– We are looking for a partner who can take over where Spark left off and with the agreement in place, we can use the data generated over the past two years in the search, says Peter Ekolind
Three years ago, out-licensed CombiGene the epilepsy project CG01 to the American gene therapy company Spark Therapeutics after a series of convincing preclinical data.
Under the agreement, CombiGene was entitled to receive up to USD 328,5 million excluding royalties, with USD 8,5 million at signing, and up to USD 50 million at preclinical and clinical milestones. In January 2024, CombiGene regained global rights to CG01 after the collaboration agreement was terminated when Sparks made a strategic revision of its pipeline. CombiGene is now looking for a new development partner for the project.
Orphazyme invested in CombiGene
The CG01 project and the previous agreement with Spark received a lot of media attention and investor interest. One of the players who caught the eye of the company was the Danish life science investor Orphazyme which in March 2024 had acquired 10 percent of the shares in CombiGene. In a interview with BioStock said Orphazyme's chairman of the board Michael Hove that he has high expectations for the company:
– When we covered the Nordic market, CombiGene was unique both with its long history in gene therapy, led by CG01, but also because they managed to sign a strategic partnership with Spark, which we see as proof of concept. We have high expectations that the company will succeed in finding a new partner who will take the promising product all the way to product launch.
New license agreement with Spark
A question that has been hanging in the air since the rights to the epilepsy project CG01 were returned was to what extent CombiGene can use the research data that the pharmaceutical company generated during the development work. At the end of last week, we got the answer.
The parties have now entered into a new license agreement covering certain intellectual property developed or used in connection with the previous license agreement for CG01. The license agreement entitles Spark to a low percentage royalty on future net sales of licensed products. The license agreement further ensures that CombiGene can use data generated in the collaboration. CombiGene is not obligated to make any upfront or milestone payments for the license and is not obligated to repay the upfront payment of USD 8,5 million received upon signing.
CombiGene will have access to data from previous and current ongoing studies no later than the beginning of Q4, 2024.
Comments from the CEO
BioStock sought CombiGene's CEO Peter Ekolind for a comment on the new license agreement.
Peter, would you like to tell us a little more about the agreement that has now been signed?
– I would like to start by saying that we are very pleased to have signed this agreement as it improves our chances of finding a new suitable partner for the epilepsy project. We will now be able to present new data to a potential collaborator and benefit from results that the previous counterpart has contributed.
– Due to the strict confidentiality surrounding the license agreement, I unfortunately cannot go into more detail about the terms of the agreement than what has been communicated via press release. But I can say this much that we are very satisfied given that the data we have received so far looks promising. And within the coming months we will receive additional data that will be crucial for CG01's continued development and the possibility of out-licensing once again.
– Data from the ongoing studies conducted by Spark will be crucial in making decisions about the future. If the data is clear and convincing, I believe there is a good chance of finding a new partner. Otherwise, there is a risk that the project cannot be out-licensed again and may then have to be terminated.
What criteria should a new development partner meet in order to take over the CG01 project in an optimal way?
– An optimal partner is someone who already works in CNS and possibly also with epilepsy, and who sees the potential of gene therapy in an area where their portfolio lacks this. They would of course also be interested in acquiring such a project.