Approaches Changing the Treatment of Cancer
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This conference presents exciting progress towards increasing lifespan and quality of life through more efficacious and potent treatments, reduced toxicity, and selection of responsive patients through biomarkers. After the success of anti CTLA4, there is huge interest in immune-mediated mechanisms, especially PD1 and PDL1, the role of B cells and complement, redirected T cell killing, and ADCC activation. In ADCs, there is increasing interest in site-specific conjugation, novel payloads and linkers, and off-target toxicity. Multi-specific antibodies are increasingly attractive owing to the better affordability they offer. Additional hot topics that will be covered are novel engineering approaches for better efficacy and manufacturability, new targets, and combination therapies that examine different antibody combinations to augment the clinical benefit.
Wednesday, February 13
7:00 am Registration and Morning Coffee
8:00 -9:40 am Plenary Keynote Presentation - Personalized Oncology – Fulfilling the Promise for Today's Patients
In honor of the 20th anniversary of the Molecular Medicine Tri-Conference, CHI and Cancer Commons will present a plenary panel on Personalized Oncology. Innovations such as NGS and The Cancer Genome Atlas have revealed that cancer comprises hundreds of distinct molecular diseases. Early clinical successes with targeted therapies suggest that cancer might one day be managed as a chronic disease using an evolving cocktail of drugs.Representing all five conference channels, Diagnostics, Therapeutics, Clinical, Informatics, and Cancer, a panel of experts will lead a highly interactive exploration of what it will take to realize this vision in the near future.
9:40 Refreshment Break in the Exhibit Hall with Poster Viewing
11:00 Chairperson's Opening Remarks
Paul Polakis, Ph.D., Director/Staff Scientist, Cancer Targets, Genentech, Inc.
11:10 FEATURED PRESENTATION: The Yin and Yang of Personalized Medicine
Stefan Scherer, MD, Ph.D., Vice President, Clinical Development & Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG
11:40 KEYNOTE PRESENTATION: Empowered Antibodies for Cancer Therapy
Peter Senter, Ph.D., Vice President, Chemistry, Seattle Genetics, Inc.
The technology surrounding antibody drug conjugates has advanced significantly in the past two years, with developments in antibody, drug, linker and conjugation technologies.This presentation will overview some of the recent technical achievements surrounding antibody drug conjugates, and include the development of a clinically approved drug.
12:10 pm Potent-Payload Linker-Drug Technology – Development of Novel Duocarmycin-Based ADCs
Marco Timmers, Ph.D., CSO, Biopharmaceuticals, Synthon BV
This presentation will highlight optimization of Synthon's unique linker chemistry and its complementarity with novel proprietary duocarmycin drugs. Latest pre-clinical results will be discussed, including CMC and in vivo therapeutic window.
12:40 Luncheon Presentation I: Challenges and Successes of Measuring Antigen-Specific T CellMagdalena Tary-Lehmann, Ph.D., CSO, Cellular Technology Limited (CTL)Increasing number of new drugs and vaccines aim to elicit a response from the cellular components (e.g. T cells) of the immune system. ELISPOT is an ideal assay system for immune monitoring of T cells. Examples will be demonstrated.
1:10 Luncheon Presentation II: (Sponsorship Opportunity Available) or Lunch on Your Own
1:45 20th Anniversary Cake in the Exhibit Hall with Poster Viewing
2:15 Chairperson's Remarks
Peter Senter, Ph.D., Vice President, Chemistry, Seattle Genetics, Inc.
2:20 Challenges Associated with Research & Development of ADCs
Paul Polakis, Ph.D., Director & Staff Scientist, Cancer Targets, Genentech, Inc.
I will include preclinical studies designed to anticipate the nature of inevitable drug resistance and emphasize the potential for combining existing targeted therapies with ADCs in the clinic.
2:50 Pre-Clinical Development of IMGN529: A Novel CD37-Targeting Antibody-Maytansinoid Conjugate for the Treatment of B-Cell Malignancies
Jutta Deckert, Ph.D., Principal Scientist, Discovery Research, ImmunoGen, Inc.
IMGN529, a CD37-directed ADC designed to kill malignant B cells using multiple, targeted mechanisms, is currently in clinical testing in non-Hodgkin's lymphoma patients. Its preclinical evaluation will be discussed with a focus on in vitro safety studies.
3:20 Predicting Clinical Efficacy of ADCs from PK/PD Modeling of Pre-Clinical Data: Can We Really Extrapolate from Mouse to Man?
Alison Betts, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism (PDM), Pfizer Worldwide Research & Development
In this presentation, a multiscale-mechanism based PK/PD model for ADCs is proposed which can integrate in vitro biomeasures and pre-clinical PK/PD data, to predict a clinical efficacious response. A case study is shown with Brentuximab-vedotin (SGN-35).
3:50 Empowering Therapeutic Monoclonal Antibodies with A Biologic Payload for Cancers
Iqbal S. Grewal Ph.D., D.Sc., FRCPath., Chief Scientific Officer, Research & Development, ImmunGene, Inc.
This presentation will highlight a novel technology to empower antibodies by fusing them to IFNα. Antibody-IFNα fusions are more potent than native antibodies or sIFNα, and, selectively target tumor cells while reducing systemic toxicity. Antibody-IFNα fusions have broad therapeutic index.
4:20 Networking Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunities Available)
5:20 Breakout Discussions in the Exhibit Hall
Roles of T Cells, B Cells, IL10 and Vascularization
Moderator: Nathalie Scholler, M.D., Ph.D., Assistant Professor, Obstetrics and Gynecology, University of Pennsylvania
- Targeted therapy for liquid vs. solid tumors; limitations of current treatment and opportunities for the future
- Using biomarkers to harness the immune response and target cancers
- Outlook for cancer vaccines by coupling immunotherapy
Progress in Diagnostic Biomarkers for Cancer Biologics
Moderator: Jason Baum, Ph.D., Principal Scientist, Research, Merrimack Pharmaceuticals, Inc.
- New approaches and emerging technologies to identifying the right target population
- Classifying patients according to the extent of perceived receptors and their ligands
- Challenges in sample definition and validation for cancer diagnostics assays
- Clinical assay development: determining sensitivity and specificity of biomarkers
- Circulating biomarkers
- Benefits of imaging studies
- Using the product as a prognoistic tool
Advances in Combination Therapies for Cancer Biologics
Moderator: Steve Olsen, M.D., Ph.D., Global Development Team Leader, Trastuzumab Emtansine Product Development-Oncology, Genentech, Inc.
- Different antibody combinations that augment the clinical benefit
- Means of assessing combinations that show synergy
- How these can be scheduled and modeled
- Clinical Advances
Challenges with Antibody Drug Conjugates
Moderator: Peter Senter, Ph.D., Vice President, Chemistry, Seattle Genetics, Inc.
- Determining the best combination of warhead and target
- Cleavage products: biologically-mediated payload release
- Selection of right linker technology for the product
- Site specific conjugation approaches: Hope or hype
- Ensuring specificity to tumor cells and not normal ones
- Means of enhancing drug clearance by linker modification
- Regulatory requirements for ADC constructs
Quantifying Preclinical Efficacy of Cancer Biologics and Translation to the Clinic
Moderators: Gregory P. Adams, Ph.D., Co-Leader, Developmental Therapeutics Program, Fox Chase Cancer Center andAlison Betts, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism (PDM), Pfizer Worldwide Research & Development
- Appropriate animal models of efficacy for cancer biologics: possibilities beyond xenografts
- Use of PD biomarkers to predict dose
- Use of PK/PD and/or systems modeling to quantify efficacy
- Considerations for clinical translation
- Prediction efficacious doses. Importance of defining MABEL (minimally anticipated biological effect level). Is dosing to MTD still appropriate?
- Role of precision medicine in informing dosing strategies
- Strategies to achieve POC earlier
Engineering of Bi/Multi-Specific Molecules
Moderator: Peter Kiener, Ph.D., President & CEO, Zyngenia, Inc.
- How do these products differentiate themselves? In what ways are they an improvement on MABs?
- The best targets for these products
- Features that make the product more potent
- Manufacturing issues
- Half-life, stability, propensity to aggregate, toxicity
- Characterization challenges
- Novel engineering approaches, especially the Fc part
- Pre-clinical and clinical advances
Clinical Development of Cancer Biologics
Moderator: Hans-Peter Gerber, Ph.D., Executive Director, BioConjugate Discovery and Development, Oncology Research Unit East, Pfizer Worldwide Research and Development
- Biomarker and companion diagnostic development: alternative approaches to IHC
- Evaluation in the clinic: to what extent do clinical results reflect pre-clinical prediction
Finding Suitable Targets for Cancer Biologics
Mary Haak-Frendscho, Ph.D., CEO,Igenica, Inc.
- Considerations for sourcing primary samples
- Balancing novelty with known biology
- Identifying pathways and signaling systems
- Assessing penetrance and abundance of expression
- Engaging the patient's immune response
- Increasing tumor delivery and penetration
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