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Investing.com -- BioNTech SE (NASDAQ:BNTX) stock surged 9.7% in premarket trading Friday after the company and partner Duality Biologics announced their experimental cancer drug met its primary endpoint in a pivotal Phase 3 trial.
The trial evaluated trastuzumab pamirtecan, an antibody-drug conjugate targeting HER2, against trastuzumab emtansine in patients with HER2-positive unresectable or metastatic breast cancer. Results showed the drug achieved its primary endpoint of progression-free survival at an interim analysis.
"It is the first of our late-stage oncology programs to meet its primary endpoint in a pivotal Phase 3 trial," said Prof. Özlem Türeci, BioNTech’s Chief Medical Officer and Co-Founder.
The trial results were evaluated by an Independent Data Monitoring Committee and Blinded Independent Central Review. Following these positive findings, DualityBio plans to discuss next steps with China’s National Medical Products Administration regarding a Biologics License Application submission.
Under their partnership agreement established in April 2023, BioNTech holds global commercial rights excluding Mainland China, Hong Kong, and Macau, while DualityBio retains rights for those regions. The companies plan to pursue regulatory applications in the United States and European Union.
The partners are also developing the drug for additional tumor types and in January 2024 began a global Phase 3 trial program for trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer.
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