CombiGene’s history in brief
The first steps were taken during the 1990s
CombiGene originated in the 1990s, when the company’s scientific founders, Professor Merab Kokaia and Associate Professor David Woldbye, demonstrated that neuropeptide Y (NPY) inhibits epileptic seizures in animals and that this positive effect is further strengthened by the NPY receptor Y2.
The great challenge at that time was that there was no adequate means of applying this knowledge to create an effective treatment, since there was no way of administering the intended treatment to humans.
The early 2000s
A decisive discovery
The discovery that a safe, non-pathogenic virus whose own DNA was largely removed and replaced with functional DNA sequences (so-called AAV vectors) can be used to “transport” gene-therapeutic drugs immediately presented entirely new possibilities for Professor Kokaia and Associate Professor Woldbye.
In April 2006 entrepreneur and financier Lars Thunberg, together with Merab Kokaia and David Woldbye, formed CombiGene AB to create a platform for further development and commercialization of the scientific discoveries.
2015 to 2018
CombiGene as a listed company
On 25 May 2015 CombiGene was listed as a public company on SPOTLIGHT Stock Market (then AktieTorget). The listing generated SEK 12.5 million in research capital and, in 2016, the strong financial position enabled CombiGene to test the final candidate drug, named CG01.
During 2017 and 2018 CombiGene carried out several preclinical studies with CG01. All studies confirmed the anti-epileptic effects of CG01 and during 2018 CombiGene began extensive preparations for clinical studies, i.e., human trials.
Since the listing, CombiGene has raised SEK 48 million in research and development capital. During 2018 CombiGene was also awarded EUR 3.36 million from Horizon 2020 (the EU framework programme for research and innovation) for the ongoing development of CG01.
The present and the future
The gene therapy explorer
During the development of CG01 CombiGene has amassed a knowledge of gene therapy and a network that is unique among Nordic companies. This knowledge covers aspects that are decisive for the successful development of gene therapeutic drugs; for example, selection of viral vectors, methodology development for GMP-classed production of gene-therapeutic substances (which is considerably more complicated than production of conventional drugs) and the regulatory issues surrounding gene therapy. Concurrently, the company has established a broad international contact network within the global pharmaceutical industry.
CombiGene is currently pursuing two gene therapy projects: CG01, for treatment of focal epilepsy, and a project for treatment of lipodystrophy, a condition characterized by an abnormal distribution of fatty tissue in the body. CombiGene’s long-term ambition is to identify and develop additional projects in the gene therapy area.
CombiGene’s lead project CG01 has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 823282
CombiGene’s vision is to provide patients affected by severe life-altering diseases with the prospect of a better life through novel gene therapies. CombiGene’s business concept is to develop effective gene therapies for severe life-altering diseases where adequate treatment is currently lacking. Development assets are sourced from an external research network and developed to achieve clinical proof of concept. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while the company may manage this process on its own for drugs targeting niched patient populations. The company is public and listed on the Swedish marketplace Nasdaq First North Growth Market and the company’s Certified Advisor is FNCA Sweden AB, +46 (0)852 80 03 99 email@example.com.