Ovarian Cancer – Fast Track Designation to GEN-1 Immunotherapy


Women with advanced ovarian cancer have limited treatment options in the standard of care and therefore they have much better chances and hope in fighting their disease with new innovative developments.

“Fast track” is a designation by the FDA of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.

The FDA emphasizes that a Fast Track designation must show some advantage over available therapy. This can include showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes; avoiding serious side effects of an available therapy; or decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment.

GEN-1 is an IL-12 encased in a nanoparticle delivery system which enables persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity.

Currently, GEN-1 is being investigated in the phase 1/2 OVATION 2 study investigating the combination of GEN-1 with standard-of-care neoadjuvant (= before surgery) chemotherapy to treat patients with newly diagnosed stage III or IV ovarian cancer. With neoadjuvant chemotherapy, the goal is to shrink the tumor for 3 cycles to allow for surgical removal.


Data for the phase 1 portion of the OVATION 2 trial was shared with the FDA prior to the Fast Track designation, finding a complete tumor resection was achieved in 7 of the 8 patients (88%) receiving GEN-1 treatment.

The control arm featuring treatment with neoadjuvant chemotherapy saw a complete tumor resection rate of 50%.


There is room for optimism that GEN-1 represents a game-changer for women with advanced ovarian cancer who have limited treatment options.

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Ovarian cancer - New drug, GEN-1
Ovarian cancer – New drug, GEN-1

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