Duality Bio Reveals Promising Clinical Data at 2025 ASCO Annual Meeting for ADC Candidates

Promising Developments from Duality Bio at ASCO 2025

The American Society of Clinical Oncology (ASCO) Annual Meeting of 2025 took place in Chicago from May 30 to June 3, attracting significant attention from the global medical community. Among the most notable presentations was the oral report by Duality Bio (HKEX: 9606.HK), which detailed preliminary findings from two clinical trials involving antibody-drug conjugates (ADCs): DB-1310, targeting HER3, and DB-1311/BNT324, aimed at B7H3, a candidate developed in partnership with BioNTech.

Overview of the Presentations

B7H3 ADC Candidate DB-1311/BNT324

During an oral session dedicated to B7H3-targeted ADC, data gathered from an ongoing Phase 1/2 clinical trial (NCT05914116) were presented. This study focuses on patients with heavily pre-treated castration-resistant prostate cancer (CRPC). The early clinical data showed promising activity with an acceptable safety profile. The reported objective response rate (cORR) was 30.8%, while the disease control rate (DCR) impressively stood at 90.4%. Moreover, 69.8% of the evaluated patients exhibited a median progression-free survival (rPFS) rate of six months.

Among the 52 patients who were evaluated, encouraging results were particularly observed in those with prior treatment of non-hormonal therapies (NHT) and in early treatment lines. Notably, adverse events primarily comprised gastrointestinal and hematologic toxicities, which were manageable. As prostate cancer rates continue to surge, the demand for effective treatments for patients with heavily characterized CRPC grows, underscoring the significance of these findings. In 2024, this program received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for advanced/unresectable or metastatic CRPC patients who have failed standard systemic therapies.

HER3 ADC DB-1310

The findings from the first-in-human Phase I/IIa study (NCT05785741) for the HER3 ADC candidate, DB-1310, were also highlighted. Led by Professor Aaron E. Lisberg from UCLA, the study reported data from 123 efficacy-evaluable patients, showing an unconfirmed objective response rate (uORR) of 31% and a disease control rate (DCR) of 84%. In a noteworthy subgroup of patients with EGFR-mutated non-small cell lung cancer (NSCLC), the uORR reached an impressive value of 44%, coupled with a DCR of 91%, median progression-free survival (mPFS) of 7.0 months, and median overall survival (mOS) of 18.9 months. In one specific treatment dosage of 5.5 mg/kg administered every three weeks, an even more striking response rate of 66.7% was observed.

Duality Bio's Commitment to Innovation

The safety data from this study indicated that DB-1310 was generally well-tolerated, with the most common treatment-related adverse effects being low-grade hematological and gastrointestinal issues, and with a low discontinuation rate of 3.5%. These positive outcomes advocate for the further exploration of DB-1310, especially among patients with EGFR-mutated NSCLC. Moving forward, Duality Bio aims to expedite its global development program by investigating DB-1310 both as a monotherapy in various tumor types and in tandem with therapies targeting EGFR TKIs and HER2.

About Duality Bio

Duality Biotherapeutics is a clinical-stage biotechnology firm focused on pioneering the development of next-generation ADCs to combat cancer and autoimmune conditions. With a robust pipeline and advanced ADC technology platforms, the company has made significant strides in clinical trials across 17 countries, enrolling over 2,000 patients. By forming strategic collaborations with major pharmaceutical companies and biotechnology innovators worldwide, Duality Bio is positioned to lead the field in ADC research, pursuing innovative candidates including bispecific ADCs and novel-payload ADCs.

For further details, visit Duality Biologics.