Copenhagen, Denmark – May 15, 2019: IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win® technology, announced the initiation of the Phase 2 portion of a global, open-label, randomized clinical trial studying the investigational candidate IO102 in combination with KEYTRUDA® (pembrolizumab) for the treatment of first-line patients with metastatic non-small cell lung cancer (NSCLC). This follows the safety portion of the trial of IO102 in combination with KEYTRUDA which has been successfully completed.
As noted on clinicaltrials.gov, the IO102-012/KEYNOTE-764 trial is “An Open-label, Randomized, Phase 1/2 Trial Investigating the Safety and Efficacy of IO102 in Combination with Pembrolizumab, with or without Chemotherapy, as first-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer” and is a global clinical trial expected to accrue 96 patients across more than 20 sites in the US and Europe. Further information on the study design can be found at www.clinicaltrials.gov (NCT03562871).
The IO102-012/KN-764 trial is part of a collaborative agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada). The clinical trial will be sponsored by IO Biotech, while MSD will supply the trial with KEYTRUDA. The rights to the study results will be shared, and IO Biotech has retained global commercial rights to IO102.
“The enrolment of the first patient in the Phase 2 part of our Phase 1/2 trial for NSCLC represents a major milestone for IO Biotech, and we are excited that our global trial is now active and recruiting patients. The first patient is now being treated in a first-line treatment setting of metastatic non-small cell lung cancer,” said Eva Ehrnrooth, MD, PhD, chief medical officer of IO Biotech. “Through this trial, we expect to get a diverse set of clinical data that will enable us to explore the potential of IO102 when added to the current standard of care.”
IO Biotech’s lead candidate, IO102, is an Indoleamine 2,3-dioxygenase (IDO) derived immune modulating therapy with a dual mode of action – killing both cancer cells and immune-suppressive cells. IO Biotech’s IDO-derived immune modulating therapies previously demonstrated both a favorable safety profile and promising anti-tumor activity in its first human clinical trial of heavily pre-treated patients with NSCLC.
According to the American Cancer Society (ACS), lung cancer is the leading cause of cancer death. Each year, more people die of lung cancer than colon, breast and prostate cancers combined. The two main types of lung cancer are non-small cell lung cancer and small cell lung cancer. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all cases. According to the ACS, the five-year survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be six percent.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About T-win® Technology Platform
IO Biotech’s proprietary T-win technology platform enables identification of compounds with dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses.
About IO Biotech
IO Biotech is a clinical stage biotech company developing disruptive immune therapies for the treatment of cancer. The pipeline of first-in-class immune modulating anti-cancer therapies is developed by a unique technology platform, T-Win®, enabling the activation of T cells that are specific for immune-suppressive molecules. IO Biotech has a proven track record of progressing preclinical and clinical compounds. The two lead compounds targeting IDO and PD-L1 are in clinical development and several pipeline compounds are in pre-clinical phase. For further information, please visit www.iobiotech.com.
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech