IBI363

Innovent Biologics to Present Breakthrough Clinical Data for IBI363 PD-1/IL-2 Bispecific Antibody at ASCO 2025

a month ago

• Innovent Biologics will showcase seven oral presentations at ASCO 2025, featuring breakthrough clinical data for its novel PD-1/IL-2α-bias bispecific antibody IBI363 in melanoma, colorectal cancer, and non-small cell lung cancer. • IBI343, Innovent's anti-CLDN18.2 antibody-drug conjugate, secured an oral presentation slot for its Phase 1b data in pancreatic cancer, demonstrating promising potential in this difficult-to-treat malignancy. • The company's robust pipeline of bispecific antibodies and ADCs highlights Innovent's growing position as a leader in the "IO+ADC" space, with multiple candidates advancing toward pivotal-stage development.

FDA Grants Second Fast Track Designation to Innovent's IBI363 for Advanced Squamous NSCLC Treatment

3 months ago

• Innovent's IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody, received FDA Fast Track Designation for treating advanced squamous non-small cell lung cancer after immunotherapy and chemotherapy failure. • Clinical trials showed promising results with 50% objective response rate in the 3 mg/kg dose group and effectiveness regardless of PD-L1 expression levels, suggesting potential benefits for cold tumors. • The drug demonstrated encouraging disease control rate of 88.9% and favorable safety profile, offering hope for patients with limited treatment options after immunotherapy failure.

Innovent's IBI343 Receives Breakthrough Therapy Designation in China for Advanced Pancreatic Cancer

4 months ago

• Innovent's IBI343, an anti-CLDN18.2 ADC, has been granted Breakthrough Therapy Designation (BTD) by China's NMPA for advanced pancreatic cancer. • The designation is based on Phase 1 data showing favorable safety and promising antitumor activity in patients who progressed after prior treatment. • In the Phase 1 trial, IBI343 demonstrated a 23.3% overall objective response rate and a median progression-free survival of 5.3 months. • Innovent plans to initiate pivotal trials to confirm IBI343's efficacy and explore its potential in combination therapies for various solid tumors.

TIL Therapy and Novel Combinations Advance Melanoma Treatment

5 months ago

• Lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, received FDA accelerated approval for unresectable or metastatic melanoma after PD-1 inhibitor treatment. • Studies show lifileucel, alone or with pembrolizumab, yields objective response rates of 31.5% to 65.2% in advanced melanoma, even after multiple prior therapies. • IBI363, a PD-1, IL-2α bispecific antibody, demonstrates promising disease control and objective response rates in melanoma patients who have progressed on PD-1 inhibitors. • Personalized cancer vaccine mRNA-4157 (V940) combined with pembrolizumab significantly reduces the risk of disease recurrence in resected stage IIIB to IV melanoma.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

Dermatology Advances: Approvals, Trial Results, and New Guidelines Emerge

7 months ago

• The FDA approved bimekizumab for moderate-to-severe hidradenitis suppurativa, marking the first treatment targeting both IL-17A and IL-17F cytokines. • Subcutaneous nivolumab's PDUFA date was updated, based on Phase 3 data demonstrating noninferiority to intravenous nivolumab in renal cell carcinoma. • New clinical guidelines emphasize image-guided superficial radiation therapy for nonmelanoma skin cancers, improving precision in treating basal and squamous cell carcinoma. • Phase 2b trial results show mRNA-4157 combined with pembrolizumab significantly improves recurrence-free survival in high-risk stage III/IV melanoma patients.

FDA Grants Fast Track Designation to IBI363 for Advanced Melanoma

9 months ago

• The FDA has granted Fast Track designation to IBI363 for unresectable locally advanced or metastatic melanoma after progression on at least one prior systemic therapy, including a PD-(L)1 inhibitor. • IBI363 is a first-in-class PD-1/IL-2α bispecific antibody fusion protein showing encouraging efficacy and a favorable safety profile in melanoma patients who have previously received immunotherapy. • Clinical data from a phase 1/2 trial demonstrated an objective response rate of 29.7% and a disease control rate of 73.0% in melanoma patients previously treated with immunotherapy. • The Fast Track designation aims to expedite the development and review of IBI363, offering potential priority review and accelerated approval to address the unmet need in immunotherapy-failed melanoma.

Ivonescimab and IBI363 Show Promise in Advanced Solid Tumors at ESMO 2024

9 months ago

• Ivonescimab demonstrates encouraging Phase II data in advanced triple-negative breast cancer, recurrent/metastatic head and neck squamous cell carcinoma, and metastatic microsatellite-stable colorectal cancer. • IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein combined with bevacizumab, shows promising anti-tumor activity in advanced colorectal cancer. • Updated Phase 3 MARIPOSA study results reveal significant overall survival improvement with amivantamab plus lazertinib over osimertinib in EGFR-mutant advanced NSCLC. • Sacituzumab govitecan and ifinatamab deruxtecan demonstrate activity in extensive-stage small cell lung cancer, offering potential new treatment options.

Drug Development Updates