Huadong Medicine Announces Positive Preliminary Results from a Phase Ⅰ study of HDM2005, a ROR1-Targeting ADC

As of July 4, 2025, a total of 29 patients were enrolled (n=1, 4, 10, 11 and 3 in the 0.3, 1.0, 1.8. 2.5 and 2.75 mg/kg dose cohorts), including 17 patients with mantle cell lymphoma (MCL), 8 patients with diffuse large B-cell lymphoma (DLBCL), and 4 patients with cHL. Most patients (21, 72.4%) had received ≥3 prior lines of anti-tumor therapy. No patient permanently discontinued treatment due to treatment related adverse events (TRAEs). In the 1.8 mg/kg and 2.5 mg/kg cohorts, 38.1% of patients (8/21) experienced Grade ≥3 TRAEs, the most common (≥5%) being neutrophil count decrease (4 patients, 19.0%). No Grade ≥3 gastrointestinal adverse reactions or peripheral neuropathy were reported. Peripheral neuropathy occurred in 4 patients (13.8%), all of which were Grade 1 or 2.

As of July 4, 2025, a total of 29 patients were enrolled (n=1, 4, 10, 11 and 3 in the 0.3, 1.0, 1.8. 2.5 and 2.75 mg/kg dose cohorts), including 17 patients with mantle cell lymphoma (MCL), 8 patients with diffuse large B-cell lymphoma (DLBCL), and 4 patients with cHL. Most patients (21, 72.4%) had received ≥3 prior lines of anti-tumor therapy. No patient permanently discontinued treatment due to treatment related adverse events (TRAEs). In the 1.8 mg/kg and 2.5 mg/kg cohorts, 38.1% of patients (8/21) experienced Grade ≥3 TRAEs, the most common (≥5%) being neutrophil count decrease (4 patients, 19.0%). No Grade ≥3 gastrointestinal adverse reactions or peripheral neuropathy were reported. Peripheral neuropathy occurred in 4 patients (13.8%), all of which were Grade 1 or 2.

In the 1.8 mg/kg and 2.5 mg/kg cohorts, the objective response rate (ORR) was 50% (6/12) in MCL patients, including 1 complete response (CR) and 5 partial responses (PR). The ORR was 100% (2/2) in cHL patients with CRs.

The preliminary results of this Phase I clinical trial show that HDM2005 was well-tolerated and demonstrated promising anti-tumor activity in patients with relapsed/refractory B-NHL or cHL. Huadong Medicine will commit to its "science-driven, patient-centered" mission, advance HDM2005 through clinical development and registration, and strive to bring more treatment options to patients.

About HDM2005

HDM2005 Injection is a Class 1 innovative biologic drug targeting ROR1. It is an ADC independently developed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, which holds global intellectual property rights. The clinical trials for HDM2005 were approved in June 2024 by the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) respectively, for the treatment of advanced malignant tumors. In February 2025, HDM2005 received Orphan Drug Designation from the U.S. FDA for the treatment of mantle cell lymphoma (MCL). In April 2025, its Investigational New Drug (IND) application for use in combination with rituximab, cyclophosphamide, doxorubicin (or epirubicin), and prednisone (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL) was approved by the NMPA.

The project is currently advancing at the first tier of the global clinical R&D landscape for ROR1 ADC. The following 3 clinical trials are currently ongoing in China:

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