The Phase 1 study was designed to investigate safety, immunogenicity, and survival in patients with advanced NSCLC when administered the allogeneic dendritic cell (DC) vaccine VAC2. 

VAC2 DC cells have been engineered to present hTERT, a tumor-associated antigen found almost exclusively in cancer cells, and it is postulated that VAC2 will stimulate an immunogenic anti-tumor CD4+/CD8+ T cell response toward hTERT expressed on tumor cells. 

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All eight subjects enrolled and treated completed the full per-protocol vaccination regimen, which consisted of six-consecutive weekly intradermal (ID) injections of 1 x 107 viable VAC2 cells. 

Overall, VAC2 was well-tolerated, there were no unexpected SAEs, and there were no dose-limiting toxicities.

Five of eight patients treated (62.5%) had a best response of immune-related stable disease, and three (37.5%) demonstrated immune-related progressive disease.

No patients had treatment-emergent serious adverse events, and all patients completed per protocol vaccination.

Three of eight treated patients (37.5%) reached the 2-year survival endpoint.

Two patients had durable responses against segments of the tumor antigen human telomerase reverse transcriptase (hTERT), and two other patients had transient responses as assessed via enzyme-linked immunospot (ELISPOT) assays.

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