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Nykode Therapeutics Receives US FDA’s IND Approval for P-II Trial (VB-C-04) to Evaluate VB10.16 in HPV16-Positive Cervical Cancer

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Nykode Therapeutics Receives US FDA’s IND Approval for P-II Trial (VB-C-04) to Evaluate VB10.16 in HPV16-Positive Cervical Cancer

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  • 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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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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