IO102 / IO Biotech - LARVOL DELTA

Translational investigations in the HN1901 phase II window-of-opportunity study investigating the biological activity of an IDO1 (IO102) and PD-L1 (IO103) immune-modulatory peptide cancer vaccines in squamous cell carcinoma of the head and neck. (PubMed, Eur Arch Otorhinolaryngol) - No abstract available

Journal • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IDO1 • PD-L1

IO 102—Application to Clinical Practice (STS 2025) - No abstract available

Clinical

KIEO: Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN). (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

KIEO: Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN). (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase I/II Trial of IO102 and Pembrolizumab With/Without Chemotherapy as First-line Treatment of Metastatic NSCLC (IASLC-WCLC 2019) - P1/2; "...Our first-generation IDO vaccine (IO101) has shown promising antitumor activity and a favorable safety in heavily pretreated NSCLC patients (Iversen, CCR 2013)...Cohort A: IO102 (100µg s.c.) and pembrolizumab (200 mg) (PD-L1 ≥ 50%); Cohort B: IO102, pembrolizumab and carboplatin plus pemetrexed (PD-L1 < 50%)... Section not applicable"

Clinical • IO biomarker • P1/2 data • PD(L)-1 Biomarker • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

An open-label, randomized, phase I/II trial of IO102 and pembrolizumab, or IO102, pembrolizumab and chemotherapy, as first-line treatment for patients with metastatic non-small cell lung cancer (ELCC 2019) - P1/2; "...Our first-generation IDO vaccine (IO101) has shown promising antitumor activity and a favorable safety in heavily pretreated NSCLC patients (Iversen, CCR 2013)...Cohort A: IO102 (100µg s.c.) and pembrolizumab (200 mg) (PD-L1 ≥ 50%); Cohort B: IO102, pembrolizumab and carboplatin plus pemetrexed (PD-L1 < 50%)...Secondary endpoints include ORR per iRECIST, duration of response, progression free survival, overall survival, and biomarkers including immunoscore in tissue, tumour mutational burden and immunomonitoring in blood. The study is enrolling in Europe and US: EudraCT Number 2018-000139-28 / IND Number 018081."

Clinical • IO biomarker • P1/2 data • PD(L)-1 Biomarker • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

IO102-IO103 Plus Pembrolizumab Shows Promise in Treatment-Naïve, Advanced Solid Tumors (Targeted Oncology) - '"IO102 and IO103 stimulate activation of human T-cells against IDO and PD-L1 expressing cells, respectively, and they have been demonstrated to activate proinflammatory immune responses and cytotoxic killing of immunosuppressive cells in vitro. Thus, treatment with IDO and PD-L1 peptides in patients with cancer may activate the immune system to eradicate IDO- and PDL1 expressing tumor and immune cells in the tumor microenvironment, facilitating the activation and proliferation of effector T-cells against tumor cells, explained Riess."

Media quote

Activity and Safety of Peptide-based Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck. (clinicaltrials.gov) - P2 | N=17 | Recruiting | Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain | N=11 ➔ 17

Enrollment change • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IFNG

KEYNOTE-764: IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC (clinicaltrials.gov) - P1/2 | N=109 | Completed | Sponsor: IO Biotech | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

An open-label, randomized, phase I/II trial of IO102 and pembrolizumab, or IO102, pembrolizumab and chemotherapy, as first-line treatment for patients with metastatic non-small cell lung cancer (ELCC 2019) - P1/2; "...Our first-generation IDO vaccine (IO101) has shown promising antitumor activity and a favorable safety in heavily pretreated NSCLC patients (Iversen, CCR 2013)...Cohort A: IO102 (100µg s.c.) and pembrolizumab (200 mg) (PD-L1 ≥ 50%); Cohort B: IO102, pembrolizumab and carboplatin plus pemetrexed (PD-L1 < 50%)...Secondary endpoints include ORR per iRECIST, duration of response, progression free survival, overall survival, and biomarkers including immunoscore in tissue, tumour mutational burden and immunomonitoring in blood. The study is enrolling in Europe and US: EudraCT Number 2018-000139-28 / IND Number 018081."

Clinical • IO Biomarker • P1/2 data • PD(L)-1 Biomarker • Tumor Mutational Burden

[VIRTUAL] Clinical efficacy and immunity of combination therapy with nivolumab and IDO/PD-L1 peptide vaccine in patients with metastatic melanoma: A phase I/II trial (ESMO 2020) - P1/2 | "Background The IDO/PD-L1 (IO102/IO103)1 peptide vaccine is a first-in-class immunomodulatory vaccine containing single IDO- and PD-L1-derived long peptide sequences designed to engage and activate IDO and PD-L1 specific T-cells mediating immune switch. Funding: Has not received any funding. Clinical trial identification: NCT03047928."

Clinical • Combination therapy • Late-breaking abstract • P1/2 data • Melanoma • Oncology • Solid Tumor • PD-L1

IO Biotech Announces Clinical Collaboration with MSD to Evaluate IO102-IO103 with KEYTRUDA (pembrolizumab) as First-Line Treatment in Metastatic Melanoma Patients in a Phase 3 Trial (PRNewswire) - “IO Biotech…announced today that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US 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), MSD's anti-PD-1 (programmed death receptor-1) therapy, in patients with previously untreated, unresectable or metastatic (advanced) melanoma….Biomarker studies will also be conducted. Under the terms of the agreement, IO Biotech will sponsor the Phase 3 trial and MSD will supply KEYTRUDA.”

Licensing / partnership • Melanoma • Oncology

Denmark's IO Vaccine Biotech Attracts Investor Interest (Scripintelligence) - "IO Biotech's Oversubscribed €127m Series B..."

Financing • Oncology

Novo Seeds' Portfolio Company, IO Biotech, Completes Oversubscribed EUR 127M Series B Financing to Accelerate Clinical Programs in Oncology (PRNewswire) - "Novo Seeds...announced today that its portfolio company, IO Biotech...has raised EUR 127 million in Series B financing...IO Biotech intends to use the proceeds from the financing to advance clinical trials for its early and late-stage immune-oncology programs, including a large randomized trial for IO102 and IO103 with anti-PD-1 monoclonal antibodies in metastatic melanoma."

Financing • Melanoma • Oncology • Skin Cancer

IO Biotech Announces Late-Breaking Oral Presentation of Phase 2 Clinical Melanoma Data Including Complete Response (CR) Rate of 45 Percent (PRNewswire) - P1/2, N=50; NCT03047928; "Data to be Presented at the ESMO Virtual Congress 2020...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."

P2 data • Melanoma • Oncology

Combination Therapy With Nivolumab and PD-L1/IDO Peptide Vaccine to Patients With Metastatic Melanoma (clinicaltrials.gov) - P1/2; N=50; Recruiting; Sponsor: Inge Marie Svane; Trial completion date: Apr 2020 ➔ Apr 2023; Trial primary completion date: Apr 2019 ➔ Apr 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC (clinicaltrials.gov) - P1/2; N=108; Active, not recruiting; Sponsor: IO Biotech; Trial primary completion date: Nov 2020 ➔ Mar 2021

Clinical • Combination therapy • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

HN1901: Activity and Safety of Peptide-based Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck. (clinicaltrials.gov) - P2; N=11; Recruiting; Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Clinical • New P2 trial • Head and Neck Cancer • Laryngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

The importance of long non-coding RNAs in neuropsychiatric disorders. (PubMed, Mol Aspects Med) - "Moreover, lncRNAs have vastly demonstrated correlations with mental illnesses such as neuropsychiatric disorders (NPDs), implying the vital jobs of these yet poorly-understood transcripts. Here, we underlie the accumulating evidence for the significance of lncRNAs in neural networks and their impairment in several NPDs including autism spectrum disorder (ASD), schizophrenia (SZ), intellectual disability (ID), major depressive disorder (MDD), Rett syndrome (RTT) and others."

Journal • Review • Autism Spectrum Disorder • CNS Disorders • Depression • Developmental Disorders • Genetic Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Combination Therapy With Nivolumab and PD-L1/IDO Peptide Vaccine to Patients With Metastatic Melanoma (clinicaltrials.gov) - P1/2; N=50; Recruiting; Sponsor: Inge Marie Svane; N=30 ➔ 50

Enrollment change • Biosimilar • Melanoma • Oncology • Solid Tumor

IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC (clinicaltrials.gov) - P1/2; N=108; Active, not recruiting; Sponsor: IO Biotech; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

An open-label, randomized, phase I/II trial of IO102 and pembrolizumab, or IO102, pembrolizumab and chemotherapy, as first-line treatment for patients with metastatic non-small cell lung cancer. (PubMed, Ann Oncol) - No abstract available

Clinical • Journal • P1/2 data

IO Biotech announces positive outcome of interim analysis of phase 2 randomized trial in first line non-small cell lung cancer (PRNewswire) - P1/2, N=108; IO102-012/KEYNOTE-764 (NCT03562871); Sponsor: IO Biotech; "IO Biotech...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."

P2 data

IO Biotech initiates global phase 2 portion of clinical trial for T-win immunotherapy in non-small cell lung cancer (PRNewswire.co.uk) - “IO Biotech…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)….'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.”

Enrollment open