mmtc archived content

Delivery of Biologics

 

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Wednesday, February 3

7:00 AM Registration and Morning Coffee

Plenary Keynote Session

8:10 When Drug Research is Personal

John F. Crowley, Founder, Novazyme Pharmaceuticals, Inc.

Mr. Crowley's emotion-packed presentation will focus on his personal struggle to find a cure for Pompe disease, a rare and fatal illness that is caused by a defective or missing enzyme. Pompe disease affects fewer than 10,000 people world-wide, including Mr. Crowley's two small children. Mr. Crowley, a Harvard educated businessman, created and built a pharmaceutical company devoted expressly to finding a cure for the disease. He will detail his journey through the labyrinth of scientific and business fronts, which lead up to a first-round clinical trial.

8:55 Technology, Aging, and the Brain

Gary W. Small, M.D., Parlow-Solomon Professor on Aging, Professor of Psychiatry & Biobehavioral Sciences, Director, UCLA Center on Aging, Director, Memory & Aging Research Center, Director, Geriatric Psychiatry Division, Semel Institute for Neuroscience & Human Behavior, David Geffen School of Medicine at UCLA

New neuroimaging and other technologies are teaching us about how the brain ages and what we can do about it. Although memory declines as we age, medical and nonpharmacological strategies may protect brain health and improve memory performance. At the same time, innovation in digital technology is not only changing the way we live and communicate, it appears to be altering how our brains function. As a consequence of this high-tech stimulation, we are witnessing the beginning of a new form of the generation gap - a brain gap dividing younger digital natives, immersed in the technology early in life, from older digital immigrants, who adapt to the new technology more reluctantly. This lecture will describe this current pivotal point in brain evolution and how we can harness the new technology and lifestyle choices to improve memory and brain function so we can live better and longer. 

9:40 Grand Opening Refreshment Break in the Exhibit Hall

 

PENETRATION AND DISTRIBUTION

11:00 Introduction and Welcome

Matthew K. Robinson, Ph.D., Assistant Professor, Molecular and Translational Medicine Program, Fox Chase Cancer Center

11:10 Tumor Penetration of Therapeutic Antibodies -The Impact of Size and Exposure Time on Distribution

David Blakey, Ph.D., Chief Scientist, Cancer and Infection Research Area, AstraZeneca

The ability of intact antibodies and fragments to access tumor cells distant from the tumor blood supply is an important therapeutic consideration for antibody based oncology drugs. Preclinical and clinical data will be reviewed regarding the impact of size and exposure time on antibody distribution within tumors.

11:40 Anti-tumor Efficacy Maximization through Blocking Multiple Targets of Angiogenesis

Dana Hu-Lowe, Ph.D., Group Leader, Associate Research Fellow, Cancer Biology, Pfizer, Inc., PGRD-La Jolla

Vascular normalization and adaptivety potentially contribute to resistance to anti-VEGF/VEGFR therapies in the clinic. Other targets, including the Activin receptor Like Kinase 1 (ALK-1), also play a role in promoting tumor angiogenesis. A fully human mAb against ALK-1 was generated. The differential and complimentary outcome of anti-ALK-1 and anti-VEGF will be discussed.

12:10 PM Optimizing Targeting of Anti-tumor Antibodies

Gregory P. Adams, Ph.D., Co-Leader, Molecular and Translational Medicine Program, Fox Chase Cancer Center

We have found that anti-HER2 scFv molecules penetrate and localize in a solid tumors less efficiently with increasing affinity. We will describe studies performed with anti-HER2 human IgGs molecules that demonstrate that affinity also impacts the targeting of intact antibodies. Studies examining the roles of affinity on in vitro ADCC and internalization into tumor cells will also be discussed.

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:45 Dessert in the Exhibit Hall

 

SELECTIVE TARGETING OF TUMORS

2:15 Chairperson's Remarks

Gregory P. Adams, Ph.D., Co-Leader, Molecular and Translational Medicine Program, Fox Chase Cancer Center

2:20 Bispecific Antibodies: An Approach to Enhance Targeting Selectivity and Efficacy

Matthew K. Robinson, Ph.D., Assistant Professor, Molecular and Translational Medicine Program, Fox Chase Cancer Center

Work will be presented on our efforts to develop and optimize the targeting selectivity of bispecific antibodies that co-target two distinct tumor associated antigens. We hypothesize that the targeting selectivity afforded by these molecules can potentially be leveraged for the development of new immunodrug conjugates.

2:50 Selective Penetration and Targeting of Tumors

Tapas K. Das Gupta, M.D., Ph.D., D.Sc., Professor and Head, Surgical Oncology, University of Illinois Chicago; Co-founder, CDG Therapeutics, Inc.

CDG Therapeutics has developed a cell penetrating peptide (28aa) from azurin, a redox protein secreted by Pseudomonas aeruginosa. p28 preferentially enters cancer cells, localizes in the nucleus and stabilizes p53 inducing cell cycle arrest and apoptosis in a series of solid tumors. p28 is stable, nontoxic and currently in a Phase I clinical trial.

3:20 A Systems Biology Approach to Engineering Therapeutic Antibodies: Development of an ErbB2/ErbB3 Bispecific Antibody

Alexandra Huhalov, Ph.D., Principal Scientist, Merrimack Pharmaceuticals

Using quantitative biological datasets of cell signaling we have generated computational models of the ErbB signaling network and identified ErbB3 as a promising target. The application of these models to guide the design of MM-111, a bispecific antibody-based therapeutic targeting the ErbB2/ErbB3 heterodimer, and its antitumor activity will be discussed.

3:50 Sponsored Presentation (Sponsorship Opportunity Available)

4:20 Reception in the Exhibit Hall (Sponsorship Available)

5:20 BREAK-OUT DISCUSSIONS in the Exhibit Hall

Utility of Effector Cell Enhanced Monoclonal Antibodies for Solid Tumors: Pre-clinical and Clinical Evidence

Moderator: Hans-Peter Gerber, Ph.D., Senior Director, Tumor Therapies, Wyeth Oncology Discovery

  • Pre-clinical models to determine efficacy and safety of effector function enhanced mAbs
  • Pre-clinical and clinical data from hematologic malignancies
  • Potential impact on toxicity
  • Utility of effector function enhanced mAbs in the context of antibody drug conjugates (ADCs)

Intact Antibodies versus Antibody Fragments as Cancer Therapeutics: Pros and Cons

Moderator: David Blakey, Chief Scientist, Oncology, AstraZeneca

  • Focus on tumor penetration, specificity, half-life and toxic load
  • When are the fragments useful and what are their advantages?

Scientific and Regulatory Concepts to Optimize the Development Process for Cancer Biotherapeutics

Moderator: Diane Seimetz, Ph.D., M.D.R.A., CSO and Executive Vice President, Fresenius Biotech GmbH

  • "Ideal patient population" for immunotherapeutics
  • Value of immunomonitoring during drug development
  • Adaptive trial designs
  • Regulatory environment

Using Pre-clinical Data to Predict Likelihood of Clinical Success for Antibody-based Compounds

Moderator: John M. Lambert, Ph.D., Executive Vice President and CSO, ImmunoGen, Inc.

  • What pre-clinical parameters (PK, Minimally effective dose, etc.) are translatable from animal models to humans?
  • Concept of clinically-relevant doses for antibody-based therapeutics in pre-clinical studies
  • What can pre-clinical efficacy data tell us about clinical responses (e.g. functional antibody data)?
  • Does MABEL provide a reasonable balance between safety and efficacy?

Comparing Multi-specific Biologics to Multiple Single Agent Combination Biologics

Moderator: Eric Furfine, Ph.D., Senior Vice President, Research and Pre-clinical Development, Adnexus Therapeutics, a Bristol-Myers Squibb R&D Company

  • Development costs (in particular pre-clinical and clinical development and expense)
  • Potential advantages based on efficacy and safety
  • Challenge of picking the correct doses or relative potency
  • Historical challenges to discovering multi-specific biologics and emerging technologies to solve these problems

6:20 Close of Day

 

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2015 MMTC Final Agenda 

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