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BioNTech and DualityBio Report the Initiation of P-III Trial for BNT323/DB-1303 to Treat Metastatic Breast Cancer

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BioNTech

BioNTech and DualityBio Report the Initiation of P-III Trial for BNT323/DB-1303 to Treat Metastatic Breast Cancer

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  • The company has initiated the treatment of the first patients in the P-III clinical trial evaluating the safety & efficacy of BNT323/DB-1303 vs SoC single-agent CT in CT-naïve patients with HR+ & HER2-low metastatic breast cancer. The 1EP of the study includes PFS & 2EPs include OS, ORR, DoR & safety
  • The P-III clinical trial is expected to enroll 532 patients at more than 223 clinical sites across the world incl. the US, China & Europe. Moreover, the P-III trial is based on the safety & efficacy data from the P-I/II clinical trial that depicted an ORR of 38.5% & a DCR of 84.6%
  • BNT323/DB-1303 is a topoisomerase-1 inhibitor-based ADC targeting HER2 & was built from DualityBio’s Duality Immune Toxin Antibody Conjugates platform

Ref: BioNTech | Image: BioNTech

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Shivani Chandra

Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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