Conference Day Two | Thursday, December 5

7:50 am Morning Coffee & Networking

8:50 am Chair’s Opening Remarks

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

9:00 am Challenges & Promises of Personalized Cancer Vaccines: Learnings From Autogene Cevumeran

Synopsis

  • Preclinical studies: vaccine immunogenicity and anti-tumor response
  • Showcasing phase 1 clinical data
  • Determining the vaccine mechanism of action

9:30 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

Virtual Session

10:00 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

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

10:45 am Morning Break & Networking

11:30 am Developing Personalized Cancer Vaccines for ‘Cold’ Tumors to Create a Successful Therapy

  • William Jia Chief Scientific Officer & Co-Founder, 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

12:00 pm 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

12:30 pm Networking Lunch Break

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

1:30 pm Personalized Cancer Vaccine: Drugs and Trials Landscape Overview

Synopsis

  • Examining trends in investigated disease indications for preclinical vs clinical drugs
  • Analyzing the personalized cancer vaccine therapeutic class distribution
  • Trials evaluating personalized cancer vaccines: phase of development

2:00 pm Roundtable Discussion: Individualized Cancer Vaccines: Development Strategies for Neoantigen Selection, Clinical Development & Regulatory Approval

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?

2:45 pm Afternoon Break & Networking

Probing into the Best Delivery Methods to Achieve Targeted Individualized Vaccines

3:30 pm Utilizing Personalized SYNC-T Therapy in situ Vaccination & Intramural Infusion to Induce Systemic Responses in Patients with Metastatic Castrate-Resistant Prostate Cancer

Synopsis

  • Targeting metastatic castrate-resistant prostate cancer (mCRPC) to improve response to immunotherapy
  • Showcasing the personalized in-situ tumor vaccine from device-induced partial cryolysis of a targeted solid tumor
  • Combining in-situ vaccine with immediate intratumoral infusion of a multi-target proprietary drug candidate SV-102 to induce a systemic immune response

4:00 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

4:30 pm Chair’s Closing Remarks

4:45 pm End of the Personalized Cancer Vaccine Summit

CONFERENCE DAY ONE
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