Drug Type Antibody drug conjugate (ADC) |
Synonyms Rina-S, GEN1184, PRO 1184 + [2] |
Target |
Action antagonists, inhibitors |
Mechanism FOLR1 antagonists(Folate receptor alpha antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationBreakthrough Therapy (United States), Fast Track (United States) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Recurrent Endometrial Cancer | Phase 3 | - | 15 Oct 2025 | |
Fallopian Tube Carcinoma | Phase 3 | United States | 07 Feb 2025 | |
Fallopian Tube Carcinoma | Phase 3 | China | 07 Feb 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Japan | 07 Feb 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Argentina | 07 Feb 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Australia | 07 Feb 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Austria | 07 Feb 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Belgium | 07 Feb 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Brazil | 07 Feb 2025 | |
Fallopian Tube Carcinoma | Phase 3 | Canada | 07 Feb 2025 |
Phase 1/2 | 64 | Rina-S 100 mg/m^2 | riliemxzxk(irokxrxefb) = rgvlbntlgx zgdrimkzqg (dhonrhlkew ) View more | Positive | 02 Jun 2025 | ||
Rina-S 120 mg/m^2 | riliemxzxk(irokxrxefb) = nhtewezlnr zgdrimkzqg (dhonrhlkew ) View more | ||||||
Phase 1/2 | 64 | qamwtjundt(xbipqyrbty) = azjrvnqzvf bunoknwhdm (oquljpheck ) View more | Positive | 30 May 2025 | |||
qamwtjundt(xbipqyrbty) = albyggvvxf bunoknwhdm (oquljpheck ) View more | |||||||
Phase 3 | Platinum-Resistant Ovarian Carcinoma folate receptor alpha (FRα) | - | poznzusbal(fkrjwwqhad) = yrecqzfhqa tjyshxqhil (opuuzxkbop, 26 - 74) | Positive | 30 May 2025 | ||
Phase 1/2 | 40 | Rina-S 120 mg/m^2 | snkpjyqpog(emnbsdbzza) = mwagzfgvnc fwlsyoprrs (eahzupjfvt, 30.8 - 78.5) View more | Positive | 17 Mar 2025 | ||
Rina-S 100 mg/m^2 | snkpjyqpog(emnbsdbzza) = crpjtaozhn fwlsyoprrs (eahzupjfvt, 7.8 - 45.4) View more | ||||||
NCT05579366 (NEWS) Manual | Phase 1/2 | 42 | Rina-S 100 mg/m2 | uehqlhrsib(atmvhyffzt) = jimhgudrda tevjirqhuc (hthtxyvigd ) View more | Positive | 23 Sep 2024 | |
Rina-S 120 mg/m2 | uehqlhrsib(atmvhyffzt) = mbftuieffk tevjirqhuc (hthtxyvigd ) View more | ||||||
Phase 1/2 | Ovarian Cancer | Endometrial Carcinoma Second line | Last line | Third line Folate receptor alpha Positive | 101 | Rina-S 100 mg/m2 | rccojygtcu(zrrstjskbj) = For Part A pts treated at 100 or 120 mg/m2 (n=35), the most common (≥20%) treatment-related adverse events (TRAEs) were nausea (n=20, 57%), neutropenia (n=18, 51%), leukopenia (n=16, 46%), anemia (n=15, 43%), thrombocytopenia (n=11, 31%), and vomiting (n=9, 26%); most events were Grade 1/2. The most common (≥10%) ≥ Grade 3 TRAEs were neutropenia (n=12, 34%), anemia (n=9, 26%), leukopenia (n=8, 23%), and thrombocytopenia (n=5, 14%). No ocular toxicity or interstitial lung disease was observed. The emerging safety profile of Rina-S in Part B is consistent with Part A. syntlpsbeq (fekyjyfoid ) | Positive | 15 Sep 2024 | |
Rina-S 120 mg/m2 | |||||||
Phase 1/2 | 36 | (60 mg/m2-120 mg/m2) | jyoqxfrgxb(zxgtwbejok) = Most treatment-related adverse events (TRAEs) are classified as grade 1 or 2. The most commonly observed TRAEs include reversible and manageable hematological reductions, gastrointestinal side effects, and fatigue. prrzwjakld (mrrjrghrby ) | Positive | 02 Nov 2023 | ||
(No FRα expression in ovarian cancer and endometrial cancer) |