8:50 am Chair’s Opening Remarks
8:51 am
Highlighting Clinical Updates of Neoantigen-Targeted Vaccines & Cell Therapies & Utilising Lessons Learnt to Facilitate Future Clinical Progression
9:00 am Nous-209 Vaccine: From Cancer Treatment to Interception in Lynch Syndrome Patients
Synopsis
- Presenting NOUS-209, an off-the-shelf cancer vaccine encoding shared neoantigens across both sporadic and hereditary Microsatellite Instable (MSI) tumours
- Showing strong immunogenicity, breadth and durability of NOUS-209 induced immune response in patients with metastatic MSI tumours and Lynch Syndrome (LS) vaccinated patients
- Highlighting NOUS-209 Potential to ‘Intercept’ Cancer in Subjects with LS
9:30 am Phase 2 Study of AI-Designed Personalised Neoantigen Cancer Vaccine, EVX-01, in Combination With Pembrolizumab in Advanced Melanoma
Synopsis
- Discussing AI designed personalised peptide vaccines
- Understanding the phase 2 clinical testing
- Considering antigen specific T-cell responses and Biomarker analysis
10:00 am Personalised DNA Therapeutic Cancer Vaccines: Clinical Efficacy & Mechanism of Action
Synopsis
- Reviewing updated clinical efficacy data from patients treated with personalised DNA therapeutic cancer vaccines
- Considering the mechanism of action
- Discovering Immune correlation and biomarker analysis
10:30 am Morning Break & Speed Networking
Synopsis
This is your opportunity to connect with global neoantigen leaders, make meaningful industry connections and share learnings and ideas to drive the future of neoantigen therapy
Advancing the Identification & Selection of Immunogenic Neoantigens for Durable Immune Response & Disease Regression in Patients
11:30 am Development of Next-Generation Neoantigen Cancer Vaccine With a Functional Discovery Platform & APC-Targeted LNP System
Synopsis
- Overviewing the development of a neoantigen discovery platform that integrates an AI algorithm deeply investigating the characteristics of neoantigens with validated immunogenicity using tumour-specific T cells derived from autologous TILs and PBMCs
- Evaluating delivery via an APC-targeted LNP system, the neoantigen cancer vaccine induced robust antigen-specific T-cell responses and effectively controlled tumours in multiple mouse tumour models
- Discussing an investigator-initiated clinical trial is set to begin in China
12:00 pm Panel Discussion: Validating Immunogenicity of Neoantigens & Establishing a Consensus on Selecting Optimal Neoantigen Targets to Generate an Efficacious Immune Response
Synopsis
- Developing a robust, functional validation platform using effector T-cells to validate neoantigen immunogenicity and avoid systemic toxicity
- Establishing a consensus on the most appropriate tools and technologies for ranking and selecting the best neoantigens for targeting
- Characterising neoantigens and selecting an appropriate number for use in therapies to invoke immunogenicity in patients
1:15 pm Lunch Break & Networking
1:15 pm Afternoon Break & Poster Session
Synopsis
Take this opportunity to showcase your latest neoantigen data and innovations with your peers and understand the strategies of your fellow neoantigen experts.
Optimising Preclinical Development of Investigational Neoantigen Therapies for Streamlined Entry Into the Clinic & Accelerated Regulatory Approval
2:15 pm A Heterologous Prime-Boost Vaccination With a Peptide-Based Vaccine & Viral Vector Improves Antitumour Therapy in Preclinical Models. Maximise the Potential of In Vivo Studies to Validate a Platform Preclinically & Prepare for Regulatory Interactions
Synopsis
- Investigating regimen, combination and vaccine MoA supported by preclinical studies
- Harnessing preclinical models to study changes in the tumour microenvironment and T-cell function after vaccination
2:45 pm From the Discovery & Validation of Public Tumour-Specific Neoantigen Derived From the Dark Genome to a Clinical Trial in Uveal Melanoma: An Academic Perspective
Synopsis
- How to test immunogenicity: in healthy donors, in patients or in preclinical models? What level of preclinical validation?
- Refining early phase testing: vaccine alone or in association with immunomodulators? Which one? Which schedule?
- Discussing primary objectives: CD4 and CD8 responses instead of clinical response. Which methods? How to monitor the Treg response?
Rethinking Clinical Trial Design to Optimise Patient Selection, Administer Neoantigen Therapies in the Correct Setting & Appropriately Determine Clinical Success
4:15 pm Roundtable: Lessons on Clinical Design, Patient Selection & Measuring Efficacy From Clinical Stage Trials
Synopsis
- Designing clinical trials to meet regulatory approval with thoughtful protocol design, patient selection and management of toxicity
- Measuring and recording patient immune response and clinical efficacy
- Selecting measures of success, from levels of efficacy to tumour regression
4:45 pm Smart Design of Neoantigen Vaccine Clinical Development
Synopsis
- Selecting the cancer type, disease setting and patient subpopulation
- Determining dosing schedules, mode of administration and alignment with standard of care
- Deciding on endpoints of immune and clinical response to demonstrate improvements over standard of care
5:15 pm BNT221: A First-in-Human Trial With a Personalised, Autologous Neoantigen-Specific T Cell Therapy in Metastatic Melanoma
Synopsis
- Understanding BNT221 Mechanism and Study Design – A personalized, neoantigenspecific autologous T cell therapy tested in a dose-finding study for advanced melanoma refractory to immune checkpoint blockade and BRAF-targeted therapy
- Navigating Safety and Tolerability – Well tolerated across doses with no severe toxicities; no cytokine release syndrome or neurotoxicity observed. Optimal dose range identified for further studies
- Evaluating Clinical and Immune Response – Six patients achieved stable disease, with some tumor reduction; strong neoantigen-specific CD4+/CD8+ T cell responses detected in blood and tumor