Immuno-Oncology
e-Xchange
(a virtual meeting)

Clinical Development

Time

Titles and Bullets

Facilitator

8:30am – 9:00am

Opening Address & Keynote

9:05am – 10:05am

Patient selection strategies during early clinical development to accelerate R&D of immunotherapies

How to increase clinical benefit in an unselected patient population treatment of cancer patients with immune checkpoint inhibitors?
What patient selection strategies using biomarkers (e.g. PD-L1, MSIhigh) can be implemented early during clinical drug development to increase the response rate and possibly accelerated approval?
Can one identify patient subsets/tumor types using large datasets early during the drug development cycle that are more likely to respond to therapy?

Dirk Brockstedt

Senior Vice President, Biology
RAPT Therapeutics

Dirk Brockstedt is Senior Vice President of Biology and has more than 20 years of experience in the fields of immunology and oncology originating with his PhD from the University of Kiel and Stanford University. Dirk joined RAPT Therapeutics in January 2018, bringing a wealth of experience in immunology at all stages of discovery, translational and clinical development. He joined RAPT from Aduro Biotech, where he served as Executive Vice President of Research and Development. Prior to Aduro, Dirk held positions of increasing responsibility within the immunology department of Cerus Corporation and at Aventis in the immunotherapy and anti-angiogenesis groups. Dr. Brockstedt co-authored over 40 scientific papers and is a named inventor on seven issued patents and several pending applications.

10:10am – 10:40am

1-2-1 Meetings

10:45am – 11:45am

Early stage characterization of IO candidates: in vitro primary immune cells and beyond

Common use cases and applications
Recognized challenges and potential solutions or alternatives
Innovative platforms and how they’ve been used

Amin Osmani

Customer Solutions Manager
ImmunXperts (a Nexelis company)

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.

11:50am – 12:20pm

1-2-1 Meetings

12:20pm – 1:00pm

Lunch Break

1:00pm – 2:00pm

What are the best approaches in evaluating potential toxicity and determining safe FIH dose for IO therapies?

Relevance of in vivo tox models – Human vs animal: target expression levels and tissue distribution, TA affinity to a target * When is a surrogate molecule needed? – Immune system – healthy animals versus cancer patients *Safety related to the tumor lysis syndrome
Use of in vitro models
Starting dose selection for FIH studies: best approaches for different IO modalities

Elena Brin

Chief Scientific Officer & Co-Founder
Athae Bio

Elena Brin earned her Ph.D. in Pharmacology from Northwestern University in 2002. She studied tumor immune evasion, immune-modulatory properties of cytokines/ cytokine gene therapy at Canji, Inc. (Schering-Plough). Elena was part of the team that developed nadofaragene firadenovec which recently showed impressive phase III results in bladder cancer patients. She continued to work on cancer drug discovery at Maxim Pharmaceuticals (EpiCept), Ambrx, Pfizer and Polaris Pharmaceuticals leading teams and projects in targeted and Immuno-Oncology, contributing from an early discovery to an IND submission. Elena co-authored multiple peer-reviewed publications, presented at conferences and is a co-inventor on several patent applications. In August 2020, Elena co-founded Athae Bio, a biotechnology company that incorporates machine learning into drug discovery.

2:05pm – 2:35pm

1-2-1 Meetings

2:35pm – 3:05pm

1-2-1 Meetings

3:10pm – 4:10pm

Leveraging in vivo models for cancer immunotherapy profiling

Are current preclinical IO models lack predictive validity with limited value in translational oncology research?
Do we have sufficient understanding of the interactions between human immune cells and tumors to develop preclinical in vivo models to enhance the predictability of IO models for improved translation?
What criteria go into selecting the most suitable models for translational studies?

Chan Whiting

Senior Vice President R&D
Tempest Therapeutics

Chan Whiting, Ph.D. is the SVP of R&D at Tempest Therapeutics. Chan has over 15 years of leadership in drug development in areas of inflammation, infectious diseases, autoimmunity and oncology. Prior to Tempest, Chan was Director and Head of Immune Monitoring and Biomarker Development at Aduro Biotech where she established key partnerships and brought in cutting edge technologies to support clinical development. Other prior experiences include leading target identification and validation programs for systems biology companies including Entelos, Inc. and Ingenuity Systems (Qiagen).

Chan received a B.S. degree in Biochemistry and a Ph.D. in Biochemistry and Immunology from UCLA. She completed postdoctoral studies at Stanford University.

4:15pm – 4:45pm

Closing Keynote & Address

Genomics in Drug Discovery

Time

Titles and Bullets

Facilitator

8:30am – 9:00am

Opening Address & Keynote

9:05am – 10:05am

Identifying immunogenic targets in solid tumours

How to best identify antigenic and tumor specific target antigens presented as peptide HLA complex on the cell surface of solid tumors that are most widely shared among patients and across solid tumor indications?
How to identify the most promising TCRs or TCR mimic compounds with the potential to induce complete tumor regressions when administered to patients with solid tumors?
How do we select the most promising TCRs or TCR mimic compounds lacking cross-reactivities to antigens presented on normal tissues?
How can we develop diagnostics to identify cancer patients that are most likely to respond to TCR guided therapeutics?
How do we select for TCR or TCR mimic compounds that can overcome treatment resistance?

Hanspeter Gerber

Senior Vice President & Chief Scientific Officer
3T Biosciences

10:10am – 10:40am

1-2-1 Meetings

11:50am – 12:20pm

1-2-1 Meetings

12:20pm – 1:00pm

Lunch Break

1:00pm – 2:00pm

Developing allogeneic off-the-shelf T cell immunotherapies

What pre-clinical models are most useful in guiding development?
How to link product characteristics with product potency?
How to apply our understanding of immune biology to implement manufacturing processes that generate potent and efficacious cells?

James Trager

Chief Scientific Officer
Nkarta Therapeutics

James Trager joined Nkarta in 2016 and leads all new product discovery efforts. James is deeply versed in the development and application of cellular therapies for cancer. He previously served as Vice President of Research and Development at Dendreon, where he was responsible for product development, clinical immunology, analytical development, and process automation, supporting the late stage development of sipuleucel-T through clinical study, approval, and commercialization. Prior to Dendreon, James was a Senior Scientist at Geron, where he was part of the team that cloned human telomerase, and later established a Quality Control function to enable the manufacture and clinical development of a telomerase inhibitor.

James is a graduate of St. John’s College in Santa Fe New Mexico; and served as a Peace Corps volunteer in the Central African Republic. He received his doctorate in Molecular Biology and Biochemistry from the University of California at Berkeley, where he performed mechanistic studies on the src oncogene.

2:35pm – 3:05pm

1-2-1 Meetings

3:10pm – 3:40pm

1-2-1 Meetings

3:10pm – 4:10pm

T cell engagers versus CAR T cells: what is the best modality for T cell redirection?

How does the two modalities compare in terms of cost, availability, convenience, ability to control dosing, ability to re-dose over time?
Which approach has a better chance to overcome immunosuppressive tumor microenvironment?
Which approach has a better potential to increase the therapeutic window by decreasing toxicities, while maintaining or even increasing potency?

Kamal Puri

Chief Scientific Officer
OncoResponse

Kamal Puri has over 20 years of R&D experience in immunology, oncology, and neurobiology. Kamal joined OncoResponse from Celgene, where he led efforts for immunology discovery. Prior to Celgene, he was at Gilead and contributed to the approval of Zydelig™ for the treatment of hematological malignancies, and directed research efforts on multiple discovery projects in inflammation and Oncology. Prior to Gilead, Kamal was Head of Research at Calistoga Pharma, where he was responsible for a wide range of activities with success in advancing several drug candidates into clinical development for multiple indications. Kamal was trained with Timothy Springer at Harvard University.

4:15pm – 4:45pm

Closing Keynote & Address

Genomics in Drug Discovery

Time

Titles and Bullets

Facilitator

8:30am – 9:00am

Opening Address & Keynote

9:05am – 10:05am

Using tumor-targeting bispecific antibodies as next-generation immune cell engagers

How do the type of immune cell and receptor class you are targeting affect the choices you make regarding MOA, antibody format, and preferred affinities/avidity effects?
Does your choice of immune cell target affect preferred characteristics for a tumor target partner? (E.g. tumor antigen density, degree of non-tumor expression, sequence similarity across species)
How important is it for your immune cell engaging BsAb to have single agent efficacy? How does that affect your choice of immune cell target? (E.g. stimulatory vs. co-stimulatory receptors)
What are your preferred in vitro and in vivo models for assessing likely efficacy and toxicity in humans?

Shelley Force Aldred

Founder & Chief Executive Officer
Seismic Bio

Shelley Force Aldred is Founder and CEO of Seismic Bio. Prior to this, she served as VP for Preclinical Development at TeneoBio where she led the preclinical efforts creating a CD3xBCMA bispecific antibody, from product concept to IND-ready package. Shelley was formerly director of R&D for Active Motif following the acquisition of SwitchGear Genomics in 2013. In 2006, she co-founded SwitchGear Genomics and she served as its COO. Prior to founding SwitchGear Genomics, Shelley was a Scientific Director on Stanford’s ENCODE Project and received her Ph.D. from Stanford University.

10:10am – 10:40am

1-2-1 Meetings

11:50am – 12:20pm

1-2-1 Meetings

12:20pm – 1:00pm

Lunch Break

1:00pm – 2:00pm

Clinical Development topic Bispecific T cell engagers: Biomarkers of synthetic immunity

What biomarkers can be used to inform dose/schedule selection?
Are there biom arkers that are associated with efficacy vs. immune-mediated toxicity (CRS)?
What are determinants of T cell fitness?

Genevive Hernandez

Director, Clinical Biomarkers
IGM Bio

Genevive Hernandez is the Director and Head of Clinical Biomarkers at IGM Biosciences, a biotechnology company pioneering the use of novel engineered multivalent and multispecific therapeutics. She was previously at Genentech, where she was the Biomarker Lead for multiple trials in hematologic and solid tumor malignancies for atezolizumab (anti-PDL1 Ab) and mosunetuzumab (CD20xCD3 bispecific Ab). Genevive has over 20 years of experience in preclinical, translational, and clinical research encompassing vaccine development, cellular immunology, and immuno-oncology. Her passion is to develop immune-based therapies with transformative benefit.

2:05pm – 2:35pm

1-2-1 Meetings

2:35pm – 3:05pm

1-2-1 Meetings

3:10pm – 4:10pm

Development challenges associated with personalized neoantigen therapeutic cancer vaccines in solid tumors

What are best approaches to arrive at an algorithm to predict optimal antigens to target?
How to best administer the vaccince? Considerations around route of administration and drug delivery
How to assess the optimal dose given interpatient variability in immune responses and relationships to vaccine exposure
Regulatory considerations in the development of therapeutic cancer vaccines is still evolving and types of studies likely needed to support submission and approval of therapeutic cancer vaccines

Sandhya Girish

Vice President, Clinical Pharmacology
Gilead Sciences

Sandhya Girish has more than 20 years of pharmaceutical industry experience in the discovery, development and approval of large (monoclonal antibodies), small (signaling molecules) and novel (ADCs/bispecifics, vaccines) molecules.

Prior to Gilead Sciences, Sandhya has worked with Genentech, Novartis/Chiron and Genesoft Pharmaceuticals. She has also been a study director and a co-principal investigator at Stanford Research Institute (SRI) International for NIAID and NIEHS studies. Sandhya has received many awards and has contributed to scientific advances with more than 40 publications, review articles and book chapters. She obtained her M.S. and Ph.D. degrees from Northeastern University and Bachelors in Pharmacy and Masters in Pharmaceutical Sciences degrees from Hamdard College in Delhi, India.

4:15pm – 4:45pm

Closing Keynote & Address

Combination Therapies

Time

Titles and Bullets

Facilitator

8:30am – 9:00am

Opening Address & Keynote

9:05am – 10:05am

How to determine the contribution of single agents in Phase II immuno-oncology combinations

Drugs with and without monotherapy activity
The role of biomarkers
Balancing benefit vs toxicities

Michelle Kuhne

Director, Immuno-Oncology
Gilead Sciences

Michelle Kuhne is an immunologist with over 18 years of industry experience ranging from small biotech to large pharma. She started her career in immuno-oncology at Medarex when nivolumab/Opdivo was still in preclinical development. During her time at Medarex and then at Bristol-Myers Squibb, she successfully led the pre-clinical development of several human monoclonal antibodies from concept to drug candidate selection and first in human clinical trials. Currently she is director of Immuno-Oncology research at Gilead Sciences where she is building a portfolio of small and large molecule therapeutics for oncology.

10:10am – 10:40am

1-2-1 Meetings

11:50am – 12:20pm

1-2-1 Meetings

12:20pm – 1:00pm

Lunch Break

1:00pm – 2:00pm

Targeting Tregs within the tumor microenvironment

What are the benefits and challenges of targeting intratumoral Tregs?
What are the pros and cons of targeting intratumoral Tregs for depletion vs other strategies?
What combination strategies make sense for therapies that target intratumoral Tregs?

Erica Stone

Vice President Oncology
GigaGen

Erica Stone is an award-winning immunologist with expertise in T cell immunology, immuno-oncology and human immunology. At GigaGen Erica is the VP of Oncology. Prior to GigaGen she was an Assistant Professor in the Immunology, Microenvironment and Metastasis Program at The Wistar Institute Cancer Center where her independent laboratory focused on understanding the multiple mechanisms of action of first-generation immune checkpoint inhibitors, including anti-CTLA4, with the goal of identifying strategies to overcome resistance. Erica holds a B.S. in Biology summa cum laude from the University of New Hampshire and a Ph.D. in Biological Sciences from UC-San Diego.

2:05pm – 2:35pm

1-2-1 Meetings

2:35pm – 3:05pm

1-2-1 Meetings

3:10pm – 4:10pm

Managing bispecific combinations

What are different classes of bispecific antibodies, e.g. T-cell engagers, tumor-directed immunomodulators, dual immunomodulators, etc.?
Which strategy is best (for which indications, i.e. heme malignancies vs. solid tumors)?
What are the advantages/disadvantages of bispecifics?
How can we overcome the challenges with bispecifics, e.g. targets, efficacy, dosing, etc.?
What are promising combinations in clinical development?

Peter Ho

Vice President, Business Development
Nektar Therapeutics

Peter Ho is currently Vice President, Business Development at Nektar Therapeutics. Prior to this, he was Senior Director of Business Development at BeiGene focusing on evaluating and partnering immuno-oncology therapies. Prior to BeiGene, Peter held Business Development positions at Iovance, ImmunoCellular Therapeutics, and Allergan. He also has experience in finance working in the venture group at D.E. Shaw and as an equity research analyst on Wall Street covering major pharmaceutical companies. Peter has an MBA from UCLA Anderson and a PhD from UC San Diego.

4:15pm – 4:45pm

Closing Keynote & Address

Immuno-Oncology
e-Xchange
(a virtual meeting)

Clinical Development

Genomics in Drug Discovery

Genomics in Drug Discovery

Combination Therapies

Partners

© Copyright 2023 by Weblify & Webtec

Immuno-Oncology e-Xchange (a virtual meeting)

Clinical Development

Genomics in Drug Discovery

Genomics in Drug Discovery

Combination Therapies

Partners

Immuno-Oncology
e-Xchange
(a virtual meeting)