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.
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
IND Enabled
Gene Therapy
AAV Redosing Safety & Efficacy
Autoimmunity
Multiple Sclerosis, Crohn’s, SLE, T1D
TX Competitive Landscape
DFI 105
|
Ocrevus
|
Kesimpta
|
Frexalimab
|
|
---|---|---|---|---|
target |
Anti-CD40
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Anti-CD20
|
Anti-CD20
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Anti-CD40L
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stage |
Ph 2 POC Q1 2025
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Commercial (IV) Approval 2024
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Commercial
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Ph 3 Data 2025
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route |
SQ (high conc. / low vol. ≥200mg/mL)
|
SQ
|
SQ
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IV
|
delivery |
Auto-injector compatibility established
|
Hyaluronidase high vol. depot
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Home use auto injector
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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 |
?
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$7B (2023)
|
$2B (2023)
|
$5B (Sanofi Est.)
|