Conference Day Two | Wednesday, 30th January
7.00 Morning Coffee & Networking
8:00 am Chair’s Opening Remarks
Advancing mRNA Vaccines & Therapies Towards the First Approval With Breaking First-InHuman Clinical Progress Data from Leaders in the Clinic
8:15 am Safety, Tolerability, Pharmacokinetics & Target Engagement of ETH47 in Healthy Subjects
Synopsis
- Showcasing nasal administration of ETH47 development for the prevention of virusdriven exacerbation in patients with asthma
- Demonstrating data on safety and well tolerated and not systemically bioavailable in healthy trial participants
- Overall, results present a dose-dependent local target protein induction
8:45 am Technical & Clinical Progress in mRNA Therapeutics Beyond COVID-19 Vaccine
Synopsis
- Demonstrating Abogen’s unique mRNA and LNP platform
- Clinical progress of mRNA cancer vaccine
- Future perspectives of mRNA therapeutics
9:15 am An mRNA Knowledge Library: Deep Profiling of Wild Type & Modified T7 Polymerases & Their Impacts on IVT Performance
Synopsis
- A high throughput screening (HTS) workflow was developed to enable comprehensive evaluation of T7 polymerase as a critical raw material in mRNA production
- Total 4 of wild type and 16 of modified T7 polymerases were systematically evaluated via DOE based IVT optimizations and subsequently mRNA analytics
- A ranking system including mRNA production performance, supply chain, and cost analysis for each T7 polymerase was established to support RecBioPharm’s advanced mRNA technology platform
9.45 Morning Networking Break
TRACK A: DISCOVERY & PRE-CLINICAL DEVELOPMENT
Synopsis
Chair: Adèle Schmitt, Expert Scientist, GSK
Turbocharging Antigen Selection & Design to Optimise mRNA Vaccine Safety & Tolerability for Emerging Infectious Diseases
10:30 am Development of a Gonorrhea Vaccine Using the mRNA Platform Established at Afrigen
Synopsis
- Overview of mRNA platform established in Afrigen
- Platform for sustainability with pipeline of disease targets
- Showcasing mRNA Gonorrhea vaccine as one of the pipeline targets, and early preclinical results
11:00 am Overcoming Limitations in RNA-Based Therapies: A Case Study on Cutaneous Squamous Cell Carcinoma Clinical Data
Synopsis
- Immagina Biotechnology has pioneered integrated technologies to study RNA processing and translation in action
- By combining advanced methods for RiboSeq, tRNAseq, and tRNA fragment analysis, we identified a novel biomarker for Minimal Residual Disease in cutaneous squamous cell carcinoma
- This biomarker also presents significant potential as a drug target, opening new avenues for therapeutic development
11:30 am Development of mRNA Vaccine Candidates for Pandemic Influenza
Synopsis
- Optimising design of different HA candidates
- Unravelling in vivo proof of concept data for an mRNA influenza vaccine
- Demonstrating scaling up and process development methods
TRACK B: CLINICAL DEVELOPMENT & MANUFACTURING
Scale & Transfer – Leveraging Sustainable Platforms to Produce mRNA Products Effectively & Affordably for LMICs
10:30 am Techno-Economic Modelling for Sustainable, Low Cost & Scalable mRNA Medicines Manufacturing for LMICs
Synopsis
- Techno-economic comparison of batch vs continuous mRNA manufacturing
- Techno-economic comparison of single use consumable vs multi-use equipment-based mRNA manufacturing
- The impact of automation on financially sustaining mRNA medicines manufacturing capacity during non-outbreak periods
11:00 am Enhanced mRNA Performance by PCR-Based Manufacturing
Synopsis
- Showcasing a versatile, scalable, and robust GMP mRNA manufacturing platform.
- Overcome the limitations of the conventional plasmid-based processes with a scalable PCR-based strategy
- Within a case study, we contrast the performance of conventional and PCR-based mRNA manufacturing
11:30 am Towards Global Access & Equity for mRNA Technology: An Update from Afrigen Biologics
Synopsis
- Unlocking mRNA vaccine design, development and production geared to enable LMICs to produce mRNA products
- Establishing a “green fields” mRNA end to end commercial production process
- Product innovations for effective, affordable and accessible mRNA vaccines for neglected diseases suitable for LMICs and relevance to pandemic preparedness
12:00 Lunch Break & Networking
TRACK A: DISCOVERY & PRE-CLINICAL DEVELOPMENT
Synopsis
Chair: Adèle Schmitt, Expert Scientist, GSK
Achieving Effective Cell & Tissue Targeting, Distribution & Translatability with Novel LNP Formulations
1:00 pm Development of a Diversity-Oriented Lipid Library to Fight Diseases
Synopsis
- A platform approach for LNP screening
- LNPs targeted for liver delivery
- LNPs targeted for immune cell delivery
1:30 pm Unlocking mRNA Therapies Through Spatial Delivery
Synopsis
- Demonstrating mRNA delivery to lung – case study lessons from mice to non-human primates
- Showcasing mRNA delivery to the spleen
- Presenting alternatives to current LNP systems for intramuscular vaccination
TRACK B: CLINICAL DEVELOPMENT & MANUFACTURING
Assessing Safety, Measures & Pandemic Preparedness to Minimise Future Risks & Accelerate Response to Health Threats & Patient-Centric Decision Making
1:00 pm Uncovering Key Critical Safety Requirements for Clinical & Post-Authorisation Measures for mRNA Vaccines & Therapeutics
Synopsis
- Leveraging case study examples on safety and pharmacovigilance for mRNA-based vaccines for COVID-19 and RSV
- Establishing regulatory measures for emerging safety concerns and restrictions, with patient and healthcare professionals in mind
- Shaping a risk management plan for pharmacovigilance, post authorization studies, and risk minimization measures for future mRNA vaccines and therapeutics
1:30 pm Overcoming dsRNA Challenge: Innovation in Assays and Enzymes
Synopsis
- Current status of mRNA therapeutic drugs:dsRNA can strongly stimulate the intracellular RNA receptors RIG-I and MDA5, activate the innate immune response, and cause inflammation. Therefore, the content of dsRNA is related to the safety and efficacy of vaccines
- mRNA therapeutic drug process development challenges and solutions:It will describe the dsRNA quantitative detection and process control challenges encountered during development, and propose solutions to overcome these challenges
- Vazyme's work in mRNA raw materials and process innovation: GMP Grade, DMF Record
2.00 Afternoon Break & Networking
Disruptive Companies Unlocking Diseases of Tomorrow With New Models Systems & Bioinformatic Approaches
Synopsis
Showcasing the emergence of new European Biotechs breaking through the mRNA industry and ready to present their exciting preclincal research
2:35 pm IL-35 mRNA Therapeutic Local Expression in the Liver Suppresses Autoimmune Hepatitis
Synopsis
- IL35 is a potent immunosuppressive cytokine regulating innate and adaptive immunity
- IL35 mRNA local expression in the liver reverses acute hepatitis
- IL35 mRNA therapeutics inhibits specifically auto-antibodies in chronic autoimmune hepatitis
3:00 pm mRNA Therapeutic Vaccine Targeting Human IL-4 & IL-13 Protects Against Asthma
Synopsis
- Showcasing first-in-class mRNA therapeutic product for asthma
- Presenting pre-clinical data in humanized mice
- Highlighting CMC and clinical programs
3:25 pm A First-In-Class Technology for mRNA Delivery
Synopsis
- Demonstrating first-in-class mRNA delivery technology at Nuntius Therapeutics
- Utilising novel machine learning guided discovery techniques
- Sharing case-study examples of tissue targeting carriers