Informa Life Sciences is part of the Knowledge and Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa
Key Sessions

Christopher Sheth

FDA Feedback: Regulatory Guidance and Expectations for Next Generation Protein Therapeutics and Bioconjugates

FDA

H. Kaspar Binz, Ph.D.

Next Generation Oncology Biologics

Molecular Partners AG

7:00am - 8:00am 60 mins
Breakfast & Registration
8:00am - 8:15am 15 mins
Chairperson’s Remarks
  • Martin Steegmaier, Ph.D. - Head of Discovery, Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Munich
8:15am - 8:45am 30 mins
Next Generation Protein Therapeutics Summit
FDA Feedback: Regulatory Guidance and Expectations for Next Generation Protein Therapeutics and Bioconjugates
  • Christopher Sheth - Supervisory Pharmacologist, Division of Hematology Oncology Toxicology, FDA
8:45am - 9:15am 30 mins
Info
Next Generation Protein Therapeutics Summit
Lessons Learned from the Clinical Development of ADCs: Moving Forward
  • Rakesh Dixit - Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune, Inc.

The ADCs as cancer therapeutics have gained significant momentum in last few years with over 60 ADCs in clinical development. While this is highly encouraging development, it is also noted that nearly 90% of ADC molecules have failed in clinical trials either due to high toxicities or very poor clinical activity. There is also high failure rate of ADCs in preclinical development as well. The presentation would review some common themes on failures and risk mitigation strategies to reduce the failure rate of ADCs and increase the clinical success.

9:15am - 9:45am 30 mins
Info
Next Generation Protein Therapeutics Summit
Next Generation Oncology Biologics
  • H. Kaspar Binz, Ph.D. - Vice President and Co-Founder, Molecular Partners AG

The requirements of multi-functional oncology treatment match perfectly well with the strengths of the designed ankyrin repeat protein platform. With the successful first systemic validation of the platform by the oncology candidate MP0250, a dual VEGF/HGF inhibitor, we now are enabled to walk new avenues for cancer treatment. I will highlight these avenues in my presentation using preclinical and the most recent clinical data on novel therapeutic concepts for clinical oncology.

9:45am - 10:30am 45 mins
Next Generation Protein Therapeutics Summit
Networking Refreshment Break
10:30am - 11:00am 30 mins
Info
Next Generation Protein Therapeutics Summit
Daiichi Sankyo ADC Technology and Updates on Preclinical and Clinical Development of DS ADC Pipeline
  • Takashi Kagari - Scientist; Biologics & Immuno-Oncology Laboratories, Daiichi Sankyo Co.,Ltd.

We developed a new ADC technology with the derivative of DX-8951 which is a novel DNA topoisomerase I inhibitor. Our ADC technology has seven unique features; novel payload, high potency, bystander effect, high clearance of the payload, stable linker, tumor selective cleavage, and high DAR. I will review this ‘smart chemo’ ADC technology and introduce some updates on ADC programs of Daiichi Sankyo.

11:00am - 11:30am 30 mins
Info
Next Generation Protein Therapeutics Summit
A Novel Multi-Specific Antibody Targeting PD-L1-Overexpressing Cancers That Redirects and Stimulates Antigen-Committed CD8+ T Cells Through Concomitant Engagement Of A T Cell Costimulatory Receptor
  • Sebastian Meyer - Chief Operating Officer, Numab Innovation AG

Targeting PD-L1-overexpressing cells with therapeutic antibodies is a clinically validated strategy for the treatment of multiple solid tumors. In order to increase efficacy, PD-1/PD-L1 blocking agents are currently being tested in combination with additional immune checkpoint modulators (ICMs). However, such combination therapies are associated with considerable treatment-related adverse events, resulting in a narrow therapeutic window and thereby limiting treatment efficacy. To maximize potency and improve the safety of ICM combination approaches, we designed a multi-specific molecule bearing two ICM domains that depletes PD-L1-overexpressing cancer cells via selective recruitment and stimulation of tumor-reactive effector T cells in the tumor microenvironment. The multi-specific antibody format potently blocks PD-L1/PD-1 signaling and elicits further T cell activation through its costimulatory domain solely in the presence of cells that overexpress PD-L1. In an HCC827 xenograft model in hPBMC-supplemented NOG mice, the tri-specific strongly slowed tumor growth and enhanced intratumoral CD8+ T cell activation to a greater extent than monospecific IgG variants of the anti-PD-L1 and anti-costimulatory receptor domains.

11:30am - 12:00pm 30 mins
Next Generation Protein Therapeutics Summit
A Phase I Study of PF-06647020, an Antibody-Drug Conjugate Targeting Protein Tyrosine Kinase 7 (PTK7), in Patients with Advanced Solid Tumors
  • Shilpa Alekar - Research and Development, Senior Director Global Clinical Lead, Immuno-Oncology, Pfizer Inc
12:00pm - 1:00pm 60 mins
Next Generation Protein Therapeutics Summit
Luncheon
1:00pm - 1:30pm 30 mins
Next Generation Protein Therapeutics Summit
Translation From Discovery To The Clinic Of Next Generation Protein Therapeutics And Bioconjugates
  • Gregory Adams - Chief Scientific Officer, Eleven Biotherapeutics
1:30pm - 2:00pm 30 mins
Info
Next Generation Protein Therapeutics Summit
Affimer Therapeutics: A Novel Human Scaffold for the Generation of Bi-Specific Antibodies
  • Amrik Basran - Chief Scientific Officer, Avacta Life Sciences

Affimer therapeutics are based on the human protein Stefin A, a small intracellular protease inhibitor. Using phage display we have generated highly selective Affimer binders to range of therapeutic targets. These molecules have then been fused to either the Fc domain or to a full antibody to create bispecific molecules that express and are able to engage both target antigens.

2:00pm - 2:15pm 15 mins
Next Generation Protein Therapeutics Summit
Networking Refreshment Break
2:15pm - 2:45pm 30 mins
Info
Next Generation Protein Therapeutics Summit
Fully Human, Heavy-Chain Antibodies Facilitate Rapid Development Of Multi-Specific Antibodies
  • Shelley Force Aldred - VP for Preclinical Development, TeneoBio

Teneobio’s discovery platform utilizes VH domains of fully human heavy chain antibodies (UniAbs) to develop bi-, tri-, and tetravalent antibodies. Binding domains of UniAbs are stable structures that can be easily put together into multi-specific antibodies. Clinical trials of Teneobio’s first tri-valent antibody will be initiated in 2018.

2:45pm - 3:15pm 30 mins
Info
Next Generation Protein Therapeutics Summit
Antibody Transport Vehicle: Delivering Biotherapeutics to the Brain
  • Adam Silverman - Group Leader Protein Engineering, Denali Therapeutics

The blood-brain barrier (BBB) limits exposure of large molecules to the central nervous system, but recent advances in utilizing natural BBB receptors to transport biotherapeutics into the brain have offered promise for treating neurological disorders. We describe the engineering and properties of the Antibody Transport Vehicle (ATV), a BBB-targeting engineered Fc platform that can deliver therapeutic concentrations of proteins into the brain.

3:15pm - 3:45pm 30 mins
Next Generation Protein Therapeutics Summit
Selecting Next Generation Protein Therapeutic Binders Against Difficult Targets
  • Shohei Koide - Professor of Biologics Design, NYU Langone Medical Center
3:45pm - 3:50pm 5 mins
End of Conference