Shots:   

• The CHMP has granted a positive opinion to Korjuny (trifunctional anti-CD3 x anti-EpCAM Ab) for treating malignant ascites in adults with EpCAM+ carcinomas, not eligible for systemic anti-cancer treatment. EC’s decision is anticipated by YE’24, & will be valid in the EU plus Norway, Iceland & Liechtenstein 

• The opinion was based on P-II/III (IP-REM-AC-01) study showing four-fold increase in the 1EP of puncture-free survival vs therapy with only puncture treatment 

• Moreover, recruitment for the P-I (CATUNIBLA) dose escalation & expansion study for high and intermediate-risk non-muscle invasive bladder cancer (HR-NMIBC) has been completed. Interim readouts were highlighted at the ESMO 2024

Ref: Lindis Biotech | Image: Lindis Biotech

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