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Nykode Therapeutics Cleared to Begin Phase II Trial of Vaccine, Tecentriq in Cervical Cancer

NEW YORK – Nykode Therapeutics on Tuesday said it was cleared by the US Food and Drug Administration to begin a Phase II trial of the therapeutic cancer vaccine VB10.16 plus Roche's immunotherapy Tecentriq (atezolizumab) in patients with advanced cervical cancer that is human papillomavirus 16-positive and PD-L1-positive.

Nykode, based in Oslo, Norway, expects to begin the trial in the fourth quarter of 2023 and begin enrolling patients with recurrent or metastatic cervical cancer. The company said it will share more details about the trial design later this month.

VB10.16 is an off-the-shelf cancer vaccine Nykode is developing to treat HPV-positive cancers. The firm is also studying the VB10.16-Tecentriq combination in a separate Phase II trial in HPV16-positive cervical cancer patients regardless of their PD-L1 status.

Interim results from that trial, reported in October 2022, showed 21 percent of all patients responded to the VB10.16-Tecentriq combo. Among PD-L1-positive patients in the trial, the response rate was 27 percent, while PD-L1-negative patients had a response rate of 17 percent.

The firm is also studying VB10.16 with Merck's checkpoint inhibitor Keytruda (pembrolizumab) in a Phase I/II trial involving patients with HPV16-positive recurrent or metastatic head and neck cancer.