Safety and efficacy of Cardonilmab as a second-line or above treatment in patients with advanced malignant melanoma and renal cell carcinoma.
To investigate the safety and efficacy of cardunnilizumab in the treatment of advanced mucosal, acral and cutaneous malignant melanoma and advanced renal cell carcinoma.
Primary end point: objective response rate (ORR) Secondary end point: progression-free survival (PFS), disease control rate (DCR), overall survival (OS), incidence of treatment-related adverse events Exploratory study end point: efficacy related marker exploration, gut microbiota or metabolomics changes

Start Date01 Dec 2024

Sponsor / Collaborator

Henan Cancer Hospital

NCT06646055 / Not yet recruitingPhase 1/2

A Phase Ib/II Clinical Study of AK112 and Cadonilimab Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer

This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab combined with chemotherapy as first-line treatment for patients with metastatic pancreatic cancer.

Start Date10 Nov 2024

Sponsor / Collaborator

Akeso Biopharma Co., Ltd.

NCT06681285 / Not yet recruitingPhase 2IIT

The Efficacy and Safety of Cadonilimab Combined With Anlotinib Followed by Radiotherapy in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (CAR-RMEC):A Single-arm, Multicenter, Phase II Clinical Trial

GLOBOCAN 2020 reported that the global incidence of esophageal cancer climbed to 604,100, accounting for 3.1% of all tumor sites and ranking 7th out of 36 cancers. In addition, about 544,076 new esophageal cancer deaths, which accounted for 5.5% of all study centers and ranked 6th among 36 cancers. Esophageal squamous cell carcinoma (ESCC) is the most common pathological type of esophageal cancer in China, and accounts for about 90% of cases. Immunotherapy has become the main treatment for second-line and later esophageal cancer patients, but because of the single target, limited mediated signaling pathway, and high drug resistance rate, single-target blocking has limited efficacy. Cadonilimab is a novel humanized bispecific antibody targeted by programmed death receptor 1（PD-1）/cytotoxic T-lymphocyte antigen 4 (CTLA-4)，which can simultaneously block the two immune checkpoint pathways of PD-1 and CTLA-4, indirectly "liberating" immune cells, and improving immune efficacy. Anlotinib inhibits tumor angiogenesis by fully acting on the VEGFR/PDGFR/FGFR pathway, while remodeling tumor microenvironment, increasing T cell activity and infiltration, and synergizing immunotherapy. In addition, the control of local tumors or oligometastases by radiotherapy combined with systemic therapy such as immunotherapy has become an important research direction for metastatic esophageal cancer. This study will explore the efficacy and safety of cadonilimab combined with anlotinib sequential radiotherapy for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) at second or later line.

Start Date01 Nov 2024

Sponsor / Collaborator

The Fourth Hospital of Hebei Medical University

100 Clinical Results associated with Cadonilimab

100 Translational Medicine associated with Cadonilimab

100 Patents (Medical) associated with Cadonilimab

Literatures (Medical) associated with Cadonilimab

31 Dec 2024·mAbs

A pivotal decade for bispecific antibodies?

Article

Author: Surowka, Marlena ; Klein, Christian

Bispecific antibodies (bsAbs) are a class of antibodies that can mediate novel mechanisms of action compared to monospecific monoclonal antibodies (mAbs). Since the discovery of mAbs and their adoption as therapeutic agents in the 1980s and 1990s, the development of bsAbs has held substantial appeal. Nevertheless, only three bsAbs (catumaxomab, blinatumomab, emicizumab) were approved through the end of 2020. However, since then, 11 bsAbs received regulatory agency approvals, of which nine (amivantamab, tebentafusp, mosunetuzumab, cadonilimab, teclistamab, glofitamab, epcoritamab, talquetamab, elranatamab) were approved for the treatment of cancer and two (faricimab, ozoralizumab) in non-oncology indications. Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.

01 Nov 2024·Thoracic Cancer

The efficacy and safety of a novel PD‐1/CTLA‐4 bispecific antibody cadonilimab (AK104) in advanced non‐small cell lung cancer: A multicenter retrospective observational study

Article

Author: Meng, Xue ; Li, Meiying ; Li, Chengming ; Zhao, Wen ; Wang, Jun ; Li, Jisheng ; Yu, Shuwen ; Han, Chunyan ; Shen, Hongchang ; Yi, Cuihua ; Wang, Chengjun ; Liu, Lian ; Li, Hongxin

Abstract:

Background:

For patients with advanced non‐small cell lung cancer (NSCLC) who have received frontline immunochemotherapy, subsequent treatment options are limited. As the first dual programmed cell death‐1 (PD‐1)/cytotoxic T lymphocyte‐associated antigen‐4 bispecific antibody approved globally, cadonilimab demonstrated potential antitumor activity in advanced NSCLC patients resistant to anti‐PD‐1/PD‐L1 antibodies.

Methods:

We retrospectively collected efficacy and safety data from advanced NSCLC patients treated with cadonilimab‐based regimens in later therapy lines.

Results:

A total of 41 advanced NSCLC patients refractory to anti‐PD‐1/PD‐L1 therapy were enrolled. More than half of the patients received cadonilimab‐based regimen as a fourth or later line of treatment. At the data cutoff date, treatment efficacy could be evaluated in 23 patients. One patient (4.3%) achieved partial response, eight patients (34.8%) experienced stable disease, and 14 patients (60.9%) progressed. The objective response rate and disease control rate were 4.3% and 39.1%, respectively. The median progression‐free survival for all evaluated patients was 108.0 days. Due to the short follow‐up period, the median overall survival has not yet been reached. Treatment‐related adverse events (TRAEs) and immune‐related AEs occurred in 63.4% and 22% patients, respectively. The most common TRAEs included gamma‐glutamyl transferase elevation (17.1%), coughing (14.6%), and fatigue (12.2%). Five patients (12.2%) experienced grade ≥3 TRAEs.

Conclusions:

In this heavily pretreated cohort of advanced NSCLC patients, cadonilimab‐based regimens showed moderate antitumor efficacy with a generally tolerable and manageable safety profile. However, more evidence is needed to support the administration of cadonilimab in NSCLC patients refractory to previous anti‐PD‐1/PD‐L1 therapy.

18 Oct 2024·BMC Oral Health

Oral Lichenoid lesions induced by programmed cell death protein 1 and cytotoxic T-lymphocyte-associated protein 4 bispecific antibody: a case report.

Article

Author: Wei, Shanni ; Chen, Xinyu ; Jiang, Qiaozhi ; Tao, Renchuan ; Wu, Jiaxuan

BACKGROUND:

Cadonilimab is the first approved dual immune checkpoint inhibitor targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), currently utilized for the treatment of various solid tumors. Oral mucosal adverse reactions, such as oral lichenoid lesions, represent one of the most prevalent immune-related adverse events associated with immune checkpoint antibodies. However, reports detailing oral side effects specifically linked to Cadonilimab are lacking. Documenting these side effects is essential to alert oncologists and stomatologists, facilitating timely intervention for affected patients.

CASE PRESENTATION:

We present a case involving a 35-year-old male patient diagnosed with hepatocellular carcinoma who received Cadonilimab following hepatectomy and subsequently developed extensive oral lichenoid lesions along with mucosal erosion at 13-14 weeks post-treatment initiation. A biopsy was conducted revealing immunohistochemical findings of CD3+, CD4+, CD8+, CD20 + lymphocytes, CD68 + macrophages, and α-SMA + myofibroblasts infiltrating the tissue of the oral lichenoid lesions. The patient's oral lesions improved after administration of systemic and local glucocorticoid therapy alongside cessation of Cadonilimab treatment.

CONCLUSION:

This report marks the first documented instance of an oral adverse effect associated with Cadonilimab use. It underscores that administration of this agent may lead to significant lichenoid lesions and erosions within the oral cavity-an issue warranting increased vigilance from both oncologists and stomatologists.

News (Medical) associated with Cadonilimab

08 Nov 2024

·www.prnewswire.com

Akeso Published Mechanism of Action for CLDN18.2/CD47 Bispecific Antibody AK132 for the First Time at SITC Annual Meeting

HONG KONG, Nov. 7, 2024 /PRNewswire/ -- At the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024), held in Houston, USA, from November 6 - 10, Akeso Biopharma (9926. HK) presented the mechanism of action (MOA) research findings of its innovative bispecific antibody, AK132, targeting both Claudin18.2 (CLDN18.2) and CD47. AK132 is an asymmetric bispecific antibody with a "1+1" valency, designed to simultaneously target and block CLDN18.2 and CD47. It features a wild-type IgG1 Fc structure and is currently in the clinical research stage. CD47 is overexpressed on a variety of cancer cells, where it interacts with its ligand SIRPα on innate immune cells to inhibit tumor phagocytosis. Claudin 18.2 (CLDN18.2), a tight junction protein, is abnormally activated and overexpressed in several primary malignancies. It has been recognized as a key tumor antigen target in gastric and pancreatic cancers. Studies have demonstrated that AK132 binds with high affinity to both human CLDN18.2 and human CD47. On one hand, it competitively blocks the interaction between CD47 and its ligand SIRPα, thereby disrupting the CD47-SIRPα axis and relieving the inhibition of tumor cell phagocytosis. This enables macrophage-mediated phagocytosis of CLDN18.2+/CD47+ tumor cells, thereby enhancing the antitumor activity of immune cells. On the other hand, AK132 also induces potent tumor cell killing through Fc-mediated effector functions, such as ADCC, ADCP, and CDC, leading to superior antitumor efficacy compared to anti-CLDN18.2 monoclonal antibodies. In subcutaneous tumor xenograft models in mice, AK132 demonstrated significantly stronger antitumor activity than anti-CLDN18.2 monoclonal antibodies. Ak132 Efficiently Binds to CLDN18.2 and CD47, Exerting Antitumor Effects through Multiple Mechanisms Research shows that AK132 binds with high affinity and specificity to human CLDN18.2 and human CD47, competitively blocking the interaction between CD47 and its ligand SIRPα. This disruption of the CD47-SIRPα interaction releases the inhibition on tumor cell phagocytosis, enhancing immune cell anti-tumor functions. AK132 mediates macrophage phagocytosis of CLDN18.2+/CD47+ tumor cells and effectively inhibits tumor growth in subcutaneous xenograft mouse models. AK132 also efficiently kills tumor cells through Fc-mediated effector functions, such as ADCC (antibody-dependent cell-mediated cytotoxicity), ADCP (antibody-dependent cellular phagocytosis), and CDC (complement-dependent cytotoxicity). AK132 Shows no RBC Toxicity, Does not Bind to Red Blood Cells or Induce Agglutination, Demonstrating Good Safety Profiles Although CD47 is considered a promising target for cancer immunotherapy, the therapeutic efficacy of CD47 monoclonal antibodies is significantly limited by their considerable toxicity to red blood cells. AK132 features a unique structural design that reduces its affinity for CD47. In vitro studies have shown that AK132 binds minimally to human red blood cells, does not induce ADCP or ADCC activity against red blood cells (thus preventing red blood cell killing), and does not cause red blood cell aggregation, demonstrating an absence of erythrocyte toxicity. Six Globally Leading Bispecific Antibodies Efficiently Propel Cancer Immunotherapy into the 2.0 Era Akeso's investigational New Drug application (IND) application for AK132, aimed at treating advanced malignant solid tumors, has been approved by the China NMPA. Akeso has strategically built a leading, target-rich pipeline of bispecific antibodies, establishing a competitive edge in cancer immunotherapy. Among these, cadonilimab (PD-1/CTLA-4 bispecific) and ivonescimab (PD-1/VEGF bispecific) are already market-approved. Four other bispecific antibodies, including AK129 (PD-1/LAG-3), AK130 (TIGIT/TGF-β fusion protein), AK131 (PD-1/CD73), and AK132 (CLDN18.2/CD47), are currently in clinical trials. ### About AK132 （ Claudin18.2/CD4 bispecific antibody ） AK132 is a bispecific antibody developed by Akeso, targeting the recombinant humanized Claudin18.2 (CLDN18.2) splice variant 2 and CD47 for the treatment of various cancers, including gastric, esophageal, pancreatic, ovarian, and lung adenocarcinomas. AK132 binds with high affinity to both human CLDN18.2 and CD47, effectively blocking the interaction between CD47 and its ligand SIRPα. In mouse subcutaneous tumor models, it significantly inhibits tumor growth. AK132 shows no ADCC or ADCP activity in human RBC-targeted assays and does not cause RBC aggregation. As a bispecific antibody, it holds potential as a cancer therapy with both efficacy and safety. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyAACR

31 Oct 2024

·pipelinereview.com

Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combined with Ligufalimab (CD47) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC), Compared to Pembrolizumab

HONG KONG, China I October 30, 2024 I Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso’s next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The AK117-302 study represents a significant milestone as the first Phase III clinical trial globally to investigate a CD47 monoclonal antibody therapy for solid tumors. This trial is the fifth Phase III study for ivonescimab, utilizing PD-1/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab. The AK117-302 trial underscores Akeso’s commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights our capability to maximize the number of cancer patients globally that can benefit from our product portfolio through a strategic approach to clinical development. In 2022, there were 770,000 new cases of head and neck cancer globally, with 84,000 cases reported in China. Squamous cell carcinoma of the head and neck (HNSCC) accounts for over 90% of these cancers. Unfortunately, the five-year survival rate for patients with recurrent/metastatic HNSCC (R/M HNSCC) is just 3.6%. While targeted therapies and immunotherapies have improved treatment options, the median overall survival (OS) remains below one year. Pembrolizumab has emerged as the first-line standard treatment for R/M HNSCC and is recommended in both CSCO and NCCN guidelines. There is a critical unmet need for more effective therapies to help HNSCC patients achieve long-term survival. At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso reported initial positive data on its combination therapy of ivonescimab and ligufalimab. This combination demonstrated significant tumor reduction and survival benefits, particularly for HNSCC patients, who require rapid tumor shrinkage. The preliminary efficacy data from this therapy surpassed that of previously disclosed PD-1 studies, positioning it as a potentially new immunotherapy option for HNSCC patients. About Ligufalimab (AK117) AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors, as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, the Chinese Phase II clinical study of the first-line treatment for unfit AML using AK117 in combination with venetoclax and zzacitidine, as well as the international multicenter Phase II clinical study of AK117 for treating MDS, are both ongoing with patient enrollment. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics’s license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them , 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE: Akeso

ImmunotherapyPhase 2Phase 3Drug ApprovalClinical Result

31 Oct 2024

·www.prnewswire.com

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso's next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The AK117-302 study represents a significant milestone as the first Phase III clinical trial globally to investigate a CD47 monoclonal antibody therapy for solid tumors. This trial is the fifth Phase III study for ivonescimab, utilizing PD-1/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab. The AK117-302 trial underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights our capability to maximize the number of cancer patients globally that can benefit from our product portfolio through a strategic approach to clinical development. In 2022, there were 770,000 new cases of head and neck cancer globally, with 84,000 cases reported in China. Squamous cell carcinoma of the head and neck (HNSCC) accounts for over 90% of these cancers. Unfortunately, the five-year survival rate for patients with recurrent/metastatic HNSCC (R/M HNSCC) is just 3.6%. While targeted therapies and immunotherapies have improved treatment options, the median overall survival (OS) remains below one year. Pembrolizumab has emerged as the first-line standard treatment for R/M HNSCC and is recommended in both CSCO and NCCN guidelines. However, many patients do not respond adequately, and the overall survival benefit remains limited. There is a critical unmet need for more effective therapies to help HNSCC patients achieve long-term survival. At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso reported initial positive data on its combination therapy of ivonescimab and ligufalimab. This combination demonstrated significant tumor reduction and survival benefits, particularly for HNSCC patients, who require rapid tumor shrinkage. The preliminary efficacy data from this therapy surpassed that of previously disclosed PD-1 studies, positioning it as a potentially new immunotherapy option for HNSCC patients. About Ligufalimab (AK117) AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors, as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, the Chinese Phase II clinical study of the first-line treatment for unfit AML using AK117 in combination with venetoclax and zzacitidine, as well as the international multicenter Phase II clinical study of AK117 for treating MDS, are both ongoing with patient enrollment. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them , 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combined with Ligufalimab (CD47) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC), Compared to Pembrolizumab

ImmunotherapyPhase 2Phase 3Drug ApprovalClinical Result

100 Deals associated with Cadonilimab

External Link

KEGG	Wiki	ATC	Drug Bank
D12190	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	CN	Akeso Pharmaceuticals, Inc.	26 Sep 2024
Uterine Cervical Cancer	CN	Akeso Pharmaceuticals, Inc.	28 Jun 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	CN	Akeso Biopharma Co., Ltd.	19 Jun 2024
Non-Small Cell Lung Cancer	Phase 3	CN	Akeso Biopharma Co., Ltd.	14 Nov 2023
Advanced Nasopharyngeal Carcinoma	Phase 3	CN	Akeso Pharmaceuticals, Inc.	01 Aug 2023
Nasopharyngeal Carcinoma	Phase 3	CN	Akeso Pharmaceuticals, Inc.	01 Aug 2023
Hepatocellular Carcinoma	Phase 3	CN	Akeso Biopharma Co., Ltd.	24 Sep 2022
Locally Advanced Cervical Carcinoma	Phase 3	CN	Akeso Biopharma Co., Ltd.	08 Jun 2022
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	CN	Akeso Biopharma Co., Ltd.	17 Sep 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	CN	Akeso Biopharma Co., Ltd.	27 Aug 2021
stomach adenocarcinoma	Phase 3	CN	Akeso Biopharma Co., Ltd.	19 Aug 2021
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	-	Akeso Biopharma Co., Ltd.	10 Nov 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2300076740 (NEWS) Manual	Phase 2	Uterine Cervical Cancer HER2 Expression	74	维迪西妥单抗联合卡度尼利单抗 (HER2表达（IHC 1+2+3+）)	oervsobpft(bkgswewxol) = usronwlhuc nqvkudqlhj (zzyshtmxln )	Positive	17 Oct 2024
NCT04982237 (Compassion-16, IGCS2024) Manual	Phase 3	Uterine Cervical Cancer First line	445	Cadonilimab (10mg/kg) + platinum-based chemotherapy ± bevacizumab (15mg/kg)	etzdxsmqyv(kytycvxtzm) = nmbfdievqy vbdgfmmhgc (wlrsxfuvok ) View more	Positive	16 Oct 2024
NCT04982237 (Compassion-16, IGCS2024) Manual	Phase 3	Uterine Cervical Cancer First line	445	Placebo + platinum-based chemotherapy ± bevacizumab (15mg/kg)	etzdxsmqyv(kytycvxtzm) = ndqttvqnli vbdgfmmhgc (wlrsxfuvok ) View more	Positive	16 Oct 2024
NCT05978609 (BicureX, ESMO2024) Manual	Phase 2	Advanced biliary tract cancer First line	65	Cadonilimab+gemcitabine+cisplatin	ndnxttjhnd(tuxormvzmt) = hrnuilcjwq kpjslbbirc (ddmcqyyfbz ) View more	Positive	16 Sep 2024
NCT05948449 (ESMO2024) Manual	Phase 2	Locally Advanced Gastroesophageal Junction Adenocarcinoma Neoadjuvant	24	oxaliplatin+S-1+Cadonilimab	onfiaplhob(koslymknzv) = yfglwuuvat qviahgkutu (cdydvhtqce ) View more	Positive	16 Sep 2024
NCT05947201 (CAPITAL, ESMO2024) Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	21	Cadonilimab+albumin-paclitaxel+cisplatin+fluorouracil	zlnqwcrtbb(ffeddeftel) = qxdjxrywdk cvewogagog (bbtrfguzzx ) View more	Positive	16 Sep 2024
NCT06140589 (ESMO2024) Manual	Not Applicable	Uterine Cervical Cancer	139	Cadonilimab	aoooomblka(epyjdtkcxf) = zddfqjbogv eqwrthftjj (vxswbyuzik ) View more	Positive	14 Sep 2024
NCT04220307 (ESMO2024) Manual	Phase 2	Nasopharyngeal Carcinoma Third line	25	Cadonilimab (10mg/kg) + TPC chemotherapy	iowanzrhal(zkknjbewbx) = tinvybfqgo qbhjjpawng (hrwyaecruy, 48 - 88) View more	Positive	14 Sep 2024
NCT05430906 (AK104-IIT-003, ESMO2024) Manual	Phase 2	Ovarian Cancer Neoadjuvant	24	Cadonilimab + Neoadjuvant Chemotherapy	tziekmcqwu(cvqhqhmgvn) = dobpqohzis palntgbrru (ddxghxjtxd ) View more	Positive	14 Sep 2024
NCT05824494 (ESMO2024) Manual	Phase 2	Uterine Cervical Cancer Second line \| Third line	21	Cadonilimab+chemotherapy	qsofqxfwns(ddadxhcikx) = nsskrynjen tisnmyzczh (reixysgpep ) View more	Positive	14 Sep 2024
NCT05824494 (ESMO2024) Manual	Phase 2	Uterine Cervical Cancer Second line \| Third line	21	Cadonilimab+chemotherapy (2nd line treatment)	wxoifzgzwx(xqfmxuxxfn) = kirzotywov ppdwrxpijx (pbncqosoao )	Positive	14 Sep 2024
NCT04982237 (AK104-303, NEWS) Manual	Phase 3	Uterine Cervical Cancer First line	-	卡度尼利+化疗±贝伐珠单抗	bcemynxlrk(msqkdttknb) = 在期中分析中达到了无进展生存期（PFS）的主要研究终点 uunbsyznug (axlhccwdjb ) Met View more	Positive	16 Jul 2024
NCT04982237 (AK104-303, NEWS) Manual	Phase 3	Uterine Cervical Cancer First line	-	安慰剂+化疗±贝伐珠单抗		Positive	16 Jul 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis