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Nykode announces positive final results from its Phase 2 trial

Michael Engsig and Agnete Fredriksen

Nykode Therapeutics has announced results from the VB-C-02 trial, investigating the use of Nykode’s therapeutic cancer vaccine candidate VB10.16 in combination with Roche’s cancer immunotherapy Tecentriq in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer.

“We are extremely encouraged by the unprecedented data that indicates a doubling of the survival of PD-L1+ patients with advanced cervical cancer compared to treatment alternatives. Not only do we see patients on average live longer, but 7 of the 14 patients who received all treatments are still alive without signs of progression. This is a landmark day for VB10.16 and for Nykode’s technology and we are excited to move the cancer vaccine forward towards the market for the benefit of patients,” says Michael Engsig, Chief Executive Officer of Nykode Therapeutics.

The trial enrolled 52 patients, of which 48% had PD-L1+ tumors, who were treated for up to one year and followed for an additional 12 months.

The new data suports the next steps

The company is planning a development strategy to take VB10.16 further in advanced cervical cancer and into head and neck cancer. This new data supports the next steps which focus on PD-L1+ patients with up to one prior line of systemic therapy, the company states.

“The data give us confidence as we now plan to initiate a potentially registrational trial in the U.S. during 4Q this year in advanced cervical cancer and work to accelerate expansion of our VB10.16 program with the goal of reaching all addressable patient populations with HPV16-positive cancers,” says Klaus Edvardsen, Chief Development Officer of Nykode.

Results details

The results showed a median overall survival of more than 25 months (median has not yet been reached) and a median progression free survival of 6.3 months in PD-L1+ patients. The median overall survival for the overall population, which also includes patients with PD-L1- tumors, was 16.9 months, while the median progression free survival was 4.1 months. With overall response rate (ORR) of 29% in PD-L1+ patients (19% in overall population) and disease control rate (DCR) of 75% in PD-L1+ (60% in overall population) the final analysis confirms the previously reported positive response rates from the interim analysis.

The duration of response in the overall population was 17.1 months. In PD-L1+ patients with one prior line of systemic treatment ORR was 40% and DCR 80% with a median progression free survival of 16.9 months and median overall survival more than 25 months (not reached). VB10.16 in combination with atezolizumab was well-tolerated and has a safety profile comparable to checkpoint inhibitor monotherapy reported in literature.

Photo of Michael Engsig, CEO, and Agnete B. Fredriksen, Chief Business Officer & Co-founder, Nykode Therapeutics