Assessment of Low Dose Vigil® Engineered Autologous Tumor Cell (EATC) Immunotherapy in Patients with Advanced Solid Tumors

Luisa Manning, Minal Barve, Gladice Wallraven, Padmasini Kumar, Nicolas Taquet, Ernest Bognar, Eric Mendeloff, Jonathan Oh, Donald D. Rao, Beena O. Pappen, Neil Senzer, John Nemunaitis

Gradalis, Inc., Dallas, TX, USA
Mary Crowley Cancer Research Centers, Dallas, TX, USA
Texas Oncology, P.A., Dallas, TX, USA
Medical City Dallas Hospital, Dallas, TX, USA
Strike Bio, Dallas, TX, USA

^*Correspondance to: John Nemunaitis 

 PDF  Full Text Research Article | Open Access

Abstract:

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.

Keywords:

Cite the Article:

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.