#United States #Duality Biologics #Princeton #GSK #DB-1324

Exclusive Option Agreement Between Duality Biologics and GSK

Duality Biologics, a promising clinical-stage biotechnology firm specializing in the innovation and development of antibody-drug conjugates (ADCs), recently announced a pivotal exclusive option agreement with GlaxoSmithKline (GSK). This landmark deal focuses on their advanced ADC candidate, DB-1324, which is designed to combat the substantial healthcare burden posed by gastrointestinal (GI) cancers.

The deal grants GSK an exclusive opportunity to obtain a license to develop and commercialize DB-1324 across the globe, specifically excluding regions like mainland China, Hong Kong, and Macau. With this agreement, GSK aims to integrate the advanced therapeutic potential of DB-1324 into their oncology portfolio, which is already rich with innovative cancer treatment solutions.

Addressing Unmet Needs in Gastrointestinal Cancer

GI cancers are among the leading causes of cancer-related mortality worldwide, accounting for roughly 35% of all cancer deaths and impacting approximately 26% of the global cancer incidence. DualityBio's DB-1324 seeks to fill this significant gap in treatment options. Utilizing the company’s proprietary and clinically validated Duality Immune Toxin Antibody Conjugate (DITAC) platform, DB-1324 targets specific pathways associated with GI cancers, potentially offering new hope for patients facing these formidable health challenges.

As stated by Hesham Abdullah, GSK's Senior Vice President and Global Head of Oncology R&D, the company has meticulously curated a portfolio of novel ADCs that leverage their extensive expertise in targeting tumor cell mechanisms. The strategic focus on these targeted therapies aims to enhance treatment efficacy while preserving healthy cells, a crucial advancement in addressing particularly aggressive cancer types.

Financial Aspects of the Agreement

The exclusivity of this arrangement comes at a substantial financial commitment. GSK will make an upfront payment of $30 million to gain the option rights for DB-1324, in addition to pre-option milestone payments. Should GSK choose to exercise this option, DualityBio stands to benefit from a cumulative potential of $975 million in development, regulatory, and commercial milestone payments. Additionally, once commercialized, GSK will owe tiered royalties based on the net sales of DB-1324 outside the excluded regions, while also earning royalties on sales within mainland China, Hong Kong, and Macau.

Future Directions for Duality Biologics

John Zhu, CEO of Duality Bio, expressed enthusiasm about this significant partnership, emphasizing their commitment to emerging as a leader in the next-generation ADC realm. This collaboration aims to expedite the development of innovative therapies that address pressing medical needs within the GI cancer sector.

The company has established multiple advanced ADC technology platforms backed by robust global intellectual properties. As they continue to refine their offerings and conduct multi-regional clinical trials involving over 1,000 participants across 17 countries, DualityBio is dedicated to enhancing treatment accessibility and effectiveness for global patients suffering from various cancers and autoimmune diseases.

In conclusion, the exclusive option agreement between Duality Biologics and GSK reflects a vital step forward in the quest for innovative cancer therapies. As both companies work collaboratively on DB-1324, their shared vision aims to bring effective treatments to patients dealing with gastrointestinal cancers, underscoring a significant advancement in the biotechnology landscape.