09/11/2018 15:04:10

Gradalis® Presents Initial Data from Phase II U.S. Trial for Ewing’s sarcoma at the Annual Meeting of the Children’s Oncology Group

DALLAS, Nov. 09, 2018 (GLOBE NEWSWIRE) -- Gradalis, Inc., a clinical-stage immunotherapy company developing investigational treatments for individuals suffering from multiple cancer indications, presented initial data from its Phase 2 trial for Ewing’s sarcoma at the 2018 Annual Meeting of Children’s Oncology Group (COG).

This is a two-part open-label, non-randomized, single-arm Phase 2 study in patients with recurrent or refractory Ewing’s Sarcoma. Part 2 of the study was established in order to assess safety and efficacy of Temozolomide / Irinotecan in combination with Vigil. All patients included in the study signed informed consent for tissue procurement treatment on the study according to the requirements of each individual institution.

Initial Data from Phase 2 Trial of Vigil in Ewing’s sarcoma presented at 2018 COG

As of October 5, 2018, eight patients were enrolled in the Part 2 of the trial, and five patients are still alive. Two patients experienced RECIST partial response and retrospectively confirmed histological complete response. Four patients had durable stable disease as best response for ≥6 months.

All eight patients had histologically confirmed Ewing’s Sarcoma. The mean age was 24 years (range: 12-46 years). All patients were heavily pretreated and failed treatment with Temozolomide and Irinotecan previously, with a mean of 5 lines of systemic treatments prior to study enrollment.

Historical progression-free survival for patients in second relapse (or greater) Ewing’s Sarcoma is 3 months or less. The median progression-free survival of the patients enrolled was 8.2 months.

The combination of Vigil, Irinotecan and Temozolomide in third-line or greater Ewing’s Sarcoma demonstrated favorable safety profile with limited treatment-related toxicities.

Phase 2 data demonstrates similar results from Phase 1 trial

Previously published data of patients in second relapse (or greater) Ewing’s Sarcoma enrolled and treated with Vigil monotherapy on a Phase 1 study revealed clinical benefit with a median survival of 2 years. While the median OS of patients in the Phase 2 study, treated with the combination of Vigil, Irinotecan, and Temozolomide has not been reached, favorable event-free survival has been observed.

Phase 1 and 2 data supports Phase 3 VITA Study

“Phase 1 and 2 data justifies safety and evidence of patient clinical benefit with Vigil to advance to Phase III registration trial of Vigil / Irinotecan / Temozolomide in in first relapse Ewing’s SarcomA compared to Temozolomide / Irinotecan,” said Dr. John Nemunaitis, Chief Medical Officer of Gradalis.  “In aggregate, these data presented at COG demonstrate Gradalis’ approach of exploiting the patient's existing, highly-adapted immune system by presenting the entire tumor neoantigen matrix and inducing T-cell responses against their cancer has great promise.”

For more information about these clinical trials, please visit https://clinicaltrials.gov/ct2/show/NCT03495921.

About Vigil

Vigil is a proprietary, investigational cellular immunotherapy technology that combines genetic engineering with the science of immuno-oncology.  Vigil is intended to stimulate and enhance the body’s natural mechanism for recognizing and killing cancer cells. It utilizes the patient’s own cancer cells to create a fully personalized cancer immunotherapy. By utilizing the patient's own tumor as the antigen source, Vigil is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient's unique tumor antigens.  Vigil is being studied in Ewing's sarcoma, in gynecological cancer and advanced women’s cancer in combination with PD-L1 inhibitors, and ovarian cancer as a single agent.

About Gradalis, Inc.

Gradalis is a late stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. We are developing Vigil, our proprietary immunotherapy platform in multiple advanced cancer indications with the lead program for the treatment of patients with Ewing's sarcoma.

For additional information, please visit https://www.gradalisinc.com

Forward-Looking Statements 

All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Gradalis cautions investors not to rely too heavily on the forward-looking statements the company makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Gradalis undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Media and Investor Inquiries:

Walter Chen

Vice President – Corporate Development

Gradalis, Inc.





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