On May 8, 2023 Excyte Biopharma reported its YK012, a bispecific antibody drug was used for the treatment of recurrent/refractory B-cell non Hodgkin’s lymphoma (CD3) × CD19) Phase I clinical research has officially started in Beijing (Press release, Excyte Biopharma, MAY 8, 2023, View Source;lang=en [SID1234646275]). On May 9th, the first subject successfully signed an informed consent form.
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Professor Shi Yuankai, Vice President of the Clinical Research Center of Cancer Hospital of the Chinese Academy of Medical Sciences and Director of the Department of Oncology (2 from the left), Mr. Meng Qingwu (1 from the left), co-founder of Yikesite (Beijing) Medical Technology Development Co., Ltd., and Dr. Yuan Qing’an (3 from the left), co-founder of Yikesite (Beijing) Medical Technology Development Co., Ltd., and Ms. Pan Liyi (4 from the left), Chief Operating Officer of Beijing New Leading Medical Clinical Business Unit, Group photo of team representatives including Ren Chong, Deputy Clinical Director of the applicant (3 from the right), and Ms. Yuan Shaoxiong, Medical Director of the CRO (4 from the right), at the kickoff meeting
CD3 is currently the main target for binding T cells in the global development of immune dual antibody drugs. CD3 molecules are widely distributed on the surface of mature T cells as membrane antigens, and combine with T cell antigen recognition receptors (TCRs) to form composite receptors. Targeting CD3 is the most important pathway for activating T cells/achieving T cell redirection. In the 1980s, CD3 targets entered the field of dual antibody development. In 1985, the concept of T cell redirection was first proposed. After nearly 30 years of research, the development of immune dual antibodies targeting other tumor targets using CD3 targets as the backbone has become increasingly intense.
As one of the most reliable surface biomarker of B cells, CD19 is widely distributed in most stages of B cell development. CD19 can regulate the activation and proliferation of B cells, participate in its signal transduction function, and play the role of Co-receptor. Since its discovery in 1983, CD19 has been confirmed to be expressed in most non Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphoblastic leukemia (CLL), and B-cell lymphoma. In fact, 80% of ALL, 88% of B-cell lymphoma, and 100% of B-cell leukemia express normal to high levels of CD19. CD19 has been clinically proven to be a therapeutic target for lymphoma, leukemia, and some autoimmune diseases.
Currently, anti CD3 × The bispecific antibody blinatumomab (Blincyto) against CD19 ， Beritol ） It is currently the only globally approved CD3 × CD19 bispecific antibody drug, which was officially commercialized and launched in China in August 2021, is used to treat refractory recurrent acute lymphocytic leukemia (r/r B-ALL) in Chinese adults.
YK012 developed by Yike Si Te has a similar mode of action to Belitol, but is significantly superior to Belitol in terms of structure, half-life, expression level, and toxicity. Preclinical studies have shown that YK012 may have better clinical efficacy and safety, and is expected to provide better treatment options for refractory recurrent ALL and NHL. In addition, through clinical trial exploration, it is possible to expand YK012 to more indications.
A good start is half the battle, and in order for patients to use new drugs faster, clinical trial research is undoubtedly racing against time. The YK012 project kickoff meeting and the signing of the first subject informed consent form indicate that Yikesite (Beijing) Pharmaceutical Technology Development Co., Ltd. will set sail with this, officially starting a new starting point, and is a key milestone in the new journey.
Yikesite (Beijing) Pharmaceutical Technology Development Co., Ltd. was jointly founded by Dr. Yuan Qing’an and Mr. Meng Qingwu, who came back from a famous American pharmaceutical company. The company makes full use of the founder’s years of experience, technical advantages and team strength to develop innovative bispecific antibody drugs for blood cancer, multiple myeloma, triple negative breast cancer and liver cancer. These projects have the characteristics of long-term, low toxicity, and high-yield technological innovation, and are positioned as the best or first of their kind. I believe that with the progress of the product pipeline, the company will have more dual antibody varieties entering the clinical stage, providing better treatment methods for patients.