ZL-1310

Zai Lab to Present Phase 1 Data on Novel DLL3-Targeted ADC for Small Cell Lung Cancer at ASCO 2025

a month ago

• Zai Lab will showcase updated results from its Phase 1a/1b trial of ZL-1310, a potentially best-in-class DLL3-targeted antibody-drug conjugate for extensive-stage small cell lung cancer at the 2025 ASCO Annual Meeting. • The novel ADC utilizes TMALIN® technology platform to overcome limitations of first-generation ADCs by leveraging the tumor microenvironment, with the FDA granting Orphan Drug Designation in January 2025. • ZL-1310 combines a humanized anti-DLL3 monoclonal antibody with a novel camptothecin derivative payload, targeting an antigen overexpressed in aggressive neuroendocrine tumors associated with poor outcomes.

FDA Grants Orphan Drug Designation to Zai Lab's ZL-1310 for Small Cell Lung Cancer

4 months ago

• The FDA has granted Orphan Drug Designation to Zai Lab's ZL-1310, a DLL3-targeted antibody-drug conjugate, for treating small cell lung cancer (SCLC). • This designation provides ZL-1310 with incentives like fee waivers, tax credits, and potential market exclusivity for seven years upon approval. • ZL-1310 is currently being evaluated in a Phase 1a/1b trial as a monotherapy and in combination with atezolizumab for extensive-stage SCLC. • Preliminary data from the trial shows promising objective response rates and a favorable safety profile in patients with recurrent SCLC.

Zai Lab Reports Strong Q3 2024 Growth, Highlights Pipeline Advances Including KarXT and ZL-1310

6 months ago

• Zai Lab's Q3 2024 net product revenue reached $101.8 million, a 47% year-over-year increase, driven by VYVGART, ZEJULA, and NUZYRA sales. • A China bridging study of KarXT in schizophrenia showed positive results, with regulatory submission expected in early 2025, potentially expanding treatment options. • Phase 1 data for ZL-1310, a DLL3-targeted ADC for extensive-stage SCLC, demonstrated promising antitumor activity, suggesting best-in-class potential. • The company anticipates launching three products in mainland China by the end of 2024 and aims for up to four regulatory submissions to the NMPA in the next six months.

ZL-1310 Demonstrates Promising Efficacy in Recurrent Small Cell Lung Cancer

7 months ago

• ZL-1310, a novel antibody-drug conjugate, shows a 74% overall response rate in patients with recurrent extensive-stage small cell lung cancer (SCLC). • The Phase Ia/Ib trial indicates that ZL-1310 is well-tolerated, with mostly Grade 1 or 2 treatment-emergent adverse events. • All patients with baseline brain metastases who were response-evaluable achieved a partial response with ZL-1310 treatment. • Zai Lab's ZL-1310, designed to mitigate payload toxicity, is being evaluated as monotherapy and in combination with atezolizumab.

Zai Lab's ZL-1310 Shows Promise in Phase 1 Trial for Small-Cell Lung Cancer

7 months ago

• Zai Lab's ZL-1310 demonstrated anti-tumor activity in 74% of heavily pre-treated small-cell lung cancer (SCLC) patients in a Phase 1 trial. • The intravenous infusion treatment exhibited a favorable pharmacokinetic and safety profile, supporting further development. • Financial firms, including Cantor Fitzgerald and JPMorgan Chase & Co, have given Zai Lab a bullish outlook after the news. • The preliminary results suggest that ZL-1310, a next-generation antibody-drug conjugate (ADC), has the potential to deliver anti-tumor responses with good tolerability.

DLL3-Guided Therapies Show Promise in Small-Cell Lung Cancer Treatment

a year ago

Recent advancements in DLL3-targeted therapies, including antibody-drug conjugates, bispecific T-cell engagers, and chimeric antigen receptor T-cell therapies, are offering new hope for patients with small-cell lung cancer (SCLC). Despite challenges, these therapies have demonstrated potential in improving clinical outcomes, with ongoing clinical trials exploring their efficacy and safety.