8:00 am Registration & Coffee

9:00 am Chair’s opening remarks

9:15 am Understanding Mechanisms of Immune Resistance in NSCLC Through Analysis of the T Cell Repertoire

  • Alexandre Reuben Assistant Professor, The University of Texas MD Anderson Cancer Center

9:45 am A CMO’s Approach to Supporting Personalized Peptide Vaccines

  • Trishul Shah Director of Business Development, PolyPeptide Group

10:15 am Identifying Functional Neo-antigens by HTS: the Unique, the Common, the Exotic

10:45 am Morning Refreshments & Networking

IDENTIFICATION & PREDICTION

CLINICAL TRANSLATION 

MANUFACTURING

Identifying Personalized and Shared Neoantigens to Accelerate Development of Cancer Immunotherapy

11.45 Vaccination Against Shared Neoantigens Induced in Recurrent & Future Tumors

• A common set of neoantigens are induced in disseminated tumor lesions by tumor targeted siRNA mediated inhibition of the peptide transporter TAP

• Vaccination against TAP downregulation induced neoantigens, by targeted inhibition of TAP in resident dendritic cells, inhibited tumor growth in transplantable and autochthonous murine tumor models that was superior to vaccination against mutation-derived neoantigens, and was devoid of measurable toxicity

• Vaccination against induced antigens using one or two broadly applicable chemically synthesized oligonucleotides will also benefit the majority of patients that do not express or express too few mutation-derived neoantigens

Eli Gilboa, Joe Enloe Dodson professor, Department of Microbiology & Immunology, Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami

Utilizing Different Delivery Platforms to Enhance Clinical

11.45 Viral Immunotherapy Meets AI Technology

• TG4050 is based on a decade long expertise in designing viral vectors

• Viral immunotherapy constitutes a promising modality harnessing the natural sensitivity of immune system to virus to target cancer cells

• Viruses can be modified to alter their immunogenic properties and enhance antitumour activity

• A review of how different viruses can be combined to enhance immunogenicity

Kaidre Bendjama, Project Leader, Personalised Cancer Vaccines, Transgene

Leveraging Partnerships to Achieve Commercial Viability of Neoantigen Based Therapies

11.45 Development & Production of a SharedNeoantigen Vaccine for a Canine Clinical Trial

• Identification of shared frameshift neoantigens that commonly occur in a number of canine cancers. which were used to design a preventative vaccine against these cancers for a large canine clinical trial

• The manufacturing of a heterologous vaccine consisting of a DNA vaccine prime followed by a pooled long peptide pool vaccine for boost

• This discussion will focus on the development of this vaccine and provide an update on the status of the clinical trial

Chris Diehnelt, Associate Research Professor, Arizona State University

12.15 Leveraging Novel TCR/Antigen Discovery Technologies for Personalized Neoantigen Targeted T cell therapy

• Extend the value of T cell-based immunotherapy to cancer types that currently do not benefit from these therapies

• We have developed TCR/antigen-identification technologies to support the development of immunotherapy for harder-to-treat cancers

• We are preparing a clinical trial on personalized TCR gene-modified cell therapy, using neoantigen-specific TCRs

Wouter Scheper, Senior postdoc, Haanen lab, Netherlands Cancer Institute

12.15 Tedopi: A Multiple Neo-epitope Cancer Vaccine in Late Clinical Developmen

• Tedopi is a ready-to-use multiple neoepitope peptides vaccines targeting tumor heterogeneity

• Strong immunogenicity and long-term survival observed in NSCLC phase 2

• Phase 3 Clinical Trial (ATALANTE-1) Update in NSCLC phase 3 in monotherapy after failure to previous immune checkpoint (PD-1/PD-L1).

Nicolas Poirier, Chief Scientific Officer, OSE Immuotherapeutics

12.15 Bringing Both Precision & Speed to Cancer Immunotherapy

• Importance of predicting accurately both Class I and Class II neo-epitopes

• Importance of predicting and removing both SelfLike inhibitory Treg neo-epitopes and Self-Like cross reactive neo-epitopes

• Importance of Time to Vaccinate and the necessity to design a biopsy-to-needle process under 4 weeks

Gad Berdugo, CEO & Co-Founder, EpiVax Oncology, Inc.

12:45 pm Lunch & Networking

Exploring Different Neoantigen Sources to Improve Prediction Accuracy

13.45 Achieving Greater Therapeutic Efficacy Utlizing Novel Neoantigen Targeted Therapies with Other Anti-Tumor Treatments

• Utilized an approach using a cancer vaccine with functionally immunogenic epitopes to produce neoantigen based monoclonal antibodies to target tumors

• Demonstrated immune and antitumor function of these monoclonal antibodies

• Preclinical data demonstrating synergy using these antibodies in combination with other anti-tumor treatments

Philip Arlen, President and CEO, Precision Biologics, Inc

Next Generation Cancer Immunotherapy: Neoantigen Targeted Cell Therapy

13.45 Targeting Neoantigens in Gliomas

• Identification of a HLA-A*0201-restricted, recurrent neoantigen epitope derived from Histone variant 3 (H3.3K27M) in diffuse midline gliomas, and conduction of vaccine trial targeting this epitope in these patients

• Cloning of a high avidity TCR for this epitope, with plans to conduct a TCR-transduced T cell therapy trial in these patients

• Evaluating the presence of neoantigens that are present across heterogeneous human gliomas

Hideho Okada, Kathleen M. Plant Distinguished Professor Director, Brain Tumor Immunotherapy Center in Neurological Surgery, University of California San Francisco Parker Institute for Cancer Immunotherapy

Leveraging Partnerships to Achieve Commercial Viability of Neoantigen Based Therapies

13.45 New Class of Antigen-Specific Cancer Active Immunotherapies Based on an Off-the-Shelf Antigen Presenting Cell line (PDC*line)

• PDC*line is a new potent and scalable therapeutic cancer vaccines based on a proprietary allogeneic cell line of Plasmacytoid Dendritic Cells

• PDC*line is much more potent to prime and boost antitumor antigen, including neoantigens, specific cytotoxic T-cells than conventional vaccines and improves the response to checkpoint inhibitors

• The technology can be applied for any cancer

Eric Halioua, President and CEO, PDC* Line Pharma

14.15 Enriching TIL Products for Neoantigen Reactivity & Maintaining Commercial Visibility

• Existing proof of concepts in solid tumors as the focus for executing and developing clinically relevant cell therapies

• T cells in the body recognize the tumor, Myst is isolating these cells to create a broad spectrum T cell therapeutic

• Using the patients own cells to prioritize neoantigens that are targeted

TJ Langer, CEO & President, Myst Therapeutics

14.15 Allogeneic Inflammatory Cells Indirectly Priming the Immune Response in the Patient’s Tumor Tissue

• Phase II data in RCC highlighting durable responses, complete responses and tail of the survival curve

• Ongoing Phase Ib combination study with checkpoint inhibitors in HNSCC, NSCLC and GA/GEJ

• Inflammatory cells producing chemokines and cytokines that recruit and activate patient’s immune cells and indirectly priming neoantigen-specific CD8+ T cell response

Sijme Zeilemaker, Chief Operating Officer, Immunicum

14.15 Addressing Challenges with Batch Consistency to Ensure Quality Control Between Patients

• How do you ensure consistency of cancer vaccines and cell therapy between patients when each product is different?

• In process and final product specifications

• Monitoring process performance

Marc Wolfgang, Vice President of Technical Operations, Neon Therapeutics

14:45 Afternoon Refreshments

15.15 Identification & Characterization of T cells Reactive to Dark Antigens

• Describe EDAPTTM transcriptomic/immunopeptidomic pipeline used to identify Dark AntigensTM

• Identification of Dark AntigenTM-reactive T cells

• Characterization of Dark AntigenTM-reactive T cell

Peter Mason, Head of Product Platform Science and Technology, Ervaxx Ltd

15.15 Overview of Neon’s Approach to the Development of a Personalized Neoantigen T Cell Therapy, NEO-PTC-01

• The recognition of neo-antigens on human cancer has strongly been connected to the clinical success of immune therapies

• Neon Therapeutics aims to generate neo-antigen specific T cell therapies that are tailored for each individual patient. Here we will present the platform, NEO-STIMTM that Neon has developed to generate such personal T cell therapies

• NEO-PTC-01, generated through NEO-STIM is a T cell product containing multiple CD8+ and CD4+ neoantigen specific T cell responses, that are highly functional and are capable of recognizing autologous tumor

• NEO-PTC-01 is planned to enter the clinic in the second half of 2020 as an adoptive cell therapy targeting multiple immunogenic neoantigens in patients with metastatic melanoma

Marit Van Buuren, Director T- Cell Immunology, Neon Therapeutics

15.15 Key Considerations & Strategies for Technical Development and Manufacturing of Personalized Neoantigen-based Cancer Vaccine and T-Cell Therapy

• Considerations for process design and specifications for a personalized neoantigen based vaccine and a personalized neoantigen based cell therapy.

• Approaches for dealing with human to human variability as well as process variability.

• Key manufacturing and supply chain considerations for delivering personalized drug product to the early phase clinical trials.

Narinder Singh, Senior Vice President, Pharmaceutical Sciences & Manufacturing, Genocea

15.45 Thousands of Novel Unannotated Proteins Expand the MHC I Immunopeptidome in Cancer

• Thousands of novel unannotated ORFs (nuORFs) revealed as translated by ribosome profiling across a range of cancer types

• Mass spectrometry analysis of the MHC I immunopeptidome identifies over 6,000 peptides from nuORFs

• Many nuORFs are translated in cancer-specific manner and can be sources of neoantigens

• NuORFs harbor cancer-specific

Tamara Ouspenskaia, Postdoctoral Fellow, Broad Institute

15.45 How to Design the Right Clinical Trial for a DNABased Neoantigen Platform

• Evaluation of options for clinical trial design

• How to define better clinical endpoints

• Considerations for in-house development and manufacturing vs outsourcing

Russell Pachynski, Assistant Professor, Division of Oncology; Faculty, Center for Human Immunology and Immunotherapy Centers (CHiiPs), Washington University School of Medicine

15.45 Panel Discussion: What are the Roadblocks in Release Assays?

• Do we need to change the standard release assays and adapt them for the personalized medicine field?

• How can this be achieved?

16:15 Chair’s Closing Remarks & End of Summit