Conference Day Two
Thursday, November 20
8:00 am Morning Coffee & Registration
8:55 am Chair’s Opening Remarks
Deconstructing the Immune Response to Personalized Cancer Vaccines to Define, Predict, & Measure the Immune Signals That Drive Durable Response
9:00 am Decoding Immune Mechanism of Action to Strengthen Biomarker Strategy & Improve Clinical Translation of Personalized Cancer Vaccines
Synopsis
• Leveraging immune profiling in early clinical trials to understand mechanism of action beyond binary vaccine response
• Evaluating epitope spreading as a mechanistic biomarker of therapeutic effect and long-term tumor control
• Designing immune monitoring strategies that integrate metabolic profiling and antigen-presenting cell functionality to capture deeper biological insight
9:30 am Enhancing T Cell Immunogenicity With Self-Amplifying RNA: Lessons from Arcturus’ Next-Gen Platform Development
Synopsis
• How to leverage self-amplifying RNA (saRNA) to increase antigen expression and prolong immune stimulation – and why this matters for robust T cell priming in cancer vaccines
• Comparative insights on saRNA vs. conventional mRNA for driving cellular immune responses, and where each platform may hold distinct clinical advantages
• Considerations for integrating saRNA into individualized vaccine workflows, including formulation, dosing strategy, and patient variability
10:00 am Session Reserved for 4basebio
10:30 am Reframing Immune Design Beyond CD8+: Lessons from CD4+ T Cell Activation & Class II Antigen Presentation for Durable Tumor Control
Synopsis
• Evaluating tumor immune evasion via MHC-I downregulation and the implications for CD8+-centric PCV strategies
• Exploring novel methods to activate cytotoxic CD4+ T cells and target class II antigens to circumvent resistance and expand vaccine applicability beyond melanoma
• Applying foundational immunology and cell therapy insights to future-proof neoantigen vaccine design across solid tumors
• Framing CD4+-based responses not as an alternative, but as a complementary and underleveraged mechanism to broaden durable clinical benefit
11:00 am Morning Break
Redesigning Clinical Trials to Translate Immune Response for Breaking Through Phase II & Enabling Late-Stage Success for PCVs
11:30 am Accelerating V940: A Strategic Blueprint for Translational to Late-Stage Clinical Development of Personalized Cancer Vaccines
Synopsis
• Integrating tumor profiling, neoantigen prediction, and manufacturing timelines to enable rapid patient-specific vaccine deployment
• Designing robust clinical trials to inform pivotal strategy: from patient selection to combination approaches
12:00 pm Clinical Translation of a viral-based Individualized Cancer Vaccine – Insights from the TG4050 Program to guide future development of Personalized Immunotherapies
Synopsis
• Presenting updated phase I translational data from TG4050, an individualized neoantigen therapeutic vaccine developed for solid tumors based on Transgene’s myvac technology and powered by NEC’s artificial intelligence (AI) expertise
• Profiling of the neoantigen-specific T cell response after adjuvant TG4050 vaccination in a randomized phase I trial for locally advanced resected HPV-negative HNSCC
12:30 pm A Phase Ia Study to Assess the Safety, Tolerability & Immunogenicity of a Personalized Cancer Vaccine (InnoPCV/INV002) in Patients With Advanced Solid Tumors
Synopsis
• Overview of Innovac’s approach to optimizing every step of the PCV value chain
• Current regulatory environment for mRNA/LNP personalized cancer vaccine entering Phase 1 clinical trials
• INV002 human safety and tolerability results INV002 neoantigen-specific T cell induction and patient biomarker results
1:00 pm Session Reserved for Almac
1:30 pm Lunch Break
De-Risking Per-Patient Economics & Investment for Personalized Cancer Vaccines to Secure Phase III-Ready Capital & Accelerate Market Entry
2:30 pm From Advocacy to Acceleration: Real-World Levers to De-Risk Development & Expand Access to Personalized Cancer Vaccines
Synopsis
• Lessons from leading a first-in-human personalized cancer vaccine trial – including key design pivots, unforeseen barriers, and how real-world constraints shaped strategic decision-making
• Strategies to improve patient access in early trials, including compassionate use and advocacy-led engagement to increase awareness and enrollment
• How coalition-led advocacy is reshaping the investment narrative by aligning patient need, early clinical wins, and regulatory flexibility
3:00 pm Health Economics, IP & Early Access: Navigating Legal Grey Zones in the Race to Personalized Cancer Vaccines
Synopsis
• How emerging legal frameworks like Montana’s Right To Try expansion could impact patient access to unapproved personalized vaccines – and what that means for regulatory strategy
• Balancing IP protection vs. platform flexibility in an era where proprietary algorithms, tumor-specific libraries and bioinformatic tools are central to value creation
• The role of patent exclusivity, trade secrets, and data protection in enabling commercial viability for PCVs – especially when facing fragmented regulatory landscapes
3:30 pm Between Approval & Execution: Early-Stage Innovation, Investment Strategy & the Future of Cancer Vaccines
Synopsis
• Understanding the unique funding challenges faced by early-stage biotech developing personalized cancer vaccines to safeguard investment success
• How to position platforms and pipelines to appeal to strategic investors and VC groups amid capital scarcity
4:00 pm Afternoon Break
Building the Regulatory Blueprint for Personalized Cancer Vaccines Across Modalities, Indications, & Regions
4:30 pm Cancer Vaccines: What Will It Take to Get Across the Regulatory Finish Line?
Synopsis
• How to map high-risk regulatory friction points across QC, automation, patient consent and biopsy logistics
• How to document control strategies and decision rationales that hold up under agency scrutiny
• How to engage regulators on batch-specific vs platform-level controls, and when to request Type C/scientific advice meetings
5:00 pm Leveraging Regulatory Momentum to Accelerate the Path to Approval for Personalized Cancer Vaccines
Synopsis
• Strategically pursuing designations like Breakthrough Therapy or ISTs to validate early clinical signals, gain FDA partnership, and build external confidence in your platform’s viability
• Using regulatory milestones to strengthen investor narratives by showcasing derisked development timelines, alignment with FDA expectations, and faster routes to market
• Designing early trials with regulatory engagement in mind, including endpoint justification, biomarker integration, and data packages that support designation eligibility and smooth progression to pivotal trial