8:00 am Chair’s Opening Remarks

8:10 am Combining ADCs & Immunotherapy: Mechanistic Insights & Clinical Observations

  • Daejin Abidoye Vice President, Clinical Development , Seattle Genetics

Synopsis

  • Analyze preclinical data demonstrating how monomethyl auristatin E (MMAE) has the potential to drive immunogenic cell death
  • Review preclinical and biomarker data on MMAE that support the induction of inflammatory cytokines and innate inflammatory responses which are consistent with MMAE-induced ICD
  • Discuss insight from how Seattle Genetics’ data provide the rationale for combining ADCs with immuno-oncology therapies including PD-L1 checkpoint blockade
  • Evaluate data from combinations of ADCs with PD-1 inhibitors with implications for future development of these combinations

8:40 am Designing Effective Antibody-Drug Conjugates: What Have We Learned in Forty Years & What Are the Future Prospects

  • John Lambert Executive Vice President, Emeritus & Distinguished Fellow, Immunogen

Synopsis

  • Effective exploitation of antibodies for treating cancer required many lessons to be learned and technologies to be developed in the 1980s and 1990s
  • Since Mylotarg’s approval in 2000, major advances in antibody-drug conjugate technologies were pioneered by ImmunoGen, Inc., and Seattle Genetics, leading to the approvals of Kadcyla and Adcetris
  • With many “tools in the toolbox”, development of ADCs for cancer treatment has a promising future

9:10 am Development of a New TROP-2 ADC with Better Therapeutic Window

  • Hui Lu Chief Executive Officer, Levena Biopharma

Synopsis

  • TROP has emerged as an appealing target for ADC development
  • Tackling the unique challenge for a target with larger tissue distribution and utilization of weaker payload
  • Witnessing how novel ADC design has achieved better linker stability, which has greatly reduced ADC toxicity and improved therapeutic window

9:40 am Speed Networking

Synopsis

This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the ADC field and establish meaningful business relationships to pursue for the rest of the conference.

10:20 am Morning Refreshments & Networking

Overcoming Manufacturing Hurdles & Roadblocks

11:00 am Key CMC Considerations for Integrated ADC Development to Production

  • Xinfan Li Chief Operating Officer , Mabplex

Synopsis

  • Integrated conjugate development approach at Mabplex including early stage linker-toxin combination evaluation
  • Implementation of new technology or continuous improvement
  • Time line fits customer needs based on risk assessment

11:30 am Next Generation Continuous Process Design on Manufacturing of ADCs

  • Gang Qin President, Founder & Chief Executive Officer, Genequantum

Synopsis

  • Exploring one real continuous process for conjugate manufacturing
  • Discussing the green process without isolator and organic solvents issues
  • Achieving unprecedented productivity, flexibility and versatility

12:00 pm Session Reserved for Piramal

12:30 pm Development of a Manufacturing Process for Dolaflexin, a Mersana Proprietary Warhead/Linker Platform

Synopsis

  • Evolution of ADC linker/warhead design and Mersana approach
  • Overcome the challenges in the manufacturing process of Dolaflexin
  • Further improvement in Mersana linker/warhead technology

1:00 pm Session Reserved for Safebridge Consultants

  • Bob Sussman Managing Director , Safebridge Consultants

1:30 pm Lunch & Networking

Exploring Novel Payloads to Inspire Innovation

2:30 pm Multi-arm Linker Units with Drug Molecules or Chelator Groups for Preparing Antibody Drug or Radionuclide Conjugates

Synopsis

  • Understanding how a drug bundle is prepared; By conjugating 3-5 cytotoxic drug molecules or chelator groups to a multi-arm linker
  • Two drug bundles are conjugated to the C-termini of H chains of an antibody molecule via a click reaction or SH-maleimide reaction
  • Reviewing one ADC with lenalidomide bundles and one ARC with DOTA chelator bundles

3:00 pm Introducing Antibody Pyrrolobenzodiazepine Conjugates

Synopsis

  • Introduction to Pyrrolobenzodiazepines (PBDs) and Spirogen
  • Analyze the properties of PBDs that make them good ADC Payloads
  • Review PBD ADC clinical highlights
  • Explore novel PBD payloads

3:00 pm Novel ADC Payloads & Linkers to Enable Expanding Therapeutic Windows

  • Robert Zhao Chief Executive Officer, Hangzhou DAC Biotech

Synopsis

  • Explore in detail the ADC platform developed at Hangzou DAC Biotech
  • Evaluate the approaches of their proprietary cytotoxic agents and novel side chain linkers which have resulted in ADC drugs showing much superior windows of antitumor activities both in vitro and in vivo than existing ADC drugs
  • Discuss the broader applications of this novel ADC platform in the treatment of
    cancer

4:00 pm Introducing Antibody Intracellular Activated Drug Conjugate (AiADC) as a Novel ADC Technology

  • Atsushi Suwa Research Scientist, Sumitomo Dainippon Pharma Co

Synopsis

• Introduce the concept of our antibody intracellular activated drug conjugate
(AiADC) technology that enhances the therapeutic widow for better clinical
outcomes
• A novel modifier (payload with chemical linker) to generate a hyrophilic ADC with
homogeneous drug-to-antibody ratio.
• Review preclinical profiles of AiADCs targeting

4:30 pm Afternoon Break & Networking
                Scientific Poster Session

Synopsis

During the afternoon break, the learning and networking carries on. The Poster Session is an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. The posters will then be left up throughout the rest of the conference.

A Landscape Review & Delving into Regulatory Challenges for Asia & the RoW

5:30 pm Antibody Drug Conjugate Development: Current Clinical Status & Future Directions

  • Jia He Analyst, Beacon Targeted Therapies

Synopsis

• Receive an update on the key movements in the clinic
• Gain insight into the rapidly evolving pipeline
• Analyze novel clinical ADCs

6:30 pm Panel Discussion: Strategy & Challenges of Filing an IND Globally from Asia

  • Alex Xu Principle Scientist , NMPA
  • Mary Hu Chief Executive Officer, Miracogen
  • Ziping Wei Chief Executive Officer, Bliss Bio

Synopsis

Discussion topics:

  • Explore the rationale for submitting INDs in different countries; how to leverage the strength of Asia and US/Europe
  • Address the challenge for filing INDs globally to meet the regulatory requirements in different regions
  • Discuss the strategy for obtaining IND approval and broaden the market opportunities globally

6:30 pm Addressing Regulatory Considerations for ADCs & How the NMPA Reform Affects Regulations

  • Alex Xu Principle Scientist , NMPA

7:00 pm Chair’s Closing Remarks