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HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

Shots:

  • China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapies
  • Preclinical studies of K1, K2, & their combination showed superior efficacy than marketed HER2-targeting ADCs in mouse tumor models, with wider efficacy to maximum tolerant dose therapeutic windows; K1 is being investigated as monotx. in an ongoing P-I trial in the US
  • Derived from HighField’s ADCplex platform, HF158K1 & HFK2 contains Topoisomerase I & II inhibitors as payloads, respectively, & are equipped with HER2 antibodies to target HER2 receptors in both high & low HER2-expressing tumors

Ref: Businesswire | Image: HighField Biopharmaceuticals

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