IMMUNEONCO-B (01541.HK): First patient dosed in IMC-003 PAH trial, SAD and MAD dose cohorts fully enrolled

NewTimeSpace News: On 25 August 2026, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (stock code: 01541) announced that IMC-003/IMM72 (IMC-003), an activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein independently developed by the Company's subsidiary Yimai Kaier Biopharmaceutical Technology (Shanghai) Co., Ltd., has achieved two important clinical milestones.

In respect of pulmonary arterial hypertension (PAH), the first subject has been enrolled and dosed in the Phase Ib/IIa clinical trial conducted in PAH patients, marking the formal transition of IMC-003's clinical development into the patient validation stage. In respect of dose escalation, the Phase I single ascending dose (SAD) study conducted in healthy postmenopausal women has completed enrollment of all seven dose cohorts and the safety observation period assessment; IMC-003 was generally well tolerated at the 8 mg/kg dose level with no dose-limiting toxicity (DLT) events reported, and the vast majority of all adverse events (AEs) related to the study drug (IMC-003 or placebo) were Grade 1, with no treatment-related Grade 3 or above AEs reported.

The fourth dose cohort (2 mg/kg) of the Phase I multiple ascending dose (MAD) study has successfully completed enrollment of all eight subjects on 17 August 2026, and all dose cohorts under the protocol design have now completed enrollment. Early safety data are encouraging: all AEs in the MAD stage were Grade 1 or 2, with no Grade 2 or above AE of hemoglobin increase reported and no DLT events in the first three dose cohorts; the fourth dose cohort has not yet reached its scheduled safety observation period assessment point.

IMC-003 is an ActRIIA-Fc fusion protein independently developed by Yimai Kaier, with a mechanism of action similar to the approved product Winrevair (sotatercept), capable of restoring the homeostasis of vascular smooth muscle cells at the pathogenic level and reversing pulmonary vascular remodeling and the disease progression of PAH. Preclinical data showed that the binding activity and signaling blockade activity of IMC-003 are both more than five times those of sotatercept, and in Sugen5416-hypoxia and monocrotaline-induced PAH animal models, IMC-003 improved key indicators including right ventricular systolic pressure and pulmonary arteriole vessel wall area, with efficacy superior to sotatercept. In accordance with the warning statement under Rule 18A.05 of the Listing Rules, the Company cannot guarantee that IMC-003 will be successfully developed or ultimately marketed and sold, and shareholders and potential investors should exercise caution when dealing in the Company's shares.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.