademark Office does publish some procedural information, but never discloses the content of discussions between an applicant and the USPTO or the exact stage of examination of an application. Also, in most cases, a company will receive documents from the USPTO well before the existence of such documents (e.g. Notices of Allowance etc) is listed on the patent office web site.

 

Where can I learn more about Arana's corporate partnerships?

Arana has a number of ongoing corporate partnerships and actively seeks new partnering opportunities. New partnerships will be announced as they develop and details will be posted on this website. To join Arana’s mailing lists please click here.

For details of Arana’s current corporate partnerships click here.

 

Where are Arana securities listed?

Arana Therapeutics is listed on the Australian Stock Exchange, under the code AAH.ASX and on the AIM in the UK. Arana’s AIM code is AAHx.

If you have a question that has not been answered by these FAQs, please contact us here and we well endeavour to answer you as soon as possible.