The US Food and Drug Administration (FDA) has granted fast track designation to Genelux’s Olvi-Vec (olvimulogene nanivacirepvec) for the treatment of patients with platinum-resistant/refractory ovarian cancer.

Olvi-Vec is a modified oncolytic vaccinia virus (smallpox virus) that selectively targets malignant cells. The therapy is being evaluated as a combination therapy with platinum-based chemotherapy in an open-label Phase III trial (NCT05281471), as per a 27 November 2023 press release.

The oncolytic virus market is expected to grow from $114m in 2023 in global sales to $2.4bn in 2029, as per GlobalData analysis. The lead therapy in the field is expected to be Replimune’s skin cancer treatment RP1 (vusolimogene oderparepvec), which is forecasted to control 74% of the market share in 2030.

GlobalData is the parent company of Pharmaceutical Technology.

Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also allows for rolling and priority reviews for the therapy.

In 2021, Genelux licensed the exclusive marketing rights for Olvi-Vec in Greater China (mainland China, Hong Kong, Macau and Taiwan) to Newsoara BioPharma, with both companies sharing the cost of drug development. Genelux retained global rights for the therapy except Greater China.

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Phase II data published

In a Phase II study that enrolled patients with recurrent ovarian cancer, the overall response rate (ORR) with the therapy was 54%, calculated using RECIST 1.1, with duration of response of 7.6 months. When assessed as per the cancer antigen 125 (CA-125) assay, the ORR was 85%. The median overall survival (OS) was 15.7 months in all patients, andmore specifically, the OS in platinum-resistant and platinum-refractory groups was 18.5 months and 14.7 months, respectively.

The median progression free survival (PFS) was 11 months, with the 6-month PFS rate was 77%. The commonly observed treatment-related adverse events were pyrexia and abdominal pain, with Grade 3 events of both being observed in 3.7% and 7.4% of the, respectively. There were no deaths, treatment related discontinuations or Grade 4 level adverse events.

Genelux is also evaluating Olvi-Vec as a combination therapy with chemotherapy in other solid tumours such as small cell lung cancer and non-small cell lung cancer.