ICP-B02 is a CD20 × CD3 targeted bispecific antibody jointly developed by Nuocheng Jianhua and Kangnuo. This therapy can bind to CD20 on tumor cells and CD3 on T cells, redirecting and activating T cells through T cell-mediated cytotoxicity (TDCC) to eliminate tumor cells, which has potential therapeutic applications in both tumor and non tumor fields. ICP-B02 is currently undergoing phase 1/2 clinical trials in China to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of the therapy in relapsed/refractory non Hodgkin lymphoma (NHL). Analysis shows that both intravenous (IV) and subcutaneous (SC) formulations of this therapy have achieved positive early results, particularly for patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Based on the encouraging results of ICP-B02 monotherapy, the company plans to conduct dose escalation studies on ICP-B02 in combination with other immunotherapy treatments for early treatment of NHL patients. The IND for combination therapy has been approved at present.
According to the terms of the agreement, Prolium will have exclusive rights to develop, register, produce, and commercialize ICP-B02 in the global non oncology field as well as in the oncology field outside of Asia. Nuo Cheng Jianhua and Kang Nuoya will receive a total payment of up to 520 million US dollars, including prepayments and short-term payments, as well as other payments that can be obtained after achieving certain clinical, regulatory, and commercial milestones.
It is worth mentioning that Ouro Medicines, which has just completed a $120 million Series A financing in early 2025, has recently obtained authorization for its fastest progressing candidate therapy, OM336, from Konya. This is a bispecific T cell adapter targeting B cell mature antigen (BCMA). Ouro Medicines plans to launch its first phase 1 clinical trial in 2025 to treat patients with B-cell mediated immune disorders. In addition, Timberlyne Therapeutics, which also completed a $180 million Series A funding earlier this year, initially developed its potential "best in class" CD38 targeted monoclonal antibody CM313. The results recently published in the New England Journal of Medicine showed that CM313 achieved the primary clinical endpoint in 95% of patients with refractory immune thrombocytopenia in a clinical trial.
<Reprinted from WuXi AppTec>
