PD-1およびPD-L1阻害剤 - 競合情勢、2023年

当レポートでは、PD-1およびPD-L1阻害剤市場について調査し、PD-1およびPD-L1阻害剤の概要と上市済みおよびパイプライン治療薬動向、アンメットニーズ、参入企業のプロファイルと製品概要などをまとめています。

目次

イントロダクション

エグゼクティブサマリー

PD-1およびPD-L1阻害剤：概要

• プログラムデス-1（PD-1）
• プログラムデスリガンド-1（PD-L1）
• PD-1およびPD-L1阻害剤のMOA
• PD-1およびPD-L1阻害剤の重要性

PD-1およびPD-L1阻害剤- 分析的視点：詳細な商業的評価

競合情勢

• 企業の比較評価（治療法別、開発段階別、技術別）

治療評価

• 製品タイプ別評価
• 段階別・製品タイプ評価
• 投与経路別評価
• 段階別・投与経路別評価
• 分子タイプ別評価
• 段階別・分子タイプ別評価

PD-1およびPD-L1阻害剤：企業および製品プロファイル（上市済み治療薬）

Merck Sharp & Dohme LLC

• 会社概要

KEYTRUDA

• 製品説明
• 研究開発活動
• 商品開発活動

PD-1およびPD-L1阻害剤：企業および製品プロファイル（パイプライン治療薬）

後期段階の製品（第III相）

• 比較解析

BIOCAD

• 会社概要

プロゴリマブ

• 製品説明
• 研究開発活動
• 商品開発活動

詳細レポートの薬剤プロファイル

中間段階の製品（第II相）

• 比較解析

会社名

商品名

詳細レポートの薬剤プロファイル

初期段階の製品（第I相）

• 比較解析

Laekna Therapeutics

• 会社概要

FAZ053

• 製品説明
• 研究開発活動
• 商品開発活動

詳細レポートの薬剤プロファイル

前臨床および創薬段階の製品

• 比較解析

会社名

商品名

詳細レポートの薬剤プロファイル

非アクティブな製品

• 比較解析

PD-1およびPD-L1阻害剤-アンメットニーズ

PD-1およびPD-L1阻害剤-市場促進要因と抑制要因

付録

List of Tables

• Table 1 Total Products for PD-1 AND PD-L1 Inhibitors
• Table 2 Late Stage Products
• Table 3 Mid Stage Products
• Table 4 Early Stage Products
• Table 5 Pre-clinical & Discovery Stage Products
• Table 6 Assessment by Product Type
• Table 7 Assessment by Stage and Product Type
• Table 8 Assessment by Route of Administration
• Table 9 Assessment by Stage and Route of Administration
• Table 10 Assessment by Molecule Type
• Table 11 Assessment by Stage and Molecule Type
• Table 12 Inactive Products

List of Figures

• Figure 1 Total Products for PD-1 AND PD-L1 Inhibitors
• Figure 2 Late Stage Products
• Figure 3 Mid Stage Products
• Figure 4 Early Stage Products
• Figure 5 Preclinical and Discovery Stage Products
• Figure 6 Assessment by Product Type
• Figure 7 Assessment by Stage and Product Type
• Figure 8 Assessment by Route of Administration
• Figure 9 Assessment by Stage and Route of Administration
• Figure 10 Assessment by Molecule Type
• Figure 11 Assessment by Stage and Molecule Type
• Figure 12 Inactive Products

DelveInsight's , "PD-1 AND PD-L1 Inhibitors - Competitive landscape, 2023," report provides comprehensive insights about 180+ companies and 200+ drugs in PD-1 AND PD-L1 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

PD-1 AND PD-L1 Inhibitors: Understanding

PD-1 AND PD-L1 Inhibitors: Overview

PD-1 (programmed cell death protein 1) is found on the surface of cancer cells. It is used by tumors to evade the immune system so blocking its action enables the body to attack and kill cancer. T cells constantly monitor our body for abnormal cells and eliminate them before they can turn into cancer. A key step in tumor development is finding ways to avoid or shut down the immune system. When a T cell becomes activated, it also needs a stop signal in order to make sure it does not get over-activated. This can be done through inhibitory receptors, such as PD-1. After activation, T cells increase the expression of PD-1 on their surface, allowing them to receive a shutdown signal. Tumor cells take advantage of this system by expressing binding partners of PD-1, prematurely shutting down the T cells. Programmed death 1 (PD-1) proteins bind with two ligands, namely Programmed death-ligand 1 (PD-L1) and Programmed death-ligand 2 (PD-L2).

Programmed death-ligand 1 (PD-L1) in humans is encoded by the CD274 gene. PD-L1 is also known as cluster of differentiation 274 (CD274). It is a 40 kDa type 1 transmembrane protein that plays a major role in suppressing the immune system during particular events, such as pregnancy, tissue allograft, autoimmune disease, and other disease states such as hepatitis. Normally the immune system reacts to foreign antigens where there is some accumulation in the lymph nodes or spleen which triggers a proliferation of antigen-specific CD8+ T cell. PD-L1 binds to its receptor, PD-1, found on activated T cells, B cells, and myeloid cells to modulate activation or inhibition. PD-1 is a checkpoint protein on immune cells called T cells. It normally acts as a type of "off switch" that helps keep the T cells from attacking other cells in the body. It does this when it attaches to PD-L1, a protein on some normal (and cancer) cells. When PD-1 binds to PD-L1, it basically tells the T cell to leave the other cell alone. Some cancer cells have large amounts of PD-L1, which helps them hide from an immune attack. Monoclonal antibodies that target either PD-1 or PD-L1 can block this binding and boost the immune response against cancer cells. These drugs have shown a great deal of promise in treating certain cancers. PD-1 inhibitors: These drugs are given by IV (intravenously). Examples of drugs that target PD-1 include: Pembrolizumab (Keytruda), Nivolumab (Opdivo), Cemiplimab (Libtayo). These drugs have been shown to be helpful in treating several types of cancer, and new cancer types are being added as more studies show these drugs to be effective. Examples of drugs that target PD-L1 include: Atezolizumab (Tecentriq), Avelumab (Bavencio) and Durvalumab (Imfinzi).

Report Highlights:

• In April 2023, Enlivex Therapeutics Ltd., announced a clinical collaboration with BeiGene to evaluate the safety and efficacy of Allocetra™, an investigational macrophage-reprogramming cell therapy, in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment of patients with advanced-stage solid tumors.
• In January 2023, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), announced that CARsgen's execution of a collaboration agreement with F. Hoffmann-La Roche Ltd ("Roche") to evaluate CARsgen's investigational drug AB011, in combination with atezolizumab, Roche's PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma . Under the terms of the agreement, Roche will be responsible for operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study.
• In December 2022, Akeso announced a collaboration and license agreement (the "Agreement") with Summit Therapeutics Inc., to out-license its breakthrough bispecific antibody, ivonescimab (PD-1/VEGF, AK112) for development and commercialization in the United States, Canada, Europe, and Japan (the "License Territories"). In addition, the Company will co-brand the product in the License Territories.
• In September 2022, Merck announced that KEYTRUDA, Merck's anti-PD-1 therapy, received four new approvals from Japan's Ministry of Health, Labor and Welfare (MHLW):
• KEYTRUDA in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for patients with hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer at high risk of recurrence, based on data from the KEYNOTE-522 trial;
• KEYTRUDA as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on data from the KEYNOTE-564 trial
• KEYTRUDA in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with advanced or recurrent cervical cancer with no prior chemotherapy who are not amenable to curative treatment, based on data from the KEYNOTE-826 trial
• KEYTRUDA as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection, based on data from the KEYNOTE-716 trial
• In July 2022, TRACON Pharmaceuticals, Inc. announced the enrollment of the 36^th patient in the ENVASARC pivotal trial at the 600 mg dose of envafolimab, which enables the initial independent data monitoring committee (IDMC) interim efficacy analysis to proceed. The interim analysis is expected to occur in the fourth quarter of this year.
• In January 2022, Merck announced that the European Commission has approved KEYTRUDA as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

PD-1 AND PD-L1 Inhibitors: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Merck

Merck, known as MSD outside of the United States and Canada, are unified around the purpose: company uses the power of leading-edge science to save and improve lives around the world. Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. Merck also continue to strengthen the portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.

Product Description: KEYTRUDA

Pembrolizumab is the active ingredient of KEYTRUDA, which is a humanized monoclonal antibody that binds to the programmed cell death - 1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response. Pembrolizumab is an IgG4 kappa immunoglobulin and has an approximate 149 kDa molecular weight. KEYTRUDA has received approval for advanced melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer, classical Hodgkin lymphoma, microsatellite-instability-high cancer, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Small Cell Lung Cancer (SCLC), Microsatellite Instability-High Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Endometrial Carcinoma and advanced urothelial bladder cancer. In January 2020, Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. In January 2023, the Food and Drug Administration (FDA) approved pembrolizumab (KEYTRUDA, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

2. Company Overview: AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. AstraZeneca is boldly pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

Product Description: IMFINZI

IMFINZI (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.

IMFINZI is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial. IMFINZI is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial. In an exploratory analysis in 2021, updated results from the CASPIAN trial showed IMFINZI plus chemotherapy tripled patient survival at three years versus chemotherapy alone. Additionally, IMFINZI is approved in combination with a short course of IMJUDO (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial. In addition to its indications in lung cancer, IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer in the US, EU, Japan and several other countries; in combination with IMJUDO in unresectable hepatocellular carcinoma in the US, EU and Japan; and in previously treated patients with advanced bladder cancer in several countries. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with bladder cancer, several gastrointestinal (GI) cancers, ovarian cancer, endometrial cancer and other solid tumors.

PD-1 AND PD-L1 Inhibitors: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Genentech

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system. In addition to Genentech's approved PD-L1 checkpoint inhibitor, the company's broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies.

Product Description: TECENTRIQ

TECENTRIQ (atezolizumab), is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery.

2. Company Overview: Tracon Pharmaceuticals Inc.

TRACON is a clinical-stage biopharmaceutical company utilizing a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies. The Company's clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON's product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent.

Product Description: Envafolimab

Envafolimab is a novel, single-domain PD-L1 antibody that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON's corporate partners, Alphamab Oncology and 3D Medicines.

3. Company Overview: BIOCAD

BIOCAD is one of the largest innovative biotech companies in Russia. It brought together world-class R&D centers, modern pharmaceutical and biotechnological production, and preclinical and clinical trials, compliant with international standards. BIOCAD is a full-cycle drug development company, from molecule search to mass production and marketing support. The drugs are intended for the treatment of oncological and autoimmune diseases. Present product portfolio includes 61 medical products, 22 of them are biological. Over 40 products are now in different development stages. Development of drugs for cancer therapy is one of the priorities of the company.

Product Description: Prolgolimab

Prolgolimab is the first immunoglobulin G1 anti-PD-1 monoclonal antibody with Fc silencing "LALA" mutation. The mechanism of action of PD-1 inhibitors is aimed at restoring the ability of T-lymphocytes to recognize and destroy malignant cells, and as a result the immune system restarts fighting the tumor. Prolgolimab is already approved in Russia for the treatment of unresectable or metastatic melanoma. BIOCAD is also investigating Prolgolimab and recruiting the patients for European Phase IIII clinical study in advanced NSCLC and has received multiple authorizations across Europe to conduct the Phase III study in advanced Cervical Cancer.

4. Company Overview: Laekna Therapeutics

Laekna is a clinical-stage global biotechnology company, dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide.

Product Description: FAZ053

FAZ053 (anti-PD-L1) is an investigational immuno-oncology treatment being developed by Laekna Therapeutics for patients with advanced cancers. It is a monoclonal antibody directed against a protein called programmed cell death-1 ligand 1 (PD-L1). Upon administration, anti-PD-L1 monoclonal antibody FAZ053 binds to PD-L1, blocking its binding to and activation of its receptor programmed death 1 (PD-1), which may enhance the T-cell-mediated anti-tumor immune response and reverse T-cell inactivation. Laekna initiated a Phase I trial in combination with PDR001 in patients with advanced solid tumors. The aim of this trial is to address the unmet needs of people with cancer and bring innovative, effective treatments to more cancer patients across China.

Further product details are provided in the report……..

PD-1 AND PD-L1 Inhibitors Analytical Perspective by DelveInsight

In-depth Commercial Assessment: PD-1 AND PD-L1 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.

PD-1 AND PD-L1 Inhibitors Competitive Landscape

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

PD-1 AND PD-L1 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 PD-1 AND PD-L1 Inhibitors drugs?
• How many PD-1 AND PD-L1 Inhibitors drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of PD-1 AND PD-L1 Inhibitors?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the PD-1 AND PD-L1 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 PD-1 AND PD-L1 Inhibitors and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Merck
• Laekna Therapeutics
• Genentech
• Tracon Pharmaceuticals Inc.
• Celgene
• MedImmune
• Hangzhou Sumgen Biotech
• Lepu Biopharma
• Harbour BioMed
• Curis
• BeiGene
• Apollomics
• STCube Pharmaceuticals
• Aptevo Therapeutics
• Atridia
• Centessa Pharmaceuticals
• Orum Therapeutics
• EMD Serono

Key Products

• Envafolimab
• Keytruda
• FAZ053
• TECENTRIQ
• Durvalumab
• SG 12473
• LP 002
• HBM 9027
• CA 170
• Tislelizumab
• Geptanolimab
• STT 01
• Adebrelimab
• APVO-711
• LB-101
• Research programme: PD-1-Cbl-b
• Bintrafusp alfa

Table of Contents

Introduction

Executive Summary

PD-1 AND PD-L1 Inhibitors: Overview

• Programmed Death-1 (PD-1)
• Programmed Death Ligand-1 (PD-L1)
• MOA of PD-1 and PD-L1 inhibitors
• Significance of PD-1 and PD-L1 inhibitors

PD-1 AND PD-L1 Inhibitors -Analytical Perspective: In-depth Commercial Assessment

• PD-1 AND PD-L1 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

PD-1 AND PD-L1 Inhibitors: Company and Product Profiles (Marketed Therapies)

Merck Sharp & Dohme LLC

• Company Overview

KEYTRUDA

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

PD-1 AND PD-L1 Inhibitors: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

BIOCAD

• Company Overview

Prolgolimab

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

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

• Comparative Analysis

Company Name

• Company Overview

Product Name

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

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

• Comparative Analysis

Laekna Therapeutics

• Company Overview

FAZ 053

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

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products

• Comparative Analysis

Company Name

• Company Overview

Product Name

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

Drug profiles in the detailed report…..

Inactive Products

• Comparative Analysis

PD-1 AND PD-L1 Inhibitors- Unmet needs

PD-1 AND PD-L1 Inhibitors - Market drivers and barriers

Appendix