Antigen-Specific Immune Tolerance Platform

Anchored by first-in-class immuno-modulatory allosteric anti-CD40 Ab

Immune tolerance platform

Diabetes Free is a clinical-stage platform biotechnology company focused on antigen-specific immune tolerance anchored by a first-in-class SQ allosteric anti-CD40 mAb across the fields of autoimmunity, particularly multiple sclerosis, gene therapy, and immunosuppression-free islet cell and other transplantation as a functional cure of diabetes, hence the company’s founding mission and name.

The Platform

Tolerance

Our immuno-modulatory Tolerance platform holds the potential to be used for several applications, including transplantation, gene therapy and for patients with autoimmune disease

Transplantation

Transplantation

IND Enabled

Gene Therapy

Gene Therapy

AAV Redosing Safety & Efficacy

Autoimmunity

Autoimmunity

Multiple Sclerosis, Crohn’s, SLE, T1D

Multiple Sclerosis mAb

TX Competitive Landscape

 
DFI 105
Ocrevus
Kesimpta
Frexalimab
target
Anti-CD40
Anti-CD20
Anti-CD20
Anti-CD40L
stage
Ph 2 POC Q1 2025
Commercial (IV) Approval 2024
Commercial
Ph 3 Data 2025
route
SQ (high conc. / low vol. ≥200mg/mL)
SQ
SQ
IV
delivery
Auto-injector compatibility established
Hyaluronidase high vol. depot
Home use auto injector
Infusion center high volume IV
efficacy
NHP data consistent with CD40 class effect
0.04 ARR
0.05 ARR
0.04 ARR (Phase 2)
safety
revenues
?
$7B (2023)
$2B (2023)
$5B (Sanofi Est.)