Nykode Therapeutics Receives US FDA’s IND Approval for P-II Trial (VB-C-04) to Evaluate VB10.16 in HPV16-Positive Cervical Cancer
Shots:
- The US FDA has approved an IND application for the P-II trial (VB-C-04) to evaluate VB10.16 (off-the-shelf therapeutic cancer vaccine) + Roche’s Tecentriq for HPV16+, PD-L1+, recurrent or metastatic cervical cancer. The trial is expected to initiate in Q4’23
- Atezolizumab is supplied by Roche while Nykode retains all commercial rights to VB10.16 globally. The P-II trial results of VB10.16 in combination with atezolizumab for advanced cervical cancer showed mOS not reached but ≥25mos. at the time of analysis in PD-L1+ patients
- In the P-I/IIa, the therapy showed a significant correlation b/w immune responses and clinical responses with favorable clinical data in pre-cancerous HPV16-induced high-grade cervical intraepithelial neoplasia
Ref: Globenewswire | Image: Nykode
Related News:- Nykode Therapeutics Expands its Clinical Collaboration and Supply Agreement with Roche to Evaluate VB10.16 for Advanced Cervical Cancer
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