CombiGene´s lead project CG01 has received funding from the European Union´s Horizon 2020 research and innovation programme

Milestones

Discovery
• Professor Merab Kokaia and Associate Professor David Woldbye initiated Swedish-Danish collaborative research to develop new forms of treatment of difficult-to-treat epilepsy.
• Several academic studies had indicated that production of NPY increases in key areas of the brain after an epileptic seizure. One hypothesis was that NPY is part of the body’s own defence for preventing epileptic seizures.
• Woldbye and Kokaia succeeded in demonstrating that a more pronounced anti-seizure effect is achieved if an increased level of NPY is combined with an increased level of the receptor Y2.

2006 – 2013: CombiGene is established, research intensifies
• A priority application was submitted to the Swedish Patent and Registration Office, PRV.
• Successes are achieved in the gene therapy field and so-called AAV vectors gain acceptance as an appropriate method of introducing therapeutic genes into human nerve cells.
• Together with entrepreneur and financier Lars Thunberg, Kokaia and Woldbye formed the company CombiGene AB to pursue development and commercialization of the discovery.
• The company submits patent applications in the USA and Europe.
• Woldbye and Kokaia’s academic research continued in parallel with the development of the company and a large number of articles were published in recognized journals.
• Company ownership is broadened.

2014 – 2015: CombiGene takes shape
• Patent applications are approved in the USA and Europe.
• CombiGene became a public limited company and the board of directors was reorganized.
• The company’s registered head office and premises were relocated to Medicon Village in Lund, Sweden.
• A heavily oversubscribed offering yielded MSEK 12.5 before issuing expenses.
• The company was listed on SPOTLIGHT Stock Market as of 25 May 2015.
• The subsidiary CombiGene Vet AB was established.
• Screening to find the optimal gene vector commences.

2016
• The first round of screening studies is conducted according to plan.
• The candidate drug was selected in the summer of 2016.
• New preclinical studies begin.
• A new patent application is submitted.

2017
• Data from CombiGene’s dose-response study confirms that the company’s candidate drug has the intended dose-dependent antiepileptic effect.
• CombiGene completes a preference share issue that was approved by an extraordinary meeting of shareholders on 26 January2017. The rights issue is oversubscribed and the Company raises MSEK 14.2 before issuing expenses.
• CombiGene begins long-term study on candidate drug CG01 for treating epilepsy.
• CombiGene is awarded the”Seal of Excellence” by Horizon 2020 and 500,000 kronor from Vinnova.
• Initial data from the long-term study on CombiGene’s candidate drug for treating epilepsy indicate positive effects in the form of fewer seizures.
• Human expression study confirms that human brain cells take up CombiGene’s candidate drug, CG01

2018
• CombiGene and Cell and Gene Therapy Catapult sign agreement for the development of a manufacturing method for innovative gene therapy treatment of epilepsy.
• Horizon 2020, the EU framework programme for research and development, invests 3.36 million euros in CombiGene’s ongoing development and commercialization of the company’s gene therapy project focussing on difficult-to-treat epilepsy.
• CombiGene carries out a preferential rights issue which raises about 31 million kronor before issuing expenses.
• On 19 December 2018 CombiGene is listed on Nasdaq First North Stockholm.