Pharma-Bio Partnering Forum: Biologics Partnering

Cambridge Healthtech Institute’s Second Annual
Antibody and Protein Engineering

April 29-30, 2013

A focused Partnering Forum designed to highlight promising early-stage technologies and applications in Antibody and Protein Engineering. Listen to three dozen different companies in a single track format, with opportunities for scheduled, as well as informal discussions with company presenters. The audience will include representatives from pharma, biotech, diagnostic and technology companies, as well as venture capitalists and other investors.

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» REASONS TO ATTEND

  • Over 35 early-stage company presentations, selected on a competitive basis from submitted proposals
  • Four lively panel discussions with experts drawn from our highly experienced Program Advisors
  • Cutting edge coverage of transgenic and in vitro antibody development platforms, approaches for development of human antibodies, bi-specific antibodies and antibody-like molecules, antibody-drug conjugates, antibodies tools, as well as protein engineering technologies, fusion proteins, techniques for incorporation of non-natural amino acids, constrained peptides, macrocyclic compounds and more.
  • Coverage of therapeutics for cancer, infectious disease, autoimmune and other indications.
  • Network with a targeted audience where essentially everyone is involved with and interested in collaborations in antibody and protein engineering
 

Program Advisors 

  • Brian Atwood, MBA, Managing Director, Versant Ventures 
  • Daniel Blom, Director, Cardiovascular Diseases, Merck & Co. 
  • Ray Camphausen, Ph.D., Associate Vice President, Protein Design, Adnexus, Bristol-Myers Squibb 
  • Jon Ellis, Ph.D., Vice President, Business Development, Biopharmaceutical R&D and Platform Technology & Science, GlaxoSmithKline 
  • Richard Harkins, Ph.D., Principal Scientist, Global Drug Discovery, Bayer Healthcare Pharmaceuticals 
  • Robert Hayes, Ph.D., Vice President & Venture Leader, Janssen R & D 
  • Margaret Karow, Ph.D., Executive Director, Protein Sciences, Amgen, Inc. 
  • Nilesh Kumar, Ph.D., Merck Serono 
  • Luke Li, M.D., Executive Director, Head, Global BioTherapeutic Technologies, Pfizer, Inc. 
  • Thomas Li, Ph.D., Senior Director, Technology, Roche Diagnostics 
  • Kia Motesharei, Ph.D., Vice President, Business Development & Alliance Management, Dyax Corp. 
  • Hilde Revets, Ph.D., Senior Research Fellow, Technology, Ablynx NV 
  • Janine Schuurman, Director, Strategic Research, GenMab BV 
  • Barry Springer, Ph.D., Head, External Research and Innovation, Biologics Research, Johnson & Johnson 

You are Invited to join us for the


PLENARY KEYNOTE PANEL


Tuesday, April 30, 2013 • 4:15 – 5:30 pm


Conventional vs. Non-Conventional Formats

Janice ReichertModerator: Janice Reichert, Editor-in-Chief, mAbs

With the explosion in the number of formats available, what are the potential benefits and risks to patients? This panel will discuss the realistic outlook and uncertainties with developing a diverse array of non-canonical antibodies in terms of immunogenicity, safety, competitive marketplace, commercial development, business strategies, regulatory approval, target validation and clinical development.

Panelists:

David MeiningerDavid Meininger, Ph.D., MBA, Executive Director, Molecular Discovery, Merck

Tillman GerngrossTillman Gerngross, Ph.D., CEO and Co-Founder, Adimab LLC; Professor, Bioengineering, Thayer School of Engineering, Dartmouth College

Trudi VeldmanTrudi Veldman, Ph.D., Senior Director, Biologics Generation, AbbVie

 

Monday, April 29


7:30 am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

Phillips Kuhl, President, Cambridge Healthtech Institute

8:40 PANEL DISCUSSION: Challenges and Opportunities for Antibody Platforms

Panelists:

Luke Li, Ph.D., Executive Director, Bioinnovation, Pfizer, Inc.

Margaret Karow, Ph.D., Executive Director, Biologics, Amgen, Inc.

Kevin Johnson, Partner, Index Venture Management LLP

 

in vitro Antibody Development Platforms 

9:10 Isolation and Maturation of Therapeutic Antibodies Using in vitro Somatic Hypermutation

David King, Ph.D., CSO, AnaptysBio, Inc.

By reproducing key features of the immune system in a controllable, in vitro system, fully-human antibodies can be selected with ideal properties for therapeutic application. The natural mechanism of antibody maturation, has been reproduced in vitro and coupled with mammalian cell-based display to enable antibodies to be generated and directly selected for their functional properties as well as excellent biophysical properties for development. The use of high-throughput sequencing methodologies during this process allows insight into the maturation pathways of antibodies and can be used to rapidly identify optimized antibodies.

9:25 Single Domain Shark Antibodies and Their Human Equivalent, i-bodies, as Novel Therapeutics

Michael Foley, Ph.D., Department of Biochemistry, Latrobe University; CSO,
AdAlta Pty. Ltd.

AdAlta’s two phage display libraries are single domain antibodies with therapeutic and diagnostic potential. The scaffolds are structural homologues based on ‘VNAR’ from the shark new antigen receptor and ‘i-body’ from domain 1 of the human neural cell adhesion molecule. They have a rigid core which confers high physicochemical and proteolytic stability, and their small size (14 kDa) may benefit tissue penetration and uptake. The scaffolds have long exposed binding loops which can mediate penetration into clefts and enzyme active sites including targets such as GPCRs, thereby accessing regions of proteins that have been difficult to target. We present data relating to high affinity binders for RANK-L and the GPCR target CXCR4.

9:40 Antibody Library Display on a Mammalian Virus Vector: Combining the Advantages of Both Phage and Yeast Display into One Technology

Ernest Smith, Ph.D., CSO, Vaccinex, Inc.

Utilizing a vaccinia virus-based library technology, we previously developed an antibody discovery platform that enabled efficient selection of fully functional IgG antibodies from gene libraries expressed on the surface of mammalian cells. Recently, we have further modified this platform to enable efficient expression of a library of fully human antibodies on the surface of vaccinia virus; an enveloped mammalian virus. Various panning and magnetic bead based methods have been developed to allow screening of a library of vaccinia-MAb virions and selection of recombinant vaccinia virus encoding specific antibodies. This technology allows for rapid high throughput selection of vaccinia-mAb virions in a cell-free panning system, followed by cell-based screening for high specificity and fine selection of optimal antibodies.

9:55 Antibody Discovery and Optimization: GMP-Ready Human Antibodies for Therapeutic Applications

Volker Lang, Ph.D., Managing Director, AbCheck s.r.o.

Outstanding human antibody discovery and lead optimization processes are applied to deliver GMP-ready antibodies within highly efficient timelines. Proprietary Phage Display libraries and Yeast Display technology combine into the unique AbSieve technology for fastest lead discovery. Importantly the screening process can be performed in virtually all antibody formats, including full length IgGs or novel bi-specific antibody formats. For affinity maturation and lead optimization AbAccel is used. AbAccel is a proprietary algorithm, which incorporates results of high-throughput antibody sequencing, structural analysis, and therapeutic biochemistry into the designs of pre-computed affinity landscape libraries. This process ensures the delivery of “GMP ready” developable antibodies with significantly increased affinities, high stabilities and minimal immunogenicity by in-silico t-cell epitope avoidance.

10:10 Networking Coffee Break

 

Transgenic Antibody Development Platforms 

10:30 Fully Human VH Antibody Fragments from the Crescendo Mouse Platform

Mike Romanos, Ph.D., CEO, Crescendo Biologics Ltd.

Crescendo is developing a transgenic mouse platform to generate high-affinity human heavy chain antibodies, which readily yield in vivo matured single domain VH fragments requiring no humanization. VH fragments are the smallest portions of immunoglobulin that retain target specificity and potency and, compared to whole antibodies, have properties more akin to small molecules, making them highly attractive therapeutic agents. A summary of platform development and timelines will be described, with outline plans for a pipeline of novel medicines and a limited number of strategic partnering relationships.

10:45 The Kymab Discovery Platform: Harnessing Human Antibody Diversity in vivo

Allan Bradley, Ph.D., CSO, Kymab Ltd.

Kymab has created a mouse mAb discovery platform that will contain the full diversity of human antibody genes in functional form. The discovery of optimal mAb drug candidates is facilitated by using the powerful processes of in vivo hypermutation, selection and maturation. Kymab has recently validated its first commercial human antibody transgenic strain which it is now using in drug discovery programs. Over the next year the platform will be expanded to include multiple strains that will harness human antibody diversity in novel ways.

11:00 OmniRat™ and OmniMouse™ for the Generation of Naturally Optimized Human Antibodies

Roland Buelow, Ph.D., CSO, Open Monoclonal Technology, Inc.

Open Monoclonal Technology, Inc. (OMT) is a private biotechnology company that has developed OmniRat™ and OmniMouse™, transgenic animals that produces fully human antibodies. Immunizations produce antigen-specific IgGs with binding affinities similar to those of wild type animals. OMT’s antibody platforms are partnered with global and speciality therapeutic companies. OMT continues to provide access to its antibody platform through outlicensing of OmniRat/OmniMouse, as well as target specific monoclonal antibodies. We offer flexible licensing terms for all targets and indications, worldwide. Access to OmniRat and OmniMouse results in more antibodies with better epitope coverage, while superior immunization and deep screening technology results in generation of superior rare antibodies.

11:15 MeMo® + Spleen to Screen™ - The platform for Human Therapeutic Bispecific Antibody and Antibody Combination Discovery

Jason Avery, Chief Business Officer, Merus BV

MeMo® is a transgenic mouse that, upon immunization, produces common light chain (cLC) human antibodies. These antibodies serve as building blocks for the efficient generation of bispecific antibodies (Biclonics™) and antibody combinations (Oligoclonics®) for therapy. Spleen to Screen™ is an optimized process that takes VH genes identified through deep sequencing (or phage display) and rapidly generates hundreds of different Biclonics™ or Oligoclonics® that can be assayed for functional activity facilitating lead identification in ~ 6 months. Development of bispecific antibodies and antibody combinations are at the forefront of next generation antibody therapeutics. They promise significant increases in clinical efficacy over conventional monoclonal antibody therapies in many disease areas. Merus has developed complementary technologies that enable the development of best in class bi-specific antibodies and more complex mixtures of antibodies addressing multiple targets. The MeMo® mouse is the only purpose built discovery platform for bispecific antibody generation.

 

Human B Cell-Derived Antibody Platforms 

11:30 Introducing Digital Antibodies

Jim Bowlby, Ph.D., COO, Single Cell Technology, Inc.

We have all benefited from digitization in many fields; Single Cell Technology “digitizes” native antibodies as soon as possible utilizing Next Generation Sequencing. The process of how we sequence the cognate light and heavy chains, measure kinetics, and performance of rapid functional assays using antibody secreting cells from a wide variety of hosts will be presented. The hundreds to thousands of antigen specific antibodies we identify delineate the repertoire of a humoral response.

11:45 Human Antibodies for ADCs and Cancer Target Discovery

Scott Dessain, Ph.D.,Founder and CSO, Immunome, Inc.

There is a tremendous interest in antibody-drug conjugates (ADCs) for the treatment of cancer. An ideal antibody to be used in ADCs must meet specific requirements, including minimal normal tissue binding. Some patients with cancer make antibodies that recognize cancer-specific antigens that are not expressed on normal cells. At Immunome, we are using our proprietary hybridoma method of human antibody cloning to isolate cancer specific antibodies from cancer patients. These antibodies identify new targets for ADC therapy. They will offer important safety advantages as well as treat diverse tumor histologies.

12:00 pm Combining Natural Immune Response with B Cell Cloning for Deep Monoclonal Discovery with Unprecedented Epitope Coverage and Potency

Jack Geltosky, Ph.D., Director, U.S. Business Development, MAB Discovery GmbH

MAB Discovery, based in Munich, Germany, is a provider of high quality IND ready monoclonal antibodies derived from rabbits and rats. Relying on the natural immune response and state of the art B cell cloning techniques, we produce monoclonals with unprecedented epitope coverage and potency, so much so that further time consuming affinity maturation is not required. The diversity of the immune responses also ensures success against targets heretofore considered intractable.  Backed by a strong investor, PPD Inc., we have chosen to keep our business terms simple and straightforward, eschewing the traditional royalty bearing IP license approach. Current partners include Boehringer Ingelheim and an undisclosed US biotech company.

12:15 pm Breakout Discussions with Morning Speakers and Lunch

1:45 Chairperson’s Remarks

 

Multi-Specific Antibody Development 

1:50 The Development of a Portfolio of Biologics Assets Using the Azymetric Platform

Ali Tehrani, Ph.D., CEO, Zymeworks, Inc.

Zymeworks is developing a portfolio of best-in-class biologics using its Azymetric platform. The Azymetric platform enables the development of multi-specific antibody therapeutics with tailored effector function and optimized serum half-life. AzymAbs are fully heterodimeric IgG1 antibodies. They consist of two distinct paired sets of heavy and light chains. Data generated in 2012 included gold standard manufacturing studies in stable cell line, in vivo PK (murine, cyno-), immunogenicity, pre-formulation, bi-physical characterization including x-ray crystallography, and efficacy data in multiple disease models. Currently Zymeworks has an active partnership with Merck, whereby Merck has obtained an non-exclusive license to the Azymetric platform to develop bispecific antibodies. In September 2012, Zymeworks announced the achievement of a major milestone in this collaboration.

2:20 Tribodies for Two-in-One Bispecific Antibody Fragments

Nico Mertens, Ph.D., Director, Antibody Research, Biotecnol, Inc.

The asymmetric nature of the Tribody scaffold facilitates creation of tri-specific or tri-functional protein fusions while keeping monovalency for each target desired. Biotecnol implemented a streamlined platform for creating Tribodies, including protein engineering and optimization technology to translate interesting molecules into products. This allows the development of dual-epitope or dual-receptor targeting T-cell activators (through an anti-CD3 binder), creating 2-in-1 bispecific antibodies which target a wider range of patients and fights tumor heterogeneity more efficiently.

2:35 Simple, Stable, Smart – The Kappa/Lambda-Body Next-Generation Bispecific Drug Discovery Platform

David Slack, Head, Corporate & Business Development, NovImmune SA

To go beyond the limits of traditional single-specificity mAbs, NovImmune established a proprietary κλ-body bispecific antibody discovery capability. Most bispecific formats are heavily engineered to force two specificities into a single antibody-like molecule via the use of linkers or mutations. These structural alterations can lead to poor stability, sub-optimal pharmaceutical properties, manufacturing issues, and immunogenicity that increase risk of patients developing unwanted anti-drug reactions. NovImmune’s solution for generating bispecific drugs is the κλ-body – unmodified, fully human bi-specific antibodies. In contrast to existing engineered formats, κλ-bodies are unique in offering biochemical, pharmaceutical and manufacturability characteristics typical of a therapeutic mAb yet with the extra functionality of a bispecific format.

2:50 DutaMabs: A Novel Bispecific Monoclonal Antibody Platform

Kristian Jensen, Ph.D., Vice President, Research, Dutalys GmbH

DutaMabs are fully human tetravalent bispecific monoclonal antibodies. They comprise one normal human heavy-chain and one normal human light-chain with two non-overlapping binding sites residing within the natural CDRs. The two binding sites in each DutaMab Fv region are completely independent of each other and can be mixed and matched from one DutaMab to another. This concept is founded in the extreme stability of DutaMabs, which further gives DutaMabs excellent developability properties. As such they are the only bispecific mAbs that retain all the advantages of state-of-the-art monospecific mAbs.

3:05 Networking Refreshment Break

 

Functional Antibody Development  

3:25 NanoMabs: A New Leap in Antibody-Drug Conjugates

Oshrat Frenkel, Ph.D., Director of Research, Immune Pharmaceuticals

 

3:40 Functional Diversity as the Key to Choice in Human Antibody Drug Discovery

Debbie Allen, Ph.D., Senior Director, Business Development, arGEN-X

Most antibody technologies offer high affinity human antibodies as a start-point for therapeutic antibody discovery. arGEN-X’s SIMPLE Antibody platform has a well-defined advantage: essentially any target epitope can be blanketed with functional antibodies - bringing new insights into how complex and highly conserved targets can be modulated. The importance of unlimited functional diversity in choosing mAbs with highly differentiated therapeutic qualities will be presented. Using a completely outbred camelid system, novel antibody leads are being progressed into development with extraordinary speed and efficiency. Furthermore, candidates are routinely identified with consistently high development qualities and often novel mechanisms of action. arGEN-X will share data from several therapeutics programs to illustrate what can be accomplished beyond traditional hybridoma and protein engineering technologies.

3:55 Selecting for Antibody Function on Target Expressing Cells by dsDNA Display with Deep Sequencing Analysis

Richard Wagner, Ph.D., Executive Chairman, X-BODY BioSciences

Diverse human libraries of antibody V domains were generated from donors’ B cells. Proprietary dsDNA display selections were performed against purified targets and targets expressed on cells. Selection pools were subjected to next- generation sequencing and analyzed by tabulating the frequency of the numerous hits. This deep sequencing hit frequency analysis identified leads with the desired specificities and functions. This approach can also be used to discover novel targets specific to disease cell membranes. Novel combinations of live cell selections and next- generation sequencing provide a powerful new approach to therapeutic antibody selections against challenging membrane targets. We will also show how this approach can allow for discovery of novel targets by performing differential screens against normal and diseased cells.

4:10 Function-Led Antibody Drug Discovery: Solving the Target Deconvolution Bottleneck

Jim Freeth, Ph.D., Managing Director, Retrogenix Ltd.

Selecting antibodies through a desired functional effect, rather than against a pre-determined target, leads to the discovery of novel, disease-relevant antibody targets. By expressing 3500 human plasma membrane proteins individually in human cells, Retrogenix’s Cell Microarray technology overcomes the target deconvolution hurdle, giving higher success rates than any other conventional approach.

4:25 Innovative Antibody Therapeutics for Your Pipeline

Oliver Middendorp, Ph.D., Chief Business Officer & Co-CSO, Numab AG

The Numab antibody platform integrates the discovery of highly potent antibody variable domains (down to single-digit pM monovalent affinities) with antibody engineering to make the discovered variable domains highly stable (Tm of 80°C, no loss of monomeric content in stability studies at 37°C for at least 7 days). These highly potent and drug-like variable domains provide maximal flexibility to serve as building blocks for designed functionality: mono- or bi-valent antibody formats with short or long half-lives. Furthermore, a case study will be presented describing a targeted discovery approach to specifically hit a pre-defined epitope. The identified antibodies had about 1000 times better affinities than state-of-the-art antibodies against the same epitope.

4:40 Rapid Design and Manufacture of Novel Protein Therapeutics Using Cell-Free Synthesis with Non-Natural Amino-acids (nnAAs)

Jeremy Bender, Ph.D., Chief Business Officer, Sutro Biopharma, Inc.

Sutro’s cell-free expression platform enables the rapid design, engineering, testing, and scalable production of novel protein therapeutics, including ADCs and bispecific antibodies. In the field of ADCs, Sutro has the ability to design, make and test a nnAA positional variant library of a mAb within days. Selection of the best candidate ADCs optimized for nnAA incorporation efficiency, drug conjugation efficiency and tumor killing efficiency have been demonstrated with yields equivalent to wild-type (natural AA only) sequences.

4:55 Breakout Discussions with Afternoon Speakers

5:45 Welcoming Reception in the Exhibit Hall with Poster Viewing

6:45 End of Day

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