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With more than 30 approved monoclonal antibody therapeutics on the market and hundreds of candidate molecules in the clinical and pre-clinical stages of testing, the development of therapeutic antibodies is a blooming field enjoying its Renaissance age. The disease indications for antibody therapeutics are rapidly diversifying beyond the two primary areas of oncology and inflammatory diseases, as exemplified by an increasing number of clinical programs in infectious diseases, Alzheimer’s Disease, and metabolic diseases. The modulation of novel targets and disease pathways are being actively pursued with antibody therapeutic candidates, and new modalities as well as innovative therapeutic approaches are being intensely explored to complement the traditional monoclonal antibody therapeutics. Despite the current success of the field, significant challenges remain, particularly on how to effectively translate antibody therapeutic candidates from research into the clinic. At this symposium, we will highlight how emerging scientific understanding of diseases and cutting-edge pharmaceutical technologies are applied to the development of next-generation antibody therapeutics. We intend to lay down the framework for addressing the translational challenges and discuss the future direction of the field.
Reception to follow.
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Agenda
* Presentation times are subject to change.
Tuesday October 23, 2012
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8:30 AM
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Registration and Continental Breakfast
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9:00 AM
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Welcome and Introduction
Jennifer Henry, PhD, The New York Academy of Sciences
Heather Shih, PhD, Pfizer External Research Solutions
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Session I: A New Paradigm for Antibody Drug Discovery
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9:10 AM
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A New R&D Ecosystem, Academia & Pharma: The Centers for Therapeutic Innovation
Anthony Coyle, PhD, Pfizer
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10:00 AM
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A New Age of Academic-Industrial Partnerships
Carl Nathan, MD, Weill Cornell Medical College
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10:50 AM
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Coffee break
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Session II: A New Generation of Antibody-Based Therapeutics
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11:20 AM
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Multi-specific and Multi-functional Antibody-Based Therapeutics
David Hilbert, PhD, Zyngenia
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12:10 PM
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Lunch break
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1:10 PM
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Camelid Single Domain Nanobodies
Serge Muyldermans, PhD, Vrijie Universiteit Brussel, Belgium
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Session III: Translating Next-Generation Antibody Therapeutics Into The Clinic
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2:00 PM
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Translational Considerations for the Development of Next Generation Antibody-Based Therapeutics
Mohammad Tabrizi, PhD, Merck Research Laboratory
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2:50 PM
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Coffee break
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3:20 PM
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Modeling the Effects of Molecular Size and Binding Affinity for Antibody-Based Anti-Tumor Therapeutics
K. Dane Wittrup, PhD, Massachusetts Institute of Technology
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4:10 PM
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From Guess and Check" to "See and Treat": Engineered Antibody Fragments for in vivo Targeting and Imaging
Anna Wu, PhD, University of California, Los Angeles
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5:00 PM
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Networking Reception
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6:00 PM
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Meeting Close
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Speakers
Organizers
Robert Martone
Covance Biomarker Center of Excellence
Robert Martone has been the Neuroscience Therapeutic Area Lead for the Covance Biomarker Center of Excellence since 2010. Prior to that he had 17 years' experience in the pharmaceutical industry leading neuroscience drug discovery and technology teams through all phases of discovery from target identification through clinical trials with expertise in both small molecule and protein therapeutics. He also has seven years of academic research experience at Columbia University in molecular neurobiology, with a focus on the molecular genetics of familial neuropathies, and CNS tumor biomarker development.
Heather Shih, PhD
Pfizer External Research Solutions
Heather received her BS in Chemistry from University of Massachusetts at Lowell and PhD in Biochemistry from Tufts University School of Medicine. She received her postdoctoral trainings at Harvard Medical School and Genetics Institute/Wyeth. During her 9 years of drug discovery career at Pfizer, Heather was deeply involved in developing and applying new technologies to biotherapeutic discovery, which included recombinant protein and phage display technologies. She also co-led a number of drug discovery projects in collaboration with scientists in Neuroscience and Cardiovascular Diseases. Currently as a biotherapeutic lead for the Pfizer External Research Solutions (ERS) group, Heather interfaces with several research units at Pfizer to manage their external research portfolios primarily in collaboration with global contract research organizations (CROs). Throughout her career, Heather authored 20 peer-reviewed papers, two book chapters on therapeutic antibody discovery process, and was a co-inventor on three patents. She was instrumental in initiating a new Gordon Research Conference series on Antibody Biology and Engineering in 2010, and co-chaired the 2011 NYAS conference on Neurodegenerative Diseases.
Mohammad Tabrizi, PhD
Merck Research Laboratory
Mohammad Tabrizifard (Tabrizi) PhD is a leader in translational sciences as related to development of antibody-based therapeutics and biologics. He has extensive experience in research and development of biologics. His product development experience spans many therapeutic areas including oncology, diabetes and inflammatory diseases, and his technical expertise includes preclinical pharmacology and safety, preclinical and clinical pharmacokinetics, pharmacodynamics (PD), GLP-compliant bioanalytics, and clinical pharmacology of therapeutic monoclonal antibodies. He has been an author or co-inventor on more than 40 original papers, reviews, book chapters, published books ("Development of Antibody-based Therapeutics: Translational Considerations," Springer 2012) and patents and has been an invited speaker to numerous national and international conferences.
Mohammad joined Merck in December 2010, and since his arrival, he has built a translational PK-PD team with a key focus on development of biologics from bench to beside. Prior to Joining Merck, he served as vice president, preclinical development at AnaptysBio, a privately held biotechnology company in San Diego, CA with a focus on Somatic HyperMutation technology for development of therapeutic antibodies. Prior to AnaptysBio, he was a director of translational sciences at MedImmune, a wholly owned subsidiary of AstraZeneca, where he was involved in the design and implementation of effective translational strategies for development of therapeutic monoclonal antibodies from discovery to the clinic. In addition, he was one of the key contributors in successful establishment of the AstraZeneca R&D, Hayward (now MedImmune) and played a vital role in the integration of the Hayward team into the global company. He served in numerous managerial and scientific positions at AstraZeneca, Abgenix Inc. (now Amgen Inc.), Coulter Pharmaceutical Inc. (later acquired by Corixa), and TAP holdings Inc.
Mohammad received his bachelor's degree in Pharmacy from University of Houston (Summa Cum Laude) and his PhD from University at Buffalo, State University of New York (SUNY) in the area of Pharmacokinetics and Pharmaceutical Sciences. He completed postdoctoral training in pharmacology at SUNY with a focus on therapeutics.
Jennifer Henry, PhD
The New York Academy of Sciences
Speakers
Anthony Coyle, PhD
Pfizer
Anthony "Tony" Coyle is Vice President and Chief Scientific Officer of the Centers for Therapeutic Innovation (CTI). CTI was established in August 2010 as a new model to drive innovation in BioTherapeutics R & D. Tony is responsible for the CTI sites, which currently include CTI-New York City, CTI-Boston and CTI-California. Tony is supported by his leadership team, which will include the site heads of each CTI, his operations team, project management, clinical and Precision Medicine heads. Tony brings an extensive knowledge of the full development process to Pfizer. As a former Vice President and Global Head of Respiratory, Inflammation, and Autoimmunity Research at Medimmune Biologics, a Division of AstraZeneca, Tony has succeeded in advancing a biologic portfolio from discovery to Phase Two in the areas of Lupus, Asthma and COPD. Prior to Medimmune, Tony was Director of Research and Biology at Millennium Pharmaceuticals, where he led a group responsible for the identification of novel target genes as well as for late stage lead optimization and delivery of both small molecule and biologic development candidates. Tony has been Associate Professor in the Department of Pathology and Experimental Therapeutics at McMaster University in Ontario since 1992, and has authored more than 180 manuscripts. He holds a B.Sc. Honours and a PhD from Kings College, University of London.
David Hilbert, PhD
Zyngenia
David Hilbert is the CSO and Head of R&D at Zyngenia, an early stage biotech developing multi-specific antibody-based therapeutics. Prior to joining Zyngenia, Dr. Hilbert worked four years (2006-2009) as an independent biotechnology consultant assisting companies with the many strategic and operational challenges associated with drug development. Prior to his consulting endeavors, Dr. Hilbert was the Vice President of Research at Cellective Therapeutics, a start-up antibody company acquired by MedImmune in October 2005. Dr. Hilbert began his biotech career at Human Genome Sciences (HGS) where he spent 8 years guiding the preclinical development of antibodies and genomics-based therapeutics. As Vice President, Research at HGS, Dr. Hilbert led the transformation of the company from a genomics research company to an integrated drug development organization. He was pivotally involved in the development of ABthrax and Benlysta. Prior to joining HGS, Dr. Hilbert was a Staff Fellow in the National Cancer Institute, NIH where he investigated neoplastic transformation of B lymphocytes. Dr. Hilbert received his B.S. from Haverford College and his Ph.D. from the University of Pennsylvania.
Serge Muyldermans, PhD
Vrijie Universiteit Brussel, Belgium
Serge Muyldermans is professor at Vrije Universiteit Brussel since 2003 where he is heading the "camel" antibody engineering group. This group is also part of the VIB, the Institute for Biotechnology in Flanders. The natural occurrence of functional Heavy-chain antibodies in sera of camelids has been the main discovery within this research group. Since then, the ontogeny of these unique antibodies and the applications of their unique single variable antigen-binding domain (now referred to as Nanobodies) became the major focus of the research activities in his group. It led to the publication of over 120 articles, many of which appeared in top journals. In January 2002, Serge Muyldermans was co-founder of a spin-off company Ablynx that generates Nanobodies for therapeutic purposes. Ablynx employs currently about 250 people and has several of their nanobody-based products in clinical trials.
Carl Nathan, MD
Weill Cornell Medical College
Carl Nathan, MD is R.A. Rees Pritchett Professor and chairman of the Department of Microbiology and Immunology at Weill Cornell Medical College and co-chair of the Program in Immunology and Microbial Pathogenesis at Weill Graduate School of Medical Sciences of Cornell University. After graduation from Harvard College and Harvard Medical School, he trained in internal medicine and oncology at Massachusetts General Hospital, the National Cancer Institute and Yale before joining the faculty of The Rockefeller University from 1977–1986. At Cornell since 1986, he has served as Stanton Griffis Distinguished Professor of Medicine, founding director of the Tri-Institutional MD-PhD Program, senior associate dean for research and acting dean. Nathan is a member of the National Academy of Sciences and the Institute of Medicine, a Fellow of the American Academy of Microbiology, associate scientific director of the Cancer Research Institute, a governor of the Tres Cantos Open Lab Foundation, and on the scientific advisory boards of the American Asthma Foundation and the Rita Allen Foundation. He served for ten years each on the SAB of the Cambridge Institute for Medical Research and the Board of Trustees of the Hospital for Special Surgery. He has helped edit the Journal of Experimental Medicine since 1981 and is a member of the Board of Reviewing Editors for Science Signaling. He received the Robert Koch Prize in 2009.
Nathan's research deals with the immunological and biochemical basis of host defense. He established that lymphocyte products activate macrophages, that interferon-gamma is a major macrophage activating factor, and that mechanisms of macrophage antimicrobial activity include induction of the respiratory burst and inducible nitric oxide synthase (iNOS). He and his colleagues purified, cloned, knocked out and characterized iNOS biochemically and functionally, discovered the cofactor role of tetrahydrobiopterin in NOS's and introduced iNOS as a therapeutic target. Although iNOS helps the host control Mycobacterium tuberculosis, the leading cause of death from bacterial infection, Mtb resists sterilization by host immunity. Nathan's lab now focuses on the biochemical basis of this resistance. Genetic and chemical screens have identified enzymes that Mtb requires to survive during non-replicative persistence, including the mycobacterial proteasome, a serine protease that controls intrabacterial pH, and components of pyruvate dehydrogenase that serve in peroxynitrite reductase. His group is identifying compounds that kill non-replicating bacteria while testing new collaborative models between academia and industry to help invigorate antibiotic research and development.
Mohammad Tabrizi, PhD
Merck Research Laboratory
Mohammad Tabrizifard (Tabrizi) PhD is a leader in translational sciences as related to development of antibody-based therapeutics and biologics. He has extensive experience in research and development of biologics. His product development experience spans many therapeutic areas including oncology, diabetes and inflammatory diseases, and his technical expertise includes preclinical pharmacology and safety, preclinical and clinical pharmacokinetics, pharmacodynamics (PD), GLP-compliant bioanalytics, and clinical pharmacology of therapeutic monoclonal antibodies. He has been an author or co-inventor on more than 40 original papers, reviews, book chapters, published books ("Development of Antibody-based Therapeutics: Translational Considerations," Springer 2012) and patents and has been an invited speaker to numerous national and international conferences.
Mohammad joined Merck in December 2010, and since his arrival, he has built a translational PK-PD team with a key focus on development of biologics from bench to beside. Prior to Joining Merck, he served as vice president, preclinical development at AnaptysBio, a privately held biotechnology company in San Diego, CA with a focus on Somatic HyperMutation technology for development of therapeutic antibodies. Prior to AnaptysBio, he was a director of translational sciences at MedImmune, a wholly owned subsidiary of AstraZeneca, where he was involved in the design and implementation of effective translational strategies for development of therapeutic monoclonal antibodies from discovery to the clinic. In addition, he was one of the key contributors in successful establishment of the AstraZeneca R&D, Hayward (now MedImmune) and played a vital role in the integration of the Hayward team into the global company. He served in numerous managerial and scientific positions at AstraZeneca, Abgenix Inc. (now Amgen Inc.), Coulter Pharmaceutical Inc. (later acquired by Corixa), and TAP holdings Inc.
Mohammad received his bachelor's degree in Pharmacy from University of Houston (Summa Cum Laude) and his PhD from University at Buffalo, State University of New York (SUNY) in the area of Pharmacokinetics and Pharmaceutical Sciences. He completed postdoctoral training in pharmacology at SUNY with a focus on therapeutics.
K. Dane Wittrup, PhD
Massachusetts Institute of Technology
Professor K. Dane Wittrup is the Carbon P. Dubbs Professor of Chemical Engineering and Biological Engineering at the Massachusetts Institute of Technology, and the Associate Director of the Koch Institute for Integrative Cancer Research. Wittrup's research program is focused on protein engineering of biopharmaceutical proteins by directed evolution. Areas of interest include: pretargeted radioimmunotherapy; biological response modification of EGFR; and immunotherapy of cancer via engineered cytokines and vaccines.
Anna Wu, PhD
University of California, Los Angeles
Anna M. Wu, PhD, is a Professor and Co-Associate Director of the Crump Institute for Molecular Imaging, in the Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at UCLA, in Los Angeles, California. She also holds an appointments as Professor in the Department of Pathology and Laboratory Medicine, and Director of the Cancer Molecular Imaging Program in the Jonsson Comprehensive Cancer Center at UCLA. Dr. Wu's research interests include engineered proteins (including antibodies) for targeting and imaging applications in cancer, including the use of SPECT, PET, optical and multimodality approaches. Dr. Wu is also Founder, Board Member, and Chief Scientific Advisor to ImaginAb, Inc., an LA-based startup company which develops and commercializes engineered antibodies for clinical imaging in cancer and other diseases. Prior to joining the faculty at UCLA, Dr. Wu was a research scientist and faculty member at the Beckman Research Institute of the City of Hope in Duarte, California. Dr. Wu received her AB degree in Biochemical Sciences from Harvard University, and a PhD from Yale University in Molecular Biophysics and Biochemistry.
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Abstracts
A New R&D Ecosystem, Academia & Pharma: The Centers for Therapeutic Innovation
Anthony Coyle, PhD, Pfizer
In 2012, Pfizer took decisive steps to launch the Centers for Therapeutic Innovation and, in doing so, has led the industry in innovation and around early R&D models. Since then, CTI has made considerable operational progress — building a strong team, establishing four US-based sites, signing 19 academic partners, and generating an early research portfolio. CTI is poised to be a transformational force, employing an entrepreneurial R&D model that access the best science in the world — regardless of geographic origin — to deliver mechanistically-relevant clinical studies that can translate into differentiated, clinically-validated candidates that align with the Company's strategy in order to deliver important medicines to patients. This year's plan focuses on our approach to building an innovative early R&D portfolio that can help create options for the other RUs and Bus across Pfizer. Importantly, precision medicine is embedded into the CTI approach, in order to deliver data-rich packages to the RUs/Bus for their consideration. Working jointly with academic medical centers and their unparalleled access to well-phenotyped human tissue samples, CTI projects can aggressively pursue patient stratification analyses and clinical strategies early in development. CTI is focused on identifying the best science in the world, demonstrating scientific and operational excellence in progressing the portfolio and building strategic alignment around projects with our RU and BU colleagues.
A New Age of Academic-Industrial Partnerships
Carl Nathan, MD, Weill Cornell Medical College
Biologic insight and public demand invite a much larger number of new therapeutics than presently offered by the pharmaceutical industry, yet industry's costs per new drug have escalated unsustainably. For its part, academia has a growing appetite to engage in translational medicine. These interests have converged to accelerate experimentation with academic-industrial partnerships. By definition, drug discovery for neglected diseases lags behind that for other indications. Yet neglected disease drug discovery provides a special opportunity for experimentation in academic-industrial partnerships, because issues involving intellectual property and sharing of reward are thought to be less momentous. Emerging models for academic-industrial partnerships in neglected disease research, such as the Open Lab, are field-testing a paradigm-shift.
Multi-specific and Multi-functional Antibody-Based Therapeutics
David Hilbert, PhD, Zyngenia
mAbs have been proven to be effective in treatment of multiple diseases but even so there is still substantial unmet medical need. Part of the issue is that mAbs address a single target in a disease process whereas most diseases involve multiple perturbations in various physiologic pathways. There is considerable interest in biological drugs that engage two or more targets, I will discuss examples. We have generated a platform that creates multi-specific antibodies, that are built around a core scaffold antibody and are able to engage up to five different targets simultaneously in a coordinated cognate manner. This biological format allows the generation of new therapeutics with novel pharmacology to improve efficacy whilst still retaining all the desirable CMC, stability and production properties of mAbs.
Camelid Single Domain Nanobodies
Serge Muyldermans, PhD, Vrijie Universiteit Brussel, Belgium
Llama and camels have unique antibodies circulating in their blood. In contrast to conventional antibodies as found in all jawed vertebrates, these antibodies lack light chains and comprise a homodimer of the heavy chain polypeptide, whereby the antigen is recognized by virtue of one single domain. A straightforward technology was developed to immunize a camel or llama, to clone the repertoire of antigen-binding fragments, from which the antigen-specific fragments are identified after phage display selections. The resulting recombinant, antigen-binding single-domain antibody fragments are also referred to as Nanobodies (Nbs) because of their size of 4 nm by 2.5 nm in diameter.
Nanobodies are well produced in microbial systems, very robust and highly soluble, bind their cognate antigen with high affinity and specificity. Very often the Nanobody recognizes an epitope that is difficult to target with human or mouse antibodies. The ‘humanization’ of a camel derived single domain antibody is straightforward. Probably, the largest advantage of Nanobodies comes from their strict monomeric behaviour and the ease to tailor them into larger pluripotent constructs.
Such beneficial properties of Nanobodies over other antigen-binding fragments from conventional antibodies inspired many researchers to employ Nanobodies as a versatile tool in various innovative applications in biotechnology and medicine. In the past years we have been exploring the application range of the Nanobodies as well. After immobilization on a solid support, we employ the ‘Nano-trap’ as a research tool to immune-capture the antigen from complex mixtures. The intracellular expression of a Nanobody fused with Red Fluorescent Protein or ‘Chromobody’ appears to be a potent probe to trace the antigen within living cells. Furthermore, we demonstrated that Nanobodies are excellent tools for non-invasive in vivo imaging after being labeled with 99mTc. In another set-up, the Nbs against a tumor specific antigen or a trypanosome parasite were coupled with an enzyme or a truncated human ApoL1, respectively. The former construct allows the eradication of tumors after ADEPT (Antibody dependent enzyme prodrug therapy), whereas the trypanolytic effect of the latter eliminates a trypanosome infection in mice models. Finally, we selected Nanobodies against AahI and AahII, the two most toxic compounds of Androctonus’ scorpion venom. The most potent neutralizing Nanobodies were fused in a single polypeptide construct. This bispecific Nanobody NbF12-10 protects mice from scorpion stings much better than the Fab’2 based horse antivenom that is currently used to treat envenomed patients.
Translational Considerations for Development of the Next-Generation Antibody-Based Therapeutics
Mohammad Tabrizi, PhD, Merck Research Laboratory
With the anticipated emergence of bio-generics, next-generation antibodies have drawn much attention as future contributors to the growth of the biologics market. As next generation monoclonal antibodies confront their first generation rivals, it is critical that the next-generation products present a clear differentiating advantage against the existing competition. Evolution of therapeutic antibodies has encompassed multiple engineering efforts in the hope of improving the efficacy, safety, and duration of effects of antibody-based drugs. Improvements in antibody affinity, multi-specificity, pharmacokinetics and potency offer critical differentiating characteristics for the next-generation antibody-based therapeutics. Despite the current success of the field, significant challenges remain, particularly on how to effectively translate antibody therapeutic candidates from research into the clinic. This presentation will focus on various approaches that are undertaken for development of the next-generation antibody-based therapeutics.
Modeling the Effects of Molecular Size and Binding Affinity for Antibody-Based Anti-Tumor Therapeutics
K. Dane Wittrup, PhD, Massachusetts Institute of Technology
Theoretical analyses of targeting agent pharmacokinetics provides specific guidance with respect to desirable design objectives such as agent size, affinity, and target antigen. These analyses suggest that IgG-sized macromolecular constructs exhibit the most favorable balance between systemic clearance and vascular extravasation, resulting in maximal tumor uptake. Quantitative predictions of the effects of dose and binding affinity on tumor uptake and penetration are also provided. The single bolus dose required for saturation of xenografted tumors in mice can be predicted from knowledge of antigen expression level and metabolic half-life. The role of high binding affinity in tumor uptake can be summarized as: essential for small peptides, less important for antibodies, and negligible for nanoparticles.
From Guess and Check" to "See and Treat": Engineered Antibody Fragments for in vivo Targeting and Imaging
Anna Wu, PhD, University of California, Los Angeles
Antibodies have become a cornerstone of molecularly targeted agents, due to the ease of generating high affinity binding proteins of any desired specificity, many with potent biological activity. In addition, antibodies can serve as highly specific vehicles for delivery of diagnostic or therapeutic cargoes, including radionuclides, drugs, toxins, etc. Here we focus on optimization of antibodies through protein engineering to modify pharmacokinetics, tissue penetration, and conjugation, for imaging applications based on positron emission tomography (PET). Engineered antibody fragments, such as minibodies (80 kDa) and diabodies (55 kDa), have been developed with accelerated pharmacokinetics suitable for rapid imaging. Cysteine-modified diabodies facilitate site-specific, stoichiometric conjugation and radiolabeling, to further preserve binding and targeting properties. Robust approaches have been developed for routine F-18 labeling of diabodies, and tumors expressing cancer biomarkers CEA, HER2, or PSCA have been detected by immunoPET at 1 to 4 h post injection in mouse models. PSCA-specific minibodies have been produced and radiolabeled with I-124 for upcoming clinical imaging studies in prostate cancer. Recent work has been extended to immunoPET detection of immune cell subsets based on targeting CD markers. Antibody-based molecular imaging stands to contribute significantly to personalized medicine by enabling direct visualization of biologically relevant markers in living subjects. ImmunoPET detection can provide quantitative biological information on target expression, in order to guide selection of targeted therapeutics, and monitor delivery and response to therapy, with applications in oncology, immunology, and other disease areas.
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