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.

NCT06654011 / Not yet recruitingPhase 2IIT

IN10018 Plus Nab-Paclitaxel and Cadonilimab for Metastatic, Recurrent, or Persistent Gastric-Type Adenocarcinoma of the Cervix: a Multicenter, Single-Arm, Phase II Trial

Gastric-type adenocarcinoma of the cervix is the most commonly diagnosed HPV-independent subtype of cervical cancer, characterized by a poor prognosis and limited responsiveness to existing therapies. Therefore, the exploration of new treatment modalities is critically important. This is an open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of IN10018 plus nab-paclitaxel and cadonilimab in the treatment of adult women with metastatic, recurrent, or persistent gastric-type adenocarcinoma of the cervix.

Start Date01 Nov 2024

Sponsor / Collaborator

Wuhan Xiehe Hospital Tower

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 Dec 2024·Clinical Lung Cancer

Evaluating Safety and Clinical Activity of Front-line Treatment with Cadonilimab plus Chemotherapy in Advanced/Metastatic Nonsmall Cell Lung Cancer Harboring STK11 Genetic Aberration: A Protocol of Phase II Study

Article

Author: Zhou, Chengzhi ; Liu, Ming ; Zhu, Yue ; Xie, Xiaohong ; Guan, Wenhui ; Xie, Zhanhong ; Lin, Xinqing ; Jiang, Huixin ; Sun, Ni ; Li, Ru

BACKGROUND:

Cadonilimab is a first-in-class bispecific PD-1/CTLA-4 antibody. Serine/threonine kinase (STK11) mutation was shown to be related to low PD-L1 expression and objective response rate (ORR) in nonsmall cell lung cancer (NSCLC), resulting in poor progression-free survival (PFS) and overall survival (OS). Herein, we hypothesized that combining cadonilimab with chemotherapy could enhance antitumor immunity and extend survival in these patients. Consequently, we designed this study to explore the clinical activity and safety of cadonilimab combined with chemotherapy in patients with advanced/metastatic NSCLC harboring STK11 alteration.

TRIAL DESIGN:

This single-center, open-label, single-arm phase II trial is conducted at the first affiliated hospital of Guangzhou Medical University. Treatment-naïve advanced/metastatic NSCLC patients harboring STK11 mutation will be enrolled in this study. Eligible patients will receive either cadonilimab (10mg/kg on Day 1) plus pemetrexed (500 mg/m²) and carboplatin (AUC = 5) for nonsquamous NSCLC or abraxane (100 mg/m²) and carboplatin (AUC = 5) for squamous NSCLC for 4 cycles, followed by maintenance therapy (cadonilimab plus pemetrexed or abraxane). The treatment will be discontinued when disease progression, intolerability to cadonilimab, and/or chemotherapy occurs. Measurable lesions were assessed according to the Response Evaluation Criteria in Solid Tumors (1.1). The main endpoint is ORR and safety. Subordinate endpoints include PFS, disease control rate, and duration of response.

RESULTS:

The study commenced enrolment in September 2023, with preliminary findings regarding the primary endpoint anticipated by January 2025.

01 Nov 2024·Med

Neoadjuvant cadonilimab plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma: A multicenter, phase 2 study

Article

Author: Zhu, Junmin ; Guan, Xiaoying ; Jiang, Xiangyan ; Li, Long ; Huang, Zeping ; Yu, Zeyuan ; Zhao, Xiaoning ; Long, Bo ; Mao, Jie ; Yang, Hanteng ; Yang, Xiaojun ; Yan, Hong ; Chen, Shigong ; Che, Shengfu ; Zhang, Wenjuan ; Jiang, Zebin ; Zhao, Da ; Zhou, Huinian ; Gao, Zhongti ; Wei, Dengwen ; Li, Yumin ; Jiao, Zuoyi ; Yu, Hongwei ; Luo, Changjiang ; Zhang, Gengyuan

BACKGROUND:

Treatment with cadonilimab and chemotherapy has shown promise as a first-line treatment for gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. However, its application in neoadjuvant settings has not yet been documented.

METHODS:

This multicenter, phase 2 trial (ChiCTR2200066893) was conducted at four hospitals across China. Treatment-naive patients with locally advanced G/GEJ adenocarcinoma (cT3/4, N+, M0) and who were human epidermal growth factor receptor 2 negative received 3-cycle or 4-cycle neoadjuvant treatment of cadonilimab plus FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy, followed by gastrectomy and 4-cycle adjuvant FLOT chemotherapy. The primary endpoint was the pathological complete response (pCR) rate. Secondary endpoints included major pathological response (MPR), overall response rate (ORR), disease control rate (DCR), R0 resection rate, downstaging rate, and safety.

FINDINGS:

Between December 23, 2022, and December 15, 2023, 32 of 38 patients completed the scheduled treatment, achieving an R0 resection rate of 100% (32/32). The pCR rate was 21.1% (8/38, 90% confidence interval [CI]: 9.7-32.4), and the MPR rate was 44.7% (17/38, 90% CI: 30.9-58.5). Radiological evaluations were available for 28 of 38 patients by blinded independent central review. The ORR was 60.7% (17/28, 90% CI: 44.7-76.7), and the DCR was 100.0% (28/28, 90% CI: 100.0-100.0). Tumor downstaging occurred in 71.9% of patients (23/32), with consistent efficacy across all populations observed in the subgroup analysis. Grade 3 adverse events occurred in 31.6% of patients without severe safety issues.

CONCLUSIONS:

Neoadjuvant cadonilimab plus FLOT chemotherapy treatment exhibits promising efficacy with manageable toxicities in locally advanced G/GEJ adenocarcinoma, providing preliminary evidence for further investigation.

FUNDING:

This study was funded by Akeso Biopharma.

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

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KEGG	Wiki	ATC	Drug Bank
D12190	-	-	-

R&D Status

Approved

10 top approved records.

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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

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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+）)	efljefncar(utbxubdkvc) = wtupjfufaz gmhlpkvgqx (fuoyqrkkwx )	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)	ocwhdtcooq(gtvakcajdy) = xijdfgkgqo cnecewhsml (aqvqozgdxb ) 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)	ocwhdtcooq(gtvakcajdy) = oymhmopyyq cnecewhsml (aqvqozgdxb ) View more	Positive	16 Oct 2024
NCT05978609 (BicureX, ESMO2024) Manual	Phase 2	Advanced biliary tract cancer First line	65	Cadonilimab+gemcitabine+cisplatin	ervyqjcwpb(clhxejcfag) = iiiucrmcfd bnbbjtkklo (khmeeoytpt ) View more	Positive	16 Sep 2024
NCT05948449 (ESMO2024) Manual	Phase 2	Locally Advanced Gastroesophageal Junction Adenocarcinoma Neoadjuvant	24	oxaliplatin+S-1+Cadonilimab	qwwrmssnhc(rweddhspnj) = hzidnixqlz kjzrnmfpic (giuiebaaud ) 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	ioswxbodhs(ajtwrhqdgb) = zyootchjho wrfvpvkjkb (xhtmhmvofg ) View more	Positive	16 Sep 2024
NCT06140589 (ESMO2024) Manual	Not Applicable	Uterine Cervical Cancer	139	Cadonilimab	ubhoommtym(vmztcxdddr) = ifvqmoagmq whwsxpzril (kollulvzrt ) View more	Positive	14 Sep 2024
NCT04220307 (ESMO2024) Manual	Phase 2	Nasopharyngeal Carcinoma Third line	25	Cadonilimab (10mg/kg) + TPC chemotherapy	kpkebmyzmp(mfsvcnmmgg) = ulshdzhefg idduiqdghd (qjjdddctem, 48 - 88) View more	Positive	14 Sep 2024
NCT05430906 (AK104-IIT-003, ESMO2024) Manual	Phase 2	Ovarian Cancer Neoadjuvant	24	Cadonilimab + Neoadjuvant Chemotherapy	epyekxwypr(qxvdokuggv) = esktjuzbno rxitweuhil (eymqezafvi ) View more	Positive	14 Sep 2024
NCT05824494 (ESMO2024) Manual	Phase 2	Uterine Cervical Cancer Second line \| Third line	21	Cadonilimab+chemotherapy	dnklrhbqmx(rgpzgdsnvb) = wiowwoqfdm svtggzaxhg (mphwthhljh ) View more	Positive	14 Sep 2024
NCT05824494 (ESMO2024) Manual	Phase 2	Uterine Cervical Cancer Second line \| Third line	21	Cadonilimab+chemotherapy (2nd line treatment)	rbokdgacxa(prwjfedory) = nloajecrsr wqjbbwzrmo (lvelbnxclw )	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	wjsplhacyc(ycxcsqqcdj) = 在期中分析中达到了无进展生存期（PFS）的主要研究终点 peqdoacdez (pwrarlcgwv ) 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

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis