ligufalimab (AK117) / Akesobio - LARVOL DELTA

A PHASE II RANDOMIZED STUDY OF AK117 VERSUS PLACEBO IN COMBINATION WITH VENETOCLAX AND AZACITIDINE IN PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA PATIENTS INELIGIBLE FOR INTENSIVE CHEMOTHERAPY (EHA 2026) - P1/2 | "Overall, no new safety signals were observed with AK117. Summary/Conclusion AK117 combined with AZA and VEN demonstrated encouraging clinical activity with a manageable safety profile in previously untreated AML pts ineligible for intensive chemotherapy, supporting further clinical development."

Clinical • Combination therapy • P2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Thrombocytopenia

AK117 (Anti-CD47 mAb) Plus Cetuximab or AK104 (Anti-PD-1/CTLA-4 bsAb) as Second-Line Therapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Active, not recruiting | N=10 ➔ 20 | Trial primary completion date: Aug 2026 ➔ Nov 2026

Enrollment change • Enrollment closed • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as first-line (1L) treatment for metastatic colorectal cancer (mCRC) (ESMO 2024) - P2 | "Background: FOLFOXIRI plus bevacizumab is the standard 1L treatment for mCRC... Ivonescimab with or without ligufalimab in combination with FOLFOXIRI showed promising efficacy and tolerable safety as 1L treatment in pts with mCRC."

Clinical • Combination therapy • IO biomarker • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS

Ligufalimab (CD47)-Based Combination Achieves Deep Responses and Survival Benefit in Frontline AML: Phase II Results Presented in Oral Session at EHA 2026 (PRNewswire) - "At a median follow-up of 10 months in the ligufalimab group and 8.8 months in the control group, median event-free survival (EFS) was 9.1 months in the ligufalimab group versus 6.9 months in the control group (hazard ratio [HR] = 0.46). The 6-month EFS rate was 67.8% versus 55.5% in the control group, and the 9-month EFS rate was 53.2% versus 14.1%. Median overall survival (mOS) was not reached in the ligufalimab group versus 8.3 months in the control group (HR = 0.46). The 6-month OS rate was 83.3% versus 73.2%, and the 9-month OS rate was 78.7% versus 43.1% in the control group....The objective response rate (ORR) was 80.0% in the ligufalimab group versus 66.7% in the control group, and the composite complete response (CRc) rate was 56.7% versus 53.3%..."

P2 data • Acute Myelogenous Leukemia

Over 40 Studies Featuring Akeso's Innovative Oncology Agents to Be Presented at ASCO 2026: Ivonescimab's HARMONi-6 Overall Survival Data Selected for Plenary Session (The Manila Times) - "The datasets featured at ASCO 2026 primarily highlight the Company's core first-in-class bispecific antibodies - cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF) - along with other novel therapeutic antibodies such as ligufalimab, a next-generation CD47 monoclonal antibody."

P1 data • P2 data • P3 data • Colorectal Cancer • Mucosal Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

AK117-204: A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=128 | Completed | Sponsor: Akeso | Trial completion date: Mar 2024 ➔ May 2026 | Trial primary completion date: Mar 2023 ➔ May 2026 | Recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

First-line (1L) cadonilimab plus AK117 and chemotherapy (chemo) in advanced gastric or gastroesophageal junction cancer (GC/GEJC): Updated results from a phase 2 study. (ASCO 2026) - P1/2 | " Eligible patients (pts) with previously untreated, advanced HER2-negative GC/GEJC received cadonilimab (10 mg/kg) and AK117 (45 mg/kg) plus oxaliplatin and capecitabine every 3 weeks... Consistent with prior reports, cadonilimab combined with AK117 and chemo showed encouraging efficacy and manageable safety in first-line treatment of advanced GC/GEJC. Clinical trial information: NCT05235542."

Clinical • IO biomarker • Metastases • P2 data • Gastric Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

ILLUMINE: Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN (clinicaltrials.gov) - P3 | N=780 | Recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete et Cou | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2030 ➔ May 2030

Enrollment open • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Phase II Data from a Randomized Double-Blind Trial of Ligufalimab (Anti-CD47) Combination Therapy in Frontline AML Published at EHA 2026 (The Manila Times) - "The objective response rate (ORR) was 80.0% in the ligufalimab arm versus 66.7% in the control arm, with a composite complete remission (CRc) rate of 56.7% versus 53.3%. Among patients achieving CRc, the measurable residual disease (MRD) negativity rate was higher in the ligufalimab arm (46.7% versus 36.7%)...At a median follow-up of 8.84 months, median overall survival (mOS) in the ligufalimab arm was not yet reached, versus 8.3 months in the control arm. The 9-month overall survival rate was 78.7% in the ligufalimab arm versus 43.1% in the control arm; the 6-month OS rates were 83.3% versus 73.2%, respectively...The incidence of overall treatment-emergent adverse events (TEAEs) and serious adverse events was comparable between treatment arms."

P2 data • Acute Myelogenous Leukemia

ILLUMINE: Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN (clinicaltrials.gov) - P3 | N=780 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

Trial initiation date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Akeso, Inc…announced today that it has received clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate Phase II clinical trials for AK146D1, a first-in-class Trop2 /Nectin4 bispecific antibody-drug conjugate (ADC), and AK138D1, an innovative HER3-targeting ADC. (The Manila Times) - "The studies will evaluate these two novel ADC candidates in combination with the Company's pioneering immuno-oncology (IO) 2.0 bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), as well as other proprietary high-potential anti-tumor assets, including AK117 (anti-CD47 monoclonal antibody) and AK109 (anti-VEGF monoclonal antibody), across a spectrum of advanced solid tumors....These Phase II studies will leverage the cadonilimab and ivonescimab as foundational backbone therapies, capitalizing on their validated clinical profiles in checkpoint blockades and dual VEGF/PD-1 inhibition."

New P2 trial • Solid Tumor

GORTEC 2024-01: Phase 3 study comparing ivonescimab alone or ivonescimab with ligufalimab versus pembrolizumab for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (clinicaltrialsregister.eu) - P2/3 | N=310 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete Cou

New P2/3 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

AK117-203: A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Akeso | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Jun 2027 | Trial primary completion date: Jul 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

AK117-201: A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=154 | Active, not recruiting | Sponsor: Akeso | Recruiting ➔ Active, not recruiting | N=114 ➔ 154 | Trial completion date: Feb 2024 ➔ Jun 2027 | Trial primary completion date: Feb 2023 ➔ Dec 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer (clinicaltrials.gov) - P3 | N=999 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

AK117-202: A Study of AK112 in Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=154 | Completed | Sponsor: Akeso | N=250 ➔ 154 | Trial completion date: Jun 2026 ➔ Dec 2025 | Trial primary completion date: May 2025 ➔ Nov 2025 | Active, not recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor

ILLUMINE: Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN (clinicaltrials.gov) - P3 | N=780 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

New P3 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of Ivonescimab in First-Line ES-SCLC (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Akeso

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Phase 1b Study Evaluating the Safety and Efficacy of AK117 (anti-CD47 monoclonal antibody) in Combination with Azacitidine in Patients with Treatment-Naïve Acute Myeloid Leukemia (ASH 2023) - "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."

Clinical • Combination therapy • P1 data • Acute Myelogenous Leukemia • Anemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

AK117 (anti-CD47 monoclonal antibody) in Combination with Azacitidine for Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS): AK117-103 Phase 1b Results (ASH 2023) - "AK117 in combination with AZA was well tolerated with low incidence of anemia and demonstrated promising efficacy in patients with newly diagnosed HR-MDS."

Combination therapy • P1 data • Anemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

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) (ASH 2024) - P2 | "Additionally, unlike the first generation anti-CD47 agents such as magrolimab, AK117 does not cause red blood cell agglutination and on-target anemia. 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."

Clinical • Combination therapy • P2 data • Acute Myelogenous Leukemia • Anemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • SIRPA

AK112-206: A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=254 | Active, not recruiting | Sponsor: Akeso | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Oncology • Solid Tumor

…Patient enrollment has been completed in a randomized, double-blind, multicenter Phase II study assessing ligufalimab combined with azacitidine in higher-risk myelodysplastic syndromes (HR-MDS). (PRNewswire)

Enrollment closed • Myelodysplastic Syndrome

Anti-CD47 drug interference in pre-transfusion testing can be overcome by antigen masking. (PubMed, Transfusion) - "These findings emphasize the need for awareness and adaptation in immunohematology practices as anti-CD47 drugs continue to advance in clinical development, and highlight the utility of antigen masking strategies to enhance the safe administration of blood products to treated patients."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • CD47 • SIRPA

Akeso's Ligufalimab (CD47 mAb) Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia (AML) (PRNewswire) - "Clinical trials have demonstrated that ligufalimab combined with azacitidine shows a favorable safety profile and promising efficacy in first-line AML treatment."

Orphan drug • Acute Myelogenous Leukemia