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CombiGene positive to new license agreement for CG01

CombiGene positive to new license agreement for CG01

26 June, 2024

CombiGene has entered into a new license agreement with Spark Therapeutics regarding intellectual property related to the epilepsy project, CG01. CombiGene’s CEO Peter Ekolind believes that they are now in better position to find a new development partner who can take the epilepsy treatment all the way to patients and the market.
– We are looking for a partner who can pick up where Spark left off, and with the agreement in place, we can use the data generated over the past two years in our search, says Peter Ekolind.

Three years ago, CombiGene out-licensed the epilepsy project CG01 to the American gene therapy company Spark Therapeutics following a series of convincing preclinical data.

According to the agreement, CombiGene was eligible to receive up to USD 328.5 million excluding royalties, with USD 8.5 million upon signing, as well as up to USD 50 million at several preclinical and clinical milestones. In January 2024, CombiGene regained the 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 some media attention and interest from investors. One of the players who caught the eye of the company was the Danish life science investor Orphazyme, who, in March 2024, had acquired 10 per cent of the shares in CombiGene. In an interview with BioStock, Orphazyme’s chairman Michael Hove said that he has high expectations for the company:

–  When we monitored the Nordic market, CombiGene was unique both regarding its long history in gene therapy with CG01 as the front runner, and also because they succeeded in signing a strategic partnership with Spark, which we consider as proof-of-concept. We have high expectations that the company will succeed in finding a new partner that 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 CG01 were returned to Combigene was, to what extent can CombiGene use the research data generated by the Spark during the development work? We got the answer last week.

The parties have now entered into a new license agreement regarding certain intellectual property developed or used in connection with the previous license agreement for CG01. Through the new agreement, Spark is entitled to a low percentage of royalties on future net sales of licensed products. The agreement also ensures that CombiGene can use the data generated in the collaboration. CombiGene is not obliged to make any advance or milestone payments for the license, nor is it liable to repay the upfront payment of USD 8.5 million received at the time of signing.

CombiGene will have access to data from previous and current ongoing studies by the beginning of Q4, 2024 at the latest.

CEO comments

Peter Ekolind, Combigene’s CEO

BioStock reached out to 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 partner and benefit from results that the previous counterpart has contributed.

– Due to the strict confidentiality surrounding the agreement, I unfortunately cannot go into more detail about the terms beyond what has been communicated via press release. But I can say this much: we are very pleased given that the data we have received so far looks promising. And in the coming months, we will receive additional data that will be crucial for the continued development of CG01 and the possibility of outlicensing it out again.

– Data from the ongoing studies being 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 outlicensed again and may have to be terminated.

What criteria should a new development partner meet in order to optimally take over the CG01 project?

– An optimal partner is someone who is already working within central nervous system, 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.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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