25. May 2021

Positive trial data for olamkicept in inflammatory bowel diseases

CONARIS announced today that its fusion protein olamkicept has now shown promising effects in two independent studies.

Recently, members of the German Cluster of Excellence “Precision Medicine in Chronic Inflammation”, in collaboration with CONARIS, had demonstrated the mechanism of action of olamkicept in humans and published initial efficacy data in 16 patients with the chronic inflammatory bowel diseases Crohn's disease or ulcerative colitis [1].

In Crohn's disease and ulcerative colitis, various immune system dysregulations cause recurrent disease flares with diarrhea, abdominal pain, and significant psychological distress. In Germany, more than 300,000 people suffer from these diseases. The few approved drugs only help a fraction of patients and often lose their effect over time. New therapeutic options are therefore urgently needed. The fusion protein olamkicept is the only active substance that selectively inhibits the trans-signaling pathway of the key immune messenger interleukin-6, which is important in chronic inflammation, but leaves other important functions of interleukin-6 - e.g. in the defense against infection or in metabolism - intact. Due to its unique mode of action, olamkicept is expected to have fewer side effects than conventional agents targeting interleukin-6 or other components of the immune system.

Olamkicept has been out-licensed by CONARIS to the Swiss pharmaceutical company Ferring Pharmaceuticals, which has been driving the development of olamkicept in Asia in recent years through its Chinese sublicensee I-Mab Biopharma. Results from a Phase II clinical trial in patients with moderate or severe ulcerative colitis have now been presented at the world's leading gastroenterology conference, Digestive Disease Week (May 22-25, 2021) [2].

In this study, a total of 91 patients received either placebo or 300 mg or 600 mg of olamkicept per day for 12 weeks. The study was double-blinded, i.e. neither patients nor medical staff knew the group allocation. Clinical improvement was significantly more frequent in the 600 mg olamkicept group, with symptoms disappearing completely in around 21% of patients (compared with 0% in the placebo group). Healing of the intestinal mucosa was observed in almost 35% of patients (compared with 3% with placebo). As expected, olamkicept was significantly better tolerated by patients than conventional inhibitors blocking interleukin-6.

Following these encouraging data, the development partnership shall be expanded to develop olamkicept further in Phase III clinical trials.

References:

[1] https://doi.org/10.1053/j.gastro.2021.02.062

[2] https://ddw.org/: DDW 2021 Late-Breaking Clinical Abstracts, Presentation Number 775b: B. Chen et al.: Olamkicept, an IL-6 trans-signaling inhibitor, is effective for induction of response and remission in a randomized, placebo-controlled trial in moderate to severe ulcerative colitis.

 

05. Mar 2021

Mechanism of action of olamkicept confirmed in patients

The Cluster of Excellence “Precision Medicine in Chronic Inflammation“ announced today that the mechanism of action of CONARIS‘ fusion protein olamkicept was confirmed in patients with inflammatory bowel diseases (press release in German, publication).

23. Mar 2020

CONARIS out-licenses release technology

CONARIS has out-licensed its proprietary release technology for improved availability of certain gut microbiome-modulating substances in exchange for single payments and revenue shares to an undisclosed global partner from the food industry.

10. Oct 2018

CONARIS out-licenses colonoscopy technology

CONARIS has out-licensed its proprietary colonoscopy technology for improved early detection of colon cancer in exchange for single payments and revenue shares to an undisclosed pharmaceutical partner.

14 Nov 2017

CONARIS sells filtration technology for stool transplantation

CONARIS has sold its proprietary filtration technology for stool transplantation (intestinal microenvironment transfer / fecal filtrate transfer) in exchange for single payments and revenue shares to an undisclosed German partner.

19 Dec 2016

Sublicensing of olamkicept (FE 999301) in Asia

CONARIS’ licensee Ferring Pharmaceuticals announced today that the Chinese biotechnology company IMAB will further advance the development of olamkicept (FE 999301) in Asia. (Ferring's press release)

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17 Nov 2016

A new treatment option for Clostridium difficile infection

The results from a small pilot study with CONARIS’ proprietory filtration technology for stool transplantation were pre-published online in the leading journal Gastroenterology today. Fecal microbiota transplantation from healthy donors is currently the treatment of last resort for patients with recurrent Clostridium difficile infection (CDI), if antibiotics fail. In the present study, clinicians at the University Hospital Schleswig-Holstein (Kiel, Germany) and researchers at the Institute of Clinical Molecular Biology at Kiel University surprisingly demonstrated that CONARIS’ invention of sterile fecal filtrate transfer also led to gut microbiota improvement and rapid relief from CDI symptoms. Fecal filtrate transfer significantly reduces the risk of transferring unknown pathogens and fundamentally questions the current understanding of viable microbiota being the therapeutic principle of stool transplantation.

07 Jan 2015

More than 20 patents for the designer protein FE301 and further variants

After the grant of the patents for the lead substance FE301 in the United States on 25 November 2014 and in South Korea on 15 December 2014, more than 20 patents protecting the biologics programme of CONARIS have been issued.

13 Aug 2014

New research programme on the systems biology of interleukin-6

On 01 September 2014, the new BMBF research consortium InTraSig was started. InTraSig is coordinated by the systems biologist Prof. Fred Schaper from the University of Magdeburg and involves project partners from the universities of Magdeburg, Kiel and Düsseldorf (all in Germany). As the industrial partner of the consortium, CONARIS can commercialise the results of the systems biology analysis and modelling of the interleukin-6 signalling pathway, in particular for the FE301 project out-licensed to Ferring Pharmaceuticals. The German Federal Ministry of Education and Research (BMBF) funds the consortium with a total of 2.1 mEUR until 2017.

26 Jul 2013

Conaris strengthens sgp130 product portfolio by new patents

The international patent protection for the production and therapeutic use of sgp130Fc and corresponding variants was recently strengthened and expanded by the grant of further patents in Australia, Eurasia, the Ukraine and the U.S. In cooperation with the pharma company Ferring the lead substance FE301 is currently developed for the treatment of chronic inflammatory diseases.

13 Jul 2011

EPO grants patent for gp130 muteins with improved binding activity

The European Patent Office (EPO) announced the grant of a further gp130 patent (EP 2 212 347) claiming the production and use of new gp130 variants. These variants comprise certain mutations within their protein sequence, which render improved activity to bind to the soluble Interleukin-6/sInterleukin-6 receptor complex. These muteins may serve as back-up or follow-up compound for FE301 or could also be used in certain IL-6-driven niche indications.

14 Dec 2010

Three new patents granted in Japan, the US and Europe

One of the most important patents to protect optimized sgp130Fc variants has been granted by the European Patent Office on 8th September 2010 (Patent No. 1 873 166). And two additional fantastic news followed shortly afterwards: the grant of a patent for optimized sgp130 sequences in Japan on 29th September 2010 (Patent No. 465016) and last but not least the grant of a patent for soluble sgp130 variants in the United States on 14th December 2010 (Patent No. 8,851,182). “This means not only that we were able to reach the next milestone in the collaboration with our licensing partner Ferring, but also adds of further important steps to the development of our lead compound FE301”, says CEO Dr. Dirk Seegert.

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23 Jun 2010

EPO grants new patent for sgp130Fc variants

Today the European Patent Office (EPO) in Munich announced the grant of a new patent for sgp130. This patent protects the production and therapeutic use of new variants of the sgp130 fusion molecule. “In contrast to our parental sgp130Fc protein, certain parts of the extracellular domain of gp130 have been replaced by optimized linkers” says Dr. Dirk Seegert, Chief Executive Officer of the Conaris Research Institute AG. These variants provide advantages regarding their simplified molecular structure and subsequently their improved production and purification properties.

19 May 2009

USPTO grants first sgp130Fc patent in the USA

The United States Patent and Trademark Office (USPTO) has issued the first sgp130 patent in the US. This patent claims PEGylated forms of CONARIS’ sgp130 proteins and their therapeutic use in several IL-6-driven diseases. Dr. Dirk Seegert (CEO): “After receiving the European patent grant for PEGylated sgp130 proteins in 2007, this new achievement represents another important milestone on the way into the world’s most important pharma market.”

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07 May 2009

Conaris receives 1.6 Mio BMBF grant

Today CONARIS received a 1.6 M EUR grant from the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung; BMBF) in line with the economic support program “Innovative therapies on molecular and cellular basis”. The project comprises toxicity studies which are relevant for a later IND filing and investigations on further target indications for sgp130Fc within the next 2 years. Collaboration partner is the Hannover Medical School (MHH, Germany). Dr. Dirk Seegert (CEO): “This grant is an important milestone for our work. We are very proud that we were able to convince the ministry about the quality of the project. This moves us significantly closer towards our aim, to start first clinical studies in 2011!”

10 Dec 2008

Conaris signs Licensing Agreement with Ferring Pharmaceuticals

Saint Prex (Switzerland) and Kiel (Germany), 10 December 2008 - Ferring Pharmaceuticals and Conaris Research Institute AG today announced that they have completed an exclusive worldwide license agreement for the development of FE301 a new recombinant protein inhibitor of the IL-6 pathway for inflammatory conditions such as IBD and rheumatoid arthritis.

(Read more)

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12 Jun 2008

EPO grants patent for optimized cDNA sequences of sgp130Fc

The European Patent Office (EPO) grants a new patent (No. 1 630 232) in Europe claiming certain optimized cDNA sequences of CONARIS’ lead product sgp130Fc. These sequences improve the stability of the corresponding mRNA and increase the production rate of the protein in CHO cells.

11 Sep 2007

EPO grants patent for PEGylated variants of sgp130Fc

The European Patent Office (EPO) grants a new patent (No. 1 636 263) in Europe claiming the production of PEGylated variants of sgp130 proteins and their use in therapeutic compositions for the treatment of inflammatory and certain oncologic indications.

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22 Jun 2007

EPO grants core patent for sgp130Fc

The European Patent Office (EPO) grants a CONARIS key patent (No. 1 148 065) for its lead product sgp130Fc, an anti-inflammatory drug candidate, in Europe. The patent claims the nucleotide and polypeptide sequences of the product, certain procedures for its production and isolation and its use for the treatment of several severe chronic diseases.

06 Apr 2006

Conaris receives 1.3 Mio grant from the BMBF

CONARIS receives a 1.3 Mio EUR grant from the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung; BMBF) for the preclinical development of its lead compound sgp130Fc.

08 Jul 2004

Conaris receives a 110.000 EUR grant from the BMBF

CONARIS receives a 110.000 EUR grant from the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung; BMBF) for the development of a technological platform for the functional evaluation of new therapeutic drugs. This project is part of the National Genome Research Network 2 (NGFN2).

01 Feb 2003

Conaris moves into new laboratory

CONARIS moves into new laboratories and offices at the “Kieler Innovations- und Technologiezentrum” (KITZ).

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01 Jan 2003

Stefan Rose-John appointed as new member of Conaris’ Advisory Board

Prof. Stefan Rose-John (Director of the Institute of Biochemistry, Christian-Albrechts-University of Kiel) becomes new member of CONARIS’ Advisory Board and replaces Hans-Ulrich Behr. Stefan Rose-John has been working on the investigation of IL-6-mediated signaling processes for more than 15 years. He designed the first sgp130 fusion protein and performed pioneer studies to discover IL-6-induced transsignaling.