Recognizing clinical evidence from the Phase 2b VITAL Study of Vigil in homologous recombination proficient (HRP) patients with high clonal tumor mutation burden (cTMB-H)
RMAT designation provides multiple benefits including increased FDA interactions and development guidance
DALLAS, Feb. 05, 2025 (GLOBE NEWSWIRE) — Gradalis, Inc., a clinical-stage biotechnology company developing personalized anti-cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Gradalis’ personalized investigational cellular immunotherapy, Vigil® (Gemogenovatucel-T) Regenerative Medicine Advanced Therapy (RMAT) designation based on favorable clinical results from the ongoing Phase 2b VITAL trial. Vigil is being developed as a maintenance treatment for women with newly diagnosed, advanced Stage IIIb/IV ovarian cancer who are homologous recombination proficient (HRP), have a high clonal tumor mutation burden (cTMB-H) and who are in complete response after debulking surgery and frontline platinum-based doublet chemotherapy. This recognition underscores the potential value for Vigil to address a critical unmet need in this patient population.
RMAT designation is reserved for advanced cellular and engineered therapies that show potential to address serious or life-threatening conditions based on preliminary clinical evidence. The designation provides benefits such as increased FDA interactions and guidance on efficient product development. RMAT designated products may qualify for FDA approval pathways that could expedite the delivery of Vigil to cancer patients.
Vigil is a first in class immunotherapy designed to target clonal mutation signals which are contained within all cancer cells, setting it apart from other treatments that focus on sub-clonal signals. Receipt of RMAT designation was based on analysis of promising clinical results from the VITAL study that demonstrated clinically meaningful and statistically significant overall survival benefits in patients with HRP ovarian cancer and cTMB-H who achieved complete response after standard of care frontline therapy.
“The RMAT designation for Vigil highlights the transformative capacity of our unique immunotherapy to benefit women battling advanced ovarian cancer,” said David Shanahan, CEO of Gradalis. “This important recognition affirms that Vigil has the potential to extend patient survival and may offer a safer, more precise therapeutic approach to a population in urgent need of innovative solutions. We continue to advance our Vigil development efforts as we work to bring this investigational therapy to patients as rapidly as possible.”
Ovarian cancer remains one of the deadliest cancers among women, with a lifetime risk of 1 in 87. Standard treatments, such as surgery and chemotherapy, often yield initial responses, but up to 75% of patients experience disease recurrence within two years. For women with HRP ovarian cancer, current treatment options are even less effective, with significantly shorter progression-free survival compared to other molecular profiles. Despite advancements, no current therapies have shown meaningful clinical benefits for this subgroup, leaving a critical gap in care.
Gradalis is continuing its efforts to bring Vigil to patients as quickly as possible.
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) in patients with the BRCAwt molecular profile. In patients with HRP ovarian cancer and cTMB-H where there is a high unmet medical need, Vigil has been designated a Regenerative Medicine Advanced Therapy (RMAT) by the FDA on the basis of a statistically significant and clinically meaningful improvement in OS.
Additionally, Phase 1 results in an “all-comer” clinical trial have shown positive signals of activity in 19 different tumor types and some patients treated with Vigil remain in the study 48 months later.
Vigil is the first cellular immunotherapy to demonstrate longer-term 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, Gynecologic Oncology and presented at the American Society of Clinical Oncology.
About Gradalis, Inc.
Founded in 2006, Gradalis is a privately held, clinical-stage biotechnology company developing a new category of personalized therapies based on proprietary bi-shRNAi technology. Its lead product, called Vigil, is an immunotherapy that has been tested in multiple studies in ovarian and other cancer tumor types.
Gradalis’ Vigil platform uses the patient’s immune system to target the entire tumor. Based on multiple clinical studies, Gradalis has developed a pioneering oncology platform that is designed to decloak the patient’s tumor 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 anti-cancer activities, potentially eliminating even the elusive metastatic cells, and as shown in Phase 2 clinical studies in ovarian cancer. 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 EWS/FLI1, KRAS, STMN1, PDX-1 in a variety of cancers and has the potential to be used in other diseases. For additional information, visit gradalisinc.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements regarding the success, cost, and timing of our product development activities and clinical trials, our plans to research, develop, and commercialize our product candidates, and our plans to submit regulatory filings and obtain regulatory approval of our product candidates. These forward-looking statements are based on Gradalis’ current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include but are not limited to: (a) the timing, costs, and outcomes of our clinical trials and preclinical studies, (b) the timing and likelihood of regulatory filings and approvals for our product candidates, and (c) the potential market size for our product candidates. These forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements. This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities.
Gradalis Contact
Mark Early
mearly@gradalisinc.com
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