{"id":39631,"date":"2025-09-05T13:38:00","date_gmt":"2025-09-05T13:38:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4766449_AE66449_0"},"modified":"2025-09-05T13:38:00","modified_gmt":"2025-09-05T13:38:00","slug":"huadong-medicine-announces-positive-preliminary-results-from-a-phase-%e2%85%b0-study-of-hdm2005-a-ror1-targeting-adc","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=39631","title":{"rendered":"Huadong Medicine Announces Positive Preliminary Results from a Phase \u2160 study of HDM2005, a ROR1-Targeting ADC"},"content":{"rendered":"

HANGZHOU, China<\/span><\/span>, Sept. 5, 2025<\/span><\/span> \/PRNewswire\/ — Huadong Medicine Co., Ltd. (hereinafter referred to as “Huadong Medicine<\/span>“) today announced positive preliminary results from a Phase I study of HDM2005, an independently developed Class 1 innovative antibody\u2013drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or classical Hodgkin lymphoma (cHL). The results showed that HDM2005 demonstrated promising efficacy with a favorable safety and tolerability profile in B-NHL and cHL, which will support the clinical development moving forward.<\/p>\n

ROR1 is a transmembrane protein overexpressed in various cancers, including lymphomas. HDM2005 is composed of a humanized IgG1 monoclonal antibody, a proteolytically cleavable linker, and the cytotoxic payload monomethyl auristatin E (MMAE). In preclinical studies, HDM2005 demonstrated potent anti-tumor activity across multiple lymphoma and solid tumor models. This first-in-human Phase I study (NCT06615193) enrolled patients with relapsed or refractory B-NHL or cHL. The primary objectives were to evaluate safety and tolerability, determine the maximum tolerated dose (MTD) and the recommended Phase \u2161 doses (RP2Ds) and perform a preliminary evaluation of antitumor efficacy in lymphoma.<\/p>\n

As of July 4, 2025<\/span>, 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 \u22653 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 \u22653 TRAEs, the most common (\u22655%) being neutrophil count decrease (4 patients, 19.0%). No Grade \u22653 gastrointestinal adverse reactions or peripheral neuropathy were reported. Peripheral neuropathy occurred in 4 patients (13.8%), all of which were Grade 1 or 2.<\/p>\n

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.<\/p>\n

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<\/span> 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.<\/p>\n

About HDM2005<\/b><\/p>\n

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<\/span>, which holds global intellectual property rights. The clinical trials for HDM2005 were approved in June 2024<\/span> 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<\/span>, HDM2005 received Orphan Drug Designation from the U.S. FDA for the treatment of mantle cell lymphoma (MCL). In April 2025<\/span>, 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.<\/p>\n

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<\/span>:<\/p>\n