I-Mab : China Accepts IND For Phase 2 Trial Of Efineptakin Alfa In Combination With PD-1 Therapy

(RTTNews) - I-Mab (IMAB) said that an IND application for the initiation of a phase 2 clinical trial of efineptakin alfa in combination with anti-PD-1 antibody in patients with advanced solid tumors, including triple-negative breast cancer or TNBC and head and neck cancers or HNC, has been accepted by the Center for Drug Evaluation or CDE of the China National Medical Products Administration (NMPA).

Efineptakin alfa is expected to show a therapeutic effect as a combination therapy with immune checkpoint inhibitors due to its inherent properties to increase T-cells that are critical for tumor suppression. Its T-cell properties comes with unique selectivity that only stimulates tumor-fighting lymphocytes and spares tumor-protecting Treg cells, differentiating it from other cytokines such as human IL-2.

The company noted that data from the phase 1b/2 Keynote-899 study have shown that simultaneuous treatment of efineptakin alfa at 1200µg/kg with pembrolizumab (Keytruda) induced 27.8% ORR in patients with metastatic TNBC.

According to the data from NIT-110 dose escalation, the combination treatment was safe and well-tolerated in the study.

In addition, interim results from the phase 1 trial (NCT03687957) in newly diagnosed patients with high-grade gliomas that have undergone chemoradiotherapy showed that absolute lymphocyte count (ALC) increased by 1.3 - 4.1 fold at week 4 in a dose-dependent manner and lasted up to 12 weeks after injection, with a one-year survival rate of 83.3% being observed so far.

In addition, a phase 1b trial (NCT04001075) in China is about to complete to facilitate the further development of efineptakin alfa.