Innovative bispecific antibody YKST02 officially started Phase I clinical trial

2024-06-17 13:19:27 admin 178

On May 21, 2024, Excyte Biopharma Ltd. officially launched the Phase I clinical trial of YKST02, a bispecific antibody drug for treating relapsed/refractory multiple myeloma, in Beijing.

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Prof. Chen Wenming, Chief Physician of the Hematology Department at the Affiliated Beijing Chaoyang Hospital of Capital Medical University (right third), Dr. Yuan Qing'an, Founder of Excyte Biopharma Ltd. (right first), Clinical Affairs Director Ren Chong (left third), Project Director Li Xiang (left second), and Senior Project Manager Zhao Yanyan of Beijing Highthink Pharmaceutical Technology Service Co., Ltd. (left first) took a group photo at the launch event.

YKST02, developed by Excyte, is a bispecific antibody with a 2+2 symmetric structure based on the company's unique FIST (Fusion of IgG and scFv technology) platform. It is a first-in-class drug and is positioned as the best in class.

YKST02, a drug for multiple myeloma patients, has a mechanism of action same to CAR-T. Preclinical data shows that YKST02 is safer and more effective than Teclistamab. The IND application was submitted to the NMPA on February 26, 2024, and approved within two months, demonstrating the strength of the preclinical data for clinical trials. The company and its partners are excited about advancing YKST02's clinical trials and exploring new indications.

In collaboration with Beijing Highthink Pharmaceutical Technology Service Co., Ltd. and the Affiliated Beijing Chaoyang Hospital of Capital Medical University, our company completed the project initiation within 20 days after IND approval. This demonstrates the efficiency of our project team, the confidence of investigators in the product, and strong support from the research institution. Excyte is fully committed to accelerating the clinical progress of YKST02 for a timely product launch, aiming to improve patients' quality of life.

Co-founder and CEO Dr. Qing'an Yuan stated, "Our company is dedicated to the development of products that possess global commercial value and superior therapeutic effects. Currently, the primary challenge in the development of CD3 bispecific antibodies for activating T cells to kill tumor cells lies in the clinical safety issue caused by severe cytokine storm (CRS). In order to address this concern, our company has developed the FIST platform, which effectively mitigates the risk of CRS through multiple approaches while also significantly enhancing the drug's half-life and yield, thus positioning it as a next-generation product. The superiority of the FIST platform has been clearly demonstrated in the Phase I clinical trial of our first drug, YK012.

Excyte was co-founded by Meng Qingwu and Yuan Qing'an, both of whom have returned from a renowned international pharmaceutical company. We have established a wholly-owned subsidiary in the United States, creating a Sino-US dual-wheel driven drug research and development center. The company utilizes the information, technology, and talent advantages of both China and the United States to develop innovative bispecific antibodies for treating blood cancers, multiple myeloma, triple-negative breast cancer, etc. Many projects exhibit long-acting, low toxicity, and high productivity, and are all updated products of international benchmark products.