IO112 / IO Biotech - LARVOL DELTA

IO Biotech Reports 2024 Business Highlights (GlobeNewswire) - "The company plans to submit an Investigational New Drug Application (IND) for IO112 to the FDA in 2025."

IND • Oncology

IO Biotech Announces Publication of Preclinical Data Investigating Immune-Modulatory Effects of IO112, an Arginase 1-Targeting Therapeutic Cancer Vaccine Candidate (GlobeNewswire) - "The present study showed how Arg1-specific T cells expanded by the vaccine enhance anti-tumor immunity by reprogramming tumor-associated macrophages (TAMs) and promote a proinflammatory TME. Arg1 plays a central role in immune suppression, and its overexpression has been reported in several cancers....We look forward to submitting an IND for IO112 in 2025 and advancing into clinical development as part of our commitment to transform the treatment of cancer patients."

Preclinical • Oncology

IO Biotech Reports Third Quarter 2024 Financial Results and Provides Business Highlights (GlobeNewswire) - "As we look to the primary endpoint data readout from our Phase 3 pivotal trial in the first half of next year, we plan to be prepared to submit a Biologics License Application (BLA) to the FDA in 2025 and potentially make our first therapeutic cancer vaccine available for patients in the US with advanced melanoma in 2026....We are excited about the strength of the data supporting the potential of IO112 and plan to submit an Investigational New Drug (IND) application to the FDA for this program in 2025."

FDA filing • IND • Launch US • P3 data • Melanoma • Solid Tumor

Immune modulating vaccine against arginase 1 controls tumor growth via modulation of tumor-associated macrophages (SITC 2024) - "We previously reported the existence of intrinsic immunity against Arg1 in human,1 and that peptide vaccines against Arg1 (T-win ® IO112) control tumor growth and alter the M1/M2 macrophage ratio in murine models of cancer.2 In this study, we investigated whether TAMs are the direct targets of T cells against Arg1...The protocol for the use of human samples was approved by the Scientific Ethics Committee for The Capital Region of Denmark and conducted in accordance with the provisions of the Declaration of Helsinki. Written informed consent from the patients was obtained before study entry."

Genito-urinary Cancer • Head and Neck Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • CD14 • CD80 • CD86 • IFNG • IL2

Pre-clinical data from IO112, IO Biotech’s second therapeutic cancer vaccine candidate derived from the company’s T-win platform (GlobeNewswire) - "The data presented in the poster showcase that IO112 vaccination leads to robust expansion of Arg1-specific T cells, which in turn directly target and reprogram immune suppressive TAMs, leading to tumor growth inhibition....This strong data adds to the rationale for IO112 clinical development, and we look forward to submitting an IND for IO112 in 2025."

IND • Preclinical • Solid Tumor

IO Biotech Announces Two Poster Presentations at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting (GlobeNewswire) - "The first abstract accepted for poster presentation contains updated and expanded data from the complete cohort (n=31) from the first line (1L) cohort of patients with PD-L1 high metastatic non-small cell lung cancer (NSCLC) in the Company’s Phase 2 basket trial of investigational IO102-IO103 in combination with pembrolizumab (KEYTRUDA), Merck’s anti-PD-1 therapy (IOB-022/KN-D38). The second abstract accepted for poster presentation contains new pre-clinical data for the next candidate in the IO Biotech pipeline, IO112, which targets Arginase 1."

P2 data • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Arginase-1 vaccine promotes T cell immunity against arginase-1+ cells, controls tumor growth via immune modulation of tumor microenvironment (SITC 2023) - "This presents an attractive alternative strategy to other existing approaches currently under nonclinical and clinical investigations. Our findings bolster the clinical development of an ARG1 vaccine as a potential therapeutic strategy for various solid tumors."

Biomarker • IO biomarker • Tumor microenvironment • Oncology • Solid Tumor • ARG1 • CD4 • FPR2 • IFNG

IO Biotech Announces Three Poster Presentations at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting (GlobeNewswire) - "IO Biotech...announced three poster presentations at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023), to be held in San Diego, California on November 1-5, 2023. Two of the posters will include new in vivo and in vitro data related to IO Biotech’s lead therapeutic cancer vaccine candidate, IO102-IO103, currently being evaluated in a pivotal Phase 3 study. The third poster contains new pre-clinical data for the next candidate in the IO Biotech pipeline, IO112, which targets Arginase 1."

Preclinical • Oncology

Dual Vaccine Trial in Myeloproliferative Neoplasms (clinicaltrials.gov) - P1/2 | N=9 | Completed | Sponsor: Inge Marie Svane | Unknown status ➔ Completed | N=48 ➔ 9

Enrollment change • Trial completion • Essential Thrombocythemia • Hematological Disorders • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera • Thrombocytosis

Arginase-1 peptide-based vaccine is an exciting approach to modulate the tumor microenvironment and drive efficacy in preclinical tumor models (SITC 2022) - P3 | "Conclusions ARG1 is an attractive TME target and vaccination against it drove efficacy in vivo by increasing the recruitment of immune cells at tumor site thus changing from an immunosuppressive to a pro-inflammatory microenvironment. These data support the preclinical development of an ARG1 vaccine for the treatment of multiple solid tumors."

IO biomarker • Preclinical • Tumor microenvironment • Melanoma • Oncology • Solid Tumor • ARG1 • IDO1 • IFNG • PTPRC

Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Herlev Hospital | Unknown status ➔ Completed | N=10 ➔ 13

Enrollment change • Metastases • Trial completion • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • PD-1 • PD-L1

Arginase-1 targeting peptide vaccine in patients with metastatic solid tumors - A phase I trial. (PubMed, Front Immunol) - P1 | "The patients received an arginase-1 peptide vaccine comprising three 20-mer peptides from the ARG1 immunological "hot spot" region in combination with the adjuvant Montanide ISA-51...Nine (90%) of ten patients had measurable peptide-specific responses in the periphery blood, and two (20%) of ten patients attained stable disease on protocol treatment. https://clinicaltrials.gov/ct2/show/NCT03689192, identifier NCT03689192."

Journal • P1 data • Immunology • Inflammation • Oncology • Solid Tumor • CD4

IO Biotech Announces Invited Oral Presentation and Two Poster Presentations at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting (GlobeNewswire) - "IO Biotech...announced an oral presentation and two poster presentations at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022)....The invited oral presentation will provide an update on the Phase 1/2 study (MM1636) with IO102-103 in combination with nivolumab for metastatic melanoma....The two posters will discuss preclinical work on the next two candidates in the IO Biotech pipeline, which target the immunosuppressive effects of Arginase 1 and transforming growth factor beta 1 (TGF-β1)."

P1/2 data • Preclinical • Melanoma • Oncology • Skin Cancer • Solid Tumor

Modulating tumor microenvironment with arginase-1 specific T cells (CIMT 2022) - "Our study provides evidence that IO112 immune therapy against arginase-1 is an attractive way of modulating the immune suppressive tumor microenvironment for therapeutic benefit. With this rationale, we are currently undertaking IND enabling studies to explore this approach in a clinical setting."

Biomarker • Tumor microenvironment • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Oncology • CD4 • CD8 • IFNG • IL13 • IL4 • PD-L1 • TNFA

Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Herlev Hospital; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • PD-L1

Arginase-1 Peptide Vaccine in Patients with Metastatic Solid Tumors (ESMO-IO 2019) - "Clinical responses are evaluated using RECIST 1.1. Clinical trial identification: Eudra CT no: 2018-000719-26"

Clinical

Arginase-1-based vaccination against the tumor microenvironment: the identification of an optimal T-cell epitope. (PubMed, Cancer Immunol Immunother) - "Arg-1-specific T cells thus appear to have an important function in immune regulation. Because Arg-1 plays an important role in the immunosuppressive microenvironment in most cancers, an immune modulatory vaccination approach can readily be employed to tilt the balance away from immune suppression in these settings."

Biomarker • Journal • Review • Tumor microenvironment