Akari Therapeutics Plc and XL-protein GmbH Sign License Agreement to Develop a Long Acting Version of Coversin Using PASylation® Technology

NEW YORK, LONDON, and FREISING, Germany, April 14, 2016 – Akari Therapeutics (NASDAQ: AKTX), an emerging growth, development-stage biopharmaceutical company, and XL-protein, a privately owned biopharmaceutical company, announced today that they have entered into a License, Development and Commercialization Agreement. This partnership is focused on developing a second generation, longer acting version of Coversin.

Under this collaboration agreement, XL-protein will apply its proprietary PASylation® technology for drug half-life extension to Coversin. Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC).

XL-protein has previously demonstrated that it can manufacture recombinant PASylated Coversin. An initial study conducted in a mouse model indicates that PASylated Coversin administered by subcutaneous injection remains fully active, with the high C5 binding activity of Coversin retained. In this study, it was found that PASylation of Coversin extended the plasma half-life by over 50 fold.

“XL-protein’s PASylation technology provides an elegant approach to extending the half-life of Coversin, which we hope to demonstrate in future studies will reduce the frequency of dosing,” said Miles Nunn, Chief Scientific Officer of Akari Therapeutics. “Our current plan is to investigate the relative performance of PASylated Coversin, administered by the subcutaneous route, in animal models of disease. If successful, we expect to progress PASylated Coversin to the clinic.””

“We are delighted to enter into the partnership with Akari Therapeutics; the data from the initial study indicate that PASylation could lead to a longer acting, less frequently dosed, subcutaneous version of Coversin”, commented Claus Schalper, Chief Executive Officer of XL-protein. “XL-protein successfully continues to add collaborations with renowned partners that can leverage our best-in-class half-life extension technology.”

Under the terms of the agreement, XL-protein will receive an upfront payment as well as payments for achievement of preclinical, clinical, regulatory and commercial milestones. Furthermore, XL-protein will receive royalties on sales from marketed compounds resulting from the collaboration. Further financial terms have not been disclosed.

About XL-protein GmbH:
XL-protein is a German biotech company commercializing the ground-breaking PASylation® technology, which enables the design of biopharmaceuticals with extended plasma half-life and enhanced action. With its strong proprietary technology position XL-protein focuses at the preclinical as well as clinical development of PASylated proteins in various disease areas.  The company is located at Freising, Germany, in the neighbourhoods of Munich International Airport and the Technical University of Munich.

(www.xl-protein.com)

About Akari Therapeutics Plc:
Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. Akari’s lead drug, Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).

(www.akaritx.com)

Download pdf
Download full press release

DNX Biopharmaceuticals and XL-protein Enter into a Shareholder Agreement to Develop and Commercialize Novel Long Acting Biopharmaceuticals.

Irvine, California, and Freising, Germany, February 1, 2016
On June 30, 2015, DNX Biopharmaceuticals (“DNX”) of Irvine, California and XL-protein GmbH (“XLp”) of Freising, Germany, announced they would collaborate in the development and commercialization of novel long acting biopharma-ceutical products with financial terms undisclosed. Under this strategic collaboration, XLp contributes its half-life extension platform technology (PASylation®) and certain molecules that have completed in vivo efficacy proof-of-concept and preclinical studies, and DNX adds its pipeline of candidate molecules for development and commercialization to address a range of unmet needs in Immunology, Metabolism and Ophthalmology.

DNX and XLp now wish to announce that as part of the financial terms, XLp will receive Preferred Shares convertible into common shares for a minority stake in DNX and, as such, have entered into a Shareholder Agreement.

Dr. Rajiv Datar, Chief Executive Officer of DNX, comments: “Given the quality and scope of our collaboration we are very pleased to grant a minority stake to XLp.  DNX was indeed seeking an exciting technology like the PASylation platform to complement our product offering.  Having XLp participate in the equity of the Company provides additional comfort to our joint effort and demonstrates XLp’s commitment.”

Claus Schalper, Chief Executive Officer of XLp, adds: “DNX has assembled an impressive Management Team, Directors and Advisors and we are proud to be part of that alliance.  Furthermore, DNX’s business model is in line with our own business strategy and warrants the quality of our partnership.”

As part of the Agreement, XLp has Board representation and has delegated Mr Schalper to this effect; Prof. Dr. Arne Skerra, Chief Scientific Officer of XLp, will be appointed to the DNX Scientific Advisory Board.

About XL-protein:
XL-protein is a German biotech company commercializing the ground-breaking PASylation® technology, which enables the design of biopharmaceuticals with extended plasma half-life and enhanced action.  With its strong proprietary technology position XL-protein focuses at the preclinical as well as clinical development of PASylated proteins in various disease areas.  The company is located at Freising, Germany, in the neighborhoods of Munich International Airport and the Technical University of Munich. (www.xl-protein.com)

About DNX:
DNX is a private biopharmaceutical company developing long-acting therapeutic proteins for the treatment of patients with life-long diseases.  Headquartered in Irvine, CA, USA, DNX is pursuing the development of new therapeutic proteins utilizing 21st century, half-life extension-based drug delivery technologies. (www.dnxbio.com)

Download pdf

Download full press release

XL-protein and Easton Pharmaceutical sign license agreement to develop biopharmaceuticals using PASylation® technology

Freising, Germany, and Chengdu, P.R. China, December 17, 2015 — XL-protein GmbH and Easton Pharmaceutical Co., Ltd. announced today that they have entered into a License, Development and Commercialization Agreement for novel, long-acting biopharmaceutical products to address a range of unmet needs in ophthalmology and potential further indications. Under this collaboration, XL-protein will apply its proprietary PASylation® technology for drug half-life extension to one Easton target. XL-protein will assume responsibility for early preclinical development activities, Easton will be entitled to further development, manufacturing and marketing of the PASylated compound.

Under the terms of the agreement, XL-protein will receive an upfront payment as well as payments for achievement of preclinical, clinical, regulatory and commercial milestones.  Furthermore, XL-protein will receive tiered, mid- to mid-high single digit royalties on sales from marketed compounds resulting from the collaboration. Easton will have exclusive marketing rights for the P.R. of China for all PASylated products under the agreement. Easton may choose to execute options to obtain world-wide rights and rights for additional therapeutic indications. Further financial terms have not been disclosed.

“We are very pleased to collaborate with XL-protein in Germany and exploit its unique PASylation technology to develop new biological molecules with extended half-life in patients, which will reduce drug administration frequency and the overall therapeutic costs as well”, said Dr. Qing Dong, VP Research & Development of Easton.

“We are excited to collaborate with Easton as one of the leading pharmaceutical companies in the P.R. of China and we are looking forward to a fruitful collaboration on the development of PASylated biopharmaceuticals as important medicines for the treatment of ocular diseases and beyond; this licensing deal further validates XL-protein’s proprietary PASylation technology”, said Prof. Dr. Arne Skerra, CSO & Managing Director of XL-protein.

About Easton Pharmaceutical Co., Ltd.
Easton Pharmaceutical Co., Ltd., was established in 2009 and is headquartered in Chengdu, China. Easton is dedicated to the development, manufacture and distribution of drug substances and finished products. Our production and manufacturing facility includes API synthesis, tablets, capsules, injection solutions and lyophilization lines, which are built in accordance with EU and US GMP standards. We have a well equipped R&D center and QC labs. Our R&D fields comprise drugs for diabetic, cardiovascular, oncology, anesthetic and analgesics. Following our culture of Sunshine, Value, Innovation and Efficiency, Easton Pharma promises to provide high quality pharmaceutical products for our customers.
www.eastonpharma.cn

About XL-protein GmbH
XL-protein is a privately owned biopharmaceutical company based in Freising, Germany, which exploits its proprietary PASylation® technology to develop biologics with extended plasma half-life and enhanced in vivo activity. PASylation is a fully biological technology that can be applied both to approved biopharmaceuticals to yield second generation drugs (‘biobetters’) and to innovative therapeutic proteins, peptides or small molecule drugs, thus allowing less frequent and lower dosing combined with better patient tolerability. XL-protein pursues the preclinical and the clinical development of PASylated biologics in commercially attractive disease areas. Furthermore, XL-protein is engaged in collaborations with the Pharma and Biotech industry and offers licenses.
www.xl-protein.com

Download pdf

Download full ress release

DNX and XL-protein Announce Collaboration to Develop Novel, Long-Acting Biopharmaceutical Products

New Half-Life Extension Platform Technology Will Support the Development and Commercialization of Novel Therapeutic Proteins Addressing Unmet Needs in Immunology, Metabolism and Ophthalmology

Irvine, CA and Freising, Germany, June 30, 2015 — DNX Biopharmaceuticals, Inc. (“DNX”) a company with a team of experienced industry professionals with a long and successful track record of developing and manufacturing biopharmaceutical products, and XL-protein GmbH (“XLp”), a leader in protein engineering and modification technologies, today announced a collaboration for the development and commercialization of novel, long-acting biopharmaceutical products.  Under this strategic collaboration, XLp will contribute its half-life extension platform technology (PASylation®) and certain molecules that have completed in vivo efficacy proof-of-concept and preclinical studies, and DNX will add its pipeline of candidate molecules for development and commercialization to address a range of unmet needs in Immunology, Metabolism and Ophthalmology.  Financial terms have not been disclosed.

Half-life extension is a critical aspect of developing a successful protein pharmaceutical, as not all efficacious payloads have natural half-lives that are amenable to reasonable dosing intervals or regimens.  The novel PASylation platform is designed to offer improved half-life, pharmacokinetics, pharmacodynamics, bioavailability, solubility and overall enhanced patient compliance and safety.  PASylation is a highly tunable technology and offers a paradigm shift in patient care and better compliance in multiple therapeutic areas to improve the quality of life for millions of patients.

“We are pleased to be partnering with XL-protein on the development of new molecules specifically designed to improving the lives of patients, while simultaneously helping to alleviate the clinical burden,” said Dr. Rajiv Datar, Chief Executive of DNX.  “By combining DNX’s 250+ person-years of experience of biologics process development, clinical development and GMP manufacturing expertise with XLp’s revolutionary PASylation platform, we hope to ‘Make Good Drugs Great,’ and to delivering more gain and less pain to patients.”

“Working with DNX to create a range of novel long-acting biopharmaceuticals that will provide benefits to patients and to the healthcare services by reducing clinical burden is exciting and satisfying,” said Claus Schalper, Managing Director of XL-protein.  “Our team shares a common passion with DNX to ‘Making Good Drugs Even Greater’ by contributing our half-life extension / drug delivery technology to support successful product development and commercialization.”

About DNX
DNX is a biopharmaceutical company developing long-acting therapeutic proteins for the treatment of patients with life-long diseases.  Headquartered in Irvine, CA, USA, DNX is pursuing the development of new therapeutic proteins utilizing 21st century, half-life extension-based drug delivery technologies. www.dnxbio.com

About XL-protein
XL-protein is a German biotech company commercializing the ground-breaking PASylation technology, which enables the design of biopharmaceuticals with extended plasma half-life and enhanced action.  With its strong proprietary technology position XL-protein focuses at the preclinical as well as clinical development of PASylated proteins in various disease areas.  The company is located at Freising, Germany, in the neighborhoods of Munich International Airport and the Technical University of Munich.
www.xl-protein.com

pdficonklein

Download full press release

XL-protein Signs Licensing Agreement with MSD Animal Health to Develop Biopharmaceuticals using its PASylation® Technology

FREISING, GERMANY, February 12, 2015XL-protein GmbH, Germany, a privately owned biopharmaceutical company, announced today that they have entered into a license agreement with MSD Animal Health (known as Merck Animal Health in the USA and Canada) to develop PASylated biopharmaceuticals for use in animal health. This license agreement follows a research collaboration between the two companies which began in 2012 and included a feasibility study in target animals.

Under the terms of the agreement, MSD Animal Health acquires worldwide exclusive rights for certain biopharmaceutical drug candidates. In support of the commercialization effort, XL-protein will further optimize the drug candidates against undisclosed MSD Animal Health targets using its proprietary PASylation® platform for plasma half-life extension. This technology has been previously used for human health medications. MSD Animal Health will be responsible for clinical development and commercialization of biopharmaceuticals generated under the collaboration.

“We are delighted to be working with such a renowned partner as MSD Animal Health, who is a leader in the field of veterinary medicine”, said Claus Schalper, CEO&CFO of XL-protein. Prof. Dr. Arne Skerra, CSO of XL-protein, added: “This agreement with MSD Animal Health reflects the significant advantages we have seen for our PASylation® platform over competing technologies for creating biologic drug candidates with extended half-life and enhanced action, especially with regard to tolerance and biodegradability in treated subjects.”

“We strongly believe in the product development synergies between human and animal health and look forward to the opportunities this collaboration will offer to meet the unique challenges in the animal health market,” says Holger Lehmann, Head of Drug Discovery at MSD Animal Health.

pdficonklein

Download full press release

XL-protein and YEDA sign business collaboration agreement to commercialize PASylated interferon superagonist

FREISING, GERMANY & REHOVOT, ISRAEL, October 21, 2014

Yeda Research and Development Company Ltd., the technology transfer arm of the Weizmann Institute of Science, Israel, and XL-protein GmbH, Germany, a privately owned biopharmaceutical company, have signed a business collaboration agreement to commercialize a PASylated interferon superagonist – PAS-YNSα8 – which has been jointly developed by scientists at the Weizmann Institute and XL-protein. Under this agreement, YEDA acquires the worldwide exclusive rights for marketing and out-licensing of this compound.

One of the potential uses of PAS-YNSα8 is for treating inflammatory diseases, in particular of the central nervous system. An example is multiple sclerosis (MS), a devastating chronic, progressive immune disease of the central nervous system that can eventually lead to paralysis. Among the drugs today used to treat MS are those based on interferon-beta (IFN-beta).

Weizmann Institute scientists developed a novel, highly active interferon variant, YNSα8. This modified IFN was engineered to bind much more tightly to the interferon receptors. The result is a very potent molecule, which shows a gene activation profile and biological activities that surpass any naturally existing interferon.

Together with scientists at XL-protein, the activity of PAS-YNSα8 was boosted by extending its half-life in the body using PASylation® technology. PASylation® involves the genetic fusion of the therapeutic protein or peptide with a non-structured, expanded polypeptide made of the small amino acids Pro, Ala and Ser (PAS).

In a study that appeared in the Journal of Biological Chemistry (2014, Vol. 289, No. 42, pp. 29014-29029) and was led by Dr. Daniel Harari and Prof. Gideon Schreiber at the Weizmann Institute, it was found that the in vivo half-life of PAS-YNSα8 was increased 10-fold in comparison to standard interferon. Most importantly, the PASylation® did not interfere with the biological activity of this potent IFN; this has been a common technical problem for other methods of extending drug circulation. In a head-to-head comparison with conventional IFN-beta, this long-living superagonist conferred highly improved protection from disease progression in a mouse model of human multiple sclerosis, despite being injected four times less often than IFN-beta and at one-sixteenth of the dosage.

“We are excited by the pronounced therapeutic effect of our PASylated IFN superagonist, which was not accompanied by any observable immunogenic side effects in mice,” said Prof. Schreiber. “Our studies suggest that this potential drug could be safe and might provide clinical benefit surpassing that of IFN-beta, all this with a significantly reduced number of injections and lower  dosage. We hope it will soon be possible to check the effectiveness of our molecule in clinical trials in humans.”

“The biological potency and bioavailability of this novel IFN-based molecule is remarkable. Improved receptor binding, achieved by advanced protein engineering, in synergy with the half-life extension provided by our PASylation® technology, will result in more effective and less frequent dosing for the benefit of patients,” said Prof. Arne Skerra, CSO of XL-protein and co-author of the study. “We are pleased to forge this business alliance with a renowned partner such as YEDA to commercialize this potent biological drug candidate,” added Claus Schalper, CEO of XL-protein.

pdficonklein

Download full press release

XL-protein announces publication of key scientific data on its PASylation® technology

FREISING, GERMANY, August 30, 2013 – XL-protein GmbH announced today that key scientific data have been published in the journal Protein Engineering, Design & Selection (2013, Vol. 26, No. 8, pp. 489–501, 2013). The Open Access Publication “PASylation: a biological alternative to PEGylation for extending the plasma half-life of pharmaceutically active proteins” is also available for download at XL-protein’s web site (http://www.xl-protein.com/publications.html).

A major limitation of biopharmaceutical proteins is their fast clearance from circulation via kidney filtration which strongly hampers efficacy in human therapy. XL-protein has developed conformationally disordered polypeptide chains with expanded hydrodynamic volume comprising the small residues Pro, Ala and/or Ser (PAS). PAS sequences are hydrophilic, uncharged, genetically encodable amino acid polymers with biophysical properties very similar to poly-ethylene glycol (PEG), whose conjugation to drugs is a well known method for plasma half-life extension.

In contrast, beside chemical coupling PAS polypeptides offer fusion to a therapeutic protein on the genetic level, permitting production of fully active proteins in E. coli and other widely used host organisms (including cell culture secretion) without any in vitro modification steps. Importantly, PAS polypeptides are biodegradable, thus avoiding organ accumulation, while showing stability in serum and lacking toxicity or immunogenicity in animals. The publication describes that PASylation® furnishes typical biologics, such as interferon, growth hormone or antibody Fab fragments, with considerably prolonged circulation in vivo.

This work is complemented by another publication “High-yield production of PASylated human growth hormone (hGH) using secretory E. coli technology” that has appeared in the journal BioProcess International (2013, Vol. 11, No. 4, pp. 30–38) and is also available for download at XL-protein’s web site.

“PASylation® offers unique advantages, that is, surprisingly similar biophysical behavior compared with PEGylation, strong and tunable PK extending effects and conservation of high target-binding activity,” stated Uli Binder, CTO of XL-protein GmbH.

Arne Skerra, CEO of XL-protein GmbH, said: “PASylation® enables the preparation of biologically and/or pharmaceutically functional proteins with prolonged and enhanced in vivo activity, which constitutes a bottleneck in current biological drug development and opens exciting commercial opportunities.”

XL-protein’s proprietary PASylation® technology can be applied both to existing biologics, yielding biobetters, or to innovative therapeutic proteins or peptides, leading to tunable prolonged plasma half-life by a factor 10-100 as demonstrated in numerous animal studies up to now.
pdficonklein

Download full press release

XL-protein and GENERIUM sign broad therapeutic license and collaboration agreement to develop PASylated therapeutics for the Russian Federation

Freising, Germany & Moscow, Russia, June 25, 2013

XL-protein and GENERIUM announce the closing of a license and a collaboration agreement. Under these agreements, XL-protein will license a PASylated blood clotting factor and apply its proprietary PASylation® technology for plasma-half life extension to a cytokine, respectively, for use in the Russian Federation and Commonwealth of Independent States (CIS).

GENERIUM acquires exclusive marketing rights for the Russian Federation and CIS and will assume responsibility for further development and marketing of said compounds within this territory. XL-protein retains development and marketing rights for Rest of World.

Under the terms of the license agreement, XL-protein receives a seven digit US$ upfront payment upon signing of the agreement. In addition, XL-protein will receive payments for the achievement of preclinical, clinical, regulatory, and commercial milestones as well as significant royalties on sales.

“This strategic cooperation with a renowned pharmaceutical company of GENERIUM’s caliber demonstrates the high potential of our PASylation® technology to develop biologics with superior activities”, noted Prof. Dr. Arne Skerra, CEO of XL-protein.

“Setting up multiple international collaborations is a key element of Generium’s strategy. The Company provides unique opportunities for international collaborative R&D projects which are often associated with technology and know-how transfer and are actively supported by the Russian Ministry of Industry and Trade”, noted PhD Sergey Ruchko, CEO of IBC Generium.

XL-protein’s proprietary PASylation® technology is a biological alternative to PEGylation, conferring an expanded hydrodynamic volume onto the biopharma-ceutical which leads to retarded kidney filtration based on a molecular size effect. A tunable prolonged plasma half-life by a factor 10-100 has been demonstrated for various compounds in preclinical animal studies. Thus, PASylation® offers a cost-effective and patient-friendly solution to a general problem in biopharmaceutical drug development.

First data from this collaboration will be presented at the 38th Congress of the Federation of European Biochemical Societies (FEBS) in St. Petersburg, Russia, July 6-11, 2013.

pdficonklein

Download full press release

XL-protein and Wacker Biotech produce a PASylated antibody fragment (Fab) with prolonged plasma half-life at more than four grams per liter culture in an E. coli expression system

High Yield with ESETEC® and PASylation®: Wacker Biotech and XL-protein Produce More than Four Grams per Liter of Fab Antibody Fragment with Prolonged Plasma Half-Life

Munich, Jena and Freising, April 18, 2013 – In the course of their
collaboration, Wacker Biotech and XL-protein have produced record yields of a PASylated Fab antibody using WACKER’s E. coli based ESETEC® secretion technology. WACKER developed an efficient bacterial cell line and was able to produce the Fab antibody in concentrations of more than four grams per liter of culture broth. This Fab antibody is being tested as a novel therapeutic agent for treating autoimmune diseases. These results open up new opportunities for developing monovalent antibody drugs that can be produced at lower cost, with fewer side-effects and with a tunable plasma half-life. As part of their recent collaboration agreement, WACKER and XL-protein are offering pharmaceutical customers access to the combination of the PASylation® platform and the ESETEC® technology. WACKER also has the necessary expertise for GMP-compliant production of biologics.

In a feasibility study, Wacker Biotech and XL-protein tested the use of WACKER’s patented ESETEC® technology to produce PASylated Fab antibody fragments for the development of new drugs to treat autoimmune

diseases. The study not only confirmed that the biopharmaceutical can be produced in high yield (4.3 g/l) by the patented ESETEC® technology. It also demonstrated that correctly folded, fully functional antibody fragments are efficiently secreted into the culture broth – this greatly simplifies downstream purification. Detailed biochemical characterization revealed monodispersity of the product and excellent antigen-binding activity.

For many years, antibody products have been a promising growth area for the pharmaceutical industry. Antibodies are highly specific in their ability to intervene with disease mechanisms, and they usually circulate in the body for several weeks. However, in certain indications, some of their features can be detrimental: stimulation of the immune system via the antibody effector region; bivalent binding or crosslinking of the antigen; or the antibodies’ long biological half-life. XL-protein therefore decided to develop a monovalent antigen-binding antibody fragment (Fab) that does not bind immunoreceptors and promises fewer sideeffects. Furthermore, PASylation® prolongs its plasma half-life and thus allows for optimal tuning of drug activity. Fab fragments are derived from human antibodies and can be manufactured as separate recombinant proteins. One of their advantages over full-length antibodies is an improved ability to penetrate the diseased tissue. Since Fabs are not glycosylated, they can be produced cost-effectively in microbial organisms such as E. coli. Nonetheless, Fab antibody fragments are much more difficult to produce than other therapeutic proteins, as they are composed of two different protein subunits and contain several disulfide bridges. So far, conventional production methods have yielded less than 2 grams per liter of culture.

“We are delighted – the results open up new avenues for the development of antibody products,” says Dr. Thomas Maier, managing director of Wacker Biotech. “ESETEC® produces Fab antibody fragments in record yields that until now had only been possible for whole antibodies using mammalian cell cultures. Yet, development and production times with ESETEC® are much faster than with mammalian cells. This saves our customers costs and shortens the time to market.” ESETEC® is a proprietary WACKER technology with a track record of cost-effective production of proteins and antibody fragments. It is based on an E. coli K12 strain which has the ability to secrete correctly folded recombinant proteins into the culture broth during fermentation. Secretion facilitates purification of the target protein, since there is no longer any need for complicated process steps such as homogenization and refolding. This makes the entire manufacturing process significantly more efficient and cost-effective. A number of biologics that have been manufactured with ESETEC® are already being evaluated in preclinical and clinical studies. Plus, a successful preliminary study with XL-protein has shown that the WACKER technology is highly efficient at producing PASylated human growth hormone.
According to Prof. Arne Skerra, managing director of XL-protein GmbH, “The fact that our PASylation® technology allows efficient and inexpensive production of antibody fragments with extended plasma half-life abolishes a major disadvantage of these highly effective and low-side-effect biologics, compared to conventional antibodies. Especially in conjunction with ESETEC®, it is now possible to rapidly manufacture improved antibody products with tailored properties in high yield.”

pdficonklein

Download full press release

Wacker Biotech and XL-protein Sign Long-Term Cooperation Agreement to Produce PASylated Biopharmaceuticals

Munich / Freising / Jena, October 30, 2012

Wacker Biotech GmbH and XL-protein GmbH are to collaborate more intensely on the production of PASylated therapeutic proteins. Today, the two companies announced the signature of an agreement to this effect. Through this collaboration, WACKER and its customers will gain access to XL-protein’s PASylation® platform. The PASylation® technology enables the development of biopharmaceuticals with extended plasma half-lives, which require less frequent injection and thus are more patient friendly. In a recent feasibility study, PASylated human growth hormone was successfully produced in high yields using WACKER’s E. coli-based ESETEC® technology.

In a feasibility study, Wacker Biotech and XL-protein tested WACKER’s patented ESETEC® technology for the production of large-sized PASylated therapeutic proteins. The study showed that ESETEC® produced a PASylated human growth hormone – correctly folded and fully functional – in high yields (3 to 4 g/l). Moreover, WACKER successfully used its secretion technology to develop an E. coli cell line for manufacturing the PASylated hormone. The production process is easy to implement on an industrial scale.

“Following the successful feasibility study, we are very much looking forward to intensifying our collaboration with XL-protein,” said Dr. Thomas Maier, managing director of Wacker Biotech GmbH. “More and more pharmaceutical companies are looking for efficient ways of prolonging the therapeutic effect of biologics. With this cooperation agreement with XL-protein,” he continued, “we can now offer our customers feasibility studies for the production of PASylated variants of their therapeutic lead candidates. Thanks to our innovative ESETEC® technology, we can supply research quantities of PASylated active ingredients for pre-clinical studies within a couple of weeks.”

“After our positive experience with WACKER’s innovative secretion technology in producing PASylated therapeutic proteins,” said Prof. Arne Skerra, XL-protein’s co-founder and CEO, “we want to continue our collaboration in this field on a long-term basis. By partnering with Wacker Biotech, we can offer access to our innovative technology to a much wider circle of customers,” he emphasized. “As an experienced GMP manufacturer, WACKER can ensure that PASylated proteins are produced quickly and professionally.”

ESETEC®, WACKER’s patented E. coli-based secretion system, is a well-established technology for producing proteins and antibody fragments cost-efficiently. It is based on a patented strain of E.coli, K12, which is capable of secreting recombinant proteins in their native conformation directly into the culture broth during fermentation. This facilitates the subsequent purification of the target protein, since complicated process steps such as homogenization and refolding are unnecessary. This makes the entire manufacturing process significantly more efficient and cost-effective. A number of biologics manufactured with ESETEC® are already being evaluated in preclinical and clinical trials.