Gradalis to Participate in the Cantor Global Healthcare Conference

DALLAS, Sept. 21, 2023 (GLOBE NEWSWIRE) — Gradalis, Inc., a privately held, clinical stage biotechnology company developing a personalized immunotherapy called Vigil^® for patients with ovarian and other cancer tumor types, today announced that Steven Engle, Chief Executive Officer, will participate in a fireside chat and one-on-one meetings at the Cantor Global Healthcare Conference, being held in New York, NY from September 26-28, 2023.

Format: Fireside Chat
Date: Thursday, September 28, 2023
Time: 1:50 – 2:20 PM ET

A live webcast and archived replay of the fireside chat can be accessed through the symposium website – https://www.meetmax.com/sched/event_96739/conference_invlogin.html.

About Ovarian Cancer

Ovarian cancer patients are composed of two groups with differing levels of DNA repair capability, each representing about 50% of ovarian cancer patients: HRP – good DNA repair; HRD/BRCA-mutant – poor DNA repair. HRP tumors are better able to repair DNA and the clonal neoantigens are better preserved. Patients with the HRD/BRCA-mutant profile have an impaired DNA repair that is associated with higher subclonal neoantigen profiles compared to the HRP profile. As a result, HRP patients’ tumors should respond better to Vigil therapy than HRD/BRCA-mutant patients. Results of Vigil in a Phase 2b study in HRP ovarian cancer patients are consistent with these findings.

About Gradalis, Inc.

Founded in 2006, Gradalis is a privately held, clinical stage biotechnology company developing a personalized immunotherapy called Vigil, that has been tested in multiple studies in ovarian and other cancer tumor types. Vigil is the first cellular immunotherapy to demonstrate survival benefits in a randomized controlled trial of patients with solid tumors. The results of the company’s Phase 2b study have been published in Lancet Oncology and presented at the American Society of Clinical Oncology. Vigil has shown positive results in combination with checkpoint inhibitors.

Gradalis’ Vigil platform uses the patient’s immune system to target the entire tumor. Based on multiple clinical studies, Gradalis has developed an oncology platform that is designed to decloak the full repertoire of a patient’s tumor antigens, including all clonal neoantigens, reactivate the immune system, and summon key effector cells to deliver a durable clinical response. When combined, these are a powerful Trifecta of anticancer activities, potentially eliminating even the elusive metastatic cells, and as shown in Phase 2 clinical studies in ovarian cancer, a potential gamechanger in oncology. Our clinical trials have also demonstrated that Gradalis’ platform is better tolerated compared to standard cancer treatments since Vigil uses the patient’s immune system operating within its natural state of balance rather than in an artificial overdrive as with some technologies. Vigil utilizes proprietary bi-shRNA technology that has been proven to silence multiple genes in a variety of cancers and has the potential to be used in other diseases.

About Vigil

Vigil^® is a novel, triple function immunotherapy platform that modifies a patient’s tumor by using bi-shRNA to reduce furin, an enzyme which facilitates immunosuppressive TGF beta protein production, and to maximize DNA expression of GM-CSF, which stimulates the immune system and attracts key immune system effector cells, including T cells. 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 “clonal” tumor neoantigens. Vigil therapy has been well tolerated in Phase 1, 2a and 2b clinical studies.

In VITAL, a multicenter, randomized, double-blind, placebo-controlled Phase 2b trial in Stage III/IV newly diagnosed, frontline ovarian cancer patients, Vigil showed a positive trend in the primary endpoint of recurrence free survival (RFS) in the overall population and a statistically significant improvement in the secondary endpoint of recurrence free survival and overall survival (OS), with a median survival time of three years to date, in patients with the BRCAwt molecular profile. Importantly in patients with tumors of the HRP type, where there is a high unmet medical need, a statistically significant improvement was seen in RFS and OS.

Additionally, Phase 1 results in an “all-comer” clinical trial have shown positive signals of activity in 19 tumor types and some patients treated with Vigil remain in the study 48 months later. The company is preparing to initiate a Phase 2 clinical study in platinum sensitive recurrent ovarian cancer patients with the HRP molecular profile.

Gradalis Contact
Mark Early
(214) 442-8161
mearly@gradalisinc.com

Life Sci Advisors Contact
Joyce Allaire
+1 (617) 435-6602
jallaire@lifesciadvisors.com