近年、様々な疾患の治療標的として有望視されている希少なGタンパク質共役型受容体である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、新たな標的療法の追求が進んでいます。GPRC5Dは、がん治療の領域、特に多発性骨髄腫などの血液悪性腫瘍の治療において、妥当な標的です。重要なことに、GPRC5Dの発現は主に形質細胞に限定されており、正常組織中の存在は最小限であり、その特異性により治療介入の理想的な標的となっています。
現在、2003年8月にFDAによって承認されたGPRC5D標的療法は、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つの前治療を受け、最後の治療で疾患の進行が実証された再発および難治性多発性骨髄腫(RRMM)の成人患者の治療のための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療法の出現が見込まれています。
それにもかかわらず、GPRC5Dを標的とする治療法の領域では、前臨床試験に加えて豊富な研究開発が進行中です。これらの研究の目的は、癌、主に多発性骨髄腫およびその他の疾患の管理のための高度で画期的で新しいGPRC5D療法を開発することです。例えば、OriCell Therapeuticsは、2024年4月に再発/難治性多発性骨髄腫の被験者を対象に、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に、第I/II相非盲検多施設共同試験を開始しました。
目次
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 and 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 and 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, and Dosing Analysis
8.1 Talvey (Talquetamab)
8.1.1 Overview
8.1.2 Pricing and Dosing
8.2 Sales Analysis and Forecast
9. Global GPRC5D Targeted Drugs Clinical Trials Insight By Company, Country, Indication and 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-ADCandtrade; - Next Generation ADC Platform
12.6 AnTenGagerandtrade; 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 and Development
14.6 Juno Therapeutics (BMS)
14.7 Nanjing Leads Biolabs
14.8 Sana Biotechnology
14.9 Simcere Pharmaceutical Group
14.10 Yake Biotechnology
List of Figures & Tables
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 and CD3
Figure 3-3: JNJ-79635322 Phase I (NCT05652335) Study - Initiation and Completion Year
Figure 3-4: OriC321 Phase I (NCT05325801) Study - Initiation and Completion Year
Figure 4-1: Anti-GPRC5D CAR-T Phase I (NCT05749133) Study - Initiation and 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 and 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 and 2028
Figure 7-1: MCARH109 WITH MCARH125 Phase I (NCT05431608) Study - Initiation and Completion Year
Figure 7-2: Bristol Myers Squibb GPRC5D Therapy Pipeline
Figure 7-3: BMS-986393 Phase II (NCT06297226) Study - Initiation and Completion Year
Figure 7-4: Integral Molecule Trispecific Antibody
Figure 7-5: CT071 Phase I/II (NCT06333509) Study - Initiation and Completion Year
Figure 7-6: SIM0500 Phase I (NCT06375044) Study - Initiation and Completion Year
Figure 7-7: IBI3003 Phase I/II (NCT06083207) Study - Initiation and Completion Year
Figure 7-8: AZD0305 Phase I/II (NCT06106945) Study - Initiation and Completion Year
Figure 7-9: Forimtamig Phase I/II (NCT06055075) Study - Initiation and Completion Year
Figure 7-10: Talvey - Approval Year by Region
Figure 7-11: Talvey - Cost per Subcutaneous Solution and Supply of 2 mg/mL (US$), May’2024
Figure 7-12: Talvey - Cost per Subcutaneous Solution and Supply of 40 mg/mL (US$), May’2024
Figure 11-1: Teclistamab with Talquetamab Phase I/II (NCT04586426) Study - Initiation and Completion Year
Figure 11-2: Forimtamig with Carfilzomib/Daratumumab Phase I/II (NCT06055075) Study - Initiation and 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-ADCandtrade; Next Generation ADC Platform
Figure 12-5: Antengene - AnTenGagerandtrade; Platform
Figure 12-6: Genmab - DuoBody Technology
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
