Gradalis, Inc.

Gradalis, Inc. We are a late-stage biopharmaceutical 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. Vigil is the first cellular therapy to show positive survival benefits in a randomized controlled clinical study of patients with solid tumors. Vigil is a self-navigating cellular immunotherapy that addresses the major deficits of leading cancer treatments. Vigil uses all of a patient’s tumor-related antigens to identify cancer cells and then enhances the training of the immune system to recognize and attack those cells. Gradalis’s proprietary bi-shRNA platform accomplishes this via three key functions: (1) it blocks furin, the enzyme that generates the immunosuppressive cytokines TGF beta types 1 and 2; (2) it activates effector cells including antigen-presenting dendritic cells and CD8+ T cells via the production of GM-CSF; and (3) it induces an immune response to the full complement of neo-antigens from the patient’s tumor via intradermal administration. In a Phase 2b trial, Vigil showed a positive trend in the primary endpoint of recurrence-free survival in the overall population and a significant improvement in recurrence-free survival and overall survival in a pre-planned subgroup analysis of Stage III/IV newly diagnosed ovarian cancer patients with the BRCA wild type (BRCA-wt) molecular profile. The company is preparing to initiate a clinical study intended for product registration in patients in this subgroup. Additionally, Phase 1 results in an all-comer trial have shown positive signals of activity in multiple tumor types.

We are hopeful for what Vigil can do for patients like Ella McKeirnan. Watch the exclusive story from CBS DFW Gladice G...
06/14/2019

We are hopeful for what Vigil can do for patients like Ella McKeirnan. Watch the exclusive story from CBS DFW Gladice Go Wallraven Staci Pritchard Horvath Meghan Elizabeth Manley Walter P. Chen Luisa Manning Ewing's Sarcoma Trial Ewings Sarcoma Cancer Survivors 1 Million 4 Anna Foundation Rutledge Cancer Foundation

https://dfw.cbslocal.com/2019/06/13/cancer-vaccine-developed-texas-simple-flu-shot/?fbclid=IwAR252fSfOr4mBjXQm3pWZyNOydzJlt7v3G7htGhkbl1-DixUiOCRNIjJJB4

The CBS 11 I-Team has been following the development of this clinical trial for more than a decade, and it's now in the final stages of the FDA approval process.

A clinical trial is enrolling now to evaluate an investigational agent for the treatment of Ewing's sarcoma. This trial ...
05/17/2019

A clinical trial is enrolling now to evaluate an investigational agent for the treatment of Ewing's sarcoma. This trial is for Ewing’s sarcoma that has come back after initial treatment with chemotherapy. Find out more at https://www.ewingstrial.com/.

Ewing’s sarcoma is a rare type of cancer that develops in the bones or in the soft tissue around the bones. It is more common in teenagers and young adults but can occur at any age.

We are humbled to announce the Initiation of our Phase 3 Study of Vigil™ in Ewing’s sarcoma. Thank you for all of our f...
08/31/2018

We are humbled to announce the Initiation of our Phase 3 Study of Vigil™ in Ewing’s sarcoma. Thank you for all of our friends, employees, physician and clinical partners for making this a reality.

https://globenewswire.com/news-release/2018/08/28/1557977/0/en/Gradalis-Announces-Initiation-of-Phase-3-Study-of-Vigil-in-Ewing-s-sarcoma.html

– The open-label trial will measure progression free survival of participants from date of randomization until first disease progression in the study –

08/20/2018

Our new website (http://www.gradalisinc.com) is up and running. We are near the launch of our Phase III Ewing's Sarcoma Clinical Trial. Be on the lookout for details.

08/20/2018
04/25/2018
04/25/2018

Address

2545 Golden Bear Drive
Carrollton, TX
75006

Opening Hours

Monday 9am - 5pm
Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm

Telephone

(214) 442-8100

Website

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