Phase 2b VITAL study of Gemogenovatucel-T (Vigil™) immunotherapy demonstrates clinical benefit in homologous recombination (HR) proficient ovarian cancer

• Results from pre-planned subgroup analysis of stage III/IV newly diagnosed ovarian cancer patients with BRCA wild type (BRCA-wt) profile and homologous recombination proficiency (HRP) have been published in Gynecologic Oncology.
• Patients treated with Vigil experienced improved overall survival (OS) and recurrence free survival (RFS) compared to placebo. No Grade 3 or 4 toxicities were observed in the Vigil-treated group.

DALLAS, March 26, 2021 (GLOBE NEWSWIRE) — Gradalis, Inc., a late clinical-stage company developing immunotherapies for multiple cancer indications, today announced that on March 12, 2021 Gynecologic Oncology published additional results from the VITAL clinical trial of gemogenovatucel-T (Vigil^TM) in ovarian cancer. These results provide evidence for the clinical utility of Vigil in Stage III/IV newly diagnosed ovarian cancer patients with BRCA wild-type molecular profile and homologous recombination proficient status.

Few treatment options exist for patients with homologous recombination proficient ovarian cancer. In particular, PARP inhibitors have not proven to be effective in this patient population.

Recently, Vigil showed significant clinical benefit with improvement in recurrence free (RFS) and overall survival (OS) in pre-planned subgroup analysis in Stage III/IV newly diagnosed ovarian cancer patients with the BRCA wild type (BRCA-wt) molecular profile. The newly published analysis further queried the homologous recombination (HR) status of patients enrolled in the VITAL study to determine clinical benefit of Vigil in HR proficient patients.

In the HR proficient subgroup, Vigil-treated patients experienced improved RFS (n = 25) compared to placebo (n = 20) (HR = 0.386; 90% CI 0.199–0.750; p = 0.007). Similarly, subgroup overall survival benefit was observed in the Vigil-treated group compared to placebo (HR = 0.342; 90% CI 0.141–0.832; p = 0.019). Vigil-treated patients did not experience any Grade 3/4 treatment-related toxicities.

“These data demonstrate that Vigil immunotherapy may provide clear clinical benefit to a patient population with limited therapeutic options,” Remarked John Nemunaitis, M.D., Chief Scientific Officer of Gradalis. “Vigil was well tolerated and effective in extending both overall survival and recurrence-free survival compared to placebo.”

Lead study investigator, Rodney P. Rocconi said, “As the field has become increasingly aware of specific molecular subgroups, we have been able to identify treatments with particular efficacy relative to alternatives. We are encouraged by these results in the HR -proficient ovarian cancer subgroup.”

Nemunaitis added, “These results published in Gynecologic Oncology provide additional clinical differentiation in a population with few therapeutic alternatives. We look forward to continued discussions on product registration with FDA.”

About Vigil

Vigil is a novel cancer cell immunotherapy that combines bi-shRNA furin, which blocks immunosuppressive protein production, with recombinant human GM-CSF, which stimulates the immune system. 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 neoantigens. Vigil is being studied in ovarian cancer, Ewing’s sarcoma as well as gynecological cancers and advanced women’s cancer in combination with PD-L1 inhibitors.

About Ovarian Cancer

Ovarian cancer (OC) is a difficult and deadly disease that is typically diagnosed in advanced stages, and overall survival rates have held relatively steady over the past 20-30 years.

Ovarian cancer is the 5th deadliest cancer among women with over 22,000 new cases are reported each year in the US, of which approximately 85% are BRCA-wt disease status. Approximately 80% of cases are diagnosed at late stage III and IV. There are 14,000 deaths per year due to Ovarian Cancer in the US. Standard of care involves a debulking surgery and one or several rounds of chemotherapy.

Primary surgery and platinum-based chemotherapy is current standard of care. Despite this aggressive first line treatment, 60-75% of patients relapse within two years, median overall survival rate of less than 3 years. Even with increased diagnostic and treatment capabilities, there are not enough effective maintenance therapy options for all patients, particularly BRCA-wt and homologous recombination proficient (HRP) population (about 50% of all ovarian cancer patients).

About Gradalis

Gradalis is a late-stage biotechnology company focused on the development and commercialization of novel personalized therapeutics to treat cancer. We are focused on the development of the bi-shRNA platform that can be utilized to silence any gene or protein and applied to any cancer type. We utilized the bi-shRNA platform to develop Vigil, our proprietary personalized cancer in multiple advanced cancer indications with the lead program for the treatment of patients with Ovarian Cancer.

For additional information, please visit http://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 Contact
Walter Chen
Gradalis, Inc.
Vice President – Finance & Corporate Development
+1 214 442 8170