체크포인트 억제제 : 경쟁 구도(2025년)

DelveInsight's, "Checkpoint Inhibitors - Competitive landscape, 2025," report provides comprehensive insights about 50+ companies and 60+ drugs in Checkpoint Inhibitors Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Checkpoint Inhibitors: Understanding

Checkpoint Inhibitors: Overview

Immune checkpoints are a normal part of the immune system. Their role is to prevent an immune response from being so strong that it destroys healthy cells in the body. Immune checkpoints engage when proteins on the surface of immune cells called T cells recognize and bind to partner proteins on other cells, such as some tumor cells. These proteins are called immune checkpoint proteins. When the checkpoint and partner proteins bind together, they send an "off" signal to the T cells. This can prevent the immune system from destroying the cancer. Immunotherapy drugs called immune checkpoint inhibitors work by blocking checkpoint proteins from binding with their partner proteins. This prevents the "off" signal from being sent, allowing the T cells to kill cancer cells.

The drugs block different checkpoint proteins including:

CTLA-4 (cytotoxic T lymphocyte associated protein 4): These inhibitors enhance the immune system's ability to attack cancer cells by blocking this checkpoint protein on T cells, which normally downregulates immune responses.

PD-1 (programmed cell death protein 1): These work by blocking the interaction between PD-1 on T cells and its ligands, preventing immune suppression by tumors and allowing T cells to remain active in attacking cancer cells.

PD-L1 (programmed cell death ligand 1): These target the PD-L1 protein on tumor cells, preventing it from binding to PD-1 on T cells, thus helping the immune system recognize and attack the cancer.

Checkpoint inhibitors work by blocking immune checkpoint proteins (like CTLA-4, PD-1, or PD-L1) that prevent T cells from attacking cancer cells, thus enhancing the body's immune response to tumors. They are commonly used in the treatment of cancers such as melanoma, lung cancer, bladder cancer, kidney cancer, and head and neck cancers. Immune-related side effects can occur, including inflammation of organs such as the lungs, liver and intestines, as the immune system may attack healthy tissues.

The immune system protects the body from disease, killing bacteria and viruses. One main type of immune cell that does this is called a T cell. T cells have proteins on them that turn on an immune response and other proteins that turn it off. These are called checkpoint proteins. Some checkpoint proteins help tell T cells to become active, for example when an infection is present. But if T cells are active for too long, or react to things they shouldn't, they can start to destroy healthy cells and tissues. So other checkpoints help tell T cells to switch off. Some cancer cells make high levels of proteins. These can switch off T cells, when they should really be attacking the cancer cells. So the cancer cells are pushing a stop button on the immune system. And the T cells can no longer recognise and kill cancer cells. They stop the proteins on the cancer cells from pushing the stop button. This turns the immune system back on and the T cells are able to find and attack the cancer cells.

Immunotherapy-based regimens have been included into the treatment's algorithm of several cancer types. Programmed death-1 (PD-1) and cytotoxic T lymphocyte antigen-4 (CTLA-4) interact with their ligands found on the surface of antigen presenting cells (APC) or tumor cells (PD-L1/2 and CD80/86). Through these interactions, stimulatory or inhibitory signals are established. Immune checkpoint inhibitors (ICIs), block these interactions, and when administered not only as monotherapy but also as part of combination regimens, have shown to improve survival results in multiple advanced cancers leading to an increasing number of patients treated with ICI and, as a consequence, a rise in the number of patients developing immune-related adverse events (irAEs). Presence of irAEs has been associated with greater benefit from treatment, especially when blocking PD-L1.

Report Highlights:

• In February 2025, Genome & Company signed a global license agreement with Ellipses Pharma, for GENA-104, a novel targeted immuno-oncology drug. Ellipses has agreed to in-license global rights to 'GENA-104', a first-in-class immuno-oncology monoclonal antibody that targets CNTN4, a recently discovered checkpoint protein that is highly expressed in a wide range of tumour types. GENA-104 is a new immune checkpoint inhibitor targeting CNTN4.
• In November 29 2024, Helix BioPharma Corp. announced that it has entered into an asset purchase agreement with Laevoroc Immunology AG. As a result of the Transaction, Helix acquired the intellectual property, inventory, assigned agreements and rights to LR 09, an oral immune checkpoint inhibitor in preclinical development for patients relapsing with leukemia after the intensive journey of allogeneic stem cell transplantation (SCT).
• In August 2024, OncoC4, Inc. announced the first patient has been dosed in the first-in-human Phase I ONC-841-002 trial (NCT06352359) evaluating ONC-841, a potential first-in-class SIGLEC10 blocking antibody for the treatment of solid tumors.
• In April 2024, OncoC4, Inc. announced that the United States Food and Drug Administration ("FDA") has cleared the investigational new drug ("IND") application for ONC-841, a potential first-in-class SIGLEC 10 blocking antibody for the treatment of solid tumors.
• In June 2024, Mozart Therapeutics, announced the dosing of the first cohort of participants in the company's initial clinical study of MTX-101, a first-in-class CD8 Treg modulator and autoimmune checkpoint inhibitor.
• In April 2024 OncoC4, Inc. announced that the United States Food and Drug Administration has cleared the investigational new drug application for ONC-841, a potential first-in-class SIGLEC 10 blocking antibody for the treatment of solid tumors.

Checkpoint Inhibitors: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Bristol Myers Squibb/ Ono Pharmaceuticals

Bristol Myers Squibb (BMS) is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines. With a strong presence in oncology, immunology, cardiovascular, and fibrosis, BMS aims to address critical medical needs. The company leverages cutting-edge science and technology to develop treatments that improve patient outcomes. BMS has a diverse pipeline of therapies, with a commitment to sustainability and social responsibility. Headquartered in New York, BMS operates globally, collaborating with various healthcare stakeholders to advance global health.

Ono Pharmaceutical Co., Ltd. is a Japanese biopharmaceutical company specializing in the research, development, and commercialization of innovative therapies. The company focuses primarily on oncology, immunology, and inflammation, with a strong pipeline of new treatments. Ono is known for its commitment to advancing cutting-edge science, including its significant role in the development of immune checkpoint inhibitors. With a global presence, Ono collaborates with various international partners to bring innovative medicines to patients. Headquartered in Osaka, Japan, Ono Pharmaceutical is dedicated to improving the quality of life through its therapeutics.

Product Description: Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo's leading global development program is based on Bristol Myers Squibb's scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company's Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

2. Company Overview: Genentech

Genentech, a member of the Roche Group, is a leading biotechnology company headquartered in South San Francisco, California. Founded in 1976, it pioneered the biotech industry with the development of recombinant DNA technology. Genentech focuses on innovative therapies in oncology, immunology, neuroscience, and ophthalmology. It has developed breakthrough biologics like Herceptin, Avastin, Rituxan, and Tecentriq. The company emphasizes a science-driven approach and strong R&D pipeline. As a part of Roche since 2009, Genentech continues to operate as an independent research and early development center.

Product Description: Atezolizumab

Atezolizumab (brand name: Tecentriq) is a monoclonal antibody and immune checkpoint inhibitor developed by Genentech/Roche. It targets PD-L1 (programmed death-ligand 1), restoring T-cell activity to help the immune system detect and destroy cancer cells. Atezolizumab is approved for multiple cancers, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), urothelial carcinoma, and hepatocellular carcinoma (HCC). It can be used as monotherapy or in combination with chemotherapy or targeted therapies. Administered intravenously, it is generally well tolerated but may cause immune-related adverse events. Tecentriq has become a key drug in the evolving field of cancer immunotherapy.

Checkpoint Inhibitors: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: OncoC4

OncoC4 is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies for cancer treatment. The company's lead product candidate is a monoclonal antibody targeting the CTLA-4 immune checkpoint, aiming to enhance the body's immune response against tumors. OncoC4's research and development efforts are centered on advancing therapies that have the potential to improve outcomes for patients with various cancers. The company is committed to leveraging cutting-edge science and technology to address critical unmet needs in oncology. Headquartered in the United States, OncoC4 collaborates with industry leaders to further its mission of transforming cancer care.

Product Description: ONC-841

ONC-841 is a humanized antagonist anti-SIGLEC10 monoclonal antibody. It is the first SIGLEC10 antagonist to enter clinical development. Siglec10 is an inhibitory receptor gene broadly expressed in tumor-infiltrating immune cells that plays an important role in tumor evasion of the immune system through its interaction with CD24 present on tumor cells. ONC-841 blocks this interaction, enabling anti-tumor activation of immune cells including NK cells, macrophages and T cells. SIGLEC10 has an authentic immunoreceptor tyrosine-based inhibitory motif, which is distinct from other siglecs such as SIGLEC15. In preclinical studies ONC-841 has been shown increased phagocytosis of cancer cells and improved function of tumor-infiltrating T cells and innate cells, as well as enhanced antibody-dependent CD16a signalling, a surrogate for antibody-dependent cell mediated cytotoxicity (ADCC). Currently the drug is in Phase I stage of its development for the treatment of advanced solid tumors.

2. Company Overview: Kyowa Kirin

Boundless Bio is a clinical-stage oncology company dedicated to unlocking a new paradigm in cancer therapeutics to address the significant unmet need of patients with oncogene amplified tumors by targeting extrachromosomal DNA (ecDNA), a root cause of oncogene amplification observed in more than 14% of cancer patients. Boundless Bio is developing the first ecDNA-directed therapeutic candidates (ecDTx), BBI-355, which is an oral inhibitor of checkpoint kinase 1 (CHK1) being evaluated in a Phase 1/2 clinical trial in cancer patients with oncogene amplifications. Boundless Bio's second ecDTx, BBI-825, is an oral inhibitor of ribonucleotide reductase (RNR) being evaluated in a Phase 1/2 clinical trial in colorectal cancer patients with BRAFV600E or KRASG12C mutations and resistance gene amplifications. Leveraging its Spyglass platform, Boundless Bio has an additional program (ecDTx 3) advancing through preclinical development and discovery. Boundless Bio is headquartered in San Diego, CA.

Product Description: BBI-355

BBI-355, is a novel, oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1) being studied in the ongoing, first-in-human, Phase 1/2 POTENTIATE clinical trial (NCT05827614) in cancer patients with oncogene amplifications. CHK1 is a master regulator of cells' response to replication stress (RS). RS is elevated in cancer cells with oncogene amplification, including on ecDNA, and, because of this, represents a key vulnerability of those cells. BBI-355 was designed to exploit the elevated RS in ecDNA-enabled oncogene amplified cancer cells by disrupting proper CHK1 function in regulating RS and thereby facilitating catastrophic RS to preferentially kill cancer cells relative to healthy cells.

3. Company Overview: OncoC4

OncoC4, Inc. is a privately held, clinical-stage biopharmaceutical company headquartered in Rockville, Maryland. Founded in 2020 by immunologists Dr. Yang Liu and Dr. Pan Zheng, the company is dedicated to developing next-generation immunotherapies targeting both innate and adaptive immune checkpoints, such as CTLA-4, CD24, and Siglecs. Its lead asset, gotistobart (ONC-392), a novel anti-CTLA-4 antibody, is being co-developed with BioNTech for multiple solid tumor indications. The company's pipeline also includes ONC-841, an anti-Siglec-10 monoclonal antibody currently in Phase 1 trials for solid tumors. In 2024, OncoC4 expanded its capabilities by merging with AcroImmune, acquiring assets like AI-081, a PD-1/VEGF bispecific antibody, and establishing in-house clinical manufacturing facilities.

Product Description: ONC-841

ONC-841 is an investigational, first-in-class humanized monoclonal antibody developed by OncoC4, Inc. It targets SIGLEC10, an immune checkpoint receptor that enables tumor cells to evade immune detection by interacting with CD24. By blocking this interaction, ONC-841 aims to rejuvenate anti-tumor immune responses from T cells, NK cells, and macrophages within the tumor microenvironment. A Phase 1 clinical trial (NCT06352359) is currently underway in the U.S., evaluating ONC-841 as a monotherapy in patients with advanced or metastatic solid tumors. Initial safety, pharmacokinetics, and efficacy data are expected in 2025. If successful, ONC-841 could represent a novel approach in cancer immunotherapy by targeting innate immune checkpoints.

4. Company Overview: Transcode Therapeutics, inc

TransCode Therapeutics, Inc. is a Boston-based clinical-stage biopharmaceutical company founded in 2016, focused on developing RNA-based therapies to treat metastatic cancer. The company's proprietary TTX platform enables targeted delivery of therapeutic RNA molecules to previously undruggable genetic targets within tumor cells. Its lead candidate, TTX-MC138, targets microRNA-10b, a key regulator of metastasis in cancers such as breast, pancreatic, and glioblastoma. Other pipeline programs include TTX-siPDL1, an siRNA therapeutic modulating PD-L1 expression, and TTX-RIGA, an RNA-based agonist of RIG-I to activate innate immunity in the tumor microenvironment. TransCode is also advancing TTX-CRISPR and TTX-mRNA platforms for gene editing and cancer vaccine development, respectively. The company collaborates with institutions like the University of Texas MD Anderson Cancer Center to accelerate its research and development efforts.

Product Description: TTX-siPDL1

TTX-siPDL1 is an investigational RNA interference (RNAi) therapeutic developed by TransCode Therapeutics to target programmed death-ligand 1 (PD-L1) in solid tumors, particularly pancreatic ductal adenocarcinoma (PDAC). Unlike traditional monoclonal antibodies that block PD-L1 at the protein level, TTX-siPDL1 employs small interfering RNA (siRNA) to silence PD-L1 gene expression post-transcriptionally, thereby reducing PD-L1 production within tumor cells.

In preclinical studies, combining TTX-siPDL1 with the chemotherapy agent gemcitabine led to a 90% tumor regression within two weeks and extended survival in 67% of treated animal models over 12 weeks. These promising results suggest that TTX-siPDL1 could enhance immune responses in tumors that are typically resistant to conventional checkpoint inhibitors.

Currently, TTX-siPDL1 is in the preclinical development stage and has not yet received FDA approval. It is part of TransCode's broader pipeline of RNA-based therapeutics aimed at improving outcomes in hard-to-treat cancers.

Checkpoint Inhibitors Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Checkpoint Inhibitors Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Checkpoint Inhibitors Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Checkpoint Inhibitors Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Checkpoint Inhibitors drugs?
• How many Checkpoint Inhibitors drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Checkpoint Inhibitors?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Checkpoint Inhibitors therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Checkpoint Inhibitors and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• CanBas Co. Ltd
• Boundless Bio
• Sumitomo Pharma America, Inc
• Pharos I&BT Co
• Virion Therapeutics
• OncoC4
• Transcode Therapeutics, inc

Key Products

• CBP 501
• BBI-355
• SMP3124LP
• PHI 101
• VRON 0200
• ONC-841
• TTX siPDL1

Table of Contents

Introduction

Executive Summary

Checkpoint Inhibitors: Overview

• Introduction
• Classification
• Risk factors
• Diagnosis
• Treatment

Checkpoint Inhibitors -Analytical Perspective: In-depth Commercial Assessment

• Checkpoint Inhibitors Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, development stage, and technology)

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

Checkpoint Inhibitors: Company and Product Profiles (Marketed Therapies)

Bristol Myers Squibb/ Ono Pharmaceuticals

• Company Overview

Opdivo

• Product Description
• Research and Development Activities
• Product Developmental Activities

Checkpoint Inhibitors: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

Company Name

• Company Overview

Drug Name

• Product Description
• Research and Development Activities
• Product Developmental Activities

Mid Stage Products (Phase II)

• Comparative Analysis

CanBas Co. Ltd.

• Company Overview

CBP 501

• Product Description
• Research and Development Activities
• Product Developmental Activities

Early Stage Products (Phase I)

• Comparative Analysis

OncoC4

• Company Overview

ONC-841

• Product Description
• Research and Development Activities
• Product Developmental Activities

Preclinical and Discovery Stage Products

• Comparative Analysis

Company Name

• Company Overview

Product Name

• Product Description
• Research and Development Activities
• Product Developmental Activities

Inactive Products

• Comparative Analysis

Checkpoint Inhibitors- Unmet needs

Checkpoint Inhibitors - Market drivers and barriers