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  • ||||||||||  muzastotug (ADG126) / Adagene
    Phase 1b/2, multicenter dose escalation and expansion study of muzastotug (ADG126, a masked anti-CTLA-4 SAFEbody (Exhibit Halls AB - George R. Brown Convention Center) -  Oct 4, 2024 - Abstract #SITC2024SITC_880;    
    P1/2
    A higher dose Muza (20 mg/kg) allows for a rapid reaching of plasma cleaved drug exposure associated with clinical efficacy and an acceptable safety profile when combined with pembrolizumab. This regimen potentially can offer a best-in-class treatment option for patients with advanced/metastasis MSS CRC.View this table:View inline View popup Download powerpoint Abstract 744 Table 1 Safety and efficacy evaluable patients by dose levels
  • ||||||||||  ADG116 / Adagene, muzastotug (ADG126) / Adagene
    Deciphering improved clinical therapeutic index (TI) of Muzastotug (ADG126), a masked anti-CTLA-4 SAFEbody (Exhibit Halls AB - George R. Brown Convention Center) -  Oct 4, 2024 - Abstract #SITC2024SITC_879;    
    ADG116, an IgG1 monoclonal antibody targeting a unique epitope of CTLA-4 which is conserved across species, has demonstrated improved TI over ipilimumab via enhanced epitope-dependent ADCC and T cell priming...When combined with toripalimab, muzastotug at 10 mg/kg Q3W showed significantly better safety and similar efficacy versus ADG116 at 3 mg/kg Q6W (highest tolerable regimen)...Modeling predicts a significantly higher and sustained SS tumor-specific engagement of CTLA-4 by muzastotug in patients. The potential best-in-class profile of muzastotug supports further clinical development.1
  • ||||||||||  ADG206 / Adagene
    Trial completion date, Trial primary completion date, Metastases:  Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) -  Aug 13, 2024   
    P1,  N=21, Recruiting, 
    Recruiting --> Completed | N=91 --> 58 | Trial completion date: Dec 2024 --> May 2024 Trial completion date: Dec 2024 --> Oct 2025 | Trial primary completion date: Apr 2024 --> May 2025
  • ||||||||||  ADG116 / Adagene, ADG106 / Adagene
    Enrollment closed, Phase classification, Trial completion date, Trial primary completion date, Metastases:  ADG116-1003: A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients (clinicaltrials.gov) -  Jan 31, 2024   
    P1,  N=72, Active, not recruiting, 
    ADG106 has a manageable safety profile and preliminary anti-tumor efficacy in patients with advanced cancers (this study was registered at ClinicalTrials.gov: NCT03802955). Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1 | Trial completion date: Jan 2024 --> Aug 2024 | Trial primary completion date: Aug 2023 --> Jul 2024
  • ||||||||||  ADG126 / Adagene, Yervoy (ipilimumab) / Ono Pharma, BMS
    Optimal dose selection of ADG126 (a masked anti-CTLA-4 SAFEbody (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1174;    
    3 4 The two models predict optimal dosing regimens, which warrant further clinical investigation to unleash the full therapeutic potential of ADG126 within targeted toxicities. Conclusions The continuously widened TI from ADG116 to ADG126 enables ADG126 to be dosed at 10 mg/kg Q3W and likely higher with anti-PD-1, resulting in significantly higher and sustained tumor target engagement than ipilimumab, potentially translating to greater clinical benefits.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), ADG106 / Adagene
    Enrollment open, Metastases:  ComPACT: Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer (clinicaltrials.gov) -  Jul 20, 2023   
    P1b,  N=51, Recruiting, 
    Conclusions The continuously widened TI from ADG116 to ADG126 enables ADG126 to be dosed at 10 mg/kg Q3W and likely higher with anti-PD-1, resulting in significantly higher and sustained tumor target engagement than ipilimumab, potentially translating to greater clinical benefits. Not yet recruiting --> Recruiting
  • ||||||||||  ADG106 / Adagene
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Metastases:  Study of ADG106 In Combination With PD-1 Antibody In Advanced or Metastatic Solid Tumors and/or Non Hodgkin Lymphoma (clinicaltrials.gov) -  Apr 24, 2023   
    P1/2,  N=25, Terminated, 
    The increased therapeutic window and efficacious dose selection of ADG126 is informed by quantitative integration of available data. N=60 --> 25 | Trial completion date: Feb 2024 --> Feb 2023 | Recruiting --> Terminated | Trial primary completion date: Jul 2023 --> Feb 2023; The safety of ADG106 combined with triprilimab has been fully understood.The overall clinical benefit of enrolled subjects was limited and further development of ADG106 was reconsidered.
  • ||||||||||  ADG116 / Adagene, ADG106 / Adagene
    Phase classification, Enrollment change, Metastases:  ADG116-1003: A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients (clinicaltrials.gov) -  Apr 24, 2023   
    P1b/2,  N=77, Recruiting, 
    N=60 --> 25 | Trial completion date: Feb 2024 --> Feb 2023 | Recruiting --> Terminated | Trial primary completion date: Jul 2023 --> Feb 2023; The safety of ADG106 combined with triprilimab has been fully understood.The overall clinical benefit of enrolled subjects was limited and further development of ADG106 was reconsidered. Phase classification: P1b --> P1b/2 | N=204 --> 77
  • ||||||||||  Tuoyi (toripalimab) / Shanghai Junshi Biosci, Coherus Biosci, ADG126 / Adagene
    Interim results of a phase 1b/2 study of ADG126 (a masked anti-CTLA-4 SAFEbody (Section 47; Poster Board #17) -  Mar 14, 2023 - Abstract #AACR2023AACR_6044;    
    P1/2
    Furthermore, promising anti-tumor activity in heavily pre-treated patients was observed in the dose escalation phase. By enabling higher dose levels in combination with anti-PD-1 therapy, ADG126 may unleash the full therapeutic potential for proven and novel indications.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), ADG106 / Adagene
    Trial completion date, Trial initiation date, Trial primary completion date, Metastases:  ComPACT: Pembrolizumab and ADG106 in Advanced Solid Cancers and Triple Negative Breast Cancer (clinicaltrials.gov) -  Nov 3, 2022   
    P1b,  N=51, Not yet recruiting, 
    Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Jul 2025 --> Dec 2025 Trial completion date: Oct 2026 --> Dec 2026 | Initiation date: Oct 2022 --> Dec 2022 | Trial primary completion date: Oct 2025 --> Dec 2025
  • ||||||||||  ADG126 / Adagene
    Phase I results demonstrate highly differentiated safety and PK profile of ADG126, a masked anti-CTLA-4 SAFEbody in patients with advanced solid tumors (Poster Area, Hall 4) -  Jul 28, 2022 - Abstract #ESMO2022ESMO_2892;    
    P1
    ADG126 SAFEbody applies precision masking peptide to the anti-CTLA-4 ADG116 NEObody™ for 6-fold greater safety over ADG116, and has an improved safety and efficacy profile over Ipi...Conclusions ADG126 shows a compelling safety profile with superior PK and early efficacy signals, with only G1 TRAEs as monotherapy given by Q3W for >4 cycles at 10 mpk and >12 cycles at 1 mpk. Combination studies with anti-PD1 therapy are initiated aiming to transform anti-CTLA-4 therapy with improved safety & efficacy.
  • ||||||||||  ADG106 / Adagene
    Trial completion date, Trial primary completion date, Metastases:  ADG106-1002: Study of ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma (clinicaltrials.gov) -  Jul 25, 2022   
    P1,  N=62, Active, not recruiting, 
    Combination studies with anti-PD1 therapy are initiated aiming to transform anti-CTLA-4 therapy with improved safety & efficacy. Trial completion date: Mar 2022 --> Aug 2022 | Trial primary completion date: Feb 2022 --> Nov 2021
  • ||||||||||  ADG206 / Adagene
    ADG206, an anti-CD137 agonistic POWERbodyTM with tailor-made efficacy and safety profiles by strong crosslinking and tumor selective activation for single and combinational cancer immunotherapy (Section 37) -  Mar 9, 2022 - Abstract #AACR2022AACR_4802;    
    Utomilumab appears safe but has modest efficacy, while urelumab is more efficacious but causes severe dose-dependent liver toxicity...In normal tissues, the CD137 antigen binding interfaces of ADG206 are masked using a covalently linked designer peptide to limit on-target off-tumor toxicities, whereas in the tumor microenvironment (TME), the masked antibody can be activated to selectively bind CD137, promoting costimulatory signaling in situ...These results demonstrate that ADG206 POWERbody acquires a tailor-made product profile toward a best-in-class anti-CD137 immunotherapeutic agent that combines conditional activation in the TME with strong agonistic activity through heightened FcγR-mediated crosslinking. Further clinical development of ADG206 POWERbody may hold promises for achieving the long-awaited desirable tolerability and efficacy outcome of an anti-CD137 immunotherapy in either single agent or combination regimens.
  • ||||||||||  ADG116 / Adagene, ADG106 / Adagene
    Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  ADG116-1003: A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients (clinicaltrials.gov) -  Feb 9, 2022   
    P1b,  N=204, Recruiting, 
    Further clinical development of ADG206 POWERbody may hold promises for achieving the long-awaited desirable tolerability and efficacy outcome of an anti-CD137 immunotherapy in either single agent or combination regimens. Phase classification: P1 --> P1b | N=60 --> 204 | Trial completion date: Feb 2023 --> Dec 2023 | Trial primary completion date: Sep 2022 --> Jul 2023