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Key Sessions

Paul Carter, Ph.D.

Bispecific Antibodies as Drugs: Are We There Yet?

Genentech, Inc.

Jennifer Cochran, Ph.D.

Next Generation Protein Therapeutics for Treating Cancer

Stanford University

Catherine Coombes

Assessing the CRISPR/Cas9 IP Landscape and the Implications of the USPTO Interference Proceeding

HGF Limited, United Kingdom

Keiichiro Suzuki

In vivo Genome Editing and Future Clinical Application

Salk Institute

7:00am 8:00am (60 mins)

Main agenda

Coffee & Registration

8:00am 8:15am (15 mins)

Next Generation Protein Therapeutics Summit

Chairperson’s Remarks

  • Dragan Grabulovski, Ph.D. - CEO and Founder, Grabulovski Consulting Services

8:00am 8:15am (15 mins)

Bioconjugates: From Targets to Therapeutics

Chairperson’s Remarks

  • Paul Davis, Ph.D. - President and CEO, Quanta BioDesign, Ltd.

8:15am 8:45am (30 mins)

Next Generation Protein Therapeutics Summit

Bispecific Antibodies as Drugs: Are We There Yet?

Bispecific antibodies are finally emerging as drugs with two such molecules approved for human therapy and >50 more bispecific antibodies in clinical trials.  We established high-resolution mass spectrometry methods to facilitate the characterization and quantitation of bispecific antibodies and other complex biologics.  Additionally, we engineered bispecific IgG for efficient production in single host cells to support drug development.

  • Paul Carter, Ph.D. - Staff Scientist and Senior Director, Antibody Engineering, Genentech, Inc.

8:15am 8:45am (30 mins)

Bioconjugates: From Targets to Therapeutics

The dPEG® as an Integrated Bioconjugate Platform: Moving Beyond Linkers

Biocompatible, hydrophilic linker technology is a critical component of bioconjugate architecture. These linkers currently maintain the solubility of hydrophobic warheads, minimize aggregation, and optimize PK of bioconjugates like ADCs. Quanta BioDesign has developed more highly functional hydrophilic, non-immunogenic bioconjugate linker constructs with completely defined structures that incorporate key bioorthogonal chemistries with flexible lengths and sizes, allowing further performance optimization.

  • Paul Davis, Ph.D. - President and CEO, Quanta BioDesign, Ltd.

8:45am 9:15am (30 mins)

Bioconjugates: From Targets to Therapeutics

Site-Specific Conjugation with Expended Genetic Code

Recent technology progress greatly improved the production of therapeutic proteins incorporated with non-natural amino acid in both E. Coli and mammalian cell. This allowed precision protein drug design for protein conjugates which include long-acting proteins and ADCs. Using this robust technology platform, Ambrx created a rich pipeline ranging from early stage discovery to marketed product.

  • Feng Tian, Ph.D. - Chief Scientific Officer, Ambrx Inc.

9:15am 9:45am (30 mins)

Bioconjugates: From Targets to Therapeutics

Efficient and Selective Lysine Bioconjugations Using Surfactants

Surfactants are used in lysine-based antibody drug conjugate (ADC) processes in Pfizer to facilitate bioconjugation between the activated calicheamicin derivative (linker payload) and monoclonal antibodies. The choice of surfactant and its concentration in the reaction were shown to have a significant impact on ADC quality attributes.   Data suggested under normal process conditions, surfactants formed micelles solubilizing the hydrophobic calicheamcin derivative in the aqueous reaction media, while minimally impacting the structure of antibodies. The charge of surfactant and the choice of linker payload influenced the lysine sites selected for conjugation. Four major conjugated lysine sites were observed in Mylotarg and Inotuzumab Ozogamicin, as compared to approximate 40 conjugated lysine sites typically observed in conventional lysine-based ADCs.

  • Xi Hu, Ph.D. - Principal Scientist, BioProcess Research & Development, Pfizer Inc.

8:45am 9:15am (30 mins)

Next Generation Protein Therapeutics Summit

Beyond Standard of Care: New and biobetter DARPin® Drugs

A strength of the DARPin® platform is its ability to yield highly potent and highly stable drug building blocks. We are using these to create both biobetter and novel drugs which are currently being evaluated in clinical trials. We will highlight key findings of the clinical trials and will look into MP’s approach of generating differentiated biologics.

  • H. Kaspar Binz, Ph.D. - Vice President and Co-Founder, Molecular Partners AG

9:15am 9:45am (30 mins)

Next Generation Protein Therapeutics Summit

Use of Phage Display and Antibody Engineering to Identify and Affinity Optimize a Bacterial Pathogen Specific Antibody for Therapeutic Application

One neutralizing antibody was identified against Staphylococcal Enterotoxin B (SEB) from a synthetic antibody phage library. By using a systematic antibody engineering approach, the mAb was affinity optimized to yield antibody candidates with sub-nanomolar affinities. The in vitro and in vivo toxin neutralizing efficacy of these antibodies were evaluated. Our results suggest these mAbs represent excellent therapeutic candidates for treatment of SEB-induced disease and lethality.

  • Gang Chen, Ph.D. - Senior Research Associate, Donnelly Center for Cellular & Biomedical Research, University of Toronto

9:45am 10:30am (45 mins)

Main agenda

Networking Refreshment Break in Exhibit & Poster Hall

10:30am 11:00am (30 mins)

Next Generation Protein Therapeutics Summit

The Benefits of Bispecific mAb² Antibodies Targeting EGFR and HGF

F-star’s Modular Antibody TechnologyTM platform introduces a novel antigen binding site into the constant (Fc) region of an antibody to create a so-called FcabTM (an Fc-domain with antigen binding activity). The resulting Fcab is then combined with variable region (Fab) of an existing antibody to generate a full-length bispecific antibody or mAb2TM. Here we show how Fcabs targeting Epidermal Growth Factor Receptor (EGFR) are utilised to generate mAb2 molecules that bind specifically EGFR and Hepatocyte Growth Factor (HGF). The EGFR/HGF bispecifics inhibit cell proliferation in vitro and show anti-tumour activity in patient derived xenograft (PDX) models in vivo. The mAb2 molecules show superior inhibition of tumour growth compared to combination treatments in tumours with specific molecular profiles suggesting novel biology of the bispecific.

  • Francisca Wollerton, Ph.D. - Principal Scientist, Discovery, F-Star Biotechnology Ltd.

11:00am 11:30am (30 mins)

Next Generation Protein Therapeutics Summit

Humabody® Therapeutics: Optimal Target Engagement by Multifunctional Immune Modulators Delivers Highly Differential Efficacy

Crescendo is developing a pipeline of novel multi-functional immuno-modulatory Humabody® therapeutics demonstrating excitingly differentiated efficacy compared with clinical mAbs. Crescendo can rapidly assemble small, robust Humabody® building blocks into an almost limitless number of mono- and multispecific configurations. Optimally configured Humabody formats engage therapeutically valuable targets in a way that is different from whole antibodies, unlocking novel modes of action and synergies in the IO space.

  • Carolyn Edwards, Ph.D. - Senior Scientist, Crescendo Biologics

11:30am 12:00pm (30 mins)

Next Generation Protein Therapeutics Summit

Bispecific IgM for a CD20 x CD3 antibody with increased potency and safety Bruce Keyt, Ph.D., CSO, IGM Biosciences

  • Bruce Keyt, Ph.D. - Chief Scientific Officer, IGM Biosciences

10:30am 11:00am (30 mins)

Bioconjugates: From Targets to Therapeutics

Stable, Versatile Conjugation Chemistries for Modifying Aldehyde-Containing Biomolecules

The need for new bioconjugation tools continues to grow as researchers seek next-generation methods that enable selective, rapid ligations that proceed under mild conditions and yield stable products. One attractive means to this end is via the introduction of aldehydes into biomolecules followed by reaction with carbonyl-selective nucleophiles. The site-specific introduction of an aldehyde group to any position in a protein has been dubbed the “aldehyde tag” or SMARTagTM technology. Once installed, the aldehyde can be reacted with a variety of nucleophiles. These chemistries will be presented and various applications of the resulting bioconjugates, including ADCs, will be highlighted.

  • David Rabuka, Ph.D. - Global Head of Research and Development, Chemical Biology, Catalent Biologics

11:00am 11:30am (30 mins)

Bioconjugates: From Targets to Therapeutics

Expressed Protein Ligation as Bioconjugation Platform

Expressed protein ligation uses self-splicing inteins to enable the production of site-specific protein conjugates. While widely used in research settings, less effort has been invested in developing an intein platform suitable for manufacturing of bioconjugate pharmaceuticals. We will present progress in engineering intein constructs to improve the expression and stability of the resulting proteins, with the goal of making commercial use of this technology feasible.

  • Alex Jacobitz, Ph.D. - Postdoctoral Fellow, Synthetic and Hybrid Technologies, Amgen

11:30am 12:00pm (30 mins)

Bioconjugates: From Targets to Therapeutics

Harnessing a Catalytic Lysine Residue for the Rapid, One-Step Preparation of Homogenous Antibody-Drug Conjugates

Here we present a novel strategy to produce site-specific antibody-drug conjugates (ADCs) using a highly reactive buried lysine residue embedded in a dual variable domain (DVD) format. This approach is mutation free, proceeds rapidly at neutral pH, and can be precisely monitored using a catalytic assay. Highly potent ADCs targeting HER2, CD138, and CD79B were prepared using this approach.

  • Alex Nanna - Graduate Student, Chemistry and Immunology, The Scripps Research Institute

12:00pm 12:30pm (30 mins)

Bioconjugates: From Targets to Therapeutics

Use of Engineered Ligases to Couple Peptides and Peptide-linked Entities to Other Peptides and Proteins

Engineered ligases derived from subtilisin are highly effective in coupling peptides to the N-terminal of other peptides and proteins. Using this chemo-enzymatic peptide synthesis (CEPS) technology, it is possible to couple several peptide fragments together, including those with unusual amino acids, to create synthetic proteins, or to enzymatically ligate such fragments or peptide-linked tags to recombinantly expressed proteins (REPEL).

  • Rodney Lax, Ph.D. - Business Development Consultant, EnzyPep B.V.

12:30pm 1:40pm (70 mins)

Main agenda

Luncheon in Exhibit & Poster Hall

1:40pm 1:45pm (5 mins)

Next Generation Protein Therapeutics Summit

Chairperson’s Remarks

  • Dragan Grabulovski, Ph.D. - CEO and Founder, Grabulovski Consulting Services

1:40pm 1:45pm (5 mins)

Bioconjugates: From Targets to Therapeutics

Chairperson’s Remarks

  • Volker Schellenberger, Ph.D. - CEO and President, Discovery, Amunix

1:45pm 2:15pm (30 mins)

Next Generation Protein Therapeutics Summit

Antibody Engineering and Design for Anti-C5 Recycling Antibody SKY59

A pH-dependent antibody-binding property is known to be effective for longer effective period and reduced amount of therapeutic antibodies given to patients. Antibody engineering applied to generate an anti-C5 recycling antibody SKY59, which is currently being evaluated in a clinical study, will be shown in this talk.

  • Zenjiro Sampei, Ph.D. - Senior Research Scientist, Biologics Discovery Department, Chugai Pharmaceutical Co., Ltd.

2:15pm 2:45pm (30 mins)

Next Generation Protein Therapeutics Summit

DutaFabs: Design and Creation of Next Generation Dual Targeting Fabs

DutaFabs are fully human bispecific Fab molecules with two independent paratopes which can be mixed and matched as desired. Maturation of the binding sites to high affinities is possible in different contexts. The talk will introduce the DutaFab technology, the structural properties of the molecules as well as the process of their discovery and engineering.

  • Sebastian Fenn, Ph.D. - Senior Scientist, Large Molecule Research, Pharma Research & Early Development, Roche Innovation Center

2:45pm 3:15pm (30 mins)

Next Generation Protein Therapeutics Summit

Multi-Specific Antibody Formats for Targeted T-cell Activity

The introduction of multi-specific antibody formats has expanded the variety of strategies that engage immune effector cells for tumor lysis. However, many such approaches present significant challenges for lead optimization. Employing highly stable antibody fragments, we have assembled a toolbox of multi-specific molecular formats. We present several format choices for selective, T-cell-driven target-cell depletion including the MATCH, a modular antibody format, designed for maximal flexibility.

  • Sebastian Meyer, Ph.D. - Vice President, Protein Engineering & CMC, Numab Innovation AG

1:45pm 2:15pm (30 mins)

Bioconjugates: From Targets to Therapeutics

Safety Assessment of EDCs in Non-Human Primates

Today, all ADCs require internalization and drug release and thus are affected by slow activation and MDR1 resistance mechanisms. EDCs circumvent the internalization and release problems by targeting another required cell target the Na,K-ATPase. The important difference is that the Na,K-ATPase can be inhibited from the outside of the cell by using a fundamental strategy of life – local concentration. By using antibodies to CD20, CD38 and dysadherin - novel drug conjugates were developed that show strong and precise activities at levels that are safe to cynomolgus monkeys. These EDCs may allow new alternatives for patients dying or suffering from life changing diseases.

  • James Prudent, Ph.D. - CEO, Centrose

2:15pm 2:45pm (30 mins)

Bioconjugates: From Targets to Therapeutics

Conjugation of Targeting Ligands to Functionalized Polymeric Nanoparticles

  • Roger Pak, Ph.D. - Associate Research Fellow, BioTherapeutics Pharmaceutical R&D, Pfizer

2:45pm 3:15pm (30 mins)

Bioconjugates: From Targets to Therapeutics

Linker Optimization Leads to Better ADCs in Terms of In Vitro and In Vivo Outcome

Drug-linker plays important roles in efficacy, physicochemical property and pharmacokinetics of antibody drug conjugate. Here we report case studies in the impacts of drug-linkers on ADCs regarding the following aspects: (1) Site of conjugation on the stability of drug-linker stability and ADC; (2) Drug-linker hydrophobicity on ADC aggregation tendency; (3) Drug-linker design on ADC potency. The optimization of drug-linkers in these aspects resulted in potent ADCs with improved PK by using Ambrx site-specific conjugation technology.

  • Ying Sun, Ph.D. - Associate Director, R&D, Ambrx Inc.

3:15pm 4:00pm (45 mins)

Main agenda

Networking Refreshment Break in Exhibit & Poster Hall

4:00pm 4:30pm (30 mins)

Main agenda

Next Generation Protein Therapeutics for Treating Cancer

We use natural ligands and receptors as scaffolds for protein engineering to leverage their inherent biophysical and biochemical properties. I will present our recent data on therapeutic candidates engineered to possess high affinity and unique specificities for applications in oncology.

  • Jennifer Cochran, Ph.D. - Associate Professor, Bioengineering & Chemical Engineering, Stanford University

4:30pm 5:00pm (30 mins)

Main agenda

Assessing the CRISPR/Cas9 IP Landscape and the Implications of the USPTO Interference Proceeding

An up to date overview of the patent landscape of the foundational CRISPR/Cas9 IP in US, Europe and further afield following the recent ruling in the US patent interference, focusing on some of the key issues and lessons that can be learnt from these as well as the commercial implication. This talk will also provide tips on how both scientific accolades and patents can be achieved in a fast evolving field.

  • Catherine Coombes - Senior Patent Attorney, HGF Limited, United Kingdom

5:00pm 5:30pm (30 mins)

Main agenda

In vivo Genome Editing and Future Clinical Application

Targeted genome editing via engineered nucleases is revolutionizing biomedical research and holds tremendous potential for clinical applications. Despite rapid advances in the field, in vivo targeted transgene integration is still infeasible because current tools are inefficient, especially for non-dividing cells, which compose most adult tissues. I will talk about the latest in vivo genome editing technologies.

  • Keiichiro Suzuki - Ph.D., Senior Research Associate, Salk Institute

5:30pm 7:15pm (105 mins)

Main agenda

Cocktail Reception in the Exhibit & Poster Hall