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, Sept. 17, 2020 /PRNewswire/ -- 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.

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