PD-1 monoclonal antibody
- Generic Name
- PD-1 monoclonal antibody
FDA Grants Second Fast Track Designation to Innovent's IBI363 for Advanced Squamous NSCLC Treatment
• 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 Highlights Promising Clinical Data on Novel Oncology Molecules at ESMO Asia 2024
• Innovent Biologics is set to present clinical data on multiple novel oncology molecules at the ESMO Asia Congress 2024, showcasing its commitment to innovative cancer therapies.
• Updated Phase 1 results of IBI343, a TOPO1i CLDN18.2 ADC, will be presented, demonstrating encouraging efficacy and safety in previously-treated pancreatic cancer patients.
• Additional studies feature combinations of sintilimab with chemotherapy and other agents, targeting various cancers including colorectal, liver, and non-small cell lung cancer.
• Innovent's robust pipeline and advanced technology platforms in immuno-oncology and antibody-drug conjugates aim to transform cancer treatment options for patients worldwide.
Innovent Highlights IBI343 Data in Pancreatic Cancer at ESMO Asia 2024
• Innovent will present clinical data on novel oncology molecules at the ESMO Asia Congress 2024, showcasing advancements in cancer treatment.
• Updated Phase 1 results of IBI343, a TOPO1i CLDN18.2 ADC, will be presented, demonstrating encouraging efficacy and safety in previously-treated pancreatic cancer.
• The company is also presenting data on combination therapies involving sintilimab and anlotinib in various cancer types, including colorectal and lung cancer.
• Innovent is dedicated to transforming cancer treatment by delivering innovative, effective, and safe therapeutic options for doctors and patients.
Imdusiran, VTP-300, and Nivolumab Combination Shows Promise in Chronic Hepatitis B
• A Phase 2a trial shows that imdusiran, VTP-300, and low-dose nivolumab led to significantly greater HBsAg declines in chronic hepatitis B patients.
• 23% of participants receiving the combination therapy achieved HBsAg loss by Week 48, indicating a potential path to functional cure.
• The triple combination was generally well-tolerated, with no immune-related adverse events reported during the study period.
• These findings support the strategy of combining surface antigen reduction with immune reawakening in HBV treatment.
Mabwell's Nectin-4 ADC, 9MW2821, Advances with Two New Clinical Trial Approvals
• Mabwell's 9MW2821, a novel Nectin-4 targeting ADC, has been approved for two new clinical trials by China's NMPA.
• One trial will evaluate 9MW2821 in combination with a PD-1 inhibitor for perioperative urothelial carcinoma.
• The second trial will investigate 9MW2821 with other antitumor agents for advanced solid tumors, expanding its potential use.
• 9MW2821 is already in Phase III trials for urothelial and cervical cancers, with FDA Fast Track designation for several indications.
FDA Grants Fast Track Designation to IBI363 for Advanced Melanoma
• 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.
Advancing Cancer Treatment: The Promise of Oncolytic Virotherapy Combinations
• Oncolytic viruses (OVs) selectively replicate within tumor cells, causing direct cell lysis while simultaneously triggering immune responses against cancer, offering a dual mechanism of action against malignancies.
• While OV monotherapy has shown limited efficacy in clinical trials, combining oncolytic viruses with other treatment modalities such as immune checkpoint inhibitors, chemotherapy, and cell therapies has demonstrated synergistic anti-tumor effects.
• Recent advances in engineering oncolytic vaccinia viruses to express immunomodulatory factors, including cytokines and antibodies targeting immune checkpoints, have shown promising results in remodeling the tumor microenvironment and enhancing therapeutic outcomes.
Drug Development Updates
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