MedPath

IO Biotech

🇩🇰Denmark
Ownership
-
Employees
68
Market Cap
$104.7M
Website
Introduction

IO Biotech, Inc. engages in the development of immune modulating cancer therapies based on its T-win technology platform. Its platform is a novel approach to cancer immunotherapy designed to activate naturally occurring T cells to target immunosuppressive mechanisms. The company was founded by Mai-Britt Zocca, Inge Marie Svane, and Mads Hald Andersen in December 2014 and is headquartered in Copenhagen, Denmark.

Clinical Trials

4

Active:2
Completed:1

Trial Phases

3 Phases

Phase 1:1
Phase 2:2
Phase 3:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (4 trials with phase data)• Click on a phase to view related trials

Phase 2
2 (50.0%)
Phase 1
1 (25.0%)
Phase 3
1 (25.0%)

Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors

Phase 2
Recruiting
Conditions
Melanoma
Squamous Cell Carcinoma of Head and Neck
Interventions
First Posted Date
2022-03-15
Last Posted Date
2024-03-18
Lead Sponsor
IO Biotech
Target Recruit Count
60
Registration Number
NCT05280314
Locations
🇺🇸

Yale, New Haven, Connecticut, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massey Cancer Center, Richmond, Virginia, United States

and more 12 locations

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

Phase 3
Active, not recruiting
Conditions
Metastatic Melanoma
Unresectable Melanoma
Interventions
First Posted Date
2021-12-13
Last Posted Date
2024-01-09
Lead Sponsor
IO Biotech
Target Recruit Count
407
Registration Number
NCT05155254
Locations
🇺🇸

Mid Florida Hematology and Oncology Center, Orange City, Florida, United States

🇺🇸

Orlando Health Cancer Institute, Orlando, Florida, United States

🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

and more 107 locations

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

Phase 2
Active, not recruiting
Conditions
Lung Cancer Non Small Cell
Head and Neck Squamous Cell Carcinoma
Urothelial Carcinoma Bladder
Interventions
First Posted Date
2021-10-14
Last Posted Date
2024-07-23
Lead Sponsor
IO Biotech
Target Recruit Count
63
Registration Number
NCT05077709
Locations
🇺🇸

City of Hope, Duarte, California, United States

🇺🇸

UC Davis Cancer Center, Sacramento, California, United States

🇺🇸

University of California San Diego, San Diego, California, United States

and more 18 locations

IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC

Phase 1
Completed
Conditions
NSCLC
Interventions
Biological: IO102
Biological: pembrolizumab (Keytruda)
First Posted Date
2018-06-20
Last Posted Date
2022-04-21
Lead Sponsor
IO Biotech
Target Recruit Count
109
Registration Number
NCT03562871
Locations
🇩🇪

Thoraxklinik Heidelberg gGmbH, Heidelberg, Community Of Heidelberg, Germany

🇩🇪

PIUS Hospital Oldenburg, Oldenburg, Germany

🇳🇱

Stichting Het Nederlands Kanker Instituut, Amsterdam, Community Of Amsterdam, Netherlands

and more 10 locations

News

IO Biotech's Novel Immune-Modulatory Cancer Vaccine Shows Promise in Phase 3 Trials

• IO Biotech's innovative T-win technology delivers dual-acting cancer vaccines that target both tumor cells and immune-suppressive cells, transforming hostile tumor microenvironments into immune-friendly ones. • The company's lead candidate Cylembio (IO102/IO103) has received FDA Breakthrough Therapy designation and demonstrated an 80% objective response rate in advanced melanoma when combined with nivolumab. • Phase 3 trial results for Cylembio combined with pembrolizumab in metastatic melanoma are expected in Q3 2025, with a Biologics License Application planned for submission to the FDA by the end of this year.

IO Biotech Completes Enrollment in Phase 2 Trial of IO102-IO103 Cancer Vaccine

• IO Biotech has completed enrollment in its Phase 2 basket trial (IOB-032/PN-E40) evaluating IO102-IO103 in combination with pembrolizumab. • The trial includes patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) receiving neoadjuvant/adjuvant treatment. • Initial data from the Phase 2 trial, which enrolled 93 patients across multiple sites, is expected in 2025. • The primary endpoint is major pathological response (MPR), with secondary endpoints including pCR, ORR, DFS, EFS, and safety.

IO Biotech Faces Nasdaq Delisting Risk Despite Promising Cancer Vaccine Advances

• IO Biotech received a Nasdaq warning for its stock price falling below $1.00 for 30 consecutive days, risking delisting. • The company has until June 2025 to regain compliance by maintaining a stock price above $1.00 for at least 10 days. • Recent data from a Phase 2 trial of IO102-IO103 showed potential in treating metastatic non-small cell lung cancer. • A €57.5 million loan from the EIB aims to advance IO Biotech's cancer vaccine development, extending financial runway into Q2 2026.

Melanoma Treatment Landscape Evolves with Novel Immunotherapies and Targeted Approaches

• The FDA granted fast-track approval to Amtagvi, a Tumor-Infiltrating Lymphocyte (TIL) therapy, for metastatic melanoma patients who have failed other treatments, marking a significant advancement in cellular immunotherapy. • Neoadjuvant immunotherapy has become the standard of care for stage III melanoma patients with resectable tumors, as highlighted at the European Society for Medical Oncology (ESMO) Congress. • Over 170 melanoma pipeline therapies are under development by 150+ companies, including IO Biotech, Moderna, Merck, and BioNTech, targeting various stages and mechanisms of the disease.

IO Biotech's IO102-IO103 Plus Pembrolizumab Shows Promise in Head and Neck Cancer

• IO Biotech's Phase 2 trial of IO102-IO103 with pembrolizumab demonstrates a 44.4% overall response rate in PD-L1 high recurrent or metastatic SCCHN patients. • The combination therapy shows an encouraging median progression-free survival of 6.6 months and a disease control rate of 66.7% in SCCHN. • The safety profile of IO102-IO103 with pembrolizumab is consistent with previous studies, showing no new systemic toxicity concerns. • These results support further investigation of IO102-IO103 plus pembrolizumab as a first-line treatment for advanced head and neck cancer.

IO Biotech's Melanoma Trial of IO102-IO103 Combination Therapy to Continue

• IO Biotech's Phase III trial of IO102-IO103 with pembrolizumab for advanced melanoma will continue following IDMC review. • The IDMC found no new safety signals, supporting the ongoing evaluation of the therapeutic vaccine combination. • The primary endpoint, progression-free survival, is projected to be reached in the first half of 2025. • The trial compares IO102-IO103 plus pembrolizumab to pembrolizumab alone in previously untreated patients.

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