Kangfang Biotech completed the first clinical trial of kaidenin (PD-1/CTLA-4 double antibody) combined with TIGIT monoclonal antibody (AK127) to treat solid tumors in Australia

[Hong Kong News, October 22, 2021] Kang Fang Biology (9926.HK) announced that the anti-TIGIT monoclonal antibody (AK127) developed independently by the company and the company's first phase I clinical trial against PD-1/CTLA-4 bispecific antibody kaidenin (AK104) to treat advanced or metastatic solid tumors has completed the first patient administration in Australia.

This trial is an open, multicenter phase I study to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity, pharmacodynamic characteristics, and antitumor activity of AK127 combined with kaidenin in advanced or metastatic solid tumor subjects.

Clinical studies have shown good clinical benefits of anti-TIGIT monoclonal antibodies combined with anti-PD-1 monoclonal antibodies in tumor immunotherapy. Kaidenin simultaneously targets PD-1 and CTLA-4, two mature immune checkpoint molecules. Preclinical results also showed that the combination of AK127 and kaidenin produced significantly enhanced anti-tumor effects in mouse models.

On the basis that anti-TIGIT monoclonal antibody combined with anti-PD-1 monoclonal antibody therapy showed good pre-clinical and clinical efficacy, AK127 combined with kaidenin is expected to achieve more significant anti-tumor activity in treating patients with solid tumors, further enhancing the potential and prospects of combination therapy.Strengthen and enrich the company's multi-target oncology immunotherapy portfolio。

Dr. Sophia Frentzas, the main researcher of the AK127-101 research project and an oncologist at Monash Health in Melbourne, Australia, pointed out: “In early studies, compared with PD-1 antibodies and CTLA-4 antibodies in combination, kaidenin has shown exciting anti-tumor activity. AK127 is a novel anti-TIGIT monoclonal antibody that has shown encouraging anti-tumor and safety data in preclinical studies. We look forward to positive results from this combination therapy clinical study. We believe this combination therapy has the potential to address the unmet clinical needs of multiple tumor types, whether resistant or tolerable.”

Relying on a rich pipeline of cancer treatment products, Kangfang Biotech is actively developing combination therapies with various promising immune targets to further explore the clinical potential and commercial value of bispecific antibodies based on anti-PD-1 antibodies. Currently, clinical studies such as kaidenin combined with AK117 (CD47 monoclonal antibody), AK109 (VEGFR-2 monoclonal antibody), combined AK119 (CD73 monoclonal antibody), and AK112 with AK117 have all been carried out efficiently.

About AK127 (TIGIT Monoclonal Antibody)

AK127 is a novel humanized IgG1K monoclonal antibody drug targeting tiGIT developed independently by Kangfang Biotech. TIGIT belongs to an expanding family of PVR-like proteins and is an immune checkpoint inhibitory receptor. It is mainly expressed on activated and “depleted” T cells and natural killer cells. Anti-TIGIT drugs prevent TIGIT from binding to its ligand CD155, thereby eliminating inhibitory signals that prevent T cells and NK cells from attacking cancer. AK127 can specifically bind to TIGIT and block the interaction of TIGIT with its ligands, thereby relieving immunosuppression and promoting the anti-tumor immune response. TIGIT expression is closely related to PD-1, especially in tumor-infiltrating T cells. These two targets are usually co-expressed on the same cell, which provides a scientific basis for the development of anti-TIGIT drugs combined with anti-PD- (L) 1 antibodies.

About cadenimab (AK104, PD-1/CTLA-4 dual antibody)

Cadenimab (AK104) is a novel and pioneering PD-1/CTLA-4 bispecific immunotherapy backbone drug independently developed by Kang Fang Biotech. The main indications include lung cancer, liver cancer, stomach cancer, cervical cancer, kidney cancer, esophageal squamous cell cancer, and nasopharyngeal cancer. Research phase data on related tumors show that compared with PD-1 and CTLA-4 combination therapy, there is a significant reduction in toxicity and efficacy advantages. Cadenimab is a major science and technology project of the 13th Five-Year Plan of the National Health and Health Commission and the Ministry of Science and Technology in 2017. It is also a support project for the introduction of innovation and entrepreneurship teams in Guangdong Province's “Pearl River Talent Program” in 2017. The development of cadenin monoclonal was jointly rated as one of the “Top Ten Advances in Chinese Pharmaceutical Biotechnology in 2017” by the China Pharmaceutical Biotechnology Association and “China Pharmaceutical Biotechnology” magazine.

About Kangfang Biotech

Kangfang Biotech (HKEx stock code: 9926.HK) is a biopharmaceutical company dedicated to the research, development, production and commercialization of innovative new antibody drugs that are affordable to patients around the world. Since its establishment, the company has established an end-to-end comprehensive drug development platform (ACE platform), covering fully integrated drug discovery and development functions, including target verification, antibody discovery and development, CMC production process development, and large-scale production in line with GMP standards. The company also successfully established a bispecific antibody drug development platform (Tetrabody platform). The company currently has more than 20 innovative drug product pipelines for the treatment of major diseases such as tumors, autoimmunity, inflammation, and metabolic diseases. Of these, 13 varieties have entered clinical research, including two internationally pioneered new bispecific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). In August 2021, the company's first independently innovated and developed differentiated PD-1 monoclonal antibody, amprizumab injection (ANICOL), was approved for marketing. Kangfang Biotech hopes to develop the world's leading biopharmaceutical company through efficient and groundbreaking R&D and innovation to develop the world's first novel drug and the best treatment of similar drugs.

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