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癌症分子标靶治疗学

市场调查报告书

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1484104

GPRC5D标靶药物的全球市场：市场机会与临床试验趋势（2024年）

Global GPRC5D Targeting Drugs Market Opportunity & Clinical Trials Insight 2024

出版日期: 2024年05月01日 | 出版商:

KuicK Research | 英文 100 Pages | 商品交期: 最快1-2个工作天内

价格

简介目录图表

在寻求新型标靶治疗的过程中，G 蛋白偶联受体C 类5 成员D (GPRC5D)，一种孤儿G 蛋白偶联受体，最近在治疗各种流行疾病方面显示出前景，已成为一种有前途的治疗方法。 GPRC5D是癌症治疗的合理标靶，特别是对于治疗多发性骨髓瘤等血液恶性肿瘤。重要的是，GPRC5D 表现主要局限于浆细胞，正常组织中几乎不表现。

目前，针对 GPRC5D 的药物只有 Talvay，而 2003 年 8 月，FDA 宣布，先前接受过至少三种类型治疗的患者，包括免疫调节剂、蛋白□体抑制剂和抗 CD38 抗体；被批准为单一疗法治疗復发性难治性多发性骨髓瘤(RRMM) 成人患者，其疾病在最后一次治疗中已出现进展。预计明年全球市场将出现更多 GPRC5D 治疗药物。

然而，除了临床前研究外，针对 GPRC5D 的治疗领域正在进行大量研究和开发。这些研究的目的是开发新颖和先进的 GPRC5D 疗法来治疗癌症，特别是多发性骨髓瘤和其他疾病。例如，2024年4月，Oricel Therapeutics, Inc.将评估安全性、药物动力学、药效学，并已启动I/II期、开放标籤、多中心研究以评估初步疗效。

GPRC5D 标靶疗法的最新进展引起了医学界的极大兴趣和兴奋。这些治疗方法包括各种创新方法，例如单株抗体、抗体药物偶联物 (ADC) 和嵌合抗原受体 (CAR) T 细胞疗法。这两种治疗方法都利用 GPRC5D 的独特表达模式来选择性地靶向和根除恶性细胞，同时保留正常组织，与传统治疗方法相比，提供了更好的安全性。

本报告调查了全球 GPRC5D 靶向药物市场，并提供了市场概况，以及 KRAS 抑製剂的作用机制、其在癌症治疗中的作用、区域趋势、临床试验趋势以及公司数量提供竞争趋势等信息。

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.

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

简介目录图表

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

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