Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.
TS10A: Introduction to Bispecifics: History, Engineering, and Applications
MONDAY, August 31 - TUESDAY, September 1
DAY 1: MONDAY
8:30 am - 12:30 pm Seminar Sessions
2:20 - 1:30 Problem Solving Breakout Discussions
4:00 - 5:40 Plenary Keynote Session
5:40 - 7:15 pm Welcome Reception in the Exhibit Hall with Poster Viewing
DAY 2: TUESDAY
8:30 am - 5:25 pm Seminar Sessions
12:30 - 1:00 pm Lunch Provided
Exhibit Hall Refreshment Breaks also provided.
Instructors:
Regis Cebe, MSc, Scientific Technical Leader, Novartis Biologic Center, NIBR, Novartis Pharma AG, Switzerland
Brian H. Santich, PhD, Research Fellow, Department of Pediatrics Memorial Sloan Kettering Cancer Center
Mahiuddin Ahmed, PhD, Chief Scientific Officer, Y-mAbs Therapeutics
G. Jonah Rainey, PhD, Vice President, Antibody Therapeutics, Gritstone Oncology, Inc.
Intro to Bispecifics will be organized as an informative and practical guide to get up to speed on critical aspects of bispecific antibody therapeutics. Topics will include historical successes, failures, and lessons learned. Specific practical instruction
will span mechanisms of action, engineering, regulatory considerations, and translational guidelines. Perspectives on ideal implementation of bispecifics as targeted and immunomodulatory approaches will be discussed.
Topics to be Covered:
- A brief history of bispecific antibodies: 57 years of progress with critical advances and key pioneers
- Bispecific applications and powerful mechanisms of action
- Engineering bispecific antibodies: 100 formats and counting
- Specific considerations in preclinical development and regulatory landscape
- Developability, manufacturing, and analytical considerations
- Clinical experience, translation, and regulatory approval
- Current trends and future opportunities in regulating immune checkpoints, cell-based therapies, and personalized approaches
Detailed Agenda
History, the Making of Bispecific Antibodies, and Modes of Action
Regis Cebe, MSc, Scientific Technical Leader, Novartis Biologic Center, NIBR, Novartis Pharma AG, Switzerland
This session will include an introduction to therapeutic antibody engineering to get everyone up to speed on challenges inherent to bispecific antibodies.
- Brief history of bispecific antibodies: more than 50 years of progress, from the first concept to a collection of over 100 formats known today.
- Engineering bispecific antibodies: strategies to design of bispecific antibodies and overview of available platforms.
- Main mechanisms of action for bispecific antibodies. Combinatorial versus obligate concepts will be discussed.
Application of Bispecific Antibodies for the Treatment of Human Diseases
Mahiuddin Ahmed, PhD, Chief Scientific Officer, Y-mAbs Therapeutics
Brian H. Santich, PhD, Research Fellow, Department of Pediatrics Memorial Sloan Kettering Cancer Center
Bispecific antibodies can be designed using many different formats. There are over 50 different formats in preclinical or clinical development for the purpose of treating patients with cancer, autoimmunity, Alzheimer’s disease, hematological
disorders or infections. The choice of format can greatly influence the antibody's biological properties, and it is important to understand which design best fits the goals of the therapeutic product. In this course, we will discuss the applications
of multiple bispecific antibody formats to treat disease, both in oncology and other fields, focusing on the design strategies and comparisons to alternative modalities, such as cell-therapy or antibody-drug conjugates.
Regulatory Challenges, Translation, and Clinical Experience
G. Jonah Rainey, PhD, Vice President, Antibody Therapeutics, Gritstone Oncology, Inc.
Once a BiSAb has been selected as a candidate drug, an arduous road lies ahead to advance it into and through the regulatory process and into the market. The challenges of this process cannot be understated, as is evidenced by the fact that we only have two actively marketed BiSAb. We will begin by discussing CMC considerations, some engineering that can be done to lower risk, and the special analytical considerations that need to be planned. The regulatory process is ever-evolving and will depend on indication, cross-reactivity, and mechanism. We will compare the regulatory process for antibody cocktails vs. BiSAbs. Finally, we will discuss the paths to approval for the currently marketed products as well as the current landscape of clinical development.
Instructors:
Regis Cebe, MSc, Scientific Technical Leader, Novartis Biologic Center, NIBR, Novartis Pharma AG, Switzerland
During the past 19 years, I have worked on protein engineering and protein production at the Novartis Institutes for BioMedical Research. What motivates me is applying science and creativity to design proteins with desired properties. I got my first
degree from the POLYTECH school of Engineering in Marseille. Attracted by the concepts of protein evolution, I joined Pr. Andreas Pluecthun group at the University of Zurich for one-year postgraduate. I started to apply these principles of molecular
evolution at Novartis for production of tool proteins used for structural analysis. Finally I moved to our Biologic Center and could focus on the engineering of therapeutic proteins. I was first involved in the optimization of mAb for better activity
and developability before to concentrate on multispecific modalities. Over past year, I contributed to the development of a technology platform that enables efficient discovery, engineering and production of several bispecific formats.
Brian H. Santich, PhD, Research Fellow, Pediatrics, Memorial Sloan Kettering Cancer Center
Brian was raised in northern California and got his bachelors degree in immunology at the University of California, Berkeley. Following this, he worked for two years as an IRTA postbac in the laboratory of Dr. Anthony Fauci, under the mentorship of
Dr. Susan Moir, studying B-cell dysfunction in HIV and other primary immunodeficiencies. Brian received his PhD from the Louis V. Gerstner Jr. Sloan Kettering Graduate School of Biomedical Sciences under the co-mentorship of Drs. Morgan Huse and
Nai-Kong Cheung. His thesis work focused on the structure-function relationship of different T-cell bispecific antibody designs. He now works as a research fellow at Memorial Sloan Kettering Cancer Center, primarily studying T-cell bispecific
antibodies and pre-targeted radioimmunotherapy strategies.
Mahiuddin Ahmed, PhD, Chief Scientific Officer, Y-mAbs Therapeutics
Mahiuddin Ahmed, PhD is the Chief Scientific Officer of Y-mAbs Therapeutics and specializes in bispecific antibody engineering. He received his PhD in Biochemistry and Structural Biology from Stony Brook University and completed postdoctoral training
in cancer immunotherapy at the Sloan Kettering Institute. Prior to joining Y-mAbs, Dr. Ahmed was an Assistant Member in the Department of Pediatrics at Memorial Sloan Kettering Cancer Center.
G. Jonah Rainey, PhD, Vice President, Antibody Therapeutics, Gritstone Oncology, Inc.
Dr. Jonah Rainey is currently the Vice President for the Antibody Therapeutics department at Gritstone Oncology. Previously, he was the CEO of Oriole Biotech, a consulting and research organization focused on discovery through early development of biologics in San Diego. He holds a PhD in Biochemistry from Tufts University and completed postdoctoral training at the University of Wisconsin and the Salk Institute. He has been actively engaged in discovery, research, and development of bispecific antibodies in a biotech setting for 14 years. He is an inventor on several patents and applications describing novel bispecific platforms as well as current clinical candidates that exploit these platforms. Dr. Rainey led or had major contributions to research and early development of at least three current clinical candidates in phase 1 and 2, and led many additional advanced preclinical programs in oncology, infectious disease, autoimmunity, and other therapeutic areas. Industry experience spans small biotech (MacroGenics, MabVax) and large pharma settings (MedImmune/Astrazeneca).
WHAT IS A TRAINING SEMINAR?
Each CHI Training Seminar offers 1.5 days of instruction, refreshment breaks, exhibit hall functions, and lunch for all registered attendees on the full day of the class. Each person registered for the Training Seminar will be provided
with a hard copy handbook for the Training Seminar in which they are registered. A limited number of additional handbooks may be available for other delegates. CHI encourages track hopping between conference programs, and we ask
that Training Seminars not be disturbed once they have begun. We ask that attendees commit to attending the entire 1.5-day training, and not engage in track hopping once the class has started.
