Approximately 1.4 million men worldwide are diagnosed with prostate cancer each year and approximately 10-20% develop advanced disease, castration resistance with metastases, within five years. For patients whose cancer has advanced to mCRPC, targeted treatment options are limited, and standard of care options may be difficult to access in community practice settings, and can be poorly tolerated with modest efficacy outcomes. Survival rates for these patients are low, with a 5-year survival rate of approximately 30% and a median survival of approximately two years.
The novel ADC, which utilises Syndivia’s next-generation GeminiMab conjugation technology, has shown enhanced anti-tumour activity and an encouraging safety profile, demonstrating best-in-class potential. In preclinical studies, the ADC was effective at shrinking tumours without causing a proportional increase in significant side effects, even at higher doses. This ADC could provide a targeted treatment directly to the tumour, currently a gap in available therapies, along with a more easily accessible treatment in the community practice setting for mCRPC.
GSK is developing a pipeline that spans ADCs with distinct antigens and payloads, next-generation small molecules, and T-cell engagers.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said, “Prostate cancer represents a significant health burden and an emerging area of growth for GSK, where targeted therapies are urgently needed in metastatic castration-resistant settings. The addition of this ADC builds on GSK's growing portfolio and strengths in tumour-targeted technologies, including GSK’227, our B7-H3-targeting ADC.”
Sasha Koniev, Chief Executive Officer, Syndivia, said, “We are proud that GSK will advance this programme on a global scale. This agreement underscores the value of our GeminiMab ADC platform and the opportunity to bring a promising new therapy to patients with pressing unmet medical needs.”
Under the terms of the agreement, Syndivia will receive an upfront payment as well as success-based development and commercial milestone payments up to a total of £268 million. They will also receive tiered royalties on future product sales worldwide. GSK will assume full responsibility for the development, manufacturing, and worldwide commercialisation of the ADC program.
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