Affibody molecule: A molecule that can detect breast cancer

In AWA Feature

31 October, 2018

Every month is breast cancer awareness month for Swedish Biopharmaceutical R&D company Affibody, which has developed unique molecular technologies to localise cancerous tumours and individualise drug treatment for patients

Director of Alliance and IP Management at Affibody Caroline Ekblad has been with the Solna based company since 2007. She started out working with research, but the past eight years she has been responsible for IP management.

“Affibody wants to take the lead in the next generation biopharmaceuticals by using two unique technologies; Affibody molecules and Albumod,” she explains.

The Affibody molecule technology aims to develop binding molecules targeting different proteins in the body. The molecules have functional similarities to the one of an antibody. But since an Affibody molecule is about 25 times smaller than a regular antibody, it can reach targets less accessible for antibodies and it enables alternative means of production which potentially are more cost efficient.

“In addition, the small size of an Affibody molecule means you can administer a much higher effective dose when injecting a patient with a pharmaceutical. Compared to antibodies, we can offer a higher amount of active substance of molecules in the same volume of drug administered to the patient. This way, patients could benefit from more efficient treatments or alternative administration routes,” says Caroline.

There are more benefits to be reaped from having a smaller molecule in pharmaceuticals.

“We can easily format and connect it to other molecules to create multispecific constructs.”

Affibody has also developed the Albumod technology. This is a specific molecule which only binds to albumin, one of the most common proteins in the blood.

“When administering a smaller drug, it often passes rapidly through the kidneys which diminishes its effect. By binding it to albumin, which is a larger molecule, it lingers in the blood circulation much longer.

“In short, with the Albumod molecule we can ensure the drug stays in the body longer to have the desired effect on the patient.”

The small Affibody molecule and the albumin binding molecule can also be combined to allow the Affibody based drug to circulate in the body for longer periods of time.

“For pharmaceuticals that need to remain in the body for several hours or days to have an effect, this is a solution which buys them more time.”

Instead of administering a drug to a patient every day, Caroline argues it could be sufficient with once a month benefiting from the Albumod technology. Not only does this result in less time spent on administering drugs in health care, i.e. cost efficiency, but it could also mean less stress and trauma for the patient in question.

We want to create the technology for the next generation’s pharmaceuticals. Protecting our molecules using intellectual property is a must for the future.
-Caroline Ekblad, Director of Alliance and IP Management at Affibody

Personalising breast cancer treatment

Apart from their own in-house research projects, Affibody has also chosen to license their albumin binding technology to other companies in possession of smaller molecules which they wish to extend the circulatory half-life of for a more lasting effect of their pharmaceuticals.

“In addition, we have also developed Affibody molecules in-house and subsequently out licensed these to other companies or we have had collaborations where we have developed Affibody molecules for a specific application as requested by the partner. It can be for therapeutic or diagnostic purposes, where we want to bind to a particular molecule in the body e.g. in order to inhibit the function of the molecule or localise its whereabouts.”

Imaging of breast cancer is the furthest advanced diagnostic application for Affibody molecules. Affibody has their own molecule product, ABY-025, developed for this purpose. It is currently undergoing a larger medical trial at the Uppsala University Hospital.

The ABY-025 molecule, which specifically binds to the HER2 receptor, is radioactively labelled and used to localise HER2 positive cancerous tumours in the body. By determining the HER2 status of the tumours it gives information on what type of breast cancer the patient has.

If the cancer has spread, Affibody’s diagnostic solution can also detect certain metastases difficult to find with other techniques.

“It has the potential to individualise breast cancer treatment as we know more specifically what we are dealing with – HER2-positive tumour or not – and can adapt the treatment accordingly.”

The requirement for an Affibody molecule to be used for pharmaceutical versus diagnostic purposes is distinct.

“For the diagnostic ABY-025 it is different when it comes to how long we want the molecule to stay in the body. In this instance, as the product contains a radioactive substance, you don’t want the molecules to linger. They need to get in, bind specifically, and the unbound fraction should clear out of there quickly to minimise side effects and allow high contrast images to be obtained soon after.”

In addition to the clinical trial for breast cancer diagnostics, they have another on-going Phase 2 study on patients suffering from psoriasis. Caroline and her team want to improve the pharmaceuticals used for treating the condition by using a specific Affibody molecule which binds to a pro-inflammatory molecule.

“This specific Affibody molecule may be used to treat other inflammatory diseases, but you have to look at the unmet medical needs and see where you can make an impact. It is a crowded market and many work towards targeting the same kind of molecules. It is crucial to find your niche, she says.

“Our dream scenario for this molecule is to find an actual cure for psoriasis. The clinical studies so far are looking promising.”

Intellectual Property

Affibody has developed a large library of Affibody molecules, from which they select molecules that bind to a certain disease-associated protein.

“We basically send in the protein that we want to find a binder for into the library and fish out binders, which are used as input library in a next round. After several repeated rounds we get an enrichment of Affibody molecules that binds stronger and specifically to the target protein. We then select them for further investigation. The aim is to find whichever molecules bind to that specific protein most efficiently and at the right place.”

Affibody has patented the platforms for their Affibody molecule and Albumod technologies with the help of European Patent Attorney and Partner Niklas Mattsson at AWA’s Stockholm office.

“They are umbrella patents. We make sure to also file a patent application for each new group of binders, targeting a specific protein in the body, to be developed towards a pharmaceutical or diagnostic. For being a small company, we have quite a lot of patents by now!”

At the time of writing, Affibody has almost 300 patents in about 20 different patent families.

The markets, in which Affibody has chosen to patent their technologies, are mainly Europe, the US, China, Japan, Korea, India, Australia, Canada, and South America.

“We obviously patent in the countries where we have partnerships and in the markets we want to target. To some extent, we also take into consideration what effort it takes to obtain a patent in a certain country.

“So far, we haven’t experienced any serious attempts of infringements but AWA regularly conducts news searches so we can stay tuned to what is going on in the IP sector.”

As Affibody licenses some of their molecules to other companies e.g. in Sweden, Germany, UK, Japan and Korea, a solid patent portfolio has been key. The commercial incentive is to get royalties for sold products using their technology.

“We want to create the technology for the next generation’s pharmaceuticals. Protecting our molecules using intellectual property is a must for the future.”

In addition to filing patent applications, Affibody has also registered ”Affibody” as a trademark.

“We have always worked actively with IP. Our contact at AWA, Niklas Mattsson, has worked with us for over a decade and he knows our company history by heart which is priceless. He helps us map out our competition and the strategy to deal with it so we can focus on improving the odds for those affected by breast cancer.”


Affibody

For more information on Affibody, please visit their website.

For their IP matters, Affibody is consulted by Niklas Mattsson at AWA’s Stockholm office.

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