双特异性抗体和癌症专利态势分析

双特异性抗体是癌症治疗的突破性IP。

BsAbs 为新药的设计和开发提供了令人兴奋的机会，并具有持久的治疗效果的潜力。

双特异性抗体 (bsAbs) 在癌症领域的发展呈现快速成长，并取得了显着的临床进展。最近的数据显示，临床试验中超过 85% 的 bsAb 用于癌症治疗，目前约有 600 种 bsAb 正在临床试验中。截至目前，已有 11 种 bsAb 获得批准用于治疗癌症，其中 10 种获得了美国 FDA 的批准。这种扩展反映了人们对这种创新治疗剂日益增长的兴趣。双特异性抗体是指旨在同时结合两种不同抗原的蛋白质。双特异性抗体既可以连接两种类型的细胞（反式结合），也可以结合单一细胞膜上的两个分子（顺式结合）。桥接细胞 BsAbs 占最大群体，其中 T 细胞重定向最为常见。 T 细胞接合剂可与细胞毒性 T 细胞和肿瘤细胞结合，促进对肿瘤的免疫反应。近年来已有多种 bsAb 获得批准。 2024年12月，美国FDA加速批准HER2 x HER3 bsAb用于治疗全身治疗之前或之后携带神经调节蛋白1（NRG1）基因融合且病情进展的不可切除或转移性晚期非小细胞肺癌（NSCLC）成年患者，或全身治疗之前或之后携带NRG1基因融合且病情进展的不可切除或晚期胰腺腺癌成年患者。然而，课题依然存在，包括生产的复杂性、毒性（细胞激素释放症候群、免疫效应细胞相关神经毒性症候群、输液相关反应）以及需要优化分子的稳定性和半衰期。为了克服这些障碍，我们正在探索创新方法，例如先进的抗体工程技术和新分子形式的开发。

从 1986 年到 21 世纪初，专利出版的数量虽然不多，但呈现成长趋势。自 2010 年以来，该领域发展显着，到 2023 年将拥有超过 400 个专利家族。 20 世纪 80 年代、90 年代和 21 世纪初，学术研究取得了许多进展，包括开发第一个不对称格式、首次展示 T 细胞重定向、第一个基于重组片段的格式、第一个通过物种限制性 LC 配对解决轻链 (LC) 关联问题、第一个通过使用互补重链 (HC) 和共同 LC 配对解决链对称问题、第一个对称物理所有这些创新都促进了 bsAbs 的建立。随后在2009年，bsAb catumaxomab（T淋巴细胞抗原CD3 x上皮细胞黏附分子（EpCAM））获得欧盟（EU）批准用于治疗恶性腹水。五年后，blinatumomab（CD3xB-淋巴细胞抗原-CD19）获得FDA批准。该药物于2015年在欧盟获得批准。

市场区隔分析

主要企业的IP简介

本报告研究了双特异性抗体和癌症专利格局，并提供了智慧财产权趋势，例如已发布专利的时间序列、专利申请国家和专利的法律状态。

目录

简介

摘要整理

专利形势概要

• 专利发布时间表
• 专利申请数量最多的公司排名
• 各大公司的现行法律地位
• 专利主体的法律地位
• 绘製目前主要智慧财产权持有者的地图
• 主要专利持有者的时间序列

新加入企业

• Start-Ups企业
• 老字号企业

联盟

主要的申请者的IP地位

• 专利申请者的IP龙头
• 专利申请者的IP领先技术的区域的可能性
• 主要专利
• 专利组合的强度指数

主要的EP专利异议提出申述

专利的市场区隔

• 定义
• 主要的发明专利权者:各技术
• CD3
• 免疫查核点
• 肿瘤抗原

主要企业的IP简介

概要，主要专利，临床试验

• Amgen
• Genentech
• Roche
• GenMab
• Janssen
• Regeneron
• Xencor

调查手法

KnowMade的简报

咨询方式

Bispecific Antibodies Mark a Breakthrough in Cancer Therapy Intellectual Property.

Report's Key Features:

• IP trends, including time evolution of published patents, countries of patent filings and patents' legal status
• Ranking of main patent assignees
• Key players' IP position and relative strength of their patent portfolios
• Segmentation: Tumor Antigens (ERBB family, BCMA, BRCA, mesothelin, PSMA, CEA, claudin, EPCAM, mucin, NKG2D, VEGF, CEACAM, MAGE, ROR1, c-Met and nectin), Immune Checkpoints (PD1 / PDL1, CTLA-4, LAG-3, TIM-3, OX40, ICOS, B7-H3, TIGIT and BTLA) and T cells (CD3).
• Analysis of collaborations and EP patent oppositions.
• Excel database containing all patents analyzed in the report, including segmentations + hyperlink to updated online database (legal status, documents etc.)

BsAbs offer exciting opportunities for the design and development of new drugs, and are expected to have lasting therapeutic impact

The development of bispecific antibodies (bsAbs) in oncology is experiencing rapid growth, accompanied by significant clinical advancements. According to recent data, more than 85% of bsAbs in clinical trials are cancer treatments, with approximately 600 bsAbs currently in clinical trials. To date, 11 bsAbs have received regulatory approval for use in cancer, ten of them by the US FDA. This expansion reflects the growing interest in these innovative therapeutic agents. Bispecific antibodies are engineered proteins designed to bind simultaneously to two distinct antigens. They can bridge two cell types (in-trans binding) or engage two molecules on the membrane of one cell (in-cis binding). BsAbs that bridge cells represent the largest group, with T cell redirection as the most common denominator. T-cell engagers bind both cytotoxic T cells and tumor cells, promoting a direct immune response against the tumor. Several bsAbs have recently received regulatory approvals. In December 2024, the U.S. FDA granted accelerated approval of a HER2 x HER3 bsAb for adults with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. However, challenges remain, such as the complexity of production, toxicities (cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, infusion-related reactions), and the need to optimize the stability and half-life of the molecules. Innovative approaches, such as advanced antibody engineering technologies and the development of new molecular formats, are being explored to overcome these obstacles. Understanding the intellectual property position and strategy of these various players is crucial in this evolving context. Detecting business risks and opportunities, anticipating emerging technologies, and enabling strategic decisions to strengthen market position can be achieved through this knowledge.

Between 1986 and the early 2000s, the number of patent publications is low but increasing. From 2010, the field is experiencing a significant acceleration, culminating in 2023 with more than 400 patent families. In the 1980s and 1990s and early 2000s, many advances were made in academic research such as the generation of the 1st asymmetric format, the 1st demonstration of T cell redirection, the 1st recombinant fragment-based formats, the 1st solution to light chain (LC) association issue through species-restricted LC pairing, the 1st solution to chain-association issue through use of complementary heavy chain (HC) (knobs into holes) and common LC, the 1st symmetric format, the discovery that natural human IgG4 is bispecific, the dual variable domain-Ig symmetric format pioneered, etc. All these innovations have contributed to the establishment of bsAbs. Then, in 2009, the bsAb catumaxomab (a T lymphocyte antigen CD3 x epithelial cell adhesion molecule (EpCAM)) received the European Union approval for the treatment of malignant ascites. Five years later, the blinatumomab (CD3xB lymphocyte antigen CD19) was FDA approved. It has been approved in the EU in 2015.

Analysis by segment

Bispecific Ab & Cancer have been investigated and the selected patent families labeled according to technologies to which they relate. This IP landscape features the following 3 types of segmentation: Tumor Antigens (ERBB family, BCMA, BRCA, mesothelin, PSMA, CEA, claudin, EPCAM, mucin, NKG2D, VEGF, CEACAM, MAGE, ROR1, c-Met and nectin), Immune Checkpoints (PD1 / PDL1, CTLA-4, LAG-3, TIM-3, OX40, ICOS, B7-H3, TIGIT and BTLA) and T cells (CD3).

EP oppositions

Currently, there is a significant number of EP oppositions which reflects the strategic issues of bispecific antibody & cancer for companies. For each opposed patent, the application date, assignee, opponent, opposition year, and results are detailed.

Identifying the companies that have recently emerged in the IP landscape

Among the players owning patent families related to Bispecific Ab & cancer, 52 newcomers were identified. These companies are either start-up firms (6) or established companies (46) developing their first technology in the field. Most IP newcomers are based in the U.S. and in Asia. It is possible that one of these innovative companies could become one of the next healthcare unicorns that the big corporations will be tempted to acquire.

IP profile of key players

This IP study includes a selection and description of main players. The patent portfolio analysis of main players includes a description of the assignee, patent portfolio description, time evolution of patent publication, main geographical coverage and live patents by technical segment. This IP profile overview is followed by the description of the technological content of their key patents and by a table with its clinical trials.

Moreover, the report includes an Excel spreadsheet with the 2895 patent families analyzed in this study. This useful patent database allows for multi-criteria searches and includes patent publication numbers, hyperlinks to the original documents, priority dates, titles, abstracts, patent assignees, each patent's current legal status and segmentation. The report also includes a Patent Online Database which legal status are updated for each patent document.

Companies mentioned in this report (non-exhaustive list):

ROCHE, AMGEN, JANSSEN, GENMAB, XENCOR, REGENERON PHARMACEUTICALS, GENENTECH - ROCHE, MACROGENICS, DRAGONFLY THERAPEUTICS, SANOFI, CHUGAI PHARMACEUTICAL, MERCK MSD, MERUS, BMS, SAMSUNG, JIANGSU HENGRUI PHARMACEUTICALS, ABBVIE, HEFEI TG IMMUNOPHARMA, MARENGO THERAPEUTICS, etc.

TABLE OF CONTENTS

INTRODUCTION

• BsAb for cancer therapy
• Scope of the report
• Reading guide
• Main patent assignees

EXECUTIVE SUMMARY

PATENT LANDSCAPE OVERVIEW

• Time evolution of patent publications
• Ranking of most prolific patent applicants
• Current legal status of the main players
• Patent legal status of the corpus
• Mapping of main current IP holders
• Time evolution of main patent assignees

NEWCOMERS

• Startup companies
• Established companies

COLLABORATIONS

IP POSITION OF MAIN APPLICANTS

• IP leadership of patent applicants
• IP prior art blocking potential of patent applicants
• Key patents
• Strength index of patent portfolios

MAIN EP PATENT OPPOSITIONS

PATENT SEGMENTATION

• Definition
• Main assignees by technology
• CD3
• Immune Checkpoint
• Tumor Antigen

IP PROFILE OF KEY PLAYERS

Overview, key patents & clinical trials of:

• Amgen
• Genentech
• Roche
• GenMab
• Janssen
• Regeneron
• Xencor

METHODOLOGY

• Patent search, selection and analysis
• Search strategy
• Terminologies for patent analysis
• Strength and blocking potential

KNOWMADE PRESENTATION

CONTACT