CSPC's bispecific SIRPα fusion protein was granted FDA Fast Track qualification

On January 27, CSPC Pharmaceutical Group announced that the company's new drug under development, JMT601 (CPO107), has been granted a fast-track qualification by the US FDA for the treatment of adult relapsed or refractory diffuse large B-cell lymphoma. JMT601 is a bispecific SIRPα fusion protein that is currently undergoing Phase 1 clinical trials in China and the United States.

Non-Hodgkin lymphoma (NHL) is a heterogeneous group of lymphoproliferative disorders caused by B, T, or NK cells. According to the bulletin, B-cell lymphomas with CD20 expression account for the majority of NHL patients in the United States (about 85%). Although most patients with inert NHL survive for 20 years after diagnosis, patients with malignant lymphoma have a poor prognosis, with an overall five-year survival rate of about 60%.

It is reported that JMT601 is a bispecific SIRPα fusion protein with a synergistic targeted binding effect, which can effectively bind to CD20 on the surface of lymphoma cells to induce antibody-dependent cell-mediated cytotoxic effect (ADCC) and complement-dependent cytotoxic effect (CDC). By binding to CD20, JMT601 can further lead to synergistic binding to CD47 expressed on lymphoma cells, thereby blocking the "don't eat me" signal transmitted by CD47 and inducing antibody-dependent macrophage phagocytosis (ADCP).

Currently, a multicenter, first-in-human, dose-escalating, and dose-expanding Phase 1/2 clinical trial is underway in the United States to evaluate the safety, pharmacokinetics, and preliminary efficacy of JMT601 in patients with advanced non-Hodgkin lymphoma, including diffuse large B-cell lymphoma subsets. The announcement noted that the acquisition of fast-track qualification indicates that the FDA believes that JMT601 has demonstrated potential to treat serious or life-threatening diseases and will facilitate and accelerate the development and evaluation of JMT601.

In addition, JMT601 has been approved for clinical studies in China and a Phase 1 clinical trial is currently underway to evaluate the safety and tolerability of JMT601 injection for relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for the Phase 2 study (RP2D).

Editor-in-charge: Li Caoyi