Times shown are in EST

9:00 am Coffee & Networking

9:20 am Chairman’s Opening Remarks

Keynote Clinical Case Studies

9:30 am Now It Gets Real- Clinical Data in Advanced Cancer Patients Treated With an Individualized Neoantigen Vaccine

Synopsis

• Neoantigen-directed immunotherapy has been developed using high quality machine learning-enabled prediction of neoantigens plus viral vector-based delivery of select individualized neoantigens to patients with advanced solid tumors
• A phase 1/2 trial has been conducted in the US/Australia to assess safety, immunogenicity and efficacy of this approach
• Clinical data with up to a year of follow-up, with a focus on colorectal cancer, will be presented

10:00 am Treos’ Novel & Potentially Transformative Big Data Approach to Increasing the Effectiveness of Cancer Vaccines by Incorporating a Systematic Understanding of Antigen Targets & HLA Responses

Synopsis

• Treos’ approach to producing two families of off-the-shelf personalized cancer vaccines
• Clinical data supporting the utility of the Treos approach
• A systematic approach to creating the future of cancer vaccines

10:30 am Personalized Cancer Vaccine for Treating Patients With Advanced Hepatocellular Cancer

Synopsis

• GT-EPIC™ DNA plasmid product designed and manufactured for each patient based on their tumor specific neoantigens
• Discuss the interim clinical safety and efficacy data from the first 10 patients treated on study
• The use of immuno-monitoring to assess the potency of the personalized cancer vaccine and mechanism of action of the targeted neoantigens in the clinic.

11:00 am Industry Leader’s Fireside Chat

Synopsis

An executive panel discussion from the C-level leaders of the field to set the scene on neoantigen based therapy development.

11:30 am Morning Break & Group Networking

Reimagining Clinical Trial Design to Show True Efficacy of Neoantigen Therapy

12:00 pm Optimizing Patient Selection & Stratification to Improve Success in Clinical Trials

Synopsis

• What should the patient cohort selection look like to give best chance of success?
• Which clinical end points to be selected to assess anti-tumor efficacy?
• How can the late stage product manufacturing process look like for neoantigen programs?

12:30 pm Developing mab Therapies From Tumor Neoantigens

Synopsis

• Monoclonal abs from Tumor antigens were charactered for specificity and antitumor function
• Identity of neo-epitopes were characterized
• Antibody functions were characterized for clinical trial development

1:00 pm Drug product manufacturing for personalized medicines

Synopsis

Personalized neoantigen cancer immunotherapies present unique manufacturing challenges related to scale and automation. John will share key considerations for manufacturing individualized drug products, including:

  • Accelerating commercialization by scaling out using standardized technologies
  • Automating aseptic processing within closed systems
  • Creating a supporting ecosystem for filtration, container / closure and visual inspection

1:30 pm Lunch & Networking

Establishing an Adjuvant Approach for Greater Clinical Outcomes

Establishing an Adjuvant Approach for Greater Clinical Outcomes

2:00 pm The Adjuvant Part of Neoantigen Cancer Vaccines: No Clear Winner Has Yet Emerged

Synopsis

  • Exploring the use of a cell-based, allogeneic, immune primer for recruitment and activation of cross-presenting DCs
  • Harnessing skin-resident memory CD8+ T cells for adaptive immune responses

2:30 pm Overcoming Challenges for Effective Cancer Vaccine Therapy

Synopsis

  • Improving vaccine activity by combining with RNA encoded cytokines
  • Novel treatments to overcome immune escape via MHC I loss

3:00 pm Panel Discussion: Exploring the Bestin-Class Adjuvant to Improve Patient Response to Neoantigen Therapy

Synopsis

  • Discussing the best approach to turn the ‘cold tumor’ into a ‘hot tumor’.
  • Outlining the variety of neoadjuvant methods to prime immune responses to neoantigen vaccination
  • Exploring the potential of a mRNA adjuvant if an mRNA vaccine platform is used for neoantigen delivery

Addressing Manufacturing Challenges to Decrease Process & Release Times for Neoantigen Therapeutic Development

2:00 pm Optimizing Release Testing for Faster Turnaround Time to Patients In Critical Need

Synopsis

  • Novel and innovative methods to ensure release of safe products in a faster manner
  • Implementation of quality controls assays at each scale up step
  • Developing more flexible, risk based approach to release testing to allow for conditional release

2:30 pm Panel Discussion: Examining the Impact of the Pandemic on Global Supply Chain to Gain Insight Into Next Strategy Steps

Synopsis

  • Discussing strategy for producing cancer vaccines on an industrial scale under GMP conditions
  • Exploring how companies have handled the low availability of raw materials (DNA vectors/ viral vectors) due to priority of Covid-19 for manufacturers
  • Assessing the best strategy to deal with the logistical manufacturing issues that have arisen due to the pandemic
  • Providing insight into different bio-manufacturing timelines, clinical readiness and capacity post-pandemic

3:00 pm Roundtable Discussion: Prioritizing Diversity, Equity & Inclusion in the Neoantigen Field

3:30 pm Afternoon Break

Looking Outside of Oncology: Examining the Use of Vaccine Platforms in Infectious Disease & Beyond

4:00 pm PeptiVAX, a Vaccine Platform for Flexibly Targeting New & Emerging Infectious Disease

Synopsis

• PeptiVAX is a platform based on peptide antigen coating of nonreplicating adenovirus for delivery of peptide vaccination in infectious diseases.
• Costly and time-consuming genetic engineering of new vaccines to emerging infectious diseases is not required
• A pancoronavirus vaccine strategy targeting existing and emerging strains of coronavirus utilizing novel antigens will be described

4:30 pm Targeting Antigens to Antigen Presenting Cells To Create More Efficacious Vaccines

Synopsis

• Vaccibody’s 3 modular format optimized for induction of rapid, strong and broad immune responses
• Targeting neoantigens to chemokine receptors on APC for induction of strong and broad CD8 T cell responses
• Combinations and applicability within personalized and off-the shelf cancer vaccines and beyond

5:00 pm Chairman’s Closing Remarks

5:15 pm Close of Summit