Germany’s BioNTech (NASDAQ: BNTX) has released preliminary data from a Phase I/IIa trial for DB-1303, a DNA topoisomerase I-inhibiting antibody-drug conjugate (ADC) licensed from China-based Duality Biologics. The trial focused on patients with solid tumors, and the results indicated that 44.2% of patients exhibited an objective partial tumor response. Notably, the anti-tumor activity was particularly encouraging in HER2+ breast cancer with brain metastasis and in HER2-low breast cancer. The candidate was well tolerated, indicating its potential safety profile.
Merck’s Phase II Data for Sichuan Kelun Pharmaceutical’s SKB264
In addition, Merck, Sharp & Dohme (MSD; NYSE: MRK) has posted Phase II data for China-based Sichuan Kelun Pharmaceutical’s (SHE: 002422) SKB264, an anti-TROP2 ADC, in the treatment of relapsed or refractory locally advanced/metastatic non-small cell lung cancer (NSCLC) and other tumor types. The data demonstrated an overall response rate (ORR) of 44%, a median duration of response of 9.3 months, and a manageable safety profile. Based on these positive results, the company is planning to advance the candidate into a Phase III trial.
