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- ||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment change, Trial completion date, Trial primary completion date: AK117-203: A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Mar 12, 2025
P2, N=120, Recruiting, Sponsor: Akeso
N=80 --> 120 | Trial completion date: Oct 2023 --> Dec 2026 | Trial primary completion date: Jan 2023 --> Jul 2025
- ||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment change, Trial completion date, Trial primary completion date: AK112-206: A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov) - Feb 27, 2025
P2, N=254, Recruiting, Sponsor: Akeso
N=80 --> 120 | Trial completion date: Oct 2023 --> Dec 2026 | Trial primary completion date: Jan 2023 --> Jul 2025 N=104 --> 254 | Trial completion date: Dec 2026 --> Aug 2028 | Trial primary completion date: Dec 2024 --> May 2026
- ligufalimab (AK117) / Akesobio
Trial in Progress: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination with Azacitidine in Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes (AK117-205) () - Dec 7, 2024 - Abstract #ASH2024ASH_8743;
P2
Stratification factors will be based on IPSS-R scores : ?4.5, >4.5-6, and >6.The primary endpoint is complete remission rate (CRR) assessed by investigators based on 2023 International Working Group (IWG 2023) response criteria (Zeidan A et al, Blood, 2023), and to determine the optimal dose of AK117 for future confirmatory trials (can expand this Phase 2 trial to a Phase 3 trial). Key secondary endpoints include overall response rate (ORR), duration of response (DoR), event-free survival (EFS), overall survival (OS), rate and duration of transfusion independence (TI), time to transformation to acute myeloid leukemia (AML), safety assessed by incidence and severity of adverse events (AEs), pharmacokinetics (PK) and immunogenicity.
- |||||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment open, Metastases: AK117-302: A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov) - Nov 14, 2024
P3, N=510, Recruiting, Sponsor: Akeso
Key secondary endpoints include overall response rate (ORR), duration of response (DoR), event-free survival (EFS), overall survival (OS), rate and duration of transfusion independence (TI), time to transformation to acute myeloid leukemia (AML), safety assessed by incidence and severity of adverse events (AEs), pharmacokinetics (PK) and immunogenicity. Not yet recruiting --> Recruiting
- ||||| AK129 / Akesobio, ligufalimab (AK117) / Akesobio
New P1/2 trial, Combination therapy, Monotherapy: A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma (clinicaltrials.gov) - Oct 15, 2024
P1/2, N=280, Not yet recruiting, Sponsor: Akeso
- ligufalimab (AK117) / Akesobio
AK132, a first-in-class asymmetric Claudin18.2/CD47 bispecific antibody for cancer immunotherapy (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_505;
Mice were treated with Isotype control antibody, AK117 (a bivalent CD47 antibody with IgG4 backbone; 20 mg/kg), anti-CLDN8.2 (a bivalent CLDN18.2 antibody with IgG1 backbone; 20 mg/kg) and AK132 (1.9 mg/kg; 5.7 mg/kg; 17 mg/kg) via i.p. injection...Conclusions AK132, an asymmetric CLDN18.2/CD47 bispecific antibody, has ADCC, ADCP and CDC effects on tumor cells but not on RBCs. It shows great anti-tumor efficacy with better safety, supporting its clinical development for the treatment of human cancers.
- | ligufalimab (AK117) / Akesobio
Journal, IO biomarker: A novel anti-CD47 antibody with therapeutic potential for NK/T-cell lymphoma. (Pubmed Central) - Sep 30, 2024
In addition, in vivo experiments showed that the anti-CD47 mAb AK117 significantly inhibited the growth of subcutaneous xenograft tumors in SCID mice compared to the control antibody IgG. Our results indicate that targeting CD47 monoclonal antibodies is a potential therapeutic strategy for NKTCL.
- |||||||||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
New P3 trial, Metastases: AK117-302: A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov) - Sep 19, 2024
P3, N=510, Not yet recruiting, Sponsor: Akeso
- | ligufalimab (AK117) / Akesobio
New P2 trial, Metastases: AK117 (Anti-CD47) + Anti-EGFR for R/M HNSCC (clinicaltrials.gov) - Jul 18, 2024
P2, N=10, Not yet recruiting, Sponsor: West China Hospital
- |||| ligufalimab (AK117) / Akesobio
New P1/2 trial, Combination therapy: A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - Apr 28, 2024
P1/2, N=180, Not yet recruiting, Sponsor: Akeso
- ||| ligufalimab (AK117) / Akesobio
Enrollment open: AK117-205: A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes (clinicaltrials.gov) - Mar 25, 2024
P2, N=90, Recruiting, Sponsor: Akeso
Our results indicate that targeting CD47 monoclonal antibodies is a potential therapeutic strategy for NKTCL. Not yet recruiting --> Recruiting
- ||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: AK117-202: A Study of AK112 in Advanced Malignant Tumors (clinicaltrials.gov) - Feb 21, 2024
P1/2, N=250, Recruiting, Sponsor: Akeso
Not yet recruiting --> Recruiting N=160 --> 250 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Aug 2024
- || Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Trial completion date, Trial primary completion date: AK112-206: A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov) - Feb 15, 2024
P2, N=104, Recruiting, Sponsor: Akeso
N=160 --> 250 | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2023 --> Aug 2024 Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024
- |||| ligufalimab (AK117) / Akesobio
New P2 trial: AK117-205: A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes (clinicaltrials.gov) - Jan 8, 2024
P2, N=90, Not yet recruiting, Sponsor: Akeso
- || ligufalimab (AK117) / Akesobio
Trial completion, Trial completion date, Metastases: A Phase 1 Dose Escalation and Expansion Study of AK117 (clinicaltrials.gov) - Nov 18, 2023
P1, N=49, Completed, Sponsor: Akeso
Trial completion date: Jan 2025 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024 Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> May 2023
- ||| Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
Enrollment open, Trial completion date, Trial primary completion date: AK104-219: Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - Nov 18, 2023
P2, N=90, Recruiting, Sponsor: Akeso
Active, not recruiting --> Completed | Trial completion date: Jan 2024 --> May 2023 Not yet recruiting --> Recruiting | Trial completion date: Aug 2027 --> Nov 2027 | Trial primary completion date: Aug 2024 --> Nov 2024
- ligufalimab (AK117) / Akesobio
A Phase 1b Study Evaluating the Safety and Efficacy of AK117 (anti-CD47 monoclonal antibody) in Combination with Azacitidine in Patients with Treatment-Na (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5715;
Not yet recruiting --> Recruiting | Trial completion date: Aug 2027 --> Nov 2027 | Trial primary completion date: Aug 2024 --> Nov 2024 The combination of AK117 and AZA exhibited a manageable safety profile with a low incidence of anemia, and demonstrated promising efficacy as a first-line treatment in AML patients who were unable to undergo intensive chemotherapy.
- ligufalimab (AK117) / Akesobio
AK117 (anti-CD47 monoclonal antibody) in Combination with Azacitidine for Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS): AK117-103 Phase 1b Results (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2291;
The combination of AK117 and AZA exhibited a manageable safety profile with a low incidence of anemia, and demonstrated promising efficacy as a first-line treatment in AML patients who were unable to undergo intensive chemotherapy. AK117 in combination with AZA was well tolerated with low incidence of anemia and demonstrated promising efficacy in patients with newly diagnosed HR-MDS.
- ivonescimab (AK112) / Akesobio, Summit Therap
Mechanism of action of ivonescimab (AK112/SMT112): a first-in-class tetravalent Fc-silent bispecific antibody with dual blockade of PD-1 and VEGF that promotes cooperative biological effects (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1495;
Importantly, the Fc-null IgG1 design resulted in reduced FcgR interactions and minimal ADCC, ADCP activities consistent with its clinical immunosafety profile. Ivonescimab is currently in Ph3 NSCLC trials in the US and EU.
- ivonescimab (AK112) / Akesobio, Summit Therap
Mechanism of action of ivonescimab (AK112/SMT112): A first-in-class tetravalent Fc-silent bispecific antibody with dual blockade of PD-1 and VEGF that promotes cooperative biological effects. (LEVEL 2, EXHIBIT HALL D) - Sep 16, 2023 - Abstract #AACRNCIEORTC2023AACR_NCI_EORTC_442;
- |||| Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
New P2 trial: AK104-219: Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - Jul 27, 2023
P2, N=90, Not yet recruiting, Sponsor: Akeso
- Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
The safety and efficacy of cadonilimab in combination with AK117 (anti-CD47 antibody) plus chemotherapy as first-line treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_5050;
P1/2
The study of Cadonilimab combined with AK117 and chemotherapy demonstrated tolerable safety profile and encouraging anti-tumor activities in pts with unresectable locally advanced or metastatic HER2(-) G/GEJ cancer. Clinical trial information: NCT05235542.
- || Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
Trial completion, Enrollment change, Trial completion date, Combination therapy, Monotherapy, Metastases: AK117-101: A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104 (clinicaltrials.gov) - Jan 9, 2023
P1, N=50, Completed, Sponsor: Akesobio Australia Pty Ltd
Clinical trial information: NCT05235542. Not yet recruiting --> Completed | N=159 --> 50 | Trial completion date: Sep 2023 --> Nov 2022
- | ligufalimab (AK117) / Akesobio
Journal, Monotherapy, PD(L)-1 Biomarker, IO biomarker: Ligufalimab, a novel anti-CD47 antibody with no hemagglutination demonstrates both monotherapy and combo antitumor activity. (Pubmed Central) - Dec 1, 2022
AK117 eliminated hemagglutination and also enabled to maintain full effectiveness of CD47 blockade on tumor cells, which resulted in excellent antitumor efficacy and favorable safety profile of AK117. A series of clinical trials of AK117 as a therapeutic agent in combination with various agents such as AK112 are in progress for the treatment of multiple hematologic malignancies and solid tumors.
- || ligufalimab (AK117) / Akesobio
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: A Phase 1 Dose Escalation and Expansion Study of AK117 (clinicaltrials.gov) - Oct 12, 2022
P1, N=49, Active, not recruiting, Sponsor: Akeso
A series of clinical trials of AK117 as a therapeutic agent in combination with various agents such as AK112 are in progress for the treatment of multiple hematologic malignancies and solid tumors. Recruiting --> Active, not recruiting | N=162 --> 49 | Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2022 --> Jan 2023
- ||| Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
Enrollment open, Trial initiation date, Combination therapy, Metastases: AK117-204: A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors (clinicaltrials.gov) - Aug 11, 2022
P1/2, N=130, Recruiting, Sponsor: Akeso
Recruiting --> Active, not recruiting | N=162 --> 49 | Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2022 --> Jan 2023 Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jul 2022
- ||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment open: AK112-206: A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov) - Aug 3, 2022
P2, N=114, Recruiting, Sponsor: Akeso
Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jul 2022 Not yet recruiting --> Recruiting
- |||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
New P2 trial: AK112-206: A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov) - May 18, 2022
P2, N=114, Not yet recruiting, Sponsor: Akeso
- ||| Yidafan (ivonescimab) / Akesobio, Summit Therap, ligufalimab (AK117) / Akesobio
Enrollment open, Trial initiation date, Combination therapy, Metastases: A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors (clinicaltrials.gov) - May 11, 2022
P1/2, N=114, Recruiting, Sponsor: Akeso
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Feb 2022 --> May 2022
- ||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
Enrollment open: AK117-203: A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Mar 27, 2022
P2, N=80, Recruiting, Sponsor: Akeso
Not yet recruiting --> Recruiting | Initiation date: Feb 2022 --> May 2022 Not yet recruiting --> Recruiting
- |||| Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
New P1/2 trial, Combination therapy, Metastases: AK117-204: A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors (clinicaltrials.gov) - Feb 10, 2022
P1/2, N=130, Not yet recruiting, Sponsor: Akeso
- |||| Yidafan (ivonescimab) / Akesobio, Summit Therap, ligufalimab (AK117) / Akesobio
New P1/2 trial, Combination therapy, Metastases: A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors (clinicaltrials.gov) - Feb 7, 2022
P1/2, N=114, Not yet recruiting, Sponsor: Akeso
- |||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
New P2 trial: AK117-203: A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Feb 7, 2022
P2, N=80, Not yet recruiting, Sponsor: Akeso
- |||| Yidafan (ivonescimab) / Akesobio, Summit Therapeutics, ligufalimab (AK117) / Akesobio
New P1/2 trial, Combination therapy, Metastases: AK117-202: A Study of AK112 in Advanced Malignant Tumors (clinicaltrials.gov) - Jan 27, 2022
P1/2, N=160, Recruiting, Sponsor: Akeso
- AK117 / Akesobio
AK117, A CD47 Blocking Antibody with Robust Macrophage Activation without Red Blood Cell Hemagglutination (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_888;
AK117 showed a rather superior safety profile to Hu5F9-G4 as a shorter duration of anemia. Conclusions With pre-clinical pharmacology activities comparable to Hu5F9-G4 as well as superior safety properties demonstrated in non-clinical pharmacodynamics studies, AK117 has emerged as a promising new treatment for solid tumor.
- |||| ligufalimab (AK117) / Akesobio
New P1/2 trial: A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - Jul 28, 2021
P1/2, N=160, Recruiting, Sponsor: Akeso
- |||| ligufalimab (AK117) / Akesobio
New P1/2 trial: AK117-103: A Trial of AK117 (Anti-CD47) in Patients With Myelodysplastic Syndrome (clinicaltrials.gov) - May 25, 2021
P1/2, N=190, Recruiting, Sponsor: Akeso
- cadonilimab (AK104) / Akesobio
[VIRTUAL] Safety of AK117, an anti-CD47 monoclonal antibody, in patients with advanced or metastatic solid tumors in a phase I study. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2687;
P1
There were no hematological TRAEs, except in a pt with baseline G1 anemia receiving 10 mg/kg AK117 . Unlike other anti-CD47 therapies, AK117 does not require a lower ‘priming’ dose to prevent anemia .
- ||| ligufalimab (AK117) / Akesobio
New P1 trial, Metastases: A Phase 1 Dose Escalation and Expansion Study of AK117 (clinicaltrials.gov) - Jan 27, 2021
P1, N=162, Recruiting, Sponsor: Akeso
- AK117 / Akesobio
[VIRTUAL] A Phase 1 study to evaluate the safety, PK, and antitumor activity of AK117, an anti-CD47 monoclonal antibody, in subjects with relapsed/refractory advanced or metastatic solid tumors or lymphomas () - Oct 14, 2020 - Abstract #SITC2020SITC_1415;
P1
In the dose expansion phase, AK117 will be studied in cohorts of 30 subjects each with selected solid tumors and selected lymphomas.Subjects with active or prior autoimmune disease that may relapse, history of hemolytic anemia of any cause within 3 months of first dose, hemophagocytic lymphohistiocytosis, defects in RBC production; or defects in hemoglobin production or metabolism will not be eligible for this study. Results N/A Conclusions N/A
- AK117 / Akesobio
[VIRTUAL] A Phase 1 study to evaluate the safety, PK, and antitumor activity of AK117, an anti-CD47 monoclonal antibody, in subjects with relapsed/refractory advanced or metastatic solid tumors or lymphomas () - Oct 14, 2020 - Abstract #SITC2020SITC_680;
P1
In the dose expansion phase, AK117 will be studied in cohorts of 30 subjects each with selected solid tumors and selected lymphomas.Subjects with active or prior autoimmune disease that may relapse, history of hemolytic anemia of any cause within 3 months of first dose, hemophagocytic lymphohistiocytosis, defects in RBC production; or defects in hemoglobin production or metabolism will not be eligible for this study. Results N/A Conclusions N/A
- ||| Kaitanni (cadonilimab) / Akesobio, ligufalimab (AK117) / Akesobio
New P1 trial, Combination therapy, Monotherapy, Metastases: AK117-101: A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104 (clinicaltrials.gov) - Apr 15, 2020
P1, N=159, Not yet recruiting, Sponsor: Akeso