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SYGNIS Pharma - the "new" one: development and commercialisation of molecular diagnostics products

Heidelberg-based SYGNIS Pharma AG is to discontinue its therapeutic R&D projects targeting human nervous system diseases and will in future focus on the research and development of novel molecular biology technologies, including DNA amplification and sequencing as well as drug screening.

In early December 2012, SYGNIS Pharma AG announced the merger with X-Pol Biotech, a subsidiary of the Spanish biotech group GENETRIX. With the deal complete, X-Pol now becomes a 100% subsidiary of SYGNIS. The Spanish company X-Pol was founded in Madrid in 2008 and is specifically focused on the development of enzymes and technologies in the fields of DNA amplification and sequencing. The acquisition of X-Pol was accompanied by a profound reorganisation of SYGNIS’ business activities. Prior to the acquisition of X-Pol, SYGNIS’ major focus was on the research and development of innovative therapies for the treatment of central nervous diseases, but in future the company will specifically focus on the field of molecular diagnostics. SYGNIS AG is listed on the Prime Standard of the German Stock Exchange.

SYGNIS’ activities previously focused on the development of AX200, its advanced drug candidate for the treatment of acute stroke. However, the hopes and expectations raised by the promising results obtained in preclinical studies and a clinical phase II efficacy trial for the treatment of acute ischaemic stroke (AXIS 2 study) led to bitter disappointment when the results of the AXIS 2 study were finally made public in December 2011. The study showed no improvement in patient outcome relative to the placebo-treated patient. The study missed its endpoints and the commercialisation of AX200 for the treatment of ischaemic stroke was rendered impossible. The company’s board of directors decided to abandon further development of the drug and bring new contents and projects into the company by way of targeted M&A (mergers and acquisitions).

Isothermal amplification of nucleic acids

Pilar de la Huerta, CEO of SYGNIS Pharma AG © SYGNIS

The adaptation of the organisation to new business activities was the result of the acquisition of X-Pol Biotech, a Spanish company focused on molecular diagnostics and owner of a new highly innovative DNA amplification technology. In July 2012, X-Pol signed an exclusive, global licensing agreement for its most advanced product, QualiPhi®, with QIAGEN, the global provider of technologies and reagents for use in the field of molecular biology. QualiPhi® is a chimeric DNA polymerase derived from bacteriophage phi29; the enzyme has a 1000- to 10000-fold higher efficiency in the amplification of DNA than any products currently on the market.

It is expected that the demand for DNA sequencing will continue to rise, not least due to growing demand in the field of personalised medicine. Estimates assume that isothermal polymerases used to amplify entire genomes will achieve growth rates of 25 percent; current estimates project that the global market proportion of isothermal polymerases accounts for as much as 70 million euros (the entire DNA amplification market volume is estimated at around 250 million euros). With the acquisition of X-Pol Biotech, SYGNIS has acquired a marketable technology that is already licensed to a renowned, globally acting company and thus able to generate immediate revenue.

Fundamental reorganisation

The new business activities required SYGNIS Pharma AG to make organisational changes to adapt to the new business activities. SYGNIS acquired 100% of X-Pol’s shares through capital increase against contribution in kind. Following the transaction, the former shareholders of X-Pol hold 77.5% of SYGNIS shares. The company is now directed by Pilar de la Huerta, former CEO of GENETRIX, supported by Peter Willinger who remains in post as Chief Financial Officer of SYGNIS and Dr. Armin Schneider as Senior Vice President Research. Dr. Cristina Garmendia Mendizábal replaces Prof. Dr. Friedrich von Bohlen und Halbach as chairperson of the company’s supervisory board. Prof. Dr. Friedrich von Bohlen und Halbach becomes the vice chairman of the company’s supervisory board.

Over the past few years, SYGNIS has addressed projects at the KIBRA pathway with the aim of developing drugs for the treatment of different forms of dementia. KIBRA (kidney and brain expressed protein) is a protein linked to human learning capacity and memory performance. The company used one of its proprietary assays to identify and characterise around a hundred compounds that enhance KIBRA expression and improve memory performance by modulating the KIBRA pathway. On 20th December 2012, SYGNIS announced the discontinuation of its therapeutic R&D project KIBRA and the adaptation of its organisation to the new business activity. The company is continuing to look for a partner interested in the further development of the KIBRA modulators. The discontinuation of the project also led to the suppression of 10 posts at the Heidelberg site, measures that were implemented in order to concentrate the company’s financial resources on the development and marketing of novel technologies in molecular biology. The company now employs 13 people at its site in Heidelberg.

Premises Sygnis Pharma AG © Sygnis

The company announced on 15th January 2013 that it had been granted the European and US patents for a new screening platform for the efficient detection and characterisation of drug candidates. The patents protect a new basic technology for the detection of protein-protein interactions that are becoming increasingly important in the development of new drugs and the identification of new therapeutic targets within the customised drug development field (personalised medicine). SYGNIS’ CEO Pilar de la Huerta commented: “The technology will be licensed to a distribution partner and we expect to see our first revenues during the current financial year.” In addition to the successful partnerships related to the QualiPhi® polymerase, these patents represent another important pillar in the organisation of the company’s new business activities. SYGNIS hopes to establish itself as a provider of technologies in the field of DNA tools and customised drugs, which are considered to be a growth market.

Further information:
Pilar de la Huerta
Im Neuenheimer Feld 515
69120 Heidelberg
E-mail: pdelahuerta@sygnis.es

Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/sygnis-pharma-the-new-one-development-and-commercialisation-of-molecular-diagnostics-products