Product Description
NG-350A is being developed by PsiOxus for the treatment of patients with Epithelial Tumor and Metastatic Cancer. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT05165433?term=NG-350A&draw=2&rank=1)
Mechanisms of Action: CD40 Agonist
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: Fast Track - Colorectal Cancer *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Akamis Bio
Company Location: Europe
Company Founding Year: 2016
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United Kingdom, United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 1: Colorectal Cancer|Oncology Solid Tumor Unspecified
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06459869 |
FORTRESS | P1 |
Recruiting |
Colorectal Cancer |
2026-11-30 |
50% |
2026-01-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05165433 |
FORTIFY | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2025-08-29 |
50% |
2025-12-17 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
10/14/2025 |
News Article |
Akamis Bio Receives FDA Fast Track Designation for NG-350A for the Treatment of Mismatch Repair-Proficient Locally Advanced Rectal Cancer |
|
05/06/2025 |
News Article |
Akamis Bio Broadens Leadership Team with Key Executive Appointments |
|
04/03/2025 |
News Article |
Akamis Bio Announces Enrollment of First Patient in Phase 1b FORTRESS Trial of NG-350A in Patients with Locally Advanced Rectal Cancer |
|
12/17/2024 |
News Article |
Akamis Bio Announces $60 Million in Funding Linked to Series A Prime Financing and New Strategic Partnership |