8:20 am Chair’s Opening Remarks
8:30 am Engaging Immune Cells While Limiting Toxicity
Synopsis
- What’s new in the T and NK cell engager field
- Ideas from some T and NK cell engagers in development
9:00 am Understanding the Cytokine-Based Drug Development Field
Synopsis
• Comprehensive coverage of the global cytokine-based drug development field,
assessing the growth and trends of the last decade
• Provide data-driven clarity and insight into the current drug and clinical trial
landscape
• Insight into future trends based on the preclinical space and the effect of their
translation into clinics
9:30 am PANEL DISCUSSION: Where Are We Now & Where Are We Going?
Synopsis
This panel will set out to address
- Where have the current cytokine engineering strategies taken us and what can we learn from this?
- Assessing the latest clinical work with lesser known and novel cytokines
- Assessing the fields biggest roadblocks for moving current promising pre-clinical candidates into the clinic
- Assessing the role of combination therapies with cytokine targeted therapies? – Where is there proven synergy?
10:00 am Enabling Cytokine Therapeutic Development with Qualified, Functional Cell-Based Assays – from Screening to QC Lot Release
Synopsis
• Discover how cell-based assays and translational services accelerate cytokine-based
immunotherapeutic development from early discovery to GMP Lot Release Testing
• Learn about industry’s largest cell-based assay portfolio covering 80+ cytokine,
interleukin and chemokine targets including IL-1, IL-2, IL-6, IL-7, IL-12, IL-15, IL-17,
GM-CSF, CCRs, and CXCRs
• Delve into custom bioassay qualification case studies showing development of
fit-for-purpose bioassays for potency, stability, and NAb testing
• Learn how method transfer support is critical for assay implementation at CRO sites
• Gain human insights early, with custom biomarker services and the BioMAP®
Platform of cell-based disease models
10:30 am
Morning Networking
Synopsis
Join us for face-to-face networking. We will pair you up with fellow attendees so you can get one on one time with the brightest minds working in the cytokine field for you to establish meaningful relationships.
11:00 am
Refreshment Break
An Update from the Clinic: Success & Failure at the Front of the Field
11:30 am Targeting IL-2 to tumor-specific T cells with novel biologic platforms
Synopsis
- Generating a therapeutic index for IL-2 via selective delivery to tumor-specific T cells demonstrates anti-tumor activity in cancer patients
- Lead clinical candidate, CUE-101, provides clinical PoC and de-risking for the Immuno-STAT platform
- Novel bispecifics that can re-direct the protective viral T cell repertoire to destroy cancers – potential for superior safety and clinical efficacy
12:00 pm Immune Humanized Platforms for Preclinical Evaluation of Tumor Efficacy & Cytokine Release Mediated Toxicity
Synopsis
• Human PBMC engraftment in MHC deficient recipients diminishes acute GvHD
• Accurate modeling of treatment induced human cytokine release in vivo
• Human donor specific differences in efficacy & toxicity for drug candidate selection
12:30 pm IL-7 therapy: Oncology and beyond
Synopsis
- NT-I7 (efineptakin alfa, a long-acting human IL-7) clinical development
- NT-I7 in combination with checkpoint inhibitors
- Potential clinical biomarkers in IL-7 treatment
1:00 pm Co-Stimulation of Adaptive and Innate Immune Cells to Achieve Clinical Benefit with MDNA11, a Long-Acting ‘Beta-only’ IL-2 Super-Agonist
Synopsis
- MDNA11 is an albumin fusion to a variant of IL-2 bestowed with enhanced affinity for CD122 and deprived of CD25 binding, with the intent to selectively stimulate immune effector cells. The presentation will comprise:
- Preliminary results from the ongoing MDNA11 Phase 1/2 ABILITY Clinical Trial in patients with advanced solid tumors
- Emerging safety and clinical benefit as we establish the recommended phase 2 dose (RP2D) and schedule during monotherapy dose-escalation, and
- Compare the PK profile and PD response of MDNA11 within the IL-2 class of immuno-therapies for oncology
1:30 pm
Lunch & Networking Break
A Deep Dive into Pre-Clinical Development Challenges & Opportunities
2:30 pm Intratumoral mRNA Approach to Delivering Cytokine Immunotherapies
Synopsis
- Comparison to other approaches
- MEDI1191: IL12 mRNA mechanism of action and preclinical data
- Update of clinical, safety, and translational data from ongoing first-in-human clinical trial in combination with durvalumab
3:00 pm Tools for Cytokine Therapeutic Development – from Discovery to Lot Release
Synopsis
• Learn how cell-based reporter bioassays are used in the development of therapeutic
cytokines to confirm mechanism of action and measure drug potency and stability
• Discover a convenient thaw-and-use assay format that saves time and provides
reproducible results across laboratories.
• Hear about a novel immunoassay technology (Lumit™) that provides a simple,
sensitive and rapid alternative to ELISA detection of cytokine release.
3:30 pm Clinically translatable cytokine delivery platform for cancer immunotherapy
Synopsis
- Describe the development of the LOCOcyteTM, an allogeneic cell-based immunotherapy platform to enable potent localized modulation of the immune system which also precipitates a systemic immune response for cancer immunotherapy
- Highlight pre clinical data with our LOCOcyteTM platform demonstrating tumor eradication in advanced ovarian cancer, colorectal, and mesothelioma cancer mouse models. Review non human primate safety, pharmacokinetics, and pharmacodynamic data with our LOCOcyteTM platform
- Describe clinical synopsis of LOCOcyteTM first in human trial for advanced recurrent ovarian cancer patients
4:00 pm
Afternoon Break
4:30 pm The role of PKPD modelling for cytokine-based therapies: challenges and future perspectives
Synopsis
- Importance of mathematical models to describe PKPD relationship for cytokine-based therapies summary of available models and key data needed for model building
- Future perspective on how this field can be enriched with relevant mathematical models
Strategies to Ensure Localizing Activity into the Tumor
5:00 pm Exploring the potential of a multi-cytokine delivery system to develop more effective cancer therapies
Synopsis
- Development and interrogation of a gold nanoparticle cytokine delivery system
- Use of a cytokine powered platform to generation multi-modal cancer therapies
- Improving key metrics of cytokine delivery including PK, tumor uptake and safety using a nanoparticle delivery system