Immuno-Oncology Xchange Seaport World Trade Center Boston

Immune Biomarkers

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Current Challenges in Immuno-Oncology Drug Development

Jeffrey Evelhoch, Vice President, Head of Translational Biomarkers, Merck

9:05am – 10:05am

Exploring non-invasive ways to predict and monitor patient responses to anti-PD1 therapy

What non-invasive approaches to monitor responses have the greatest potential now and in 3-5 years?
What non-invasive ways to predict patient responses have the greatest potential now and in 3-5 years?
What is needed to accelerate the development of high potential non-invasive assays?

Jeffrey Evelhoch

Vice President, Head of Translational Biomarkers
Merck

Jeffrey Evelhoch is responsible for development and qualification of novel biomarkers, use of biomarkers to inform pipeline decisions and the development and deployment of companion diagnostics at Merck. He joined Merck Research Laboratories in 2008 as Vice President of Imaging and was named Vice President of Translational Biomarkers in 2015. He joined Merck after four years at Amgen, following 2 years at Pfizer/Pharmacia. Prior to joining the biopharmaceutical industry, Jeffrey was on the faculty of Wayne State University for 18 years, where he was Professor of Internal Medicine, Cancer Biology and Radiology.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Developing predictive biomarkers for immune checkpoints

Practical clinical support for new therapeutic strategies (what can you realistically do in a late stage clinical trial and after)
Understanding immune phenotypes and how they affect patient response (what types of cells, and where, will get you the best response)
Supporting combination trials with biomarker data

Trevor Johnson

Chief Executive Officer
Flagship Biosciences

Trevor Johnson is co-founder and Chief Executive Officer of Flagship Biosciences. He has experience in executive management, software development, marketing, business development, and services operations for medical technology companies, specifically in image analysis and machine learning applications. He has been working with tissue and contextual biomarkers for over 15 years and is focused on creating more accurate and informative data for researchers and clinicians.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Circulating tumor biomarkers – where are we and where we going?

What is the potential of circulating tumor biomarkers in immune-oncology? Could they be disruptive?
Exosomes – why the excitement?
Circulating tumor cells – obsolete or useful?
ctDNA – what are the most promising approaches?
What about other approaches such as microRNA?
How can we best accelerate meaningful progress in realizing the potential of circulating tumor biomarkers?

Kevin Horgan

Chief Medical Officer & Executive Vice President
Seres Therapeutics

Kevin Horgan graduated in medicine from University College Cork in 1982. He completed postgraduate medical training at the Johns Hopkins Hospital in Baltimore, MD, the National Cancer Institute in Bethesda, MD, and UCLA in internal medicine, immunology and gastroenterology. At Merck Research Laboratories, he led the development of Emend® for the prevention of nausea and vomiting associated with cancer chemotherapy. Most recently he led the development of combination immunotherapies in oncology at Astra Zeneca, prior to joining Seres as Chief Medical Officer in October 2018.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session: Analysis of companion diagnostic potentials for multifaceted PD-L1 assays – Flagship Biosciences

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

Evaluating biomarkers for treatment selection and monitoring

How is immunogenomics driving precision oncology in immunotherapy?
How to identify the best biomarker candidates and how to implement them in the clinic?
What technologies/platforms will be best for pre-clinical R&D vs. clinical biomarker applications?
How do we identify the best combinations and patients who can benefit from them? (for e.g. combining target therapy with immunotherapy)

Tooba Cheema

Senior Principal Scientist
ABclonal

Li Hui has a decade of experience in leading antibody discovery and development projects that target key signaling pathways in cancer cell biology, metabolism, immunology and neurodegenerative diseases. Currently she leads efforts to optimize rabbit monoclonal antibody discovery technology at ABclonal for large scale and efficient development of both customized and catalog monoclonal antibody products.

5:15pm – 5:45pm

Closing Keynote & Address

The Gastrointestinal Microbiome and Immuno-Oncology: Emerging Themes

Kevin Horgan, Chief Medical Officer & Executive Vice President, Seres Therapeutics

5:45pm

Canape/Drinks Reception

Translational Research

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Current Challenges in Immuno-Oncology Drug Development

Jeffrey Evelhoch, Vice President, Head of Translational Biomarkers, Merck

9:05am – 10:05am

Using mouse models to develop strategies for clinical translation of optimal combinations

Clinical relevance of currently existing mouse models: Syngeneic, humanized and GEMM models
Rationally designed vs empirical combination studies in mouse models: design and analyses
PD Biomarkers, mouse to man

Sangeetha Palakurthi

Vice President In Vivo Pharmacology
Elstar Therapeutics

Sangeetha Palakurthi is the VP, In Vivo Pharmacology at Elstar Therapeutics, with a mission to generate antibody-based, multi-functional therapeutics, of relevance in Cancer Immunotherapy. She has extensive oncology drug discovery and non- clinical development experience both within pharmaceutical and academic settings. Most recently, she served as the head of the Cancer Biology and Pharmacology team at the Belfer Center for Applied Cancer Science at the Dana-Farber Cancer Institute. Her responsibilities there included design and execution of a portfolio of industry and academic investigator sponsored translational pharmacology projects of targeted agents and immunotherapies to enable better clinical trial design decisions. Prior to that, Sangeetha led and supported oncology drug discovery programs from target identification to candidate drug nomination at AstraZeneca. Her research included design of strategies and execution of rationale-driven “proof of concept” studies to guide translation of right drugs to the right patients. Sangeetha received her Ph.D. in Biochemistry from the Osmania University in India and worked as a Scientist at Dr. Reddy’s Laboratories prior to her postdoctoral fellowship at Harvard Medical School.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Benchmarking immuno-oncology leads through in-vitro cell-based assays

Why are early in vitro assays becoming important?
Which types of assays have been the most reliable?
What are some common challenges and how can they be overcome?

Amin Osmani

Business Development Manager
ImmunXperts

Amin holds a Bachelor of Science degree in Biology from McGill University, a Graduate Diploma in Biotechnology & Genomics, and a Master of Science degree in Cell & Molecular Biology both from Concordia University.

Early in his career, Amin worked on the cell cycle genetics of the fungal pathogen Candida albicans, characterizing the role a protein plays in modulating response to the environment. His passion for entrepreneurship led him to a business development role in the personalized medicine field before joining the contract research industry to help bring safe and effective medical innovations to patients.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session – Case Study: Assessing the therapeutic potential immuno-oncology candidates in vitro – ImmunXperts

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

5:15pm – 5:45pm

Closing Keynote & Address

The Gastrointestinal Microbiome and Immuno-Oncology: Emerging Themes

Kevin Horgan, Chief Medical Officer & Executive Vice President, Seres Therapeutics

5:45pm

Canape/Drinks Reception

Targeted Immunotherapies

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Current Challenges in Immuno-Oncology Drug Development

Jeffrey Evelhoch, Vice President, Head of Translational Biomarkers, Merck

9:05am – 10:05am

Designing trials to explore immunotherapy combinations

Which endpoints can provide Proof of Concept and predict clinical benefit?
How are pharmacodynamics biomarkers useful to establish activity of combinations?
What are the pros/cons of using a single-arm study vs. a trial with a control arm?
How can trials be used to generate or test patient selection hypotheses?
What are the pros/cons of testing patients who are checkpoint-inhibitor (CPI) naïve vs. patients who received prior CPI?

Joanne Lager

Chief Medical Officer
Iteos Therapeutics

Joanne (Jo) Lager received her Bachelor of Arts in Psychobiology from Wellesley College and her Medical Doctorate from Duke University School of Medicine. She completed her medical residency in Pediatrics at the University of North Carolina – Chapel Hill and her fellowship in Pediatric Hematology/Oncology at Duke University School of Medicine. She studied Clinical Trial Design and Biostatistics at the Duke Clinical Research Institute while completing a fellowship in Oncology Drug Development that was jointly sponsored by Duke University and GlaxoSmithKline.

After working in the Pediatric Blood and Marrow Transplant Program at Duke University Hospital, Jo joined the Oncology Clinical Pharmacology and Discovery Medicine group at GlaxoSmithKline where she led the early and full development of several novel drugs and was responsible for Clinical Pharmacology, Early Development and Pediatric Development of Votrient (pazopanib). In 2009, she moved to join the Global Oncology Division at Sanofi, where she was the Project Head for PI3K inhibitors then, in 2014, became the Head of Global Oncology Development overseeing the entire Oncology portfolio from preclinical development through post-marketing commitments and life-cycle management, including the approval of Libtayo for the treatment of cutaneous squamous cell carcinoma. Jo recently left Sanofi to join Iteos Therapeutics as Chief Medical Officer to work on novel cancer immunotherapies.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Translational Research topic: Selecting combination strategies in the face of complex biology and heterogeneous populations

How to discover and select meaningful biomarkers to inform combination strategies?
Learning from previous clinical studies to direct future combination trials (“from the bench to the bedside and back to the bench”)
How do we gain confidence in clinical success of a particular combination from translational models?

Stefan Jellbauer

Technical Liaison, Biopharma Business Development
Mitra Biotech

Stefan Jellbauer is the Technical Liaison for Translational Applications and works with clients to craft custom solutions for their drug development needs. He supports the Biopharma Business Development side of Mitra Biotech. After 10 years in academic research he joined Affymetrix/eBioscience, where he worked in the roles of Field Application Scientist and Technical Sales Specialist with Affymetrix and Thermo Fisher Scientific. He joined Mitra Biotech in May 2018.

Stefan received his Ph.D in Biology from Ludwig-Maximilians University in Munich (Germany), focusing on tumor vaccination. He completed his post-doctoral work at University of California, Irvine studying mucosal immunology and host-pathogen interactions.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Challenges of first-in-human Phase I dose-escalating trials in patients with advanced cancers

Enrolling the right patient population (e.g., crowded competitive landscape, cross-over effect from prior therapies; short life-expectancy at enrollment for testing immunotherapies, etc.)
Defining the best dose-finding strategy for immunotherapies (e.g., 3 #3 design vs. novel designs, characterization of chronic toxicity, modeling & simulation in late-phase studies, etc.)
Increasing complexity of biosafety and regulatory requirements at the sites and agencies

Andres Gutierrez

Executive Vice President & Chief Medical Officer
Advaxis

Andres Gutierrez is the Executive Vice President and Chief Medical Officer for Advaxis, where he leads efforts to advance a broad portfolio of new Lm-based immunotherapies to patients with solid tumors. He has guided Advaxis’ first patient-specific and cancer-specific neoantigen vaccines into the clinic, ADXS-NEO and ADXS-503, respectively. Prior to Advaxis, Andres has led pioneering work and landmark clinical studies for carfilzomib, talazoparib, an anti-LAG3 antibody and other IO agents.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session (Translational Research topic): Translational efficacy of oncolytic HSV-1 in glioblastoma multiforme (GBM) using a human autologous ex vivo platform, CANscript™ – Mitra Biotech

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

Evaluating efficacy using clinical trial endpoints

Surrogate endpoints: when to use well-established surrogate endpoints, and when endpoints that reflect patient benefit?

The importance of clinical trial design and clinical setting: pivotal study vs. confirmatory study?

Phase 2 Studies: to randomized or not? that is the question!
Master protocols: all comers? Tissue/site-agnostic indication? other enriched clinical designs?
Multiple primary endpoint: when to consider, why?
Predictive biomarkers: what is bottom-up approach?

Alejandro Ricart

Senior Principal Scientist
ABclonal

5:15pm – 5:45pm

Closing Keynote & Address

The Gastrointestinal Microbiome and Immuno-Oncology: Emerging Themes

Kevin Horgan, Chief Medical Officer & Executive Vice President, Seres Therapeutics

5:45pm

Canape/Drinks Reception

Targeted Immunotherapies

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Current Challenges in Immuno-Oncology Drug Development

Jeffrey Evelhoch, Vice President, Head of Translational Biomarkers, Merck

9:05am – 10:05am

Cell-intrinsic and extrinsic strategies to overcome checkpoint blockade in cellular immunotherapy

PD-L1 and TMB: What do these measures tell us about immune response and resistance? And why?
TNFR pathway and influence on the ability to elicit an immune response after checkpoint blockade
Driver mutations and susceptibility to immune response
Compensatory mechanisms of immune resistance; are all checkpoints created equal?

Xingfeng Bao

Senior Director, Immuno-Oncology Research
H3 Biomedicine

Xingfeng Bao is a Sr. Director at H3biomedicine Inc where he heads the Immuno-Oncology Discovery and Pharmacology responsible for advancing preclinical cancer immunotherapy programs into early clinical development. He provides support for both small and large molecule programs and has led several drug discovery projects (e.g. EP4 antagonist and STING agonist ) at all stages of discovery and translational research in the area of immune-oncology and oncology. He received his doctorate in 2002 and completed his postdoctoral training in Tumor Microenvironment Biology and Immunobiology in Kobe, Japan and La Jolla, California before he joined the industry in 2011.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Translational Research topic: Relevance of current animal models for translational drug discovery in immuno-oncology

What are the advantages and limitations of syngeneic models
Utility of humanized models (PBMC engrafted versus CD34 HSC engrafted)
What are the next gen models for combination therapies: GEMMs
What is more important: efficacy or PD to move a drug discovery program forward?

Rajendra Kumari

Global Head, Scientific Communication
Crown Bioscience

After receiving her Ph.D from the University of Leicester in Molecular Pharmacology, Rajendra joined the Division of Pre-clinical Oncology, School of Clinical Sciences, University of Nottingham as a postdoctoral fellow. In 2005, Rajendra took the role of Project & Business Manager of the Preclinical Oncology Services (PRECOS) contract research business unit and lecturer/assistant professor in 2008. Rajendra’s expertise in cancer cell biology, model development, in vitro, in vivo, imaging capabilities and the commercialisation of the unit led to the spinout of PRECOS Ltd in 2010, acting as Chief Operations Officer, Board Director and co-founder. Following the merger with Crown Bioscience in 2013, Rajendra led Crown’s European site took as CSO & General Manager. In 2018, Rajendra became Global Head of Scientific Communications for Crown Inc.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Using mathematical modeling to generate hypotheses and de-risk decisions in R&D

What are the biggest challenges in I/O R&D where mathematical modeling could help?
What types of questions can we answer with the help of mathematical modeling?
Where is the biggest ROI for incorporating mathematical modeling into an I/O program?

John Burke

Co-Founder, President & Chief Executive Officer
Applied Biomath

John Burke received his PhD in Applied Mathematics from Arizona State University, and his BS and MS in Applied Mathematics from the University of Massachusetts, Lowell. Prior to co-founding Applied BioMath, John was at Boehringer Ingelheim as Associate Director, Head of Systems Biology and promoted to Senior Principal Scientist. John has also held positions at Merrimack Pharmaceuticals, the Systems Biology Department at Harvard Medical School, and in Douglas A. Lauffenburger’s lab at MIT.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session: Effect of immune cell depletion on the responses to PD-1 treatment in syngeneic models – Crown Bioscience

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

The next wave in IO: can synthetic agents replace or complement existing biologicals?

Can the development of synthetic agents address the limitations of biologics like dosing, toxicity and cost?
Can the development of synthetic agents address the limitations of biologics like dosing, toxicity and cost?
Can we develop small molecule inhibitors that truly replicate the activity of existing biological agents?
How can we exploit the different dosing and cost characteristics of peptides and small molecule?
Are oral alternatives to immune-oncology biologics possible?

Luca Rastelli

Senior Principal Scientist
ABclonal

5:15pm – 5:45pm

Closing Keynote & Address

The Gastrointestinal Microbiome and Immuno-Oncology: Emerging Themes

Kevin Horgan, Chief Medical Officer & Executive Vice President, Seres Therapeutics

5:45pm

Canape/Drinks Reception

Combination Therapies

Time

Titles and Bullets

Facilitator

8:00am – 8:30am

Registration

8:30am – 9:00am

Opening Address & Keynote

Current Challenges in Immuno-Oncology Drug Development

Jeffrey Evelhoch, Vice President, Head of Translational Biomarkers, Merck

9:05am – 10:05am

How to mitigate risk of late-stage failures

Is single agent activity needed for experimental agents to be added to anti-PD(L)1s?
Small positive randomized data set may de-risk new combinatorial approaches with assets w/o single agent activity?
Which other endpoints or strategies may help in early stage IO development to confirm a signal?

Dhiraj Gambhire

Senior Medical Director
Pfizer

Dhiraj Gambhire is Sr. Medical Director Immuno-oncology at Pfizer Inc, and is responsible for two platform studies evaluating immunotherapy combinations. The studies are evaluating multiple immunotherapy combinations to establish safety and proof of clinical activity.

He joined Pfizer in 2015 after six years of drug development experience at two previous organizations. At Boston Biomedical he worked with the lead compound BBI608 (A STAT3 targeting agent), phase 3 gastric cancer and phase 2 CRC studies. At Zydus Cadila Healthcare Ltd, in Mumbai, India, he managed various clinical trials, including the registrational trial for saroglitazar (PPAR agonist), next to work in oncology and inflammation.

He received his MD in internal medicine at Dr. Babasaheb Ambedkar Marathwada University (BAMU) in Aurangabad, India. Subsequently, he obtained his MPH (Biostatistics) at the University of Texas School of Public Health, Houston, TX.

10:10am – 10:40am

1-2-1 Meetings / Networking Break

10:40am – 10:50am

Morning Refreshments

10:50am – 11:50am

Translational Research topic: From sample to discovery: eliminating data silos and integrating research data to accelerate bio-marker discovery

How can the challenges of integrating sample phenotype data with sample genotypic information be overcome?
How do you identify where the samples are in your research workflows?
What strategies can be implemented to integrate sample location data with the sample analysis and quality data?
How do you address the difficulties of integrating the data and meta-data between wet lab and dry lab (analysis)?

Vasu Rangadass

President & Chief Executive Officer
L7 Informatics

Vasu Rangadass, PhD is the CEO at L7 Informatics, Inc. L7 provides software and services that enable synchronized solutions for science + health. Prior to L7 Informatics, Vasu was the Chief Strategy Officer at NantHealth following its acquisition of Net.Orange, the company he founded to provide an enterprise-wide platform – Clinical Operating System (cOS) to simplify and optimize care delivery processes in health systems. Vasu holds several patents in “Master Data Management” (MDM), Enterprise “Operating Systems”, and Workflow Management (as well as extensive process experience in the Life Sciences & Healthcare Industries.

11:55am – 12:25am

1-2-1 Meetings / Networking Break

12:30pm – 1:30pm

Selecting the best indication(s) and line of therapy to evaluate combinations

Rationale for selecting combinations
Toxicity management
Reversal of resistance to therapy

Ramon Mohanlal

Executive Vice President & Chief Medical Officer
BeyondSpring Pharmaceuticals

Ramon Mohanlal has more than 20 years of global experience in strategic drug development at big pharma, and biotech start-ups, including GlaxoWellcome (GSK), Pharmacia (Pfizer), Vertex, Interleukin Genetics, Syntium, Novartis, and AstraZeneca. His expertise includes drug development in all Phases (preclinical and 1, 2, 3, 4 clinical, post-marketing), regulatory filings and maintaining drugs on the market. Ramon played a crucial role in bringing five drugs to market and was deeply involved in the development of 15 marketed drugs. He also developed immuno-oncology development programs based on checkpoint inhibitor combination therapy at AstraZeneca. Ramon earned his M.D. and Ph.D. in Experimental CV Pharmacology, both from the University of Leiden, The Netherlands, as well as his M.B.A. from the American Intercontinental University in Illinois, with post-graduate business training at the MIT Sloan School of Management.

1:30pm – 2:30pm

Networking Lunch

2:30pm – 3:00pm

Poster Session (Clinical Trials topic): Data and workflow management for immuno-oncology clinical trials – L7 Informatics

3:00pm – 3:30pm

1-2-1 Meetings / Networking Break

3:30pm – 3:40pm

Afternoon Refreshments

3:40pm – 4:10pm

1-2-1 Meetings / Networking Break

4:15pm – 5:15pm

How to stand out in an increasingly crowded market developing agents against the same IO targets

What is the barrier to entry late entries on a target?
What are the strategies to differentiate for investors and partners?
Will the industry hit a limit of immuno-oncology targets?
How do you reap the benefit of class-wide positive outcomes?
How do you avoid letting a first in class bomb take you down?

Russell LaMontagne

President & Chief Executive Officer
Boston Immune Technologies & Therapeutics

Russell is the cofounder of Boston Immune Technologies and Therapeutics, Inc. (BITT) and has lead all aspects of growth including platform development and rounds of financing. Prior to BITT was President of Corinth Group and has been a senior advisor to biotechnology and pharmaceutical companies for over 20 years. He has played a predominant roll in the development of several early stage companies, and has advised numerous pharmaceutical companies regarding commercialization strategies.

5:15pm – 5:45pm

Closing Keynote & Address

The Gastrointestinal Microbiome and Immuno-Oncology: Emerging Themes

Kevin Horgan, Chief Medical Officer & Executive Vice President, Seres Therapeutics

5:45pm

Canape/Drinks Reception

Immuno-Oncology Xchange Seaport World Trade Center Boston

Immune Biomarkers

Translational Research

Targeted Immunotherapies

Targeted Immunotherapies

Combination Therapies

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