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IO Biotech Announces Late-Breaking Oral Presentation of Phase 2 Clinical Melanoma Data Including Complete Response (CR) Rate of 45 Percent

- Data to be Presented at the ESMO Virtual Congress 2020

- Melanoma trial (MM1636) shows best-in-class efficacy data in first line melanoma of IO102 and IO103 in combination with nivolumab (anti-PD1 antibody)

Copenhagen, Denmark – September 18, 2020: IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating anti-cancer therapies based on its proprietary T-win® technology, today announced a late-breaking, oral presentation of best-in-class efficacy data in first line melanoma for its cancer vaccines, IO102 and IO103 in combination with anti-PD1, nivolumab. According to the abstract, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance  of their tumors. Vaccine specific T-cells were located in peripheral blood mononuclear cells (PBMCs) and at the tumor site.  These data will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 by Professor Inge Marie Svane, MD, Copenhagen University Hospital, Herlev. The abstract was published today online via the ESMO website (presentation number LBA48).

As of the data cut-off in August 2020, 30 patients were enrolled with a median follow up time of 15 months. One patient is pending first evaluation, 29 were evaluated, and by investigator review per RECIST v1.1, an ORR of 79 percent was reached; ORR was 94 percent and 62 percent in PD-L1 positive and negative patients, respectively. At data cut-off, 45 percent had reached a complete response and 34 percent achieved a partial response, which was significantly higher than a matched control group extracted from the Danish Metastatic Melanoma Database receiving anti-PD-1 monotherapy treatment as standard of care. The median progression free survival (mPFS) was 25.6 months. Except for local reactions at the vaccination site, toxicity was comparable to patients receiving nivolumab monotherapy. Vaccine specific T-cells against either IDO and/or PD-L1 were detectable from all treated patients in PBMCs and in several patients’ tumor sites where a biopsy was feasible. Preliminary results from tumor immune contexture analyses were also indicative of response.

“These early results are extremely encouraging and point toward a significant advantage of adding the vaccine to standard anti-PD1 therapy,” said Professor Inge Marie Svane, MD, Director at Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital Herlev, Denmark. “Not only have we seen almost twice as many patients benefitting from the treatment as expected, but it is also important to note that the combination was very well tolerated by the patients.”

“We are very pleased that the MM1636 study is selected as a late-breaking abstract at ESMO,” said Mai-Britt Zocca, PhD, Chief Executive Officer and founder at IO Biotech. “There is a high unmet need for a more effective treatment for melanoma patients, and our data demonstrate clearly our anticipated hypothesis of our T-win compounds to add additional efficacy to anti-PD1 treatment without any observed safety concerns.”

About MM1636 trial
The MM1636 trial is an investigator-initiated trial at the Copenhagen University Hospital, Herlev and enrolled 30 patients with metastatic melanoma. In this Phase 2 clinical trial, patients are receiving the anti programmed death 1 (PD-1) antibody nivolumab in combination with a multi antigen vaccine, IO102 and IO103, as first line treatment. Patients are being treated with nivolumab every second week as long as there is a clinical benefit or no adverse events prohibiting further treatment. IO102 and IO103 are given from the start of administration of nivolumab and every second week for the first six vaccines and thereafter every fourth week up to one year. The trial objectives are to assess safety, immune response in blood and biopsies as well as efficacy.

About IO102 and IO103
IO102 is a first-in-class, second-generation immune modulatory vaccine containing a single Indoleamine 2,3-dioxygenase (IDO) derived peptide sequence designed to engage and activate IDO specific human anti-regulatory T-cells.

IO103 is a first-in-class, immune modulatory vaccine containing a single PD-L1-derived peptide designed to engage and activate PD-L1 specific human anti-regulatory T-cells.  

Both compounds are based on IO Biotech’s proprietary T-win technology platform which enables the identification of compounds with a 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.

Media Inquiries
Jennifer Williams, Cook Williams Communications, Inc.    E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Exciting preclinical data confirm T-win MOA: IDO1 vaccine modulates tumor microenvironment leading to tumor reduction

- Lankenau Institute for Medical Research in collaboration with IO Biotech publish article in the Journal for ImmunoTherapy of Cancer

Copenhagen, Denmark – September 15, 2020: IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win® technology, announces preclinical data showing that the company’s off-the-shelf immunotherapy approach effectively reduced tumor growth in a colon cancer model.  The article "Peptide vaccination directed against IDO1-expressing immune cells elicits CD8+ and CD4+ T cell-mediated anti-tumor immunity and enhanced anti-PD1 responses," was first published online in the Journal for ImmunoTherapy of Cancer on July 20, 2020.

In this article, vaccines targeting IDO1 (enzyme which limits the cancer-fighting immune response) effectively reduced tumor growth in a colon carcinoma model. Intriguingly, anti-tumor responses were elicited despite the fact that IDO1 was expressed exclusively in tumor infiltrating lymphocytes; and vaccination resulted in a significant reduction in IDO1 expression in the tumor micro environment (TME). The in vivo anti-tumor effects in the TME confirm the mechanism of action (MoA) of identifying and eliminating cancer cells and reinforce the potential of the T-win platform to improve patient response rates to anti-PD1 therapy. Additionally, when subjects were rechallenged with tumor cells, they displayed complete protection from the cancer cells due to activation of the immune system, which suggests that the IDO1 vaccine could prevent cancer relapse in patients.

“While tremendous progress has been made with immunotherapies for cancer in recent years, many patients still experience eventual disease progression, which is why continued research on novel immunotherapies remains vitally important. ,” said Professor Alexander Muller, Lankenau Institute for Medical Research, Wynnerwood, Pennsylvania, USA. “I see IO Biotech’s T-win platform as one of the most exciting prospects on the immunotherapy horizon given its ability to simultaneously activate the immune system to target immunosuppressive cells as well as tumor cells.

"These results demonstrate clearly our anticipated hypothesis of our T-win platform," said Mai-Britt Zocca, PhD, Chief Executive Officer and founder at IO Biotech "T-win is based on novel science with a potentially profound impact, and we are excited to see this unfold in our clinical trials and now also supported with additional strong mechanistical data.”

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 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.