Sponsored by
7th framework program of the EU

Coordinator: NBE Therapeutics

SME partner: ERA Biotech, Tube Pharma

Summary Project

sponsored by 7th framework program of the EU

Therapeutic antibodies have transformed cancer therapy during the last decade, due to their high selectivity of targeting cancer cells in comparison to standard small molecule chemotherapy drugs. Most recently, the coupling of cellular toxins to therapeutic antibodies has demonstrated an even greater efficacy for the therapy of certain cancers and two first antibody drug conjugates (ADCs), Adcetris® for the treatment of Hodgkin lymphoma, and Kadcyla® for the treatment of therapy-resistent Her-2+ breast cancer, have recently been approved by the FDA.

However these approved and all ADCs currently in clinical development are generated by chemical conjugation of small molecular toxins to antibodies. This is a challenging process, as the coupling site and the ratio of toxin to antibody coupling cannot be controlled. In addition, the chemical coupling involves chemical modification of the antibody, e.g. by mild reduction of disulphidebonds, which then serve as chemical coupling sites. This can have negative effects for the stability and structure of the antibody. All this adds variability and poor efficiencies in ADC manufacturing and challenges in regulatory approval of ADCs, adding to development time and costs and especially delaying noveldrug approvals for cancer patients.

The MABTOX consortium has combined know-how and expertise for leveraging novel technologies of enzymatically linking small molecule toxins to antibodies in a controlled fashion allowing precise control of toxin coupling site and ratio. This requires antibody engineering expertise to generate antibodies for enzymatic coupling, expertise in production of coupling enzymes, and expertise in synthesizing derivatives of small molecule toxins, that serve as substrates for the enzymatic coupling of toxins to antibodies. The combination of these three complementary expertises will result in the development of “next-generation” ADCs with expected better potency in cancer therapy with better controlled, moreefficient synthesis processes.

#PARTNERS

Partners

NBE-Therapeutics

coordinator

NBE-Therapeutics is a Swiss Biotech company headquartered in Basel, Switzerland. It was founded in April 2012 by experienced Biotech entrepreneur, Dr. Ulf Grawunder, who, in 2002 already co-founded the Swiss-based Biotech company 4-Antibody, initially as start-up CEO and later as CSO to an organization with 50 FTEs. This company was recently sold to US-based Agenus (NASDAQ:AGEN). At NBE-Therapeutics, Ulf Grawunder has generated novel patent-pending technologies for the discovery and engineering of fully human monoclonal therapeutic antibodies and for novel, enzymatic methods ofcoupling molecules to antibodies, which will be leveraged for the development of “next-generation” antibody drug candidates (ADCs) during the coming years. NBE-Therapeutics currently employs a staff of 9 employees, which is further expanding.

ERA Biotech

sme-partner

ERA Biotechis a mid-size biotechnology company located in Barcelona, Spain. It was founded in 2002 as a spin-off from CSIC (public research institute in Spain) and currently employs 5 employees with a passion for Science and Business. ERA Biotech develops its proprietary technology, Zera®, to provide user benefits to antigens, enzymes and peptides by formulating these as particles assembled in vivo. ERA Biotech has two business units, one in red biotech-pharma developing Zera®vaccines and the other in the white biotech sector producing enzymes for industrial applications and/or diagnosis. ERA Biotech owns a portfolio of more than 60 patents and has several agreements with commercial organizations. ERA Biotech will profit from the project by gaining expertise in combining ERA's core expertise in protein-splicing with antibody engineering aspects required to generate enzymatically conjugated ADCs. The company will further profit in valuation by the co-ownership of IPR generated in the project, which will increase the valuation of the company and may result in the attraction of additional revenue and financing proceeds.

Tube Pharma

sme-partner

Tube Pharma is a lifescience company founded in January 2011 in Vienna, Austria by a group of experienced pharma and biotech entrepreneurs. In addition to its CEO Wolfgang Richter, the Company employs several chemists. TUBE pursues the development and commercialization of synthetic highly active molecules derived from natural products for better and more efficient therapeutic options in the field of oncology. In combination with targetingprinciples of tumor cells an improvement of efficacy and a better safety profile can be achieved. An active partnering- and licensing strategy supports the own product developments.

A polymer-tubulysin-conjugate is currently in preclinical development by TUBE. TUBE has closed several licensing agreements with life science companies and receives payments for support and is eligible to obtain milestone payments as well as royalties. TUBE holds the worldwide exclusive license for the IP portfolio from the Helmholtz Center for Infectious Diseases (HZI) for tubulysins. Furthermore, TUBE has several own patent applications in this area as well as new patent applications for novel synthetic analogs („Cytolysine“).

Evitria

rtd-partner

Evitria is a fee-for-service contract manufacturing organization (CMO), located in Schlieren, Switzerland, near Zurich. The company has state-of-the art cell fermentation and protein expression infrastructure established in state-of-the art labs. Thecompany employs 5 FTEs with a high degree of technically specialized personnel. Evitria is a specialized CMO that focuses its activities on the manufacturing of eukaryotic proteins in CHO cells by rapid transient expression. The company has large experience with high-quality and rapid expression of monoclonal human antibodies. The management team of Evitria has combined 20 years of experience in protein design, vector design and transient gene expression reflected inover 30 peer-reviewed publications and 12 pending and 5 granted patents.

Protagen Protein Services

rtd-partner

Protagen Protein Services is a fee-for-service contract research organization (CRO), with state of the art infrastructure and over 15 years of dedicated biopharmaceutical research and diagnostic expertise, with particular know-how and expertise in chromatographic analyses of antibodies in connection with mass-spectrometric analytics at the molecularlevel. Protagen is an industry leader in the area of analyzing antibody biosimilars in comparison to originator antibodies at a level required for regulatory studies, including analyses of antibody primary structure, glycosylation patterns, N and C-terminal modifications, and analyses of impurities and antibody aggregates. The company is located in Dortmund, Germany, and employs a staff of 20.

Oncotest

rtd-partner

Oncotest is a fee-for-service contract research organization (CRO), headquartered in Freiburg, Germany, with long-standing special expertise in testing compounds in in vitro and in vivo tumor cell models. The company employs a staff of 85 and has 20 years of experience in cancer research. Oncotest has established a unique collection of more than 200 patient-derived tumor models representing early passage tumors from cryopreserved master stocks, retaining the same histology and malignant phenotype as in the patient.

Innotune

rtd-partner

Innotune is a SME specialized in taking advanced technology to the next level of its intrinsic value though proof-of-concept studies, feasibility studies and prototyping of novel biochemical compounds. It’s corporate strategy has been for the last 10 years to focus on duration-defined result-based collaborations with the best experts in the field so to gain a competitive advantage over larger organizations. INNO has built an international network in the Fine Chemical and Biotech sector (manufacturers, scientists, universities, KOL, a.o.) and more in particular in the field of the Inteins with ERA Biotech, Prof Dr Mootz (University of Munster, Germany), NEB (Leader in inteins in the US), Proteodesign (Inteins for ADC, US and Spain), PPP-UAB Laboratory (specialists in protein synthesis, Spain).

JPT Peptide Technologies

rtd-partner

JPT Peptide Technologies is a Berlin, Germany, based peptide drug Discovery Company established in 2004 as a spin-off of Jerini AG with a work force of 46 employees. JPT is a leading provider of innovative peptide-based services and research tools, serving a worldwide customer base in the pharmaceutical andbiotechnology industries, as well as researchers in universities, governmental and non-profit organizations. JPT Peptide Technologies has substantial, long-standing expertise in providing custom peptides and proteins to the global scientific community using the most appropriate methods and techniques including state-of-the-art automated synthesis approaches, optimized solution phase procedures, and chemistries involving a variety of protection schemes.

Biomedal

rtd-partner

Biomedal is a Spanish biotechnology company founded in the year 2000 with the mission of developing and commercializing new technologies, services and products for research, bioindustry and diagnostics. Its Life Science Division also functions as a fee for service CRO (Contract Research Organization) and provides services and support to pharmaceutical or biotechnology companies. Biomedal offers services integrated in protein expression and purification, both in E. coli and yeast. Biomedal has been focused, since its foundation, on the development of new technologies that increase the efficiency of thisprocess and the quality of the protein, holding great experience in this sector, to offer, together with its technology, installations, and staff, the adequate customized and flexible service. currently employs 25 employees.

TBD Biodiscovery

rtd-partner

TBD Biodiscovery is a contract manufacturing and research company in Tartu, Estonia, focusing its activities towards synthetic chemistry and product development - from route selection and feasibility studies to the scale-up and technology transfer to commercial production. The company has a staff of 17 employees that are experienced in the synthesis of building blocks and their upscaling but also especially in the synthesis of complex molecules.

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NBE-Therapeutics Ltd

Technology Park Basel, Hochbergerstr. 60C, CH-4057 Basel

p: +41-61-633-2230 f: +41-61-633-2231

mabtox(at)nbe-therapeutics.com

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