IO103 / 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

A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma (clinicaltrials.gov) - P2a; N=10; Completed; Sponsor: Herlev and Gentofte Hospital; Recruiting ➔ Completed; Trial completion date: Jul 2019 ➔ Feb 2020; Trial primary completion date: Jan 2019 ➔ Feb 2020

Clinical • IO biomarker • Trial completion • Trial completion date • Trial primary completion date • Basal Cell Carcinoma • Oncology • Skin Nodular Basal Cell Carcinoma • CD8 • PD-L1

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

PD-L1 Peptide Vaccination in High Risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P2a | N=6 | Terminated | Sponsor: Lene Meldgaard Knudsen | N=20 ➔ 6 | Recruiting ➔ Terminated; Insufficient recruitment within planned enrolmentperiod.

Enrollment change • Monotherapy • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology • PD-L1

Peptide Vaccination With PD-L1 and PD-L2 Peptides in Untreated Chronic Lymphatic Leukemia. (clinicaltrials.gov) - P2 | N=19 | Completed | Sponsor: Lars Møller Pedersen | Active, not recruiting ➔ Completed

IO biomarker • Trial completion • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • IGH

A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma. (PubMed, Nat Med) - P1/2 | "We tested a first-in-class immune-modulatory vaccine (IO102/IO103) against indoleamine 2,3-dioxygenase (IDO) and PD ligand 1 (PD-L1), targeting immunosuppressive cells and tumor cells expressing IDO and/or PD-L1 (IDO/PD-L1), combined with nivolumab. T cell influx of peripherally expanded T cells into tumor sites was observed in responding patients, and general enrichment of IDO- and PD-L1-specific clones after treatment was documented. These clinical efficacy and favorable safety data support further validation in a larger randomized trial to confirm the clinical potential of this immunomodulating approach."

Combination therapy • Journal • P1/2 data • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • PD-L1

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: IO Biotech

Clinical • Combination therapy • New P2 trial • Pan tumor • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • PD-L1

[VIRTUAL] Efficacy and safety of IO103 a novel anti PD-L1 vaccine in basal cell carcinoma. (ASCO 2020) - P1, P2a | "In this exploratory study, one target tumor achieved partial response. Nonetheless, the two clearances and one partial response of non-target tumors suggest that IO103 may be effective against BCCs. The vaccine was well tolerated."

Clinical • Basal Cell Carcinoma • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Multiple Myeloma • Oncology • PD-L1

PEPTIDE VACCINATION AGAINST PD-L1 (IO103) IN MULTIPLE MYELOMA - A PHASE I FIRST IN HUMAN TRIAL (EHA 2019) - P1, P2a; "All patients received zoledronic acid. The vaccine is highly immunogenic. Two phase IIa studies testing PD-L1 (IO103) as monotherapy are ongoing, one for patients with high-risk smoldering multiple myeloma (NCT03850522) and one for patients with basal cell carcinoma before surgery (NCT03714529)."

P1 data

[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

Vaccination against PD-L1 with IO103 a Novel Immune Modulatory Vaccine in Basal Cell Carcinoma: A Phase IIa Study. (PubMed, Cancers (Basel)) - P2a | "Immune responses against IO103 were induced in blood samples from nine of ten and skin-infiltrating lymphocytes from five of the nine patients. The regressions seen in non-target tumors suggest that IO103 may be effective against a subtype of BCC."

Journal • P2a data • Basal Cell Carcinoma • Immune Modulation • Inflammation • Non-melanoma Skin Cancer • Oncology

Peptide Vaccination With IO103 and IO120 in Patients With Chronic Lymphocytic Leukemia. (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: Lars Møller Pedersen; Trial completion date: Oct 2020 ➔ Mar 2021; Trial primary completion date: Oct 2020 ➔ Mar 2021

Clinical • IO biomarker • Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • IGH

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

Peptide Vaccination Against PD-L1 With IO103 a Novel Immune Modulatory Vaccine in Multiple Myeloma: A Phase I First-in-Human Trial. (PubMed, Front Immunol) - P1 | "This study has prompted the initiation of later phase trials to assess the vaccines efficacy. clinicaltrials.org, identifier NCT03042793."

Journal • P1 data • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Multiple Myeloma • Oncology

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

Peptide Vaccination With IO103 and IO120 in Patients With Chronic Lymphocytic Leukemia. (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: Lars Møller Pedersen; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • IO Biomarker • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • IGH

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

Peptide Vaccination With IO103 and IO120 in Patients With Chronic Lymphocytic Leukemia. (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Lars Møller Pedersen

Clinical • IO Biomarker • New P2 trial • PD(L)-1 Biomarker

Phase IIa Trial of PD-L1 Peptide Vaccination as Monotherapy in High Risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P2a; N=20; Recruiting; Sponsor: Lene Meldgaard Knudsen

Monotherapy • New P2a trial