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The Next Wave of Antibody Therapeutics Agenda
Drug Discovery & Development Week 2009: August 3-6, 2009 · The World Trade Center Boston and Seaport Hotel · Boston, MA
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Main Conference - Monday, August 3, 2009
7:30
Registration and Coffee
8:30
Conference Chair Opening Remarks
Ulrik Nielsen, Ph.D., Chief Scientific Officer, Merrimack Pharmaceuticals
Antibody-Drug Conjugates and Other Conjugation Strategies
8:40
Antibody-Drug Conjugates for Cancer Therapy
Extensive mining of large volumes of gene expression data led to the identification of cell surface proteins preferentially expressed on human cancers. Monoclonal antibodies to these proteins were generated and armed with highly potent cytotoxic agents. New approaches for arming antibodies and the resulting preclinical studies will be discussed.
Paul Polakis, Ph.D., Director, Cancer Targets, Genentech, Inc.
9:10
Preclinical Development of Novel Antibody-Drug Conjugate Technology Based on Potent DNA Damaging Duocarmycins
Syntarga's Potent Payload Technology comprises the combination of highly potent DNA-damaging duocarmycins and suitable linker technologies. We provide an overview of our linker-drug discovery efforts and discuss several aspects of multiple Potent Payload-based Antibody-Drug Conjugates (ADCs), such as drug potency, linker stability and therapeutic window (preclinical efficacy & safety).
Vincent de Groot, Ph.D., Chief Executive Officer, Syntarga B.V., The Netherlands
9:40
Development of Antibody-Drug Conjugates Targeting Novel Cancer Targets
Abstract not available at time of print.
Aya Jakobovits, Ph.D., Executive Vice President and Head, Research and Development, Agensys, Inc.
10:10
Networking Refreshment Break
10:40
PSMA ADC, an Antibody-Drug Conjugate as a Potential Prostate Cancer Treatment and Antineovascular Therapy
Prostate-specific membrane antigen (PSMA) is expressed abundantly and preferentially on prostate carcinomas and the neovasculature of other solid tumors. PSMA ADC comprises a fully human monoclonal antibody to PSMA and an antimitotic agent, monomethylauristatin E. PSMA ADC potently reduced or eliminated tumors expressing PSMA in animal models of human prostate cancer and has entered clinical testing in advanced prostate cancer.
William C. Olson, Ph.D., Senior Vice President, R&D, Progenics Pharmaceuticals, Inc.
11:10
Novel Antibody-Drug (mAb-SN-38) Conjugates in Solid Tumor Therapy
Antibody conjugates of potent topoisomerase I inhibitor, SN-38, which selectively target CEACAM5, EGP-1, and mucin antigens on colon, non-small cell, and pancreatic cancers, respectively, and their utility in significantly controlling the growth of human tumor xenografts in nude mice, at essentially nontoxic doses, will be described.
S.V. Govindan, Ph.D., Senior Director, Conjugation, Immunomedics, Inc.
11:40
An Antibody-Cytotoxic Conjugate, BIIB015, is a New Targeted Therapy for Cripto Positive Tumors
BIIB015 is an immunoconjugate created for the treatment of solid tumors and is currently in Phase I of clinical evaluation. BIIB015 consists of a humanized monoclonal antibody against the Cripto protein (huB3F6) carrying a payload, via a hindered disulphide linker, of the maytansinoid derivative, DM4. Cripto is a cell surface GPI-linked protein required for signal transduction of the TGFb ligand, Nodal. Cripto expression is highly prevalent on a number of solid tumors, including greater than 75% of breast, non-small cell lung, and colorectal tumors. Preclinical in vitro and in vivo data will be presented to describe our lead molecule selection and demonstrate that BIIB015 is an effective means of inhibiting or regressing growth of Cripto positive tumors.
Michele Sanicola-Nadel, Ph.D., Associate Director, Tumor Cell Growth and Adhesion, Discovery Oncology, Biogen Idec
12:10
Networking Luncheon with Attendee/Speaker Chat Sessions
Informal roundtable discussions during the luncheon will be led by conference speakers. Grab your lunch, pick a topic, join a table and meet fellow attendees and conference speakers. Additional topics will be added. To suggest a discussion topic, please contact us.
Immunogenicity of Protein Therapeutics in the Clinic
Discussion Leader: William C. Olson, Ph.D., Senior Vice President, R&D, Progenics Pharmaceuticals, Inc.
Antibody-Drug Conjugates
Discussion Leader: Nils Lonberg, Ph.D., Senior Vice President, Scientific Director, Medarex
Multispecific or Bispecific Antibody Drugs
Discussion Leader: David M. Goldenberg, ScD, MD, Founder and Chairman, Immunomedics, Inc.
Considerations When Optimizing Therapeutic Antibodies for Specific Disease Indications
Discussion Leader: Sanjay D. Khare, Ph.D., CEO & President, ImmunGene, Inc.
Pharmacodynamic Biomarkers of Antibodies
Discussion Leader: Frank Calzone, Ph.D., Executive Scientific Director, Oncology Research, Amgen, Inc.
1:30
Targeting B-Cell Lymphomas with Inotuzumab Ozogamicin (CMC-544), an Anti-CD22 Immunoconjugate
Inotuzumab ozogamicin (CMC-544) is a humanized IgG4 anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic antitumor agent. CMC-544 targets CD22 which is expressed in the majority of B cell lymphomas. CMC-544 has demonstrated activity against indolent and aggressive CD22 positive B-cell lymphomas in phase 1 and phase 1/2 trials when used as monotherapy or in combination with rituximab. Its activity and safety profile warrants continued development of this investigational agent.
Erik R. Vandendries, M.D., Ph.D., Associate Director, Clinical Research and Development, Hematology Medical Research, Wyeth Research
2:00
MDX-1203: A CD70 Directed Antibody-Drug Conjugate Comprising a Novel Highly Potent Alkylating Agent
MDX-1203 is an antibody drug conjugate comprising an anti-CD70 monoclonal antibody and a novel alkylating agent activated through a multistep mechanism including esterase mediated removal of a blocking group and protease mediated release of the cytotoxic drug. MDX-1203 is now in Phase I clinical development for kidney cancer and lymphoma.
Nils Lonberg, Ph.D., Senior Vice President, Scientific Director, Medarex
2:30
IMGN901: An Active Maytansinoid Conjugate Targeting CD56
IMGN901 is an antibody-maytansinoid conjugate that targets CD56, an antigen expressed on multiple myeloma, small cell lung cancer, various neuroendocrine tumors, and ovarian cancer. Preclinical studies demonstrate excellent activity, both as a single agent and in combination, in xenograft models of all target tumor-types. Signals of activity have been seen in three early-phase clinical trials. The focus of the next steps in the clinical development of this compound is in multiple myeloma.
John M. Lambert, Ph.D., Executive Vice President and Chief Scientific Officer, ImmunoGen, Inc.
3:00
Networking Refreshment Break
3:30
SGN-35 and SGN-75: Development of Antibody-Drug Conjugates for the Treatment of Cancer
Seattle Genetics is developing multiple Antibody-Drug Conjugates (ADCs) that kill tumor cells via targeted delivery of auristatins, a class of potent cytotoxic drugs. SGN-35 has proven to effectively shrink tumors in a high percentage of patients with advanced Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL) in two phase 1 studies. SGN-35 is currently in a pivotal trial for relapsed or refractory HL. An update of the clinical experience with SGN-35 as well as the preclinical development of SGN-75, an ADC targeting CD70 that is advancing towards a 2009 IND, will be presented.
Jonathan G. Drachman, M.D., Vice President, Translational Medicine, Seattle Genetics, Inc.
4:00
CR011-vcMMAE, an Antibody-Drug Conjugate for the Treatment of Melanoma and Breast Cancer
CR011-vcMMAE is comprised of a fully human monoclonal antibody to GPNMB conjugated to monomethylauristatin E. The antigen is highly expressed in tumors and is involved in invasion and metastasis. Data from ongoing Phase II trials in patients with melanoma and breast cancer will be presented.
Ronit Simantov, M.D., Chief Medical Officer, CuraGen Corporation
4:30
Clinical Results of the Phase I and Phase II Studies of Trastuzumab-DM1, A First-in-class HER2 Antibody-Drug Conjugate, in Patients with HER2+ Metastatic Breast Cancer
T-DM1 is an ADC that combines the biological activity of trastuzumab (T) with the targeted delivery of a potent anti-microtubule agent (DM1) to HER2-expressing cancer cells. Now in phase III, T-DM1 has significant single-agent activity in patients with previously treated, HER2+ MBC, and is well tolerated at 3.6 mg/kg IV every 3 weeks.
Barbara Klencke, M.D., Group Medical Director, Genentech, Inc.
5:00
Strategic Discussion GroupAntibody-Drug Conjugates and Other Approaches to Enhance Efficacy and Potency
- Advantages and disadvantages of different cytotoxic drugs
- Role of linker stability
- Utility of animal models
- Identifying ideal targets for ADC drugs
Moderator: Nils Lonberg, Ph.D., Senior Vice President, Scientific Director, Medarex
6:00
Attendee Networking Dinner
Join fellow attendees of The Next Wave of Antibody Therapeutics conference for dinner. Space is limited and an additional fee applies. Check box on registration form to sign up.
Main Conference - Tuesday, August 4, 2009
8:10
Conference Chair Opening Remarks
William Dall'Acqua, Ph.D., Director, R&D, MedImmune, Inc.
Approaches to Improve Antibody Efficacy and Potency
8:15
Optimizing Targeted Anti-tumor Biologics with Immune Effector Molecules
Optimization and the development of targeted anti-cancer biologics (CmAb) will be discussed. The CmAb platform is being developed by genetically engineering tumor targeting moiety with bonafide immune effector molecules (e.g. select cytokine and chemokines molecules). The first set of CmAbs have anti-proliferative, apoptotic (independent of ADCC and CDC) and potentially anti-angiogenic properties built in one molecule. These molecules have demonstrated potent anti-tumor activity in preclinical cancer models resistant to naked antibody therapeutics.
Sanjay D. Khare, Ph.D., President, R&D, ImmunGene, Inc.
8:40
Optimizing Antibody Efficacy, Effector Selectivity, and Half-life with Fc Engineering
We have created and validated a suite of antibody Fc variants that enhance in vivo pharmacokinetics, cytotoxicity, and/or immune selectivity of targeted antibodies. Application of these variants to a variety of systems has demonstrated a range of variant-dependent pharmacologic effects, such as longer in vivo half-life, higher cytotoxicity, or B cell immunosuppression, in various mouse and primate models.
John R. Desjarlais, Ph.D., Vice President, Research, Xencor, Inc.
9:05
Biologics for the Treatment of Respiratory Diseases; A Place for Anti-IL-9, Anti-IL5R and Anti-IL-13 Therapies in Bronchial Asthma
Asthma is a chronic inflammatory disorder of the airways associated with airway hyperresponsiveness and structural changes termed airway remodeling. The airway inflammation is characterized by increased numbers of eosinophils, mast cells, basophils and Th2 lymphocytes. These cells are robust sources of inflammatory mediators, namely leukotrienes and prostaglandins, as well as cytokines, such as IL-4, IL-5, IL-9 and IL-13, each of which can orchestrate different aspects of asthma pathology. We have designed specific monoclonal antibodies that have been optimized and engineered to allow for the efficient interference with the signaling pathways of many of these cytokines. The relative contribution of IL-9, IL-5R and IL-13 to asthma pathology and the optimization of inhibitory monoclonal antibodies for clinical development will be discussed.
Alison Humbles, Ph.D., Senior Scientist, Department of Respiratory, Inflammation and Autoimmunity, Medimmune, LLC
9:30
T Cell Engaging BiTE Antibodies: Clinical Proof of Concept and Recent Developments
BiTE antibody technology is based on single chain bispecific antibody molecules, binding to CD3 on cytotoxic T cells and a surface antigen on a target cell, such as a cancer cell. This close cell contact leads to the efficient killing of the target cell. The first BiTE antibody directed against CD19 on NHL cancer cells has proven efficacy in a clinical phase I trial. Results will be discussed. An advanced new BiTE platform was recently developed and recent data will be presented.
Tobias Raum, Ph.D., Senior Director Lead Discovery, Human Antibody Technologies, Micromet AG, Germany
Bispecific and Multispecific Drugs
9:55
Multi-Specific Adnectins: Realizing the Promise of a Novel Class of Targeted Biologics
Adnectins offer numerous potential advantages compared to traditional targeted biologics, including speed of discovery, ease of manufacturing, and the ability to create multi-functional targeted products. We are currently advancing in our pipeline multi-specific Adnectin products where two different Adnectins are combined into a single molecule to specifically modulate two distinct targets. We will discuss methods to engineer and optimize multi-specific Adnectins, as well as present preclinical data demonstrating the clinical potential of these novel drugs.
Sharon Cload, Ph.D., Vice President, Discovery, Adnexus, A Bristol-Myers Squibb R&D Co.
10:20
Networking Refreshment Break in Exhibit & Poster Hall
11:00
MM-111: A Novel Bispecific Antibody Targeting ErbB3 with Potent Anti-tumor Activity in ErbB2 Over-expressing Malignancies
MM-111 is a bispecific antibody designed with the aid of computational modeling, which inhibits ligand-induced phosphorylation of ErbB3 with sub-nanomolar potency by exploiting the abundant expression of its dimerization partner, ErbB2, for specific targeting to cancer cells expressing both receptors. The design and antitumor mechanism of MM-111 both in vitro and in vivo will be discussed.
Charlotte McDonagh, Ph.D., Associate Director, Merrimack Pharmaceuticals, Inc.
11:25
DVD-Ig™: A Novel Dual-Targeting Technology
DVD-Ig™ biologics can target 2 or more disease mechanisms simultaneously. They can be made easily by linking, in tandem, variable domains from any 2 pre-existing mAbs and retain in vitro/in vivo functions of both parental mAbs. Recent data for making DVD-Ig™ against various targets will be discussed.
Tariq Ghayur, Ph.D., Senior Principal Scientist & Research Fellow, Abbott Bioresearch Center
11:50
Selection of Stable Single-chain Variable Fragments for Assembly of Anti-PDGFRB/VEGFA Dual-targeting Proteins
We address the engineering challenges pertaining to the stability and manufacture of dual-targeting proteins with the selection of stable single-chain variable fragments (scFvs) targeting PDGFRB and VEGFA. Selected scFvs were assembled in dual-targeting, tetravalent Fc-fusion formats and demonstrated in vitro and in vivo blocking of VEGFA and PDGF pathways.
Robert Mabry, Ph.D., Senior Scientist, Department of Protein Engineering, ZymoGenetics, Inc.
Strategic Discussion Group
12:15
Challenges and Risks of Developing Antibodies and Biologics in New Formats
- Engineered antibodies and bispecific antibodies
- Dealing with manufacturability challenges
- Managing immunogenicity
- Pharmacokinetics of new antibody formats
Moderator: Ulrik Nielsen, Ph.D., Chief Scientific Officer, Merrimack Pharmaceuticals
John R. Desjarlais, Ph.D., Vice President, Research, Xencor, Inc.
Tobias Raum, Ph.D., Senior Director Lead Discovery, Human Antibody Technologies, Micromet AG, Germany
Eric Furfine, Ph.D., Senior Vice President, Research & Preclinical Development, Adnexus, A Bristol-Myers Squibb R&D Co.
12:40
Networking Luncheon in Exhibit & Poster Hall
Combination Strategies to Enhance Antibody Therapies
2:00
Antibody Combinations Targeting erbB Receptors in Solid Tumors
Novel combinations of antibodies are currently being studied targeting erbB receptors. Both erbB1 and erbB2 targeted antibodies are being investigated in combination with anti-VEGF antibodies in colorectal cancers and breast cancers. In colorectal cancer two randomized phase 3 studies of anti-erbB1 antibodies have been tested in combination with bevacizumab. Results from these trials have thus far been disappointing. Meanwhile, investigations are continuing with erbB2 antibodies in combination with bevacizumab in breast cancer both in the metastatic and adjuvant settings. Finally, second generation anti-erbB2 antibodies are now being tested in combination with trastuzumab in the phase 3 setting in breast cancer.
Mark D. Pegram, M.D., Professor of Medicine, Hematology/Oncology, University of Miami
2:25
Combination and Bispecific Anti-CD20/CD22 Immunotherapy
Since both rituximab and epratuzumab have single-agent activity in NHL, two multicenter trials have studied their tolerability and efficacy when combined in full doses. The results show no enhanced toxicity with improved and durable complete responses in indolent and aggressive relapsed/refractory NHL patients. In order gain the benefit of targeting both CD20 and CD22 expressed by lymphoma and leukemia cells, we have generated bispecific, hexavalent, anti-CD20/CD22 MAbs, derived from epratuzumab and veltuzumab, showing more potency in vitro compared to their parental antibodies, and comparable in vivo anti-growth activity in human NHL models in SCID mice.
David M. Goldenberg, ScD, M.D., Founder and Chairman, Immunomedics, Inc.
2:50
Combinatorial Strategies for Tumor Inhibition using AMG 479, a Fully Human Monoclonal Antibody that Inhibits the Insulin-like Growth Factor (I) Receptor (IGF-1R)
AMG 479 is a fully human monoclonal antibody that binds IGF-1R (without INSR crossreactivity) and prevents receptor activation by both IGF-1 and IGF-2. Clinical studies indicate that AMG 479 and other inhibitory IGF-1R antibodies may have some single-agent efficacy in the treatment of selected cancers such as Ewing's sarcomas. We have systematically examined the efficacy of AMG 479 achieved in preclinical models when combined with cytotoxic and targeted therapeutics. The results identify potential opportunities to enhance existing cytotoxic regimens, and suggest a rationale for combining AMG 479 with newer pathway specific inhibitors.
Frank Calzone, Ph.D., Executive Scientific Director, Oncology Research, Amgen, Inc.
Conference Keynote
(open to all attendees and exhibit hall visitors)
3:15
Quantitative Prediction of Anti-tumor Antibody Macro and Microdistribution
The effects of molecular size and binding affinity on the overall accumulation of antibodies in tumors, as well as their spatial distribution within tumors, can be quantitatively predicted with simple mathematical models. These principles can be used for protein engineering efforts to design improved targeting molecules.
K. Dane Wittrup, Ph.D., J.R. Mares Professor of Chemical Engineering and Bioengineering, Massachusetts Institute of Technology
3:40
Networking Refreshment Break in Exhibit & Poster Hall
Pharmacodynamic Biomarkers in Antibody Development
4:25
Clinical Development of the IGF-IR inhibitor Figitumumab for the Treatment of Cancer
Figitumumab (CP-751,817) is a fully human IgG2 monoclonal antibody highly potent and specific against the Insulin-Like Growth Factor Type 1 Receptor (IGF-IR). Updates on the Figitumumab development program, predictive biomarkers currently employed, and the rationale for further testing of this agent in oncology will be presented. In addition, the scientific background of this project describing strategies involved in its transition from discovery to the clinic and the use of pharmacodynamic biomarkers will also be discussed.
Antonio Gualberto, M.D., Ph.D., Senior Director, Pfizer Oncology
4:50
Pharmacodynamic Approach in Early Trials with an Anti-Interferon-a Monoclonal Antibody in Lupus
Type I interferons (IFN), especially IFN-a, may play a pivotal role in the pathogenesis of systemic lupus erythematosus (SLE). MEDI-545 is a fully human monoclonal IgG1 antibody that binds to and neutralizes IFN-a and is currently in phase 2 testing in SLE. The level of expression of type I IFN-inducible genes (type I IFN gene signature) is being used as a pharmacodynamic marker in early clinical development of MEDI-545. In phase 1 testing, this PD marker performed well, with MEDI-545 inhibiting the type I IFN gene signature in a dose-dependent manner in the whole blood and in involved skin of SLE patients.
Barbara White, M.D., Vice President, Clinical Development, MedImmune
5:15
Close of Antibody Therapeutics Main Conference and Proceed to Plenary Keynote
Plenary Keynote
5:20
Keynote Introduction
Osamu Sato, Ph.D., Director & Head of Medical Writing Group, Daiichi-Sankyo Co., Ltd., Japan
5:25
Global Pharma Innovator: Daiichi Sankyo's Challenge to Build a Competitive Pharmaceutical Company in the Global Market
The current challenge for Japanese pharmaceutical companies to stay competitive in the global marketplace is to expand product offerings and sales and increase R&D and clinical development capabilities in the U.S., Europe and other markets outside of Japan. This presentation will discuss Daiichi Sankyo's vision and strategy for transforming itself from a Japan-based pharmaceutical company to a truly global pharmaceutical player. Recent implementations of this strategy including the incorporation of Ranbaxy (India) and U3 Pharma (Germany) into the Daiichi Sankyo family will be discussed.
Takashi Shoda, President and CEO, Daiichi Sankyo Co., Ltd., Japan
6:00
Cocktail Reception in Exhibit & Poster Hall
Post-Conference Workshop - Wednesday, August 5, 2009
Understanding and Exploiting the Role of Cancer Stem Cells in Drug Development
8:30
Conference Chair Opening Remarks
Lyuba Varticovski, M.D., Staff, Cancer Research Center, National Cancer Institute
8:40
Targeting Cancer Stem Cells
Cancer stem cells are thought to mediate tumor initiation, metastasis, and recurrence. We have isolated and characterized CSCs from a variety of major tumor types and have found that these cells are preferentially resistant to many current therapies. As part of our effort to develop novel agents targeting CSCs, we have developed an anti-DLL4 antibody that blocks Notch signaling. Anti-DLL4 inhibits tumor growth through multiple mechanisms including a reduction in CSC frequency.
Timothy Hoey, Ph.D., Vice President, Cancer Biology, OncoMed Pharmaceuticals, Inc.
9:05
Drug Discovery Approaches in Self-Renewal Pathways that Drive Cancer Stem Cells
Effective treatments for disease recurrence are a major area of unmet need in cancer. Recent progress in defining tumor cell populations that have stem cell properties provides new insight on the mechanisms that initiate, drive and maintain tumor growth. The canonical self renewal pathways defined by Wnt, Hedgehog and Notch are frequently activated in tumors and drive stem cell behavior. For many years these pathways have been refractory to small molecule drug discovery. I will discuss novel approaches to targeting these pathways.
Speaker: TBA
9:30
Selection and Expansion of Stem-like Cells from Solid Tumors Based on Growth and Survival Properties: Cell Surface Antigens Useful as Drug Targets
The CSC hypothesis has important implications for drug development and cancer treatment. Most CSC studies use cell populations enriched using prospectively defined markers. We have used defined media to select subpopulations of cells from solid tumors, including colon and prostate, which are capable of self-renewal and form well differentiated tumors. These cell lines can be used to develop and screen drug candidates and to further characterize gene and cell surface marker expression. Preclinical and clinical data from two projects…a novel target/Mab and a set of novel Mabs to a known target… that we find on our stem or progenitor cells and cancer stem cells will be presented.
Jenny P. Mather, M.D., Ph.D., Senior Vice President, Cancer Stem Cell Research, MacroGenics, Inc.
9:55
Developing Drug Candidates Directed to Cancer Stem Cell Targets: Preclinical and Clinical Update
Stemline Therapeutics, a clinical stage biopharmaceutical company, is developing a broad portfolio of small molecule and biologic compounds directed to cancer stem cell targets of both solid and hematological cancers. Stemline has built its pipeline through a combination of acquisition and internal discovery. Stemline has also developed several novel cancer stem cell focused drug discovery platforms, including a proprietary high throughput screen ("StemScreen®-2"), which the Company has utilized to identify multiple anti-cancer stem cell compounds. Emerging data from the Company's multiple cancer stem cell projects, including its IL-3R and Notch directed programs as well as its discovery platform, will be presented.
Ivan Bergstein, M.D., CEO, Stemline Therapeutics, Inc.
10:20
Networking Refreshment Break in Poster & Exhibit Hall
11:00
Targeting the Hedgehog Pathway in Cancer Treatment
Hedgehog (Hh) pathway activity plays a crucial role in embryonic development and tissue homeostasis. Mutations of the pathway effector genes and increased Hh ligand expression have been identified in human tumors. Inhibition of the Hh pathway has resulted in clinical benefit for patients with tumors driven by activated Hh pathway.
Chia Portera, M.D., Ph.D., Assistant Medical Director, Exploratory Clinical Development, Genentech BioOncology
Strategic Discussion Group
11:30
Cancer Stem Cells
- Is there a difference between a cancer stem cell and a tumor initiating cell?
- Defining molecular and functional characteristics of cancer stem cells
- Understanding mechanisms of resistance of cancer stem cells
- What is the best way to target tumor stem cells?
Moderator: Lyuba Varticovski, M.D., Staff, Cancer Research Center, National Cancer Institute
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