Luisa Manning1, Minal Barve2,3,4, Gladice Wallraven1, Padmasini Kumar1, Nicolas Taquet1, Ernest Bognar1, Eric Mendeloff4, Jonathan Oh3, Donald D. Rao5, Beena O. Pappen1, Neil Senzer1,2,5, John Nemunaitis1,2,3,4,5*
1Gradalis, Inc., Dallas, TX, USA
2Mary Crowley Cancer Research Centers, Dallas, TX, USA
3Texas Oncology, P.A., Dallas, TX, USA
4Medical City Dallas Hospital, Dallas, TX, USA
5Strike Bio, Dallas, TX, USA
Previously we demonstrated not only safety but also provided evidence of clinical benefit to Vigil®vaccine (1 x 107cells/injection 1x/month for 1-8 injections). In addition, we identified a relationship between survival and Vigil® induced circulating activated T-cells against autologous, preprocessed tumor cells (γIFN-ELISPOT) [1,2]. Here we review 15 patients with advanced, heavily pretreated progressive metastatic disease who underwent autologous tumor harvest and subsequent Vigil®construction but in whom manufacturing was only able to construct low-dose Vigil® (1 x 106 – 8.3 x 106 cells/injection 1x/month for 1-8 injections). Of the 12 patients for whom sequential γIFN-ELISPOT assessment was available, all were γIFN-ELISPOT response negative (<10 spots) at baseline and subsequently developed a positive response. Specifically, 11 converted after 1 cycle of Vigil® immunotherapy and one after 2 cycles. The median (range) γIFN-ELISPOT response was 143.5 (6-474) spots post Vigil® compared to 1 (0-2) pre Vigil®. Median overall survival for these 12 patients was 28.7 months. The three patients without γIFN-ELISPOT assessment had a median survival of 25.3 months. No ≥ grade 1 Vigil® related toxicity was observed. These data which suggest comparable immunological and clinical effectiveness of low-dose Vigil® imply that a smaller harvest tumor volume may be adequate for Vigil® construction, possibly allowing for an image guided core needle biopsy procedure rather than excisional resection for tumor acquisition.
Manning L, Barve M, Wallraven G, Kumar P, Taquet N, Bognar E, et al. Assessment of Low Dose Vigil® Engineered Autologous Tumor Cell (EATC) Immunotherapy in Patients with Advanced Solid Tumors. Clin Oncol. 2017; 2: 1254.