Charlotte Fribert
Cheif Executive Officer Bonsai Biotherapeutics
Seminars
Tuesday 3rd March 2026
Proof in the Patients: Strategic Approaches to Advancing Tolerizing Therapies into Successful Clinical Trials
1:00 pm
This workshop will focus on clinical strategy for ASIT from concept to clinical proof. Discussing how companies are generating proof of mechanism and proof of concept data, selecting the right patient populations, and designing trials that can show durable clinical benefit. Drawing on past experiences from successful mechanistic readouts using biomarker-driven approaches to lessons from less successful trials to explore what has and hasn’t translated effectively into clinical benefit. Participants will debate what level of efficacy, durability, and regulatory evidence is needed for clinical and commercial success.
Key Questions to be answered:
- How can early-phase trials best demonstrate proof of mechanism and proof of concept in tolerizing therapies?
- What are the priority considerations moving from healthy-volunteer studies to patient-based proof-of-mechanism designs?
- What lessons from past antigen-specific programs can improve antigen selection, delivery, and trial design?
- What trial strategies have best translated mechanistic signals into durable, clinically meaningful outcomes?
- What level of durability, dosing practicality, and clinical benefit will regulators and clinicians expect for tolerizing therapies to gain acceptance?
