Huadong Medicine reported encouraging early results from a Phase I clinical trial of HDM2005, its novel antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). The trial focused on patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or classical Hodgkin lymphoma (cHL).
The study demonstrated that HDM2005 exhibited a favorable safety profile and promising efficacy in these lymphoma types. This suggests potential for the drug’s continued development.
HDM2005 is a first-in-class ADC composed of a humanized monoclonal antibody, a cleavable linker, and the cytotoxic agent monomethyl auristatin E (MMAE). Preclinical research indicated strong anti-tumor activity against various lymphoma and solid tumor models.
The Phase I trial (NCT06615193) enrolled 29 patients, with a majority having received multiple prior treatments. The trial’s primary goals were to assess safety, determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D), and conduct a preliminary efficacy evaluation.
Researchers observed an objective response rate (ORR) of 50% in mantle cell lymphoma (MCL) patients at specific dose levels, including complete and partial responses. In classical Hodgkin lymphoma (cHL) patients, the ORR was 100% at these same dose levels.
While some patients experienced grade 3 or higher treatment-related adverse events (TRAEs), mainly decreased neutrophil count, no patients discontinued treatment due to these side effects. Peripheral neuropathy, a known side effect of some ADCs, was reported but was generally mild.
Huadong Medicine plans to continue developing HDM2005, aiming to bring a new treatment option to patients with these aggressive lymphomas. The company’s commitment to science and patient-centric development guided this research.
HDM2005 is an independently developed drug by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a Huadong Medicine subsidiary, with global intellectual property protection. The drug has received regulatory approvals from both the National Medical Products Administration (NMPA) in
Related
