PRINCETON,N.J.,SHANGHAI and SUZHOU,China,Dec. 4,2024 -- Duality Biologics ("DualityBio"),a clinical-stage biotech company focusing on the discovery and development of next-generation antibody-drug conjugate (ADC) therapeutics,today announced that it has entered into an exclusive option agreement with GSK for a potentially best-in-class ADC candidate,DB-1324. Under the agreement,DualityBio will grant GSK an exclusive option to obtain a license to develop and commercialize DB-1324 worldwide (excluding mainland China,Hong Kong,and Macau) (the "Option").

DB-1324 is an ADC candidate built with DualityBio's proprietary and clinically validated Duality Immune Toxin Antibody Conjugate (DITAC) platform. The molecule,currently in preclinical development,leveragesDualityBio's DITAC platform against a gastrointestinal (GI) cancer target. There is high unmet medical need for patients with GI cancer as it represents 35% of all cancer-related deaths and approximately 26% of the global cancer incidence.[1] This ADC molecule has the potential to unlock multiple combination therapy opportunities to strategically complement GSK's oncology portfolio.

Under the terms of the agreement,GSK will pay $30 million upfront and additional pre-option milestone payments to obtain an exclusive option for exclusive worldwide rights for DualityBio's ADC (excluding China's mainland,and Macau). Upon GSK exercising the Option,DualityBio will receive an option exercise fee as well as potential development,regulatory and commercial milestone payments totalling up to $975 million. Upon commercialisation,GSK will pay tiered royalties on DB-1324's global net sales outside mainland China,and Macau. GSK will receive royalties on net sales in mainland China,Hong Kong and Macau.

Hesham Abdullah,SVP,Global Head Oncology,R&D,GSK,said: "GSK has built a portfolio of novel antibody-drug conjugates underpinned by our deep expertise in tumour cell-targeting mechanisms. Given the unique ability of ADCs to address certain targets on tumour cells while sparing healthy ones,we are confident in our strategic focus on this modality as it could advance new therapeutic treatments for the most challenging tumour types."

John Zhu,Chief Executive Officer of Duality Biologics,said: "DualityBio is dedicated to becoming a leading global next-generation ADC company. We are very glad to have entered into this agreement with GSK. Through this collaboration,we will work together to advance our innovative ADC program in gastrointestinal cancer to address unmet medical needs. DualityBio's unique and validated ADC technology platform can continue to empower more partners around the world and provide innovative treatment options for global patients."

About Duality Biologics

Duality Biologics ("DualityBio") is a clinical-stage biotech company focusing on the discovery and development of next-generation antibody-drug conjugate (ADC) therapeutics to treat cancer,autoimmune diseases,and beyond. DualityBio has successfully built several cutting-edge ADC technology platforms with global intellectual property rights. Based on deep understanding of diseases,DualityBio has built a robust pipeline of ADCs,including several candidates in clinical stage. DualityBio has multiple ongoing global multi-regional clinical trials (MRCTs) across 17 countries with over 1,000 patients enrolled. In addition,DualityBio is leveraging its novel protein engineering and unique ADC technologies to develop the next generation of "Super ADCs",such as bispecific ADCs,ADCs with novel MOA payload and antibody-immune modulator-conjugates.

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References

[1] Arnold M,Abnet CC,Neale RE,Vignat J,Giovannucci EL,McGlynn KA,et al.Global burden of 5 major types of gastrointestinal cancer. Gastroenterology,159(1):335–349.e15.