IO Biotech Announces New Clinical Collaboration with Merck to Evaluate Neoadjuvant and Adjuvant IO102-IO103 in Combination With KEYTRUDA® (pembrolizumab) in a Phase 2, Multi-cohort Trial in Patients with Resectable Tumors
NEW YORK, Nov. 03, 2022 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win® technology platform, announced today that it has entered into a fourth clinical trial collaboration and supply agreement with Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary. The purpose of the collaboration is to evaluate IO Biotech’s lead candidate, IO102-IO103, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 (programmed cell death receptor-1) therapy, as neoadjuvant and adjuvant treatment in a multicenter, multi-cohort trial evaluating anti-tumor activity, safety and immune infiltration. The proof-of-concept trial will include patients with resectable tumors in at least two indications.
“We are pleased to extend our collaboration with Merck into this new exploration of IO102-IO103 in combination with pembrolizumab in earlier, neoadjuvant and adjuvant settings,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “IO102-IO103 has shown promising early clinical activity with a positive safety profile in melanoma thus far and, as highlighted in our Key Opinion Leader webinar this past spring, a compelling need remains among patients with advanced melanoma for effective treatments with reduced toxicity. We believe that the novel biology of IO102-IO103 represents a potential paradigm shift in the management of additional cancer types beyond melanoma, and we look forward to expanding our dataset to evaluate our medicine in combination with pembrolizumab in earlier neoadjuvant and adjuvant settings.”
The primary objective of the proposed study is to investigate the activity of neoadjuvant treatment with IO102-IO103 in combination with pembrolizumab, in terms of pathologic tumor response in resected tumors. Secondary objectives include anti-tumor effect based on standard imaging of IO102-IO103 in combination with pembrolizumab as neoadjuvant treatment and as adjuvant treatment, overall survival after neoadjuvant/adjuvant treatment with IO102-IO103 in combination with pembrolizumab and the requirement for post-operative chemotherapy/radiotherapy following IO102-IO103 in combination with pembrolizumab as neoadjuvant treatment.
Under the terms of the agreement, IO Biotech will sponsor the Phase 2 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. Additional information about the trial can be found at clinicaltrials.gov.
IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1. IO102-IO103, in combination with pembrolizumab, was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for treatment of unresectable/metastatic melanoma, based on the results of a Phase 1/2 clinical trial (MM1636). IO Biotech has also begun patient recruitment into a Phase 3 trial (IOB-013 / KN-D18) of IO102-IO103 in combination with KEYTRUDA® (pembrolizumab) as first-line treatment in advanced melanoma patients, which is designed to be potentially registrational.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win® technology platform. The T-win® platform is a novel approach to cancer immunotherapy designed to activate naturally occurring T cells to target immunosuppressive mechanisms. IO Biotech is advancing in clinical studies its lead immuno-oncology candidate, IO102-IO103, targeting IDO and PD-L1, and through preclinical development its other pipeline candidates. IO Biotech is headquartered in Copenhagen, Denmark and has additional offices within the United States (New York, New York and Rockville, Maryland) and United Kingdom (Monmouthshire).
For further information, please visit www.iobiotech.com
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding future clinical trials, objectives and results, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Chief Financial Officer
IO Biotech, Inc.
Corey Davis, Ph.D.
Raena Mina, Ph.D.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, US