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基因治療學和RNAi 核酸藥物

市場調查報告書

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1799230

雙環毒素偶聯物的全球市場 - 臨床試驗，獨自平台，市場機會(2025年)

Global Bicycle Toxin Conjugates Clinical Trials, Proprietary Platforms & Market Opportunity Insight 2025

出版日期: 2025年08月01日 | 出版商:

KuicK Research | 英文 55 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

全球雙環毒素偶聯物市場亮點 - 臨床試驗、專有平台及市場機會 (2025) 報告

全球及地區洞察
雙環毒素偶聯物專有平台概覽
雙環毒素偶聯物研究及市場趨勢（依適應症劃分）
雙環毒素偶聯物臨床管線（依公司、適應症及分期劃分）
未來商業機遇
競爭格局

對雙環毒素偶聯物的需求及本報告的意義

對更安全、更有效、更有針對性的抗癌療法的需求日益增長，這推動了新療法的藥物研發。雙環毒素偶聯物 (BTC) 代表了新一代標靶治療藥物，其特徵是精準度高、藥物動力學良好、腫瘤穿透性強。 BTC 結合了雙環肽的親和力和化療藥物的細胞毒性有效載荷，旨在發揮高效的抗癌活性，同時最大限度地降低全身毒性。

本報告的發布意義非凡，正值雙環毒素偶聯物領域從早期臨床前景向堅實成果邁進之際。儘管該領域仍處於起步階段，但臨床進展、監管審批和研究投入的步伐正在加快。本分析全面概述了雙環毒素偶聯物目前的科學、臨床和商業發展狀況，為利益相關者提供了對這一快速發展領域的重要見解，該領域有可能重塑腫瘤學及其他領域的未來。

報告包含臨床試驗洞察

本報告詳細總結了正在進行的雙環毒素偶聯物臨床試驗，並概述了關鍵早期和中期候選治療藥物的開發。由Bicycle Therapeutics公司開發的三種雙環毒素偶聯物——BT1718、BT5528和澤來奈克肽培維多汀（Zele，BT8009）——目前正在進行早期和晚期臨床試驗。這些試驗針對多種實體瘤中的多種腫瘤相關抗原，包括MT1-MMP、EphA2和Nectin-4。

本報告記錄了這些試驗的重要訊息，包括臨床試驗階段、地理位置、申辦機構和正在研究的適應症。報告也總結了迄今為止的關鍵試驗結果。這些數據清晰準確地描繪了雙環毒素偶聯物的臨床進展和監管潛力。

技術平台、合作與協議

Bicycle Therapeutics 專有的 Bicycle® 平台構成了雙環毒素偶聯物開發的技術基礎。我們的化學合成勝肽技術能夠產生與 MMAE 和 DM1 等細胞毒素偶聯的小型、高選擇性結合物。這產生了一類介於生物製劑和小分子之間的治療藥物，可增強深層腫瘤滲透並促進清除。

合作是我們方法的核心。透過與英國癌症研究中心 (Cancer Research UK) 的新合作，BT1718 已進入由英國癌症研究中心贊助和資助的 1/2 期臨床試驗。此外，我們也參與了美國食品藥物管理局 (FDA) 的癌症管理和臨床研究實踐 (CDRP)。

活躍於雙環毒素偶聯物研發的主要公司

目前，Bicycle Therapeutics 是唯一一家積極進行雙環毒素偶聯物臨床階段研發的公司。 Bicycle Therapeutics 成立於英國劍橋，是該領域的全球領導者，擁有一系列針對多種腫瘤的雙環毒素偶聯物產品組合。公司持續開發第一代、第二代和第三代雙環毒素偶聯物，體現了其致力於推進此類新型療法的承諾。透過全球臨床試驗以及與大西洋和太平洋地區監管機構的互動，Bicycle Therapeutics 正在全球闡明雙環毒素偶聯物的未來方向和潛力。

一份關於雙環毒素偶聯物領域未來發展方向的報告

本報告顯示，雙環毒素偶聯物是精準腫瘤學領域一個重要的新興類別，在某些適應症上可能與抗體偶聯藥物（ADC）相媲美甚至超越ADC。快速通道和CDRP認定等監管方面的關注反映出機構對雙環毒素偶聯物日益增長的興趣。聯合療法的臨床療效表明，雙環毒素偶聯物可能很快就會成為第一線癌症治療方案中不可或缺的一部分。

隨著進一步發展，雙環毒素偶聯物平台的應用範圍可能超越腫瘤學，在傳染病和其他需要靶向有效載荷遞送的疾病領域展現出良好的前景。本文概述的雙環毒素偶聯物領域的發展清晰地展現了其獲得監管部門認可、擴大應用範圍和廣泛行業應用的途徑。

The increasing need for safer, more effective, and highly targeted anticancer therapies has driven pharmaceutical discovery towards new therapeutic modalities. Bicycle Toxin Conjugates (BTCs) are a new generation of targeted therapies possessing a distinctive blend of precision, favorable pharmacokinetics, and tumor penetration. Combining the binding affinity of bicyclic peptides and the cytotoxic payloads of chemotherapy drugs, BTCs are engineered to provide highly effective anti-cancer activity with reduced systemic toxicity.

This report is timely and critical as the bicycle toxin conjugates space transitions from initial clinical promise to solid achievements. While the area remains in its infancy, the velocity of clinical advancement, regulatory acceptance, and research investment is increasing. This analysis provides an all-encompassing perspective on where bicycle toxin conjugates are scientifically, clinically, and commercially now and gives stakeholders critical insight into a fast-developing area that can reshape future benchmarks in oncology and beyond.

Clinical Trials Insight Included In Report

The report offers an in-depth summary of the ongoing bicycle toxin conjugates clinical trial landscape, outlining the development of major therapeutic candidates through early- and mid-stage studies. Three bicycle toxin conjugates created by Bicycle Therapeutics, namely BT1718, BT5528, and zelenectide pevedotin (Zele, BT8009), are being studied in early and late-stage clinical trials. These trials are directed against several tumor-associated antigens, MT1-MMP, EphA2, and Nectin-4, in a variety of solid tumors.

This report records notable information on these trials, such as trial phases, geographical regions, sponsoring organizations, and indications being researched. It also summarizes key trial results to date; this data offer a clear, precise view of bicycle toxin conjugates clinical progress and regulatory promise

Technology Platforms, Collaborations and Agreements

Bicycle Therapeutics' proprietary Bicycle(R) platform constitutes the technological underpinning of bicycle toxin conjugates development. The chemically synthesized peptide technology allows small, highly selective binding agents to be generated coupled with cytotoxins such as MMAE and DM1. This results in a class of therapies that are intermediate between biologics and small molecules, showing enhanced deep tumor penetration and accelerated clearance.

Cooperative action is at the core of the firm's approach. A new collaboration with Cancer Research UK has brought BT1718 to Phase 1/2 trials, with CRUK sponsoring and funding the trial. Furthermore, the firm's engagement in the FDA's CMC Development and Readiness Pilot (CDRP).

Major Companies Active In R&D of Bicycle-Toxin Conjugates

Currently, Bicycle Therapeutics is the only company actively working on bicycle toxin conjugates at a clinical stage. Established in Cambridge, UK, the company is the global leader in this area with a portfolio of bicycle toxin conjugates addressing a variety of tumors. Its continued development of first-, second-, and third-generation bicycle toxin conjugates reflects its focus on advancing this new class of therapy. Through global trials and regulatory interaction on both Atlantic sides, Bicycle Therapeutics is outlining the future direction and potential of bicycle toxin conjugates worldwide.

Report Suggesting Future Direction Of Bicycle-Toxin Conjugates Segment

This report identifies bicycle toxin conjugates as an essential up-and-coming category in precision oncology with the potential to either match or even outperform ADCs in some indications. Regulatory interest, including Fast Track and CDRP designation, reflects increasing institutional interest in bicycle toxin conjugates. Clinical efficacy in combination therapies implies bicycle toxin conjugates may become an integral part of front-line cancer regimens within a short while.

As it continues to develop, the bicycle toxin conjugates platform can also be utilized outside of oncology, with promise in infectious disease and other indications that call for targeted payload delivery. The development of the bicycle toxin conjugates segment, as illustrated here, clearly shows a path toward regulatory acceptance, expanded application, and increased industry uptake.

1. Introduction To Bicycle Toxin Conjugates

1.1 Overview
1.2 History & Evolution

2. Bicycle Toxin Conjugates - Mechanism Of Action

3. Global Bicycle Toxin Conjugates Research & Market Trends By Indication

3.1 Cancer
3.2 Viral Diseases

4. Bicycle Toxin Conjugates - Proprietary Platforms

5. Global Bicyclic Toxin Conjugates Clinical Trials Overview

5.1 By Company
5.2 By Indication
5.3 By Location
5.4 By Phase

6. Global Bicyclic Toxin Conjugates Clinical Pipeline By Company, Indication & Phase

6.1 Phase-I/II
6.2 Phase-III

7. Global Bicycle Toxin Conjugates Current & Future Market Trends Outlook

7.1 Current Market Trends, Developments & Clinical Trials Assessment
7.2 Future Commercialization Opportunity

8. Global Bicycle Toxin Conjugates Research & Market Trends By Region

8.1 US
8.2 EU
8.3 UK

9. Global Bicycle Toxin Conjugates Market Dynamics

9.1 Market Drivers & Commercial Opportunities
9.2 Market Challenges & Restraints

10. Competitive Landscape

10.1 Bicycle Therapeutics

簡介目錄圖表

List of Figures

Figure 1-1: Bicycle Toxin Conjugate - Structure
Figure 2-1: Bicycle Toxin Conjugates - Mechanism Of Action
Figure 3-1: Zelenectide Pevedotin - Structure
Figure 3-2: Duravelo-1 Phase 1/2 (NCT04561362) Study - Initiation & Completion Year
Figure 3-3: Duravelo-2 Phase 2/3 (NCT06225596) Study - Initiation & Completion Year
Figure 3-4: Duravelo-3 Phase 2 (NCT06840483) Study - Initiation & Completion Year
Figure 3-5: Duravelo-4 Phase 2 (NCT06933329) Study - Initiation & Completion Year
Figure 3-6: BT5528 - Structure
Figure 3-7: BT5528-100 Phase 1/2 Study - Initiation & Completion Year
Figure 3-8: BT1718 - Structure
Figure 4-1: Bicycles - Advantages
Figure 4-2: Bicycles - Key Properties
Figure 5-1: Global - Bicyclic Toxin Conjugates Clinical Trials By Company (Number), 2025
Figure 5-2: Global - Bicyclic Toxin Conjugates Clinical Trials By Indication (Number), 2025
Figure 5-3: Global - Bicyclic Toxin Conjugates Clinical Trials By Location (Number), 2025
Figure 5-4: Global - Bicyclic Toxin Conjugates Clinical Trials By Phase (Number), 2025
Figure 7-1: Global Bicycle Toxin Conjugates Market - Future Opportunities
Figure 9-1: Bicycle Toxin Conjugates Market - Drivers & Opportunities
Figure 9-2: Bicycle Toxin Conjugates Market - Challenges & Restraints