Conference Day Two | Thursday, December 5

7:50 am Morning Coffee & Networking

8:50 am Chair’s Opening Remarks

  • Myriam Mendila Chief Scientific Officer & Head of Research & Development, CureVacSE

Supercharging the Development of Personalized Cancer Vaccines by Overcoming Regulatory Challenges in the Clinic to Achieve Market Approval

9:00 am Developing a Fully Individualized mRNA Cancer Immunotherapy: Regulatory Innovation & Challenges

  • Ruben Rizzi Senior Vice President - Global Regulatory Affairs, BioNTech AG

Synopsis

  • Lessons learned from the development of fully individualized mRNA immunotherapy across multiple tumor types
  • Key questions to identify the most appropriate development strategy
  • Navigating an evolving regulatory landscape and identifying the areas of uncertainty

9:30 am Panel Discussion:Examining the Route of Personalized Cancer Vaccines From a Range of Modalities Through the Clinic to Get Effective Therapies to Patients Faster

Synopsis

  • Uncovering how successful trials are in selecting patients and achieving clinical efficacy
  • Understanding the importance of durability and half-life of vaccines in patients for a swift journey through the clinic
  • Navigating the regulatory frameworks for personalized medicine to ensure success post-approval

10:15 am Morning Break & Networking

Unlocking Personalized Vaccine Development for Different Indications of Cancer to Induce an Immune Response to Shrink the Tumor

11:00 am Developing Personalized Cancer Vaccines for ‘Cold’ Tumors to Create a Successful Therapy

  • William Jia Chief Scientific Officer, Virogin Biotech

Synopsis

  • Turning cold tumors to hot by attracting immune cell infiltration and cytokine release with intratumorally infected oncolytic viruses
  • Inducing tumor cell lysis to release the entire neoantigens of the tumor as personalized intratumor vaccination to broaden tumor specific T-cell repertoire.
  • Employing a prime-boost strategy with tumor vaccine as a prime and intra-tumoral infection with oncolytic virus as a boost to enhance anti-tumor immunity

11:30 am Overcoming the Challenges in Targeting Low Tumor Mutational Burden Cancers for Improved Therapies

Synopsis

  • Utilizing neoantigen personalized vaccines in lung, breast, and colorectal cancers to evoke an immune response
  • Examining the clinical efficacy of cancer indications with low tumor burden to highlight the therapeutic impact of personalized cancer vaccines
  • Overcoming difficulties in treating low tumor mutational burdens in cancers using dendritic cell-based personalized cancer vaccines that show clinical efficacy

12:00 pm Networking Lunch Break

Uncovering Best Strategies With Clinical Trial Design, Regualtions, & Combination Therapies to Achieve Efficacy

1:00 pm Proving the Clinical Efficacy of SV-102 in Multiple Cancer Indications

Synopsis

  • Transforming the personalized cancer space by freezing tumors in situ, lysing and releasing the neoantigens to activate T cells
  • Employing a two-pronged attack with a cocktail of checkpoint inhibitors in the same local environment for maximum patient effect
  • Demonstrating the viability of this personalized cancer therapy in metastatic prostate cancer and beyond

1:30 pm Roundtable Discussion:Individualized Cancer Vaccines: Development Strategies for Neoantigen Selection, Clinical Development & Regulatory Approval

  • Philip Arlen President & Chief Executive Officer, Precision Biologics
  • Ruben Rizzi Senior Vice President - Global Regulatory Affairs, BioNTech AG

Synopsis

  • How to determine the best clinical setting for individualized cancer therapies for the easiest path through the clinic
  • What are the different combination therapy strategies with personalized cancer vaccines for positive patient response?
  • What is the dosing schedule in trials for personalized cancer vaccines for the most effective patient response?

2:30 pm Afternoon Break & Networking

Probing into the Best Delivery Methods to Achieve Targeted Individualized Vaccines

3:15 pm Employing Enucleated Cell Carriers as Delivery Systems to Improve Targeted Cancer Vaccine Delivery for More Successful Therapies

  • Richard Klemke Founder & Chief Scientific Officer, Cytonus Therapeutics

Synopsis

  • Overcoming the blood barrier using enucleated mesenchymal stromal cells that can migrate into the tumor environment for targeted personalized cancer vaccine delivery
  • Utilizing mRNA and cell-penetrating peptides as vaccine modalities to efficiently target the cancer tumor
  • Amplifying the targeted effect of enucleated cell carriers by cargo sites to specifically deliver the cancer vaccine for the most effective therapy

3:45 pm A Novel Delivery System for Personalized Peptide & mRNA Vaccines for More Targeted Therapies

Synopsis

  • The DPX™ platform is a novel delivery system for packaging multiple proteins, peptides, cancer neoantigens, viruses and viral-like particles, and polynucleotides
  • The DPX™ package is highly versatile and can accommodate multiple peptides plus immunostimulants, such as macrophage activators
  • DPX™ is highly stable and remains localized at the injection site, thereby avoiding potential systemic toxicities

4:15 pm Chair’s Closing Remarks

4:30 pm End of the Personalized Cancer Vaccine Summit

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