Next Geneartion

The recent years have seen huge excitement in the field of cancer biotherapeutics, led by the earlier approval of 2 antibody-drug conjugates to the recent bispecific antibody approval, to the current clinical progresses made with CAR, TCRs and TILs. At Next-Generation Cancer Biotherapeutics meeting, leading scientists will share their strategies to develop next-generation ADCs, clinical updates on bispecific and multi-specific antibodies, showcase novel engineered antibodies with increased properties for efficacy and anti-tumor activity, as well as approaches to overcome the challenges in developing immunotherapy antibodies.

No drug development can be accomplished without an understanding of the clinical and regulatory environments in which they operate, so we are also bringing you a Plenary Session featuring recent updates on regulatory changes in China, and strategies to navigate the complex clinical and regulatory pathways for new biologics development in China.

WEDNESDAY, APRIL 6

1:00 pm Registration


JOINT PLENARY SESSION
THE PROMISE OF NOVEL CANCER BIOTHERAPEUTICS

2:00 Chairperson’s Opening Remarks

Daotian Fu, Ph.D., General Manager, Livzon MabPharm

2:05 Developing Antibody-Drug Conjugates for the Treatment of Solid Cancers

Parren PaulPaul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director, Genmab

Therapeutic antibodies have revolutionized the treatment of cancer. However, many patients still fail to respond or become resistant to targeted treatment and novel innovative approaches to improve therapy are therefore required. Chemical engineering of antibodies, fueled by recent molecular insights, is providing important opportunities for the development of more potent antibody therapeutics. The progress in two antibody-drug conjugate programs from Genmab’s portfolio will be highlighted.

2:35 Engineering the Next-Generation Antibody-Drug Conjugates for Cancer Therapy

Wu HerrenHerren Wu, Ph.D., CTO, MedImmune/AstraZeneca

Linking of highly potent cytotoxic warheads to tumor-targeting antibodies has the potential to attack tumors with missile-like precision and avoid toxicity to normal tissues. However, clinical observations indicate that the therapeutic window of most antibody-drug conjugates (ADCs) remains narrow. I will discuss our efforts in developing next-generation ADC technology which seeks to address the short-comings observed with current ADCs and help realize the full potential of this drug class to provide new breakthrough agents for the treatment of cancer.

3:05 Cancer Immunotherapy: Delivering the Promise

Weikang TaoWeikang Tao, Ph.D., Vice President & CEO, R&D Center, Jiangsu Hengrui Medicine Co., Ltd.

Recent breakthroughs in treating different types of advanced-stage malignancies by harnessing self immunity against neoplastic cells showed a great promise of immunotherapy for cancer treatment. Various strategies have been employed to unleash, enhance or elicit anticancer immune reactions, which include T-cell checkpoint blockade, engineered T cells, BiTE, modified cytokines and cancer vaccines. This presentation will review recent progress in cancer immunotherapy and discuss some immunotherapeutic agents discovered and developed at HengRui Medicine Co., Ltd.

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing


CHALLENGES FOR NEW BIOLOGICS DEVELOPMENT IN CHINA

4:10 Update on Recent Regulatory Changes for Biologics Development in China

Fu DaotianDaotian Fu, Ph.D., General Manager, Livzon MabPharm

Over the past several years, the biotech industry in China has experienced tremendous growth, both in biosimilars and innovative biologics. In the meantime, the CFDA is also going through significant reforms with respect to guidance and the reviewing process for development of both biosimilars as well as innovative biologics. In this presentation, the author intends to provide an update on the recent development in CFDA’s guidance for biologics development in China, and how the biotech industry can best position itself to take advantage of the recent regulatory changes.

4:40 PANEL DISCUSSION: Understanding the Clinical and Regulatory Pathways for New Biologics Development in China

Moderator: James Cai, Ph.D., Vice President, Global Regulatory Affairs, Access & Policy, Amgen Shanghai

Panelists:
Daotian Fu, Ph.D., General Manager, Livzon MabPharm
Weidong Jiang, Ph.D., CSO, Shanghai Henlius
Weikang Tao, Ph.D., Vice President & CEO, R&D Center, Jiangsu Henrui Medicine Co., Ltd.
Scott M. Wheelwright, Ph.D., CEO, Complya Asia


5:40 Close of Day


THURSDAY, APRIL 7

8:30 am Morning Coffee

8:50 Chairperson’s Opening Remarks

Ting Xu, Ph.D., CEO and President, AlphaMab Co.


IMMUNO-ONCOLOGY ANTIBODIES

9:00 Challenges in Developing Immunotherapy Antibodies

Weidong_JiangWeidong Jiang, Ph.D., CSO, Shanghai Henlius

Cancer immunotherapy is the most exciting development for cancer treatment in recent years. Immuno checkpoints are the most popular targets for antibody drug development. We have developed anti-PD1 and anti-PD-L1 antibodies via different methodologies with success and failure. Both case studies will be presented to share our experience about how to obtain therapeutic antibodies from research to preclinical validation, including in vitro functional assays, in vivo animal model efficacy studies, and importance of affinity maturation for these antibodies.

9:30 Antibody-Cytokine Heterodimeric Fusion in Oncoimmunology - Efficacy, Characterization and Mode of Action

Ting Xu, Ph.D., CEO and President, AlphaMab Co.

This presentation will examine strategies to booster immune status in non T-cell infiltrated tumor; cytokines for tumor immunotherapy and selection of right cytokines; as well as the design of heterodimeric antibody-cytokine fusion. Preclinical studies of two types of cytokines fusion, efficacy and mechanism will be presented.

10:00 Cancer Biotherapeutics - Affimers: A Novel
Scaffold for Biotherapeutics

Amrik Basran, Ph.D., CSO, Therapeutics, Avacta Life Sciences

Affimers are a new protein scaffold with great potential for the generation of biotherapeutics. Based on the protease inhibitor Stefin A, large diverse libraries have been created by engineering in peptide loops into the scaffold backbone. Using phage display, we have identified competitive binders to a ranage of targets, including the immune check point, PD-L1. We have shown that the scaffold is amenable to being engineered with a range of half-life extension technologies, giving “IgG like” PK.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing


BISPECIFIC AND MULTI-SPECIFIC ANTIBODIES

11:00 Bispecific FynomAbs: Novel Modes of Action Through Tailored Architecture

Kristina Klupsch, Ph.D., Associate Director, Discovery Research, Covagen AG

Covagen develops bispecific FynomAbs by fusing its Fynomer binding proteins to antibodies, resulting in bispecific protein therapeutics with novel modes of action and enhanced efficacy for the treatment of inflammatory diseases and cancer. We will present case studies demonstrating that FynomAbs with tailored architecture overcome limitations encountered with other therapeutic protein formats, such as suboptimal efficacy or lack of tumor selectivity. 

11:30 Design of Multispecific Antibodies Modulating T-Cell Functions for Redirected Cytotoxicity

Ji Jie Gu, Ph.D., Senior Principal Research Scientist, Global Biologics, AbbVie

With four DVD-Ig molecules currently in clinical development, we have furthered the DVD-Ig concept to the design of multispecific molecules to address additional unmet needs. In this presentation we will discuss: (1) improvement on DVD-Ig technology and beyond; (2) some basic structural and functional features of emerging multispecific molecules; and (3) how these molecules could be used to fine tune T cell functions for re-directed toxicity against tumor cells.

12:00 pm Bispecific Antibody Targeting of Nanomedicines for Cancer Therapy

Christopher Howard, Ph.D., Senior Research Fellow, Australian Institute for Bioengineering and Nanotechnology, University of Queensland

A simple method to generate actively targeted nanomaterials using bispecific antibodies with dual specificity for nanomaterials and cancer targets such as Epidermal Growth Factor Receptor (EGFR) will be discussed. The design, expression, stability and target binding of the BsAbs will be outlined. The delivery of imaging agents and therapeutics to tumour sites using BsAb tethered nanomaterials will also be discussed.

12:30 Networking Luncheon in the Exhibit Hall with Poster Viewing


EMERGING PLATFORMS FOR CANCER THERAPY

1:45 Chairperson’s Remarks

Weidong Jiang, Ph.D., CSO, Shanghai Henlius

1:50 Development of an Anti-HGF Antibody for Cancer Therapy

Junho_ChungJunho Chung, M.D., Ph.D., Professor, Biochemistry and Molecular Biology, Seoul National University

We developed an anti-HGF rabbit humanized antibody. In mouse xeno-graft models, this antibody effectively inhibited the growth of human glioblastoma, sarcoma and colorectal cancer cells. The pharmacokinetic property of the antibody was determined in primate and no drug-related toxicity was monitored. This antibody is now in phase I clinical trial (ClinicalTrials.gov Identifier: NCT02499224).

2:20 Targeted Treatment of Cancer Using ADCs Containing Specifically Conjugated Prodrugs of Novel Cytotoxic Agents

Robert Y. Zhao, Ph.D., CEO and Chairman, Hangzhou DAC Biotech, Ltd.

This talk focuses on developing new generation ADCs using prodrug and specific conjugation methodology. Through the approaches of our proprietary prodrugs of novel cytotoxic agents, and novel specific linkages to the antibodies, our ADC drugs have shown much superior windows of antitumor activities both in vitro and in vivo than existing ADC drugs. This novel ADC platform would have broader applications in the treatment of cancer.

2:50 A Novel Engineered VEGF Blocker with a Robust Anti-Tumor Activity

XiangYang_ZhuXiangYang Zhu, Ph.D., CEO, Huabo Biopharma (Shanghai) Co., Ltd.

A VEGF trap containing the second immunoglobulin-like domain of the VEGF tyrosine kinase receptor was fused to IgG1 Fc region, and a robust upstream and downstream process has been developed to assume enough materials for multiple clinical indications. Our results showed a strong anti-tumor activity in multiple animal models, indicated VEGF-Trap-mediated blockade may be superior to that achieved by other agents, such as monoclonal antibodies targeted against the VEGF receptor.

3:20 GC1118, A Novel EGFR-Targeting Antibody, with a Distinct Binding Epitope and Efficacy

Jonghwa_WonJonghwa Won, Ph.D., Senior Research Director, Oncology Team, Green Cross Corp./Mogam Biotechnology Institute

Finding a differentiating factor is a key to position successfully into competitive, existing anti-cancer therapeutics. GC1118 has a distinct EGFR binding epitope and shows potent inhibitory activities on high-affinity EGFR ligands to which current antibodies have limited efficacy. Our study suggests that GC1118 would give prominent therapeutic effects on tumors refractory or resistant to current EGFR-targeting therapeutics. Potential hypothesis in working mechanism and clinical implications of GC1118 will be presented.

 

3:50 FIT-Ig: A Novel Bispecific Antibody Technology

Stephan Lensky, Ph.D., COO, EpimAb Biotherapeutics, Inc.

 

4:20 Close of Conference


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Track 1

Protein & Antibody Engineering

Track 2

Analytical Characterization of Biotherapeutics

Track 3

Next-Generation Cancer Biotherapeutics

Track 4

Protein Aggregation & Stability