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IO Biotech Announces Positive Outcome of Interim Analysis of Phase 2 Randomized Trial in First Line Non-small Cell Lung Cancer

- Data position the company to start potential registrational trials with two drugs in two tumor types

Copenhagen, Denmark – February 25, 2020: IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win® technology, announced the successful outcome of a scheduled interim analysis of the ongoing Phase 2 trial (IO102-012/KEYNOTE-764) of its lead cancer therapeutic vaccine, IO102, in non-small cell lung cancer (NSCLC).  In this randomized trial, IO102 is being tested in combination with Merck’s anti-PD1 therapy, Keytruda (pembrolizumab) as a first-line therapy in patients with metastatic non-small cell lung cancer.  The interim analysis was designed as a futility analysis.  The Safety Monitoring Committee has recommended to continue the trial without modifications as the futility boundary was successfully passed.

“We set a very high hurdle for the futility boundary for the interim analysis in this difficult to treat disease.  Specifically, the successful outcome of this interim analysis required the objective response rate in the experimental arm to exceed the futility boundary which was substantially higher than the historical experience with Keytruda monotherapy in this population.  We are excited to note that this hurdle has been successfully crossed,” said Eva Ehrnrooth, MD, PhD, chief medical officer of IO Biotech. “Through this trial, we expect to get a comprehensive data set that paves the way for a potential pivotal trial of IO102 addressing the unmet medical need in NSCLC and solid tumors.”

“The year 2020 will be a transformational year for IO Biotech.  We are pleased by the data generated thus far in the ongoing trial of our off-the-shelf subcutaneous injectable treatment for patients with lung cancer. Additionally, the exciting data being generated in the ongoing melanoma trial with our proprietary T-win cocktail that includes IO102 and IO103 (our two clinical lead programs based on targeting IDO and PD-L1) will allow the company to initiate pivotal trials in two indications with two drugs,” said Mai-Britt Zocca, PhD, CEO and Founder of IO Biotech. “We continue to demonstrate long term durability of drug effect with a very attractive safety profile for each of our clinical stage candidates, whether alone or in any combination.”

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.

About the Study
IO102-012/KEYNOTE-764 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. This global clinical trial is planned to accrue 108 patients across around 20 sites in the U.S. and Europe.

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 is sponsored by IO Biotech. The rights to the study results will be shared, and IO Biotech has retained global commercial rights to IO102.

About 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.  The company’s compounds are administered as “off-the-shelf” subcutaneous injections, distinguishing these treatments from many immuno-oncology therapies.

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.

Contacts
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. 

IO Biotech Initiates Global Phase 2 Portion of Clinical Trial For T-win® Immunotherapy in Non-small Cell Lung Cancer

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.

About 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.

Contacts
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. 

IO Biotech to Participate in Panel Discussion at 30th Annual Cancer Progress Conference in New York

Copenhagen, Denmark – April 30, 2019:  IO Biotech’s CEO, Mai-Britt Zocca, Ph.D., will participate in a panel discussion entitled, “IO Session I: Combination Failures & Futures: Much Ado About What?” at the 30th Annual Cancer Progress Conference in New York City on May 7-8, 2019. 

IO Biotech will participate in the discussion together with senior executives from GlaxoSmithKline, Cancer Research Institute, Parker Institute For Cancer Immunotherapy, Agenus, and KAPital Consulting. The discussion will be moderated by Jeffrey M. Bockman, PhD, Executive Vice President, Head of Oncology Practice, Cello Health BioConsulting.

The discussion is to take place on Tuesday, May 7, 2019 from 3:15 to 4:30 PM at Convene at 32 Old Slip, New York. More information is available at www.cancerprogressbydh.com.

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.

Contacts
Mai-Britt Zocca, PhD, CEO and founder of IO Biotech
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.