Drug Profile

Adjuvanted imsapepimut and etimupepimut - IO Biotech

Alternative Names: Cylembio; IO102-IO103; PD-L1/IDO peptide vaccine

Latest Information Update: 03 Oct 2025

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At a glance

Originator IO Biotech
Developer IO Biotech; Merck & Co
Class Antineoplastics; Cancer vaccines; Immunotherapies; Peptide vaccines
Mechanism of Action Immunostimulants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Phase III Malignant melanoma
Phase II Bladder cancer; Non-small cell lung cancer; Squamous cell cancer
Phase I Solid tumours

Most Recent Events

29 Sep 2025 IO Biotech plans to discuss the data from IOB-013 study with European regulators and determine a path to submission in the EU
29 Sep 2025 US FDA recommends IO Biotech to not submit a Biologics License Application (BLA) for Malignant melanoma
29 Sep 2025 IO Biotech plans a registrational trial of Cylembio for Malignant melanoma (Late-stage disease, First-line therapy)

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