Dataset updated 01/23/17. *MC/RC = Matched Control/Randomized Control 2.5 Vigil Phase II Trial: Ewing’s sarcoma (CL-PTL-121, Part 2) Part 2 of CL-PTL-121 was initiated to study the safety of the combination of irinotecan, temozolomide and Vigil in patients with refractory or recurrent (≥1 line of prior treatment line(s)) Ewing’s sarcoma. Ten third-line (received ≥ 2 prior systemic chemotherapy regimens) adv anced disease Ewing’s Sarcoma patients were entered into Part 2 of CL-PTL-121 study. One patient did not receive any protocol treatment, another patient received only 1 dose of temozolomide/irinotecan and did not receive Vigil before rapid disease progression. These two patients were not evaluable for efficacy. One patient is still being treated on study without progression but is too early for efficacy evaluation (< 6 months SD, stable disease). All other 7 currently evaluable patients for response have received a mean of 8 cycles of Vigil and temozolomide/irinotecan (range 3 to 12). D ose and schedule involved Vigil (1x 10e6 or 1x 10e7 cells/dose on D ay 15 every 3 weeks ), irinotecan (50 mg/m2/d D ays 1-5 orally every 3 weeks) and temozolomide (100 mg/m2/d D ays 1-5 orally every 3 weeks ). Notably all 7 of these patients had progressed following prior temozolomide/irinotecan before entry into CL-PTL-121. Group N Mean Survival ( mo.) Median Survival (mo.) P- value MC/RC* 22 12.8 6.8 0.041 Vigil 21 24.9 24.0 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 35 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document.