Hutchmed launches new phase one study in China

The AIM-traded firm said the first patient enrolled in the study received their initial dose on 6 July.

It described the trial as a multi-centre, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy profile of HMPL-415 as a single agent in patients diagnosed with advanced malignant solid tumours.

The study was aiming to enrol around 80 patients, including participants in the dose escalation stage and additional patients at the recommended phase two dose (RP2D).

Hutchmed said the principal investigators leading the trial were Dr Tianshu Liu from Zhongshan Hospital, Fudan University, and Dr Nong Yang from Hunan Cancer Hospital.

“HMPL‑415 is a novel, highly potent and selective allosteric inhibitor targeting SHP2 - a non-receptor protein tyrosine phosphatase ubiquitously expressed mainly in the cytoplasm of several tissues,” Hutchmed explained in its statement.

“SHP2 modulates diverse cell signalling events that control metabolism, cell growth, differentiation, cell migration, transcription and oncogenic transformation.

“It interacts with diverse molecules in the cell, and regulates key signalling events including RAS/ERK, PI3K/AKT, JAK/STAT and PD-1 pathways downstream of several receptor tyrosine kinases (RTKs) upon stimulation by growth factors and cytokines.”

Hutchmed said dysregulation of SHP2 expression or activity was the cause of many developmental diseases, and haematological and solid tumours.

“Hutchmed currently retains all rights to HMPL-415 worldwide.”

At 1102 BST, shares in Hutchmed China were down 2.72% at 187.76p.

Reporting by Josh White for Sharecast.com.