同质化CAR专利状况分析（2023年）

Allogeneic CAR Patent Landscape Analysis 2023

出版日期: 2023年09月21日 | 出版商:

KnowMade | 英文 PDF > 120 Slides, Excel file: 416 Patent Families | 商品交期: 最快1-2个工作天内

价格

简介目录

同种异体 CAR，比自体 CAR-T 细胞更快、更便宜的治疗

细胞和基因治疗管道正在迅速进展，临床开发也是如此。FDA 表示，自 2017 年以来，细胞和基因治疗的 IND 申请数量增加了一倍以上。目前有超过 100 项临床试验正在进行中，而且这一数字还在不断增长，反映出人们对该主题日益增长的兴趣以及公司的经济利益。不过，迄今为止，欧美市场还没有产品，但针对主要专利已经提出了几项专利申请，并且有几家公司（主要是美国公司）正在新进入类似的CAR领域。

该报告调查了类似CAR的专利状况，并提供了400多项专利的资料库、已公布专利的时间趋势、专利申请国家和专利法律状态等资讯。

The pipeline for cell and gene therapies has been increasing at a rapid rate as are clinical developments. According to the FDA, the number of investigational new drug applications for cell and gene therapies has more than doubled since 2017. To manage this influx, in March 2023, the Office of Therapeutic Products was established as the first super office at the FDA's Center for Biologics Evaluation and Research. Chimeric antigen receptor (CAR) cell therapies are one of the major, and perhaps, best known, components of cell and gene therapies. CAR therapies, mainly to treat cancer, are immune cells engineered to express a chimeric receptor directed against tumor antigens. Currently, there are 2 main types of CAR therapies: autologous (patient-derived) and allogeneic (from healthy donor). Allogeneic CAR are produced from third-party healthy immune cells which confers many advantages. First, allogeneic CAR treatment enables the process to be done in 10 to 11 days versus a minimum of three weeks with autologous CAR therapy. This accelerated process eliminates the need for bridging therapy therefore allowing better results. Second, a high number of CAR immune cells can be produced from a single donor enabling an industrialized manufacturing processes. Moreover, CAR products can be standardized thanks to the production of batches of cryopreserved immune cells. This industrialization also leads to a reduction of manufacturing cost and ultimately reduces the price of treatments. However, allogeneic CAR can generate graft-versus-host disease, which is life-threatening. To overcome this major problem, companies and academics develop several approaches such as the use of various immune cells (e.g., NK, macrophage), the use of induced pluripotent stem cells or umbilical cord blood as source of immune cells or gene editing tools (e.g., CRISPR, TALEN). Currently, more than 100 clinical trials are in progress, but this number increases, reflecting the interest in this topic as well as the economic stakes for companies. However, to date, there is still no product on the European and United States markets, but some patent oppositions have already been initiated against key patents, and several newcomers, mainly American, are entering the allogeneic CAR field. In this evolving context, it is crucial to understand the intellectual property position and strategy of these different players. Such knowledge can help detect business risks and opportunities, anticipate emerging technologies, and enable strategic decisions to strengthen market position.

The analysis of the time evolution of patent publications shows that interest in allogeneic CAR began in the late 2000s. However, in 2017, for the 1^st time, two autologous CAR therapies have been approved by the FDA: KYMRIAH™ (tisagenlecleucel) from Novartis and YESCARTA™ (Axicabtagene Ciloleucel) from Kite Pharma, a Gilead company. These two therapies are CD19-directed genetically modified autologous T cell immunotherapies. This event allowed the CAR technology to fully develop and led to a significant increase in the number of patent families published since 2019 in allogeneic CAR area.

Analysis by segment

Allogeneic CAR have been investigated and the selected patent families labeled according to technologies to which they relate. This IP landscape features the following 4 types of segmentation: cells (T cells, NK, other), cells origin (PBMC from peripheral blood, iPSC, cord blood & placenta), gene editing tools (CRISPR, TALEN, ZFN, Meganuclease, other) and therapeutic areas (hematological malignancies , solid tumor).

EP oppositions

Currently, there is few EP oppositions which reflects the novelty of allogeneic CAR technology. Most of the proceedings are recent, having been filed in the past 5 years, and are still pending. 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 allogeneic CAR, 31 newcomers were identified. These companies are either start-up firms (8) or established companies (23) 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 also includes an Excel database with the 416 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.

INTRODUCTION

CAR 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
Patenting activity of IP leading companies
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
Cells
Cells origin
Gene editing tool
Therapeutic area

IP PROFILE OF KEY PLAYERS

Overview, key patents & clinical trials of:
- Adicet Bio
- Allogene Therapeutics
- Cellectis
- CRISPR Therapeutics
- Fate Therapeutics
- Gracell
- Precision Biosciences