In 2021, CombiGene’s epilepsy project CG01 will focus on the final preclinical studies, not least the important biodistribution and toxicology studies, with the aim of starting studies in humans, so-called clinical studies, in 2022. A central area for both the final preclinical studies and future clinical studies is the GMP manufacturing of CG01. CombiGene has therefore recruited Martin Linhult, as the company’s CMC expert (Chemistry, Manufacturing and Controls) starting in December 2020. In addition to his expertise in the CMC field, CombiGene will benefit greatly from his experience in taking pharmaceutical products all the way to market.
Martin Linhult holds a PhD in molecular biology at Royal Institute of Technology (KTH) in Stockholm (1998-2003) and holds a Master of Chemical Engineering from the same university. In addition, Martin has extensive experience from a number of senior positions in the Swedish pharmaceutical industry and is used to interacting with regulatory authorities at an international level, including the FDA and EMA. Martin has worked in all parts of the production process of biological drugs and was responsible for building up the production unit at Octapharma. Martin will primarily work on the various aspects of the manufacture of the drug candidate CG01, which is now entering a very intensive development phase. Martin will report to CombiGenes Chief Research and Development Officer Karin Agerman.
“I am incredibly pleased that we have succeeded in recruiting Martin Linhult to CombiGene”, says Karin Agerman. “Martin has exactly the deep knowledge in all aspects of the production of biological drugs that we are looking for and has, in addition to this, experience of taking a product all the way to market. His broad international experience in regulatory matters will be of great benefit in the further development of CG01.”
CombiGene is now continuing the process of strengthening the company with one or two more people.
Contacts
Jan Nilsson, CEO
Phone: +46 (0)704 66 31 63
jan.nilsson@combigene.com
Bert Junno, Chairman of the board
Phone: +46 (0)707 77 22 09
bert.junno@combigene.com
www.combigene.com
CombiGene AB (publ) Medicon Village, SE-223 81 Lund, Sweden
info@combigene.com
About CombiGene
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, info@fnca.se.
CombiGene’s lead project CG01 has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 823282