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
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
10:45 am Morning Break & Networking
Unlocking Personalized Vaccine Development for Different Indications of Cancer to Induce an Immune Response to Shrink the Tumor
11:30 am Developing Personalized Cancer Vaccines for ‘Cold’ Tumors to Create a Successful Therapy
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