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This is an exciting time for antibody-drug conjugate developers. With many ADCs moving into later-stage clinical trials, the industry is eagerly anticipating the results from these trials. Some of the lessons learned from earlier trials have already been applied to new generations of ADC design, helping the industry to overcome the setbacks previously experienced. The industry is now eagerly anticipating data from new pivotal trials in solid tumors, results from trials with new payloads and linkers, and outcomes from combination therapies.

In this Antibody-Drug Conjugates II: Advancing Toward the Clinic conference, we invite scientists to present their latest clinical and preclinical data, as well as lessons learned to help drive the industry toward clinical success.

Final Agenda

SC9: Target Selection for Biologics - Detailed Agenda

*Separate registration required

THURSDAY, MAY 4

12:00 pm Registration

12:35 Luncheon in the Exhibit Hall with Poster Viewing

1:40 Chairperson’s Remarks

John Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, ImmunoGen

1:50 KEYNOTE PRESENTATION: Leveraging Antibody-Drug Conjugates to Eradicate Tumor-Initiating Cells

Alex_BankovichAlex Bankovich, Ph.D., Senior Director, Head of Late Stage Research, AbbVie Stemcentrx, LLC

Tumor-initiating cells (TICs) will remain controversial until findings in the lab translate into drugs providing clear clinical benefit to patients.  Antibody drug conjugates (ADCs) are a promising class of drugs able to target and reduce the frequency of TICs in patient-derived xenografts.  My company has worked to discover TIC phenotypes and to utilize methods well-suited to specifically identify cell surface proteins targetable by specific ADCs.   My talk will explain the drug development path that we followed to some of our current clinical programs.


Modeling and Simulation Approaches

2:20 Novel Approaches for Modeling Pre-Clinical Activity of ADCs and Informing Biomarker Strategy

Tony_DAlessioTony D'Alessio, Ph.D., Research Investigator, Novartis Institutes for Biomedical Research, Inc.

Using PTX mouse clinical trials, we have begun to generate population-based in vivo activity datasets on several emerging ADC programs. By integrating response data with molecular features across these models, we are building a rich dataset for biomarker analysis. Additionally, we are employing fully syngeneic murine tumor models to profile ADC activity in immune-competent settings and characterized pharmacodynamic changes in the tumor microenvironment to inform rational combination approaches.

2:50 Predicting Clinical Success of ADCs using a Mechanistic Modeling & Simulation Approach

Alison_BettsAlison Betts, Ph.D., Associate Research Fellow, Biomedicine Design, Pfizer

Quantitative modeling and simulation was used to analyze data on 10 ADCs in patient trials or approved for oncology indications. Clinical efficacious dose was predicted from preclinical PK/PD studies and compared with clinical MTD, recommended Phase II and clinically approved doses. Monte Carlo clinical trial simulations were performed to predict objective response rate. This information can be used to select the best ADC, to optimize clinical trial design and determine likelihood of success versus clinical standard of care.

3:20 Poster Spotlight

Glypican-3 Specific Antibody-Drug Conjugate for Hepatocellular Carcinoma

Ying Fu, Ph.D., Postdoctoral Fellow, Laboratory of Molecular Biology, National Cancer Institute, National Institutes of Health

Hepatocellular carcinoma (HCC) is the third most common cause of cancer-related death. Glypican-3 (GPC3) is a potential target for HCC. The hypothesis of using anti-GPC3 antibody-drug conjugate to treat HCC patients has not been tested in clinical trials. Here we report the development of hYP7-PC, a humanized anti-GPC3 antibody conjugated to a highly potent DNA damaging agent through cysteine via protease-cleavable linker. hYP7-PC caused tumor remission in HCC Hep3B xenograft model.

3:50 Refreshment Break

PKPD and Bioanalytics of ADCs in Support of Clinical Development

4:20 Relationship between the Mononuclear Phagocyte System and the Pharmacokinetics and Pharmacodynamics of Antibody Drug Conjugates in Patients

William_ZamboniWilliam C. Zamboni, Pharm.D., Ph.D., Associate Professor; Director, TOND2I Lab, University of North Carolina at Chapel Hill

The PKPD of carrier-mediated agents (CMA) and ADC agents are dependent on their recognition and interaction with the mononuclear phagocyte system (MPS) where the conjugated drug is cleared via interactions with the MPS. It is important to evaluate how mediators, characteristics and function of the MPS affect the PK and PD of ADCs. We will discuss: 1) pharmacologic methods to characterize ADCs ex vivo and in vivo; 2) MPS variability across patient populations; and 3) relationship between mediators, characteristics and function of the MPS and the PK and PD of ADCs in patients.

4:50 Challenges and Solutions Associated with Bioanalysis of Antibody Drug Conjugates in Support of Clinical Studies

Rafiq_IslamRafiq Islam, Ph.D., Senior Director, Bioanalytical Services, Celerion, Inc.

Since ADCs are generally complex heterogeneous mixtures of multiple species, these novel therapeutic products present unique bioanalytical challenges. Novel bioanalytical approaches and strategies including a combination of ligand-binding assays (LBA) and LC–MS-based platforms are needed to overcome challenges unique to ADCs. This presentation will examine the different methodologies such as LBAs and LC-MS/MS methods for the bioanalysis of ADCs using Kadcyla® (ado-trastuzumab emtansine) as a case study.

5:20 End of Day

5:20 Registration for Dinner Short Courses

Recommended Dinner Short Course*

SC15: Critical Considerations for the Design and Development of Antibody-Drug Conjugates - Detailed Agenda

*Separate registration required

FRIDAY, MAY 5

8:00 am Morning Coffee

Preclinical and Clinical Updates

8:30 Chairperson’s Remarks

Christopher D. Thanos, Ph.D., Senior Director, Biotherapeutics Discovery, Halozyme Therapeutics

8:35 Clinical Development of ADCs: From Bench to Clinic and Back Again

Jonathan_DrachmanJonathan Drachman, M.D., CMO and Executive Vice President, Research and Development, Seattle Genetics

Antibody-drug conjugates are emerging as an important therapeutic option for both hematologic malignancies and solid tumors. As more clinical trials are completed, it may be possible to identify patterns that will help guide future technological advances. Lessons learned from different antigens, payloads, and early trial design will be discussed.

9:05 Antibody-Cytokine Fusion Proteins for the Therapy of Cancer and of Chronic Inflammation

Frances_PrettoFrancesca Pretto, Ph.D., Head, Preclinical Development, Philochem AG

Antibodies represent ideal vehicles for the delivery of cytokines to the site of disease and for the selective modulation of the immune system in pathological conditions. In this lecture, I will present preclinical and clinical data on antibody-cytokine fusion proteins that we have moved to advanced controlled clinical trials in patients with cancer or with chronic inflammatory conditions.

9:35 Pre-Clinical Development of a Novel FLT3 Targeting Antibody-Drug Conjugate Employing Site-Specific Conjugate for the Treatment of Acute Myeloid Leukemia Regardless of FLT3 Status

Nandini_Rudra-GangulyNandini Rudra-Ganguly, Ph.D., Principal Scientist, Discovery Research, Agensys


10:05 Coffee Break

10:35 ImmunoGen’s ADC Platform Technologies: Current Progress and Future Prospects

John Lambert, Ph.D., Executive Vice President and Distinguished Research Fellow, ImmunoGen

11:05 Update on Mersana’s Antibody-Drug Conjugates: Progress into the Clinic

Donald_BergstromDonald A. Bergstrom, M.D., Ph.D., CMO, Mersana Therapeutics

XMT-1522 is a HER2-targeting ADC that induces complete regressions in models of heavily-pretreated HER2-positive breast tumors, as well as breast and non-small cell lung cancer (NSCLC) without HER2 gene amplification and lower HER2 expression. XMT-1522 entered clinical development in October 2016. XMT-1536 is a Dolaflexin ADC targeting NaPi2b that is highly active in models of NSCLC adenocarcinoma and epithelial ovarian cancer. XMT-1536 has significantly improved efficacy and tolerability compared to a monomethyl auristatin E ADC against the same target. XMT-1536 will enter clinical development in late 2017.

11:35 Treatment of Non-Hodgkin Lymphoma with the Beta-Emitting Anti-CD37 Antibody Radionuclide Conjugate Betalutin®

Jostein_DahleJostein Dahle, Ph.D., CSO, Nordic Nanovector ASAc

177Lu-satetraxetan-lilotomab (Betalutin®) is a novel CD37-binding antibody radionuclide conjugate (ARC). CD37 is an internalizing transmembrane antigen highly expressed on most B-cell malignancies. Betalutin is currently in Phase I/II clinical development for the treatment of Non-Hodgkin lymphoma. View Speaker Interview

12:05 pm Development of Novel EGFR Antibody Drug Conjugates for Solid Tumor Indication

Ed Reilly, Ph.D., Senior Research Fellow, Project Director, Oncology Discovery, AbbVie

Abbvie has multiple antibody drug conjugate (ADC) programs encompassing various linker payload combinations. Several of these ADCs have advanced to clinical trials where objective responses in patients with different solid tumors have been observed. Appropriate patient selection biomarker strategies have been developed including protein, RNA and gene amplification detection methods. This presentation will focus on the development of a tumor-target specific ADC from discovery to clinical trials.

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:05 Refreshment Break

Novel ADC Concepts with Promising Preclinical Results

1:35 Chairperson’s Remarks

Ed Reilly, Ph.D., Senior Research Fellow, Oncology Discovery, AbbVie

1:40 Synergistic Potential of Combining Antibody-Drug Conjugate and Immunotherapy for Cancer Treatment

Herren Wu, Ph.D., Senior Vice President, CTO, MedImmune, LLC.

  • Race to develop combinatory cancer therapy of ADC and IO
  • Promising preclinical results
  • Opportunities and challenges

2:10 HTI-1511, A Novel Anti-EGFR-ADC, Demonstrates Significant Activity against KRAS- or BRAF-Mutated Tumors of Various Types In Preclinical Studies

Christopher_ThanosChristopher D. Thanos, Ph.D., Senior Director, Biotherapeutics Discovery, Halozyme Therapeutics

We have previously described HTI-1511, an ADC in pre-clinical development that targets EGFR. Here we screened a panel of over 70 tumor cell lines derived from various solid tumor malignancies. Evaluations in several human xenograft tumor models and patient derived tumor models in mice demonstrated potent tumor regression. These results support further development of HTI-1511 as a possible treatment for EGFR overexpressing tumors, including those with downstream activating mutations in the KRAS/BRAF pathway.

2:40 Novel Medicines that Exploit Extracellular Protein-Protein Interactions

James_PrudentJames R. Prudent, Ph.D., President & CEO, Centrose

The talk will review the development of EDCs to multiple cancer-related targets and describe their extracellularmechanism which resembles necrosis. In addition, data using cynomolgus monkey models will be discussed, where a CD20-specific EDC was able to eliminate all CD20+ B-cells while having no effect on other cells or tissues. This talk will therefore describe a new level of therapeutic precision that depends on protein-protein proximity and not simply expression.

3:10 Probody Drug Conjugates for the Treatment of Cancer

Jason_SagertJason Sagert, Ph.D., Senior Scientist II, Oncology, CytomX Therapeutics

Probody™ Drug Conjugates (PDCs) are a class of antibody-based therapeutics that remain in a substantially inert, masked form until activated proteolytically in the tumor microenvironment. This platform allows the targeting of antigens that are highly expressed on tumor cells with high prevalence across multiple types of cancer regardless of normal tissue expression. Preclinical data supporting the development of PDCs will be presented.

3:40 End of Conference


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