April 29^th, 2025, Chicago —At the 2025 American Association for Cancer Research (AACR) Annual Meeting, DualityBio (HKEX：9606.HK; “DualityBio” or “the Company”) presented clinical and preclinical data for multiple antibody-drug conjugate (ADC) candidates, developed in collaboration with BioNTech SE, as well as data on novel ADC combination therapy approaches from studies being conducted by BioNTech and the Company. These data highlight scientific advancements in potential treatments for advanced and hard-to-treat solid tumors.

Duality Bio also presented the study design for its FIH global trial (NCT06554795) of DB-1419, a bispecific ADC targeting B7H3 and PD-L1 with a topoisomerase I inhibitor payload.

A preclinical study analyzed the combinations of the BioNTech-partnered ADC candidates BNT325/DB-1305 (TROP2), BNT323/DB-1303 (HER2) or BNT324/DB-1311 (B7H3), in combination with BNT327, BioNTech’s PD-L1/VEGF-A bispecific antibody candidate. The preclinical data indicate anti-tumor activity compared to each candidate alone in tumor models. 

Preliminary clinical data of the ongoing global Phase 1/2 trial (NCT05438329) for the combination of BNT325/DB-1305 with BNT327 involving 67 patients with advanced/metastatic solid tumors were presented. The data signaled a manageable safety profile with few overlapping toxicities and a low discontinuation rate (4.5%). In addition, the presentation included early efficacy data from a cohort with heavily pretreated patients with platinum-resistant ovarian cancer (PROC). In this cohort, the combination of BNT325/DB-1305 plus BNT327 showed early signs of anti-tumor activity in efficacy evaluable patients (n=13), with 7 patients achieving partial response (PR) and 3 with stable disease (SD). 

BioNTech’s bispecific antibody candidate BNT327 combines PD-L1 checkpoint inhibition with VEGF-A neutralization aimed at restoring T-cell function and normalizing tumor vasculature in the tumor microenvironment. The combination treatment approach leverages the dual mechanism of BNT327 with the aim of enhancing immune activity and potentiating ADC penetration.

First-in-Human Trial for Bispecific ADC DB-1419 

Duality Bio presented the study design for its FIH global trial (NCT06554795) of DB-1419, a bispecific ADC targeting B7H3 and PD-L1 with a topoisomerase I inhibitor payload.

The clinical trial is currently enrolling patients with advanced/metastatic solid tumors. Preclinical data underscore the dual mechanisms of direct tumor killing and immune modulation.

“These data validate our strategy of combining ADCs with immune-modulating agents to address unmet needs in oncology,” said Dr. John Zhu, Founder and CEO of Duality Bio. “In the future, we will continue to drive the Duality Flywheel model, optimize the 4 ADC innovation platforms, refine the clinical strategy for CP², and collaborate with more multinational pharmaceutical companies to deliver even more groundbreaking innovative therapies for patients worldwide.” 

About DualityBio

Duality Biotherapeutics is a clinical-stage biotech company dedicated to the discovery and development of next-generation ADC to treat cancer and autoimmune diseases. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Leveraging a robust pipeline, DualityBio is conducting multiple global clinical trials across 17 countries, has enrolled over 2,000 patients for multiple clinical-stage ADC candidates.

Additionally, DualityBio have established strategic collaborations with global MNCs and leading biotech innovators. As a global ADC powerhouse, DualityBio is developing novel ADCs" including bispecific ADC candidates, novel-payload ADC candidates , and autoimmune ADC candidates. For more information, please visit www.dualitybiologics.com.

Media Contact:

PR@dualitybiologics.com

--- 

*DB-1305/BNT325, DB-1311/BNT324, DB-1303/BNT323, DB-1419, and BNT327, which is fully owned and developed by BioNTech, are clinical stage candidates and have not been approved by any regulatory authority.