Powerhouse Partnership: Akeso and RemeGen Join Forces for Groundbreaking Clinical Study, Pioneering PD-1/CTLA-4 Bispecific Antibody with HER-2 ADC Combo in Gastric Cancer Treatment

On September 28, 2023, Akeso (9926.HK) made an exciting announcement regarding its subsidiary, Akeso Pharma, which is set to collaborate with RemeGen (Yantai) Co., Ltd. (688331.SH/09995.HK).

The partnership aims to advance the development of Akeso’s groundbreaking PD-1/CTLA-4 bispecific antibody, cadonilimab (trade name: 开坦尼®), and RemeGen’s domestically developed antibody-drug conjugate (ADC) injection, Disitamab Vedotin (trade name: 爱地希®), in combination therapy. This collaboration also includes the initiation of a phase II clinical study focusing on gastric cancer.

Cadonilimab represents a significant advancement in cancer treatment. It is a human tetravalent bispecific IgG1 antibody with a symmetric IgG-single-chain variable fragment (scFv) structure, designed to target both PD-1 and CTLA-4.

What sets it apart is its exceptional affinity for tumor-infiltrating lymphocytes (TILs) compared to surrounding tissues in the tumor microenvironment (TME). With its Fc-null design, cadonilimab offers improved safety while fully harnessing the synergistic anti-tumor effects of inhibiting PD-1 and CTLA-4 immune checkpoints.

Clinical trials have demonstrated the remarkable anti-tumor efficacy of cadonilimab across various solid tumors. Two-year follow-up data presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting showcased the high overall response rate and long-term survival benefits in advanced gastric/esophagogastric junction adenocarcinoma patients, irrespective of their PD-L1 expression.

These results indicate that cadonilimab has the potential to enhance the effectiveness of immunotherapy in patients with low or negative PD-L1 expression, making it a promising option for advanced gastric cancer treatment.

爱地希® (Disitamab Vedotin) is another significant player in the collaboration. It employs a novel, highly-affinity, and efficient humanized antibody, Disitamab Vedotin monoclonal antibody, combined with advanced linker technology and small molecule cytotoxic drugs. This combination results in specific targeting, exceptional efficacy, and an excellent safety profile.

The drug has already received recognition in the 2023 Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Gastric Cancer as a preferred third-line treatment for HER2-positive advanced gastric cancer, further underscoring its clinical value.

Preclinical studies have shown the potential synergy between immune checkpoint inhibitors and ADC drugs, paving the way for promising combination therapies. The collaboration between cadonilimab and Disitamab Vedotin is expected to achieve synergistic efficacy in anti-tumor treatment, potentially offering a more efficient and safer combination therapy option for cancer patients.

Akeso is fully committed to exploring cadonilimab’s potential as a cornerstone cancer treatment, actively working on developing various combination therapies. This includes collaborations with its innovative product pipeline and partnerships within the industry to fully unlock the clinical value of cadonilimab. The future holds exciting prospects for advancing cancer treatments and improving patient outcomes.

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