Replacing Vaccine Injections with a Tablet

Replacing Vaccine Injections with a Tablet

Author: Catharina Goedecke, Adrian Sprenger

 

Dr. Adrian Sprenger from Bionicure, Freiburg, Germany, talks to Catharina Goedecke for ChemViews Magazine about injectable drug depots and their promise for improved patient compliance as well as better healthcare in developing countries.

Bionicure is a spin-off of the University of Freiburg, co-founded by Adrian Sprenger. The team has developed an injectable depot formulation that can release a drug in a short, high-concentration burst triggered by a tablet the patient can take at home, with no need for another visit to the doctor’s office or hospital. This approach has special promise for vaccinations, which usually require several shots over a period of time to provide effective protection from disease.

 

Please tell us about your idea.

Bionicure develops a remote controlled drug depot formulation for injectable drugs. Our depot formulation stores the drug until a small molecule triggers its dissolution, which results in a short peak tissue concentration of the cargo drug. The trigger is orally available in form of a tablet, allowing the patient to release the injected drug when needed without further medical assistance.

 

Which problem does it solve?

The need for repeated medical assistance in therapies requiring injection is a limiting factor in developing countries and a major reason for low patient compliance in the western world. It deteriorates treatment success and thereby the cost efficiency of the health care system. For instance, according to some studies, more than 50 % of all vaccination treatments against the carcinogenic Human papillomavirus (HPV) were not completed.

Our formulation ensures a reliable immunization while offering a viable therapy scheme for developing countries and improved patient compliance by replacing injections with tablets to be taken at home. Vaccination with our depot formulation requires only one medical contact as opposed to the conventional prime-boost approach. To ensure the timely ingestion of the trigger tablets in developing countries, one person per community would be trained and responsible.

 

What does the encapsulation material consist of?

Our depot formulation consists of polyethylene glycol, one half modified with a pharmacologically inactive small molecule, fluorescein, and one half with a humanized antibody fragment. The molecular interaction between both is responsible for the crosslinking of the depot and can be inhibited competitively by addition of fluorescein in its free form.

The building blocks have been in clinical use for many years and are pharmacologically well characterized. They are generally recognized as safe and are readily excreted after dissolution of the depot formulation.

 

What happens with the capsules in noncompliant patients?

I would rather speak of depot formulation than depot capsules, since it consists of a hydrogel. In a proof-of-principle study, the depot formulation stayed intact for at least nine weeks without any change of the surrounding tissue. If the patient omits the trigger tablet over very long time periods, we suspect the depot will be naturally encapsulated by tissue and enzymatically degraded. As the depot formulation is injected right under the skin, adverse events can be dealt with quickly and do not pose a major problem.

 

Are there possible uses apart from vaccinations?

All therapies requiring repeated injections and short and high drug exposure benefit from our technology, as consecutive injections can be replaced by tablets. This is especially desirable if the injection is particularly unpleasant, such as injections into the eyeball or prostate. Additionally, our technology enables drug release at tissue sites where administration by injection would be undesirable – for example in the middle of a wound healing process. A depot could be placed into the wound during surgery and the required drug could be released from the depot instead of being administered by injection.

 

You founded Bionicure as a spin-off while working at the Center for Synthetic Biology at the University of Freiburg. How did the university support you during the founding process?

We got very good support through the Freiburg University Founder Office in the form of seminars, lecture courses, startup competitions, and review of our grant applications. In the beginning, we were financially supported by our mentor Professor Wilfried Weber and the university.

 

Why do you participate in start-up competitions such as the ACHEMA Gründerpreis?

Start-up competitions provide young start-ups like ours with feedback on their business model and access to important networks and infrastructure. Throughout the ACHEMA competition, we got very valuable feedback to our business plan and, as it is organized in three stages, very good ideas to which parts of the plan we should pay more attention for the next stage.

The competition even provided us with a business development expert supporting us. Another special perk of the ACHEMA Gründerpreis is the chance to win a booth at the ACHEMA fair. It provides a unique opportunity to quickly get in personal contact with experts and executives.

 

What are the challenges of starting your own company as a scientist?

Particularly challenging is the shift from the university perspective on research and development to the perspective you need in the biotech and pharma industry. Each molecule used and each step in the production process need special consideration if the end product is meant to be used in humans and not just for a publication. Getting up to speed with regulatory processes in general is challenging.

 

How do you handle the business aspects?

Projects in the Weber laboratory for Synthetic Biology are always designed with a real application in mind. The project that lead to the foundation of Bionicure, for instance, was initially funded by the “Starting Grant” of the European Research Council which particularly supports ideas with a high socio-economic potential and commercial feasibility. With this mindset, our colleagues regularly attend business and patent workshops and are well prepared for business. But the most helpful source of business advice so far has been our advisory board.

 

At what point would you recommend looking for outside experts?

I would generally recommend to focus on the core competences of the team in the first years of starting a company and look for outside expertise for everything else. Particularly in regulatory affairs, we count on outside experts since mistakes in the development plan are even more costly than the experts.


Adrian Sprenger

Adrian Sprenger studied biochemistry at the University of Tübingen, Germany, and business administration at the Distance University Hagen, Germany. He received his Ph.D. for research on big data analysis in clinical proteomics from the University of Freiburg, Germany, in 2013. Between 2010 and 2013, he worked as a lecturer for biochemistry at the Academy for Medical Professions, University Medical Center, Freiburg, Germany, and as a freelancer for Novartis Pharma Schweiz AG, Basel Switzerland, and for YES Pharmaceutical Development Services GmbH, Friedrichsdorf, Germany.

Since 2014, Dr. Sprenger is CEO of Bionicure, a Freiburg University spin-off specializing in drug delivery, founded in cooperation with Professor Wilfried Weber.


Selected Awards

  • Fellow of “EXIST Research Transfer”
  • 2nd and 3rd prize at levels 2 and 3 of the StartInsLand Start-Up Competition in Freiburg, Germany

 

Selected Publications

 

Also of Interest

 

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