The US Food and Drug Administration (FDA) has granted clearance to Gradalis for the Phase III VITAL-V clinical trial of Vigil (gemogenovatucel-T) to treat advanced ovarian cancer patients.

The randomised, registrational placebo-controlled, double-blind trial will assess Vigil in patients with recently diagnosed advanced-stage ovarian cancer.

It will enrol such subjects with homologous recombination proficient (HRP) undergoing tumour profiles receiving maintenance therapy who attain a full clinical response after surgical procedure and frontline chemotherapy. 

Following front-line chemotherapy, subjects will be categorised to receive either Vigil in combination with bevacizumab or bevacizumab alone. 

Progression-free survival (PFS) is the primary endpoint of the trial while a crucial secondary endpoint is overall survival (OS). 

The company plans to commence enrolment of nearly 300 subjects in the US in the second half of next year.

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A new, tailored immunotherapy platform, Vigil is created to attain a Trifecta of immune anticancer activity utilising a bifunctional short hairpin ribonucleic acid (bi-shRNA) deoxyribonucleic acid (DNA)-based plasmid and the tumour tissue of the patient. 

Gradalis co-founder and chief scientific officer John Nemunaitis said: “The current single modality attempts to engage the immune system do not solve the problem, especially for solid tumours like ovarian cancer. 

“We have built upon earlier single modality approaches to develop a Trifecta of anti-cancer activity –tumour target identification, immune activation, and immune evasion. 

“Utilising the patient’s own tumour as the antigen source, Vigil provides the full repertoire of personal neoantigen targets that naturally educate circulating immune effector cells.”

In October this year, the company reported positive data from a pilot study of Vigil plus AstraZeneca’s durvalumab (Imfinzi), a PD-L1 checkpoint inhibitor, in advanced triple-negative breast cancer (TNBC) or recurrent/refractory ovarian cancer patients. 

According to the findings, Vigil plus durvalumab boosted PFS in PD-L1 positive tumour patients versus those with PD-L1 negative tumours.