China’s Duality Biotherapeutics Seeks IPO to Accelerate ADC Development

China’s clinical-stage biotech company, Duality Biotherapeutics, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange. The company, specializing in antibody-drug conjugates (ADCs), aims to raise an undisclosed amount to develop its extensive pipeline of ADC candidates further. 

Established in 2019, Duality Biotherapeutics has quickly emerged as a key player in the antibody-drug conjugate (ADC) space. The company has developed a portfolio of 12 internally discovered ADCs, half of which are currently undergoing clinical trials. 

DualityBio, based in Shanghai, has developed multiple ADC platforms and currently has 12 in-house candidates, half of which are already in clinical trials. The company has also partnered with Germany’s BioNTech, BeiGene and Adcendo to enhance its ADC portfolio, with total deal values potentially exceeding $4 billion. 

The recent IPO filing reveals new insights into DualityBio’s collaboration with BioNTech, which began in 2023. One of the core products, BNT323 (formerly DB-1303), is a HER2-targeted ADC. DualityBio aims to file for accelerated FDA approval for this ADC by 2025, focusing initially on endometrial cancer. BNT323 is designed to enhance antitumor activity while reducing off-target toxicities and has shown promise against other cancers such as breast, ovarian, and colorectal.

Another notable program is BNT324 (formerly DB-1311), which targets the B7-H3 protein associated with several cancers, including non-small-cell lung cancer (NSCLC) and castration-resistant prostate cancer (CRPC). Currently, in Phase I/IIa trials, BNT324 has received FDA Fast Track Designation and is being evaluated both as a monotherapy and in combination with other treatments. 

DualityBio’s pipeline also includes BNT325 (formerly DB-1305), an ADC targeting TROP2. This program is in Phase I/IIa trials for advanced solid tumors, including NSCLC and cervical cancer. The company is positioning BNT325 as a potential backbone therapy in the TROP2 ADC landscape, with promising early efficacy results.

The IPO filing highlights DualityBio’s ambitions and its strategy to leverage partnerships and innovative ADC technologies. With its pipeline and collaborations, DualityBio aims to advance its therapies towards commercialization and address unmet needs in cancer and autoimmune disease treatment.

Duality Biotherapeutics, which has rapidly expanded its pipeline, currently has six assets in clinical trials and several more nearing this stage. Among these, DB-2304 stands out as the company’s primary autoimmune disease program, targeting blood dendritic cell antigen 2 (BDCA2). 

This ADC, aimed at treating lupus erythematosus (LE), will soon have investigational new drug (IND) applications submitted for both systemic and cutaneous forms. The company is also advancing two bispecific ADCs, with DB-1419 being the most developed. This bispecific targets both B7-H3 and PD-L1 and is designed to deliver a toxic payload while modulating T-cell activation. The first patient in a Phase I/IIa trial for DB-1419 is expected to be dosed within the next six months.

Despite challenges, including legal issues in China related to patent applications, DualityBio plans to leverage its novel payloads and bispecific formats to differentiate itself in the ADC market.

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