DualityBio, BioNTech's ADC Partner, Plans Hong Kong IPO

Duality Biotherapeutics has unveiled significant details about its comprehensive antibody-drug conjugate (ADC) pipeline, following a recent filing indicating its plans to go public on the Hong Kong stock exchange. This disclosure sheds light on the company's diverse 12-production portfolio and its collaborations, particularly with Germany's BioNTech, which teamed up with DualityBio in 2023 to expand beyond its core mRNA vaccine business. The filing highlights that these partnerships, including those with BeiGene and Adcendo, collectively represent over $4 billion in value. Shanghai-based DualityBio anticipates that its advanced-stage ADCs will reach commercial availability in the coming years.

The company has 12 ADCs in development, with half of them already in clinical stages. Several others are also nearing clinical trials, such as DB-2304, which is aimed at treating autoimmune diseases. This ADC targets the blood dendritic cell antigen 2 (BDCA2) receptor found on plasmacytoid dendritic cells, which are linked to lupus erythematosus (LE) pathogenesis. DualityBio plans to submit investigational new drug (IND) applications for both systemic and cutaneous forms of LE in the near future.

Additionally, the company is working on two bispecific ADCs designed to target two different epitopes, either on the same or distinct antigens. This approach aims to reduce off-target toxicities, overcome drug resistance, and enhance ADC internalization. The leading bispecific ADC in their pipeline, DB-1419, targets B7-H3 and PD-L1. It is expected to deliver a toxic DNA topoisomerase I inhibitor payload while modulating T-cell activation. The first patient in a Phase I/IIa global trial is slated to be treated soon.

The collaboration with BioNTech features three key programs. The most advanced is BNT323 (formerly DB-1303), an ADC targeting HER2. This candidate is currently in three potentially registrational trials and aims for accelerated FDA approval next year for HER2-expressing endometrial cancer. BNT323 uses a stable, cleavable linker and topoisomerase-based payload to minimize off-target effects and enhance antitumor activity. Besides endometrial cancer, it has shown promise against a range of solid tumors, including breast, ovarian, colorectal, and esophageal cancers.

The second BioNTech-partnered program, BNT324 (DB-1311), targets the protein B7-H3, which is crucial in tumor progression and is overexpressed in various cancers like non–small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), castration-resistant prostate cancer (CRPC), and esophageal squamous cell carcinoma (ESCC). BNT324 is in a Phase I/IIa trial for solid tumors, including SCLC and CRPC. The FDA has granted it fast track designation for CRPC and orphan drug designation for ESCC. DualityBio intends to evaluate it both as a monotherapy and in combination with immunotherapies.

The third program, BNT325 (DB-1305), targets TROP2 for treating less-explored indications such as ovarian cancer. The compound also shows potential for combination therapies in NSCLC, cervical cancer, and triple-negative breast cancer. BNT325 is currently in a Phase I/IIa study for advanced solid tumors, including NSCLC, where promising preliminary efficacy signals have been noted.

DualityBio's most advanced wholly owned asset is DB-1310, a HER3-targeting ADC. The company believes this candidate can address a broad patient population with minimal reliance on biomarker-based patient selection and can overcome resistance to standard treatments. Currently in Phase I trials, DB-1310 will be explored for its effectiveness in KRAS-mutant NSCLC and in combination with AstraZeneca’s Tagrisso (osimertinib) for EGFR-mutated NSCLC patients who are resistant to tyrosine kinase inhibitors.

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