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GPRC5D標的薬の世界市場：市場機会と臨床試験動向（2024年）

Global GPRC5D Targeting Drugs Market Opportunity & Clinical Trials Insight 2024
出版日: | 発行: KuicK Research | ページ情報: 英文 100 Pages | 納期: 即日から翌営業日

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GPRC5D標的薬の世界市場：市場機会と臨床試験動向（2024年）
出版日: 2024年05月01日
発行: KuicK Research
ページ情報: 英文 100 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

新奇な標的治療を追求する中で、Gタンパク質共役型受容体クラスCグループ5メンバーD（GPRC5D）は、オーファンGタンパク質共役型受容体であり、最近、蔓延する様々な疾患に対する有望な治療標的として浮上してきました。GPRC5Dはがん治療、特に多発性骨髄腫のような血液悪性腫瘍の治療において、妥当な標的です。重要なことは、GPRC5Dの発現は主に形質細胞に限られており、正常組織にはほとんど存在しないことです。

現在、GPRC5Dを標的とする治療薬はタルベイ1剤のみであり、2003年8月にFDAより、免疫調節剤、プロテアソーム阻害剤、抗CD38抗体を含む少なくとも3種類の前治療を受け、最後の治療で病勢進行が認められた再発難治性多発性骨髄腫（RRMM）の成人患者に対する単剤療法として承認されています。世界市場では来年、より多くのGPRC5D治療薬の登場が予想されます。

とはいえ、GPRC5Dを標的とする治療法の領域では、前臨床試験に加え、多くの研究開発が進行中です。これらの研究の目的は、がん、特に多発性骨髄腫やその他の疾患の管理のために、先進的で画期的な新規GPRC5D療法を開発することです。例えば、オリセル・セラピューティクス社は、2024年4月に再発/難治性多発性骨髄腫患者を対象に、抗GPRC5D CAR-T細胞製剤（OriCAR-017）の安全性、薬物動態、薬力学、予備的有効性を評価するため、第I/II相非盲検多施設共同試験を開始しました。

GPRC5Dを標的とした治療における最近の進歩は、医学界に大きな関心と興奮をもたらしました。これらの治療法には、モノクローナル抗体、抗体薬物複合体（ADC）、キメラ抗原受容体（CAR）T細胞療法などの様々な革新的アプローチが含まれます。これらの治療法はいずれも、GPRC5Dのユニークな発現パターンを利用して、正常組織を温存しながら悪性細胞を選択的に標的にして根絶するもので、従来の治療法と比べてより良好な安全性プロファイルを提供できる可能性があります。

当レポートでは、世界のGPRC5D標的薬市場について調査し、市場の概要とともに、KRAS阻害剤の作用機序、癌治療における役割、地域別動向、臨床試験動向、および市場に参入する企業の競合動向などを提供しています。

目次

第1章 GPRC5D標的：治療の進歩における今後の見通し

  • GPRC5Dの概要
  • GPRC5D療法の臨床的進化
  • GPRC5D標的療法の必要性

第2章 予後におけるGPRC5Dの役割

第3章 GPRC5Dを標的とした治療戦略

  • モノクローナル抗体
  • 抗体薬物複合体
  • 二重特異性抗体
  • 三重特異性抗体
  • CAR-T細胞療法
  • CAR-NK療法
  • 腫瘍ワクチン

第4章 適応症別のGPRC5D標的療法：臨床動向とイノベーション

  • がん
    • 血液がん
    • 固形腫瘍
  • 筋骨格疾患

第5章 世界のGPRC5D標的薬：臨床試験の概要

  • 相別
  • 国別
  • 企業別
  • 適応症別
  • 優先度別
  • 患者セグメント

第6章 世界のGPRC5Dの現在の市場動向と動向

  • 現在の市場の概略
  • 今後の市場見通し

第7章 GPRC5D市場のマッピング：地域分析

  • 米国
  • 中国
  • 欧州

第8章 世界のGPRC5D標的薬- 概要、価格設定、投与量分析

  • タルベイ（タルケタマブ）
  • 売上分析と予測

第9章 企業、国、適応症、相別の世界のGPRC5D標的薬：臨床試験の洞察

  • 前臨床
  • 第I相
  • 第I/II相
  • 第II相

第10章 上市済みGPRC5D標的薬：臨床的洞察

第11章 GPRC5D療法を前進させるための併用戦略

  • 免疫療法
  • 標的療法
  • 免疫調節薬

第12章 先進的なGPRC5D治療法を開発するためのプラットフォーム

第13章 世界のGPRC5D療法：市場力学

  • 市場促進要因
  • 市場の課題

第14章 競合情勢

  • AstraZeneca
  • Beijing Mabworks Biotech
  • Cell Inspire Bio( Sanqi Biotech )
  • Guangzhou Bio-gene Technology
  • Janssen Research & Development
  • Juno Therapeutics (BMS)
  • Nanjing Leads Biolabs
  • Sana Biotechnology
  • Simcere Pharmaceutical Group
  • Yake Biotechnology
図表

List of Figures

  • Figure 1-1: Overview to GPRC5D
  • Figure 1-2: Need for GPRC5D Therapy
  • Figure 3-1: Therapeutic Strategies to Target GPRC5D Protein
  • Figure 3-2: Approved Bispecific Antibody (Talvey) Targeting GPRC5D & CD3
  • Figure 3-3: JNJ-79635322 Phase I (NCT05652335) Study - Initiation & Completion Year
  • Figure 3-4: OriC321 Phase I (NCT05325801) Study - Initiation & Completion Year
  • Figure 4-1: Anti-GPRC5D CAR-T Phase I (NCT05749133) Study - Initiation & Completion Year
  • Figure 4-2: Combination Studies Ongoing for GPRC5D therapy to Treat Hematological Cancer
  • Figure 4-3: BCMA/GPRC5D double CAR-T (NCT06068400) Study - Initiation & Completion Year
  • Figure 5-1: Global - GPRC5D Targeted Drugs Clinical Trials By Phase (Numbers), 2024
  • Figure 5-2: Global - GPRC5D Targeted Drugs Clinical Trials By Country (Numbers), 2024
  • Figure 5-3: Global - GPRC5D Targeted Drugs Clinical Trials By Company (Numbers), 2024
  • Figure 5-4: Global - GPRC5D Targeted Drugs Clinical Trials By Indication (Numbers), 2024
  • Figure 5-5: Global - GPRC5D Targeted Drugs Clinical Trials By Priority Status (Numbers), 2024
  • Figure 5-6: Global - GPRC5D Targeted Drugs Clinical Trials By Patient Segment (Numbers), 2024
  • Figure 6-1: Global: GPRC5D Targeting Drugs Market Forecast (US$ Million), 2024 & 2028
  • Figure 7-1: MCARH109 WITH MCARH125 Phase I (NCT05431608) Study - Initiation & Completion Year
  • Figure 7-2: Bristol Myers Squibb GPRC5D Therapy Pipeline
  • Figure 7-3: BMS-986393 Phase II (NCT06297226) Study - Initiation & Completion Year
  • Figure 7-4: Integral Molecule Trispecific Antibody
  • Figure 7-5: CT071 Phase I/II (NCT06333509) Study - Initiation & Completion Year
  • Figure 7-6: SIM0500 Phase I (NCT06375044) Study - Initiation & Completion Year
  • Figure 7-7: IBI3003 Phase I/II (NCT06083207) Study - Initiation & Completion Year
  • Figure 7-8: AZD0305 Phase I/II (NCT06106945) Study - Initiation & Completion Year
  • Figure 7-9: Forimtamig Phase I/II (NCT06055075) Study - Initiation & Completion Year
  • Figure 7-10: Talvey - Approval Year by Region
  • Figure 7-11: Talvey - Cost per Subcutaneous Solution & Supply of 2 mg/mL (US$), May'2024
  • Figure 7-12: Talvey - Cost per Subcutaneous Solution & Supply of 40 mg/mL (US$), May'2024
  • Figure 11-1: Teclistamab with Talquetamab Phase I/II (NCT04586426) Study - Initiation & Completion Year
  • Figure 11-2: Forimtamig with Carfilzomib/Daratumumab Phase I/II (NCT06055075) Study - Initiation & Completion Year
  • Figure 12-1: Integral Molecular - MPS Antibody Discovery Platform
  • Figure 12-2: Integral Molecular - Development of Trispecific Antibody Targeting GPRC5D
  • Figure 12-3: Simcere Zaiming - T Cell Engager Polyspecific Antibody Technology Platform
  • Figure 12-4: LaNova Medicines - LX-ADC(TM) Next Generation ADC Platform
  • Figure 12-5: Antengene - AnTenGager(TM) Platform
  • Figure 12-6: Genmab - DuoBody Technology

List of Tables

  • Table 3-1: CAR-T Therapy Approaches Targeting GPRC5D
  • Table 4-1: GPRC5D Targeting Therapies for Hematological Cancers
  • Table 7-1: Talvey - Weekly Dosing Schedule
  • Table 7-2: Talvey - Biweekly (Every 2 Weeks) Dosing Schedule
  • Table 7-3: Recommendations for Restarting Talvey after Dose Delay - Weekly Dosing Schedule
  • Table 7-4: Recommendations for Restarting Talvey after Dose Delay - Biweekly (Every 2 Weeks) Dosing Schedule
  • Table 7-5: Talvey - Recommendations for Management of Cytokine Release Syndrome (CRS)
  • Table 7-6: Talvey - Recommendations for Management of Immune effector cell-associated neurotoxicity syndrome (ICANS)
  • Table 7-7: Talvey - Recommendations for Management of Neurologic Toxicity (excluding ICANS)
  • Table 7-8: Talvey - Recommended Dose Modifications for Other Adverse Reactions
目次

Global GPRC5D Targeting Drugs Market Opportunity & Clinical Trials Insight 2024 Report Highlights:

  • Global GPRC5D Targeting Drugs Market Opportunity: > USD 1500 Million
  • Approved GPRC5D Targeting Drugs In Market: 1 Drug (Talvey)
  • Approved Drug Dosage, Pricing & Sales Insight
  • GPRC5D Targeted Drugs Clinical Trials Insight By Company, Country, Indication & Phase
  • Insight On More Than 15 Drug In Clinical Trials
  • Platforms For Developing Advanced GPRC5D Therapy

In the pursuit for newfangled targeted therapies, G protein-coupled receptor class C group 5 member D or GPRC5D, an orphan G protein-coupled receptor, that has recently emerged as a promising therapeutic target for various diseases prevalent. GPRC5D is a plausible target in the realm of cancer care, particularly for the treatment of hematologic malignancies such as multiple myeloma. Importantly, GPRC5D expression is predominantly restricted to plasma cells, with minimal presence in normal tissues, making it an ideal target for therapeutic intervention due to its specificity.

Currently, only one GPRC5D targeting therapy, Talvey, has been approved by FDA, in August 2003, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. The upcoming year in the global market is anticipated to witness the advent of more GPRC5D therapies in future.

Nevertheless, copious research and development in addition to preclinical studies are ongoing in the GPRC5D targeting therapies domain. The aim of these studies is developed an advanced, groundbreaking and novel GPRC5D therapy for the management of cancer, chiefly multiple myeloma and other diseases. For instance, OriCell Therapeutics has begun a phase I/II, open-label, multicenter study in order to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of anti-GPRC5D CAR-T cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma in April 2024.

Recent advancements in GPRC5D targeting therapies have generated significant interest and excitement within the medical community. These therapies include a variety of innovative approaches such as monoclonal antibodies, antibody-drug conjugates (ADCs), and chimeric antigen receptor (CAR) T-cell therapies. Each of these modalities leverages the unique expression pattern of GPRC5D to selectively target and eradicate malignant cells while sparing normal tissues, thus potentially offering a more favorable safety profile compared to traditional treatments.

Amid all GPRC5D targeting therapeutic approaches, CAR T-cell therapies and bispecific antibodies are most used methods for the treatment of multiple myeloma as these modalities have shown particularly remarkable results. Introductory preclinical studies have exemplified that using CAR T cells coupled with bispecific antibody targeting GPRC5D can induce intense and durable remissions in patients with relapsed or refractory multiple myeloma. This is especially significant given the typically poor prognosis and limited treatment options for this patient population.

Interalia, the clinical development of GPRC5D targeting therapies is being rigorously pursued through a series of clinical trials designed to assess their safety, tolerability, and efficacy. Such as, Jiangsu Simcere Pharmaceutical in collaboration with Shanghai Xianxiang Medical Technology is planning to commence a phase 1 clinical trial, open-label, multicenter study to assess the safety, tolerability, effectiveness, and pharmacokinetics of SIM0500 in adult patients with relapsed or resistant multiple myeloma by May 2024.

These findings suggest that GPRC5D targeting therapies could potentially become a cornerstone in the treatment paradigm for multiple myeloma. Furthermore, the specificity of GPRC5D targeting therapies for plasma cells minimizes off target effects, which translates into a more manageable side effect profile for patients. This is a crucial consideration in cancer treatment, where treatment related toxicity can significantly impact the quality of life and overall outcomes for patients.

Several biopharmaceutical companies, such as AstraZeneca, Bristol Myers Squibb, Genmab, Johnson & Johnson, Roche and many more are actively engaged in the development of GPRC5D targeting therapies, with a focus on CAR T-cell products, monoclonal antibodies, and antibody drug conjugates.

Coupled with this, one of the fundamental prime movers which aid to expand the market of global GPRC5D targeting therapy is augmenting collaboration with global partners as well as expedited clinical trial approvals. For instance, in May 2023, LaNova Medicines, based in China, has signed a license agreement with UK based AstraZeneca Company to advance LaNova GPRC5D contender, LM-305. As per licensing agreement, AstraZeneca will have the solitary universal right to conduct research, develop and launch LM-305 in market.

In summary, GPRC5D targeting therapies represent a cutting-edge advancement in the treatment of multiple myeloma. Their development is driven by the unique expression pattern of GPRC5D, which allows for highly specific targeting of malignant plasma cells. As clinical trials continue to advance, there is optimism that these therapies will provide significant clinical benefits to patients, addressing a critical unmet need in the management of multiple myeloma along with other diseases in future.

Table of Contents

1. GPRC5D Targeting: A New Frontier in Therapeutic Advancements

  • 1.1 Overview of GPRC5D
  • 1.2 Clinical Evolution of GPRC5D Therapy
  • 1.3 Need For GPRC5D Targeting Therapy

2. Role Of GPRC5D in Prognosis

3. GPRC5D Targeting Therapeutic Strategies

  • 3.1 Monoclonal Antibody
  • 3.2 Antibody Drug conjugate
  • 3.3 Bispecific Antibody
  • 3.4 Trispecific Antibody
  • 3.5 CAR-T Cell Therapy
  • 3.6 CAR-NK Therapy
  • 3.7 Tumor Vaccine

4. GPRC5D Targeting Therapy By Indications: Clinical Trends & Innovations

  • 4.1 Cancer
    • 4.1.1 Hematological Cancers
    • 4.1.2 Solid Tumors
  • 4.2 Musculoskeletal Disease

5. Global GPRC5D Targeted Drugs Clinical Trials Overview

  • 5.1 By Phase
  • 5.2 By Country
  • 5.3 By Company
  • 5.4 By Indication
  • 5.5 By Priority Status
  • 5.6 Patient Segment

6. Global GPRC5D Current Market Trend & Developments

  • 6.1 Current Market Outline
  • 6.2 Future Market Outlook

7. Mapping GPRC5D Market: Regional Analysis

  • 7.1 US
  • 7.2 China
  • 7.3 Europe

8. Global GPRC5D Targeting Drugs - Overview, Pricing, & Dosing Analysis

  • 8.1 Talvey (Talquetamab)
    • 8.1.1 Overview
    • 8.1.2 Pricing & Dosing
  • 8.2 Sales Analysis & Forecast

9. Global GPRC5D Targeted Drugs Clinical Trials Insight By Company, Country, Indication & Phase

  • 9.1 Preclinical
  • 9.2 Phase I
  • 9.3 Phase I/II
  • 9.4 Phase II

10. Marketed GPRC5D Targeted Drugs Clinical Insight

11. Combinations Strategies To Advance GPRC5D Therapy

  • 11.1 Immunotherapy
  • 11.2 Targeted Therapy
  • 11.3 Immunomodulatory Drugs

12. Platforms For Developing Advanced GPRC5D Therapy

  • 12.1 MPS Antibody Discovery Platform
  • 12.2 T-Cell Engager Polyspecific Antibody Technology Platform
  • 12.3 OriCAR CAR-T Platform
  • 12.4 CARcelerateTM Platform
  • 12.5 LX-ADC(TM) - Next Generation ADC Platform
  • 12.6 AnTenGager(TM) Platform
  • 12.7 DuoBody Technology Platform

13. Global GPRC5D Therapy Market Dynamics

  • 13.1 Market Drivers
  • 13.2 Market Challenges

14. Competitive Landscape

  • 14.1 AstraZeneca
  • 14.2 Beijing Mabworks Biotech
  • 14.3 Cell Inspire Bio( Sanqi Biotech )
  • 14.4 Guangzhou Bio-gene Technology
  • 14.5 Janssen Research & Development
  • 14.6 Juno Therapeutics (BMS)
  • 14.7 Nanjing Leads Biolabs
  • 14.8 Sana Biotechnology
  • 14.9 Simcere Pharmaceutical Group
  • 14.10 Yake Biotechnology