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The Swedish Gene Therapy Company CombiGene aims to complete its preclinical program for the epilepsy project CG01 this year, in order to begin studies in humans in 2022. In this transitional phase, CombiGene has accelerated its recruitment process to occupy several key positions. BioStock has spoken with the newly recruited CMC expert Martin Linhult who, with his long experience of bringing pharmaceuticals to the market, will primarily focus on the manufacturing process of CG01.

Drug development is a complicated and time-consuming process where the basic research leads to a product idea, then comes the preclinical research and proven proof-of-concept, followed by safety evaluations and a functioning manufacturing process of drug substance. Only then can studies in humans begin. An additional challenge is that the longer the projects advance, the more capital is required.

CombiGene’s epilepsy project

The gene therapy company CombiGene has come a long way in the first parts of this process, especially in 2020. In 2022, the company intends to start the first in-human studies, but first, the last preclinical steps must be completed. The drug candidate CG01 is intended to be injected into the brain of patients with drug-resistant focal epilepsy, the most common form of epilepsy in adult epileptics.

Overall, 2020 turned out well on several parameters for CombiGene. On the capital front, the company received a third payment from the EU program Horizon 2020, which means that EUR 2.85 million of the total EUR 3.36 million allocated to the company has now been invested in CombiGene’s epilepsy project. In April, a rights issue of SEK 26.3 million and a directed issue of SEK 4 million provided additional capital. A private placement of SEK 15.5 million was also made to the Dutch life science investor Nyenburgh Holding.

»All in all, these are several smaller as well as larger milestones that are of crucial importance to the company as we approach the first study in humans« – Martin Linhult, CMC-expert CombiGene

In August, the exercise of TO 3 warrants was nearly fully subscribed, which added SEK 17.7 million. In November, the company’s two remaining warrants (TO4 and TO5), were exercised at almost 100 per cent, which added SEK 25 million to the company. Emission costs are to be deducted from all above amounts.

In addition, Associate Professor David Woldbye, one of the company’s scientific founders, presented the results of CombiGene’s preclinical pharmacokinetics study, the company’s preclinical learning and memory study and the preclinical tropism study. All studies were performed with CG01 with a positive result.

The company also finalised its production platform to be able to produce materials for all final studies, which, in addition to the aforementioned financing, means that another critical component of the company’s development plan has been accomplished.

New recruitments will fill key positions

On December 14, CombiGene announced that it has begun the process of strengthening the company’s competencies through new recruitments to fill up key positions for the upcoming development stages. The first of these new employees is Martin Linhult who holds a PhD in molecular biology and a Master’s degree in chemical engineering from KTH. BioStock contacted Martin, who will be the company’s CMC (Chemistry, Manufacturing and Controls) expert, to find out more about what he will bring to the company.

Martin Linhult, CMC-expert CombiGene

Martin Linhult, you have extensive experience from the pharmaceutical industry, can you tell us a little about your professional background and how you will primarily use this knowledge and network of contacts in your new role?

– Before CombiGene, I worked at Chiesi as CMC project manager within Biologics for two and a half years and before that I worked at Octapharma with their recombinant FVIII product Nuwiq for 14 years. I have worked as an engineer, manager and project manager and hope that my knowledge will contribute to CG01’s manufacturing process being robust and safe. I will also be involved in the manufacturing process of CGT2 at an early stage.

What attracted you to become the company’s CMC expert?

– What made the choice easy for me, is that gene therapy has opened up for completely new possibilities for the treatment of diseases that currently lack treatment options. Being part of the exciting development of a technology that is groundbreaking will thus be very stimulating. I also have great team chemistry with my colleagues at CombiGene.

What will be your main tasks at CombiGene?

– To ensure that CombiGene’s production method conforms to the absolute highest standards, through close contact with our manufacturer Viralgen, our regulatory consultants and pharmaceutical authorities.

Finally, what are your hopes for 2021?

– To learn more about gene therapy and to prepare the CMC part so that clinical trials can start according to plan in 2022. In 2021, I hope that we can communicate that the preclinical studies, in particular the biodistribution and toxicology studies, have been completed with a positive outcome. Within the lipodystrophy project CGT2, where, as I said, I am involved in the manufacturing process itself, it would be exciting if we could announce the choice of a drug candidate.

– All in all, these are several smaller as well as larger milestones that are of crucial importance to the company as we approach the first study in humans.

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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