CombiGene AB has decided to discontinue the preclinical development of the lipodystrophy project CGT2. After receiving data that was difficult to interpret during the course of the project, CombiGene conducted additional studies in 2023 to provide a basis for a correct assessment of the project. Now that these studies have been conducted, the Company can conclude that there is no conclusive data that justifies continued development. The lipodystrophy project was licensed from Lipigon Pharmaceuticals AB on October 10, 2019. CombiGene has now terminated the in-licensing and collaboration agreement with Lipigon and the rights to the project will revert to Lipigon no later than August 5, 2024.
In February 2021, the Lipodystrophy project was awarded EUR 882,500 in project grants by the EU’s Eurostars international funding program. Thanks to this funding CombiGene has been able to initiate a collaboration with the University Medical Center Hamburg-Eppendorf, which has a research group with experts in lipid research. The researchers at Hamburg-Eppendorf are involved in evaluating the different drug candidates CombiGene has in the pipeline and conducts several different preclinical efficacy studies.
CombiGene's project CGT2 is supported by the Eurostars Programme. Project ID: 114714
CombiGene collaborates with Professor Ormond MacDougald at the University of Michigan Medical School. The collaboration comprises one pilot study and one main study in which CombiGene’s most promising gene therapy candidate within the lipodystrophy project CGT2 will be evaluated.
Lipigon is developing new treatments for patients with lipid-related diseases. The company’s foundation is based on 50 years of lipid research at Umeå University. The company’s primary focus is on orphan drugs and niche indications. CombiGene will continue the development of CGT2 with scientific support from Lipigon.
UKE is an important research facility and hospital in Hamburg. UKE researches in five main areas; neuroscience, oncology, cardiovascular research, health sciences research and immunology. Professor Jörg Heeren and his team have significant expertise in the target protein of CGT2, its function in the adipose tissue and its influence on lipid metabolism.
In-licensing of the project from Lipigon.
Design of expression plasmids, which are a starting material for gene-therapeutic vectors CombiGene intends to develop for treatment of partial lipodystrophy.
In vitro studies (tests on liver cells) show proper protein expression.
Priority-based patent application filed with the UK Patent Office.
In vivo studies initiated for evaluation of the different gene therapy vectors.
The lipodystrophy projects receive EUR 882,500 in development grants from the EU Eurostars program.
In August 2021, CombiGene submitted a so-called PCT application to protect the vectors developed within CGT2.
The first in vivo study, a so-called expression study, shows that several drug candidates result in correct protein expression specifically in the liver, the organ that CombiGene intends to treat.
For the remaining drug candidates, efficacy studies are initiated in several experimental animal models.
CombiGene signs agreement with Professor Ormond MacDougald at the University of Michigan Medical School to evaluate the leading gene therapy candidate within the lipodystrophy project CGT2.
National patent applications filed in the US and EU.