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癌症分子標靶治療學

市場調查報告書

商品編碼

1484104

GPRC5D標靶藥物的全球市場：市場機會與臨床試驗趨勢（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個工作天內

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簡介目錄圖表

在尋求新型標靶治療的過程中，G 蛋白偶聯受體C 類5 成員D (GPRC5D)，一種孤兒G 蛋白偶聯受體，最近在治療各種流行疾病方面顯示出前景，已成為一種有前途的治療方法。 GPRC5D是癌症治療的合理標靶，特別是對於治療多發性骨髓瘤等血液惡性腫瘤。重要的是，GPRC5D 表現主要局限於漿細胞，正常組織中幾乎不表現。

目前，針對 GPRC5D 的藥物只有 Talvay，而 2003 年 8 月，FDA 宣佈，先前接受過至少三種類型治療的患者，包括免疫調節劑、蛋白□體抑制劑和抗 CD38 抗體；被批准為單一療法治療復發性難治性多發性骨髓瘤(RRMM) 成人患者，其疾病在最後一次治療中已出現進展。預計明年全球市場將出現更多 GPRC5D 治療藥物。

然而，除了臨床前研究外，針對 GPRC5D 的治療領域正在進行大量研究和開發。這些研究的目的是開發新穎和先進的 GPRC5D 療法來治療癌症，特別是多發性骨髓瘤和其他疾病。例如，2024年4月，Oricel Therapeutics, Inc.將評估安全性、藥物動力學、藥效學，並已啟動I/II期、開放標籤、多中心研究以評估初步療效。

GPRC5D 標靶療法的最新進展引起了醫學界的極大興趣和興奮。這些治療方法包括各種創新方法，例如單株抗體、抗體藥物偶聯物 (ADC) 和嵌合抗原受體 (CAR) T 細胞療法。這兩種治療方法都利用 GPRC5D 的獨特表達模式來選擇性地靶向和根除惡性細胞，同時保留正常組織，與傳統治療方法相比，提供了更好的安全性。

本報告調查了全球 GPRC5D 靶向藥物市場，並提供了市場概況，以及 KRAS 抑製劑的作用機制、其在癌症治療中的作用、區域趨勢、臨床試驗趨勢以及公司數量提供競爭趨勢等信息。

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

簡介目錄圖表

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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