Gradalis Receives Clearance to Begin Pivotal Phase 3 Clinical Trial of Vigil® (gemogenovatucel-T) in Patients With Advanced Ovarian Cancer in the U.S.

Novel, personalized immunotherapy platform designed to achieve Trifecta of anti-cancer activity using unique bi-shRNA DNA-based plasmid and patient's own tumor tissue

VITAL-V pivotal trial is planned for the second half of 2023

DALLAS, Dec. 21, 2022 /PRNewswire/ -- Gradalis Inc., a late-stage biotechnology company developing personalized immunotherapies for ovarian and other cancers, today announced it has received clearance by the U.S. Food and Drug Administration (FDA) to proceed with the registrational Phase 3 VITAL-V study for Vigil^® (gemogenovatucel-T) in patients with advanced ovarian cancer.

"This clearance by the FDA to initiate the pivotal VITAL-V Phase 3 clinical trial of Vigil in HRP ovarian cancer is a major milestone for Gradalis," said Steve Engle, Gradalis' chief executive officer. "We look forward to initiating this pivotal study so that we can bring a much-needed new treatment option to patients as quickly as possible."

The VITAL-V study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate Vigil in newly diagnosed advanced stage ovarian cancer patients with tumor profiles that are homologous recombination proficient (HRP) undergoing maintenance therapy who achieve a complete clinical response following surgery and frontline chemotherapy. Upon completion of front-line chemotherapy, patients will be randomized to receive either Vigil plus bevacizumab or bevacizumab alone. The study's primary endpoint is progression-free survival (PFS); overall survival (OS) is a key secondary endpoint. The study is planned to enroll approximately 300 patients in the U.S. Gradalis plans to begin enrolling patients in the second half of 2023.

"Cancer represents a failure of immune response. The current single modality attempts to engage the immune system do not solve the problem, especially for solid tumors like ovarian cancer," said John J. Nemunaitis, M.D., co-founder and chief scientific officer of Gradalis. "We have built upon earlier single modality approaches to develop a Trifecta of anti-cancer activity –tumor target identification, immune activation, and immune evasion. Utilizing the patient's own tumor as the antigen source, Vigil provides the full repertoire of personal neoantigen targets that naturally educate circulating immune effector cells." 

"HRP ovarian cancer represents a major unmet medical need because of its greater resistance to platinum chemotherapy and the limited role of PARPi therapy," said Rodney Rocconi, M.D. FACOG, professor, Division of Gynecologic Oncology, University of Alabama at Birmingham and principal investigator of the VITAL-V trial. "Preliminary clinical testing of Vigil has demonstrated an effective mechanism of action and consistent efficacy and safety."

About Vigil^® (gemogenovatucel-T)
Vigil^® (gemogenovatucel-T) is a novel, personalized immunotherapy platform designed to achieve a Trifecta of immune anticancer activity using a unique bi-shRNA DNA-based plasmid and the patient's own tumor tissue. The Trifecta of systemic activity involves knock down of TGFβ1 and TGFβ2 which function as tumor suppressor cytokines, increased GM-CSF expression to enhance local immune function, and presentation of the patient's clonal neoantigen epitopes via use of autologous cancer tissue. 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.

About Gradalis, Inc.
Gradalis is a privately held, late-stage clinical biotechnology company developing personalized immunotherapy medicines for ovarian and other cancer tumor types, using the patient's immune system to target the entire tumor. Gradalis' platform is designed to decloak the full repertoire of a patient's tumor neoantigens, reactivate the immune system, and summon key effector cells to deliver a durable clinical response. When combined, these are a powerful Trifecta of anti-cancer activities, potentially eliminating even the elusive metastatic cells. Visit www.gradalisinc.com for more information. 

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SOURCE Gradalis, Inc.