Innovent presented Phase 1 data of its PD-1/IL-2α-bias bispecific antibody fusion protein

CLINICAL AND REGULATORY 

Egle Therapeutics to share preclinical data for its IL-2 mutein EGL-003 

The presentation, entitled “EGL-003, a novel IL-2 mutein to selectively expand and activate regulatory T cells and improve therapeutic efficacy in autoimmune disease”, will show evidence that EGL-003, a non-targeted Fc-fused IL-2 agonist mutein, selectively binds to Treg and induces Treg IL-2 signaling. The resulting increase of Treg frequencies was observed in vitro and in different mouse models. Accordingly, EGL-003 significantly improved clinical, macroscopic, and histological parameters in a DSS-induced colitis mouse model with expansion of tissue-resident Tregs. EGL-003 is the first drug candidate being developed for treatment of autoimmune diseases in Egle’s pipeline and has advanced into IND-enabling studies. 

Innovent presents IBI363 clinical data on NSCLC and solid tumors at 2024 ESMO virtual plenary 

Innovent Biologics recently presented clinical data on its novel drug IBI363 during the 2024 ESMO Virtual Plenary. IBI363 is a PD-1/IL-2α-bias bispecific antibody fusion protein designed to treat advanced solid tumors. The drug is part of Innovent’s drive to innovate in the field of immunotherapy. The Phase 1 study of IBI363 involved over 300 subjects with advanced solid tumors, including NSCLC, melanoma and CRC. These subjects had undergone multiple prior systemic therapies. IBI363 demonstrated good tolerability and safety at unprecedented dosing levels compared to traditional IL-2 therapy. Grade 3 immune-related adverse events were occurring in 10.4% of subjects. No new safety signals were detected. In terms of efficacy, 300 subjects receiving IBI363 at doses of 0.1 mg/kg or higher had post-baseline tumor assessments. Among these, three achieved complete responses, and 49 had partial responses. The overall response rate (ORR) in immunotherapy-treated subjects was 17.6 %. Particularly, subjects receiving the highest dose of 3 mg/kg Q3W showed an ORR of 46.7 % and a DCR of 80%. In NSCLC, IBI363 showed strong efficacy, especially in squamous cell carcinoma, with an ORR of 35.1% and a DCR of 75.7 %. For those receiving the 3 mg/kg dose, the ORR was 100 % for squamous NSCLC and 33.3% for adenocarcinoma NSCLC, with DCRs of 100% in both subtypes. These results are promising given the high resistance to immune checkpoint inhibitors in NSCLC patients. In melanoma, IBI363 also showed promising efficacy. Among immunotherapy-treated subjects, the ORR was 29.7 %, with a DCR of 73.0%. For immunotherapy-naïve mucosal melanoma subjects, the ORR was 75 %, and the DCR was 100%. Given these encouraging results, Innovent plans to continue exploring the potential of IBI363 in treating NSCLC, melanoma, and other tumors.