Gradalis Announces Publication of Phase 2b VITAL trial of Vigil® demonstrating RFS and OS advantage in women with first-line platinum-responsive BRCA1 and BRCA2 wild-type advanced ovarian cancer in The Lancet Oncology

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  • The VITAL study, published in The Lancet Oncology, demonstrates that Vigil first-line maintenance treatment resulted in improved RFS in BRCA1/2-wt ovarian cancer when compared to placebo.
  • Importantly overall survival was also significantly longer for Vigil treated ovarian cancer patients with BRCA1/2-wt disease compared to placebo.

DALLAS, Jan. 07, 2021 (GLOBE NEWSWIRE) — Gradalis, Inc., a clinical-stage immunotherapy company developing investigational treatments for individuals suffering from multiple cancer indications, today announced that The Lancet Oncology published data from the VITAL clinical trial showing Vigil front-line maintenance use was well tolerated with improved recurrence-free survival (RFS) and overall survival (OS) in patients with BRCA1/2-wt advanced ovarian cancer. These results were published online in The Lancet Oncology on December 1, 2020.

“As ovarian cancer is becoming increasingly molecularly annotated for BRCA mutations, identifying effective treatment options for women whose tumors are BRCA1/2-wt is a priority.” said Robert L. Coleman, MD, FACOG, FACS and member of Gradalis Scientific Advisory Board. “The results from this study provide important context for the strategic development of Vigil in primary treatment algorithms. We are excited to bring a new approach to this setting.”

“The results of this study bring a new option to those least likely to benefit from PARP inhibitor maintenance, namely those without a BRCA mutation.” said Bradley J. Monk, MD, FACS, FACOG and member of Gradalis Scientific Advisory Board. “In addition to the unprecedented efficacy of this cell-based immune maintenance therapy, the adverse event profile was favorable meaning that patients are not only likely to remain free of cancer progression, but also without maintenance treatment related adverse reactions. We look forward to continuing to study this novel intervention in future trials.”

“Results published in The Lancet Oncology after years of intense investigation are very gratifying. We are encouraged now to pursue product registration advancement with FDA.” According to John Nemunaitis, MD and Gradalis’ Chief Scientific Officer.

Highlights from The Lancet Oncology Publication Data

There are few options for advanced front-line ovarian cancer management. Despite primary care management of primary debulking surgery followed by adjuvant or neoadjuvant chemotherapy, delayed but persistent relapse occurs at a rate of almost 75% within the first 2 years of primary treatment. Consolidation or maintenance treatment including PARP and VEGF inhibitors have recently shown improvement in progression-free survival (niraparib PFS HR 0.62, 95% CI 0.50–0.76; p<0.001), however, high proportions of grade 3 or 4 drug-related toxic effects and dose interruptions related to toxicity were concerning.

We observed an advantage in recurrence-free survival (HR 0.51, 90% CI 0.30–0.88; p=0.020) and overall survival (HR 0.49, 90% CI 0.24–1.01; p=0.049) in the Vigil vaccine group in a planned sub-analysis of patients with BRCA-wt disease compared to placebo from randomization.

In a post-hoc analysis, the 1-year overall survival rate from randomization was 100% (95% CI 100–100) for patients with BRCA-wt disease in the Vigil group compared to 89% (95% CI 78–100) in the placebo group (p=0.033). The 2-year overall survival rate was 90% (95% CI 79–100) for patients with BRCA-wt disease in the Vigil group versus 67% (95% CI 51–89) in the placebo group (p=0.021). We observed no overall survival difference between patients in the Vigil group and patients in placebo group in those with BRCA-m disease.

The primary endpoint of recurrence-free survival in all per-protocol (PP) patients some of whom had BRCA-m disease was not met (median RFS 11.5 months (95% CI 7.5–not reached) in Vigil group versus 8.4 months (7.9–15.5) in placebo group (HR 0.69, 90% CI 0.44–1.07; one-sided p=0.078) but, Vigil clearly showed benefit as a front-line maintenance therapy in patients with ovarian cancer with BRCA-wt disease status.

Commentary in the same issue of The Lancet Oncology by Peter G. Rose further supported Vigil results as evidence of a “landmark study”. Moreover, recent highlights of “Gemogenovatucel-T (Vigil) Maintenance in Stage III/IV Ovarian Cancer” covered by Matthew Stenger in The ASCO Post, December 22, 2020, further support relevance of Vigil in the BRCA-wt cancer population.

About Vigil

Vigil® is a novel triple function immunotherapy that combines bi-shRNA furin, which blocks immunosuppressive protein production, with DNA expressive 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 about 85% are BRCA-wt disease status. Approximately 80% of cases are diagnosed at late Stage III/IV. There are 14,000 deaths per year due to Ovarian Cancer in the US.

Debulking surgery and platinum-based chemotherapy is current initial standard of care for Stage III/IV disease patients. Despite this aggressive front-line treatment, 60-75% of patients relapse within two years and median overall survival is less than 3 years. Even with increased diagnostic and treatment capabilities, there are not enough effective maintenance therapy options for all patients, particularly the 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


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