Immunovaccine begins Phase Ib trial of triple drug combination for recurrent ovarian cancer - Clinical Trials Arena
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Immunovaccine begins Phase Ib trial of triple drug combination for recurrent ovarian cancer

08 Sep 2016

Clinical-stage vaccine development firm Immunovaccine has begun dosing in a Phase Ib clinical trial of DPX-Survivac combined with epacadostat and low-dose cyclophosphamide to treat recurrent ovarian cancer.

Clinical-stage vaccine development firm Immunovaccine has begun dosing in a Phase Ib clinical trial of DPX-Survivac combined with epacadostat and low-dose cyclophosphamide to treat recurrent ovarian cancer.

Developed on a DepoVax adjuvanting platform, DPX-Survivac is composed of survivin-based peptide antigens, which are recognised as tumour-associated antigen (TAA).

Survivin is mostly expressed in multiple cancer types including ovarian, breast, colon and lung cancers and resists anti-cancer therapies.

The DPX-Survivac vaccine is believed to trigger a cytotoxic T-cell immune response against cells expressing survivin peptides and detects and kills tumour cells without affecting the normal cells.

"We believe that combining immune-targeted therapies has great potential to lead to new and potentially better therapeutic options for patients with ovarian and other cancers."

Epacadostat is an orally administered product selective inhibiting the IDO1 enzyme resulting the reversal of tumour-induced immune suppression and restoring anti-tumour immune responses.

Cyclophosphamide is a chemotherapy drug that stalls or stops cancerous cell growth.

Conducted as a collaborative approach between Immunovaccine and US-based biopharmaceutical company Incyte, the Phase Ib clinical trial has been designed as a single-arm, open-label study intended to determine the safety and efficacy of the triple combination of DPX-Survivac, epacadostat and cyclophosphamide.

The trial is planning to enrol 32 patients and is primarily focused on determining the safety and immunogenicity of the drug combination, as well as detecting the changes in the immune cell infiltration into tumours.

The secondary objectives of the trial are to determine the objective response rate, duration of response and time to progression resulted by the triple drug combination.

Incyte chief medical officer Steven Stein said: “We believe that combining immune-targeted therapies has great potential to lead to new and potentially better therapeutic options for patients with ovarian and other cancers.

“This study provides us with the opportunity to investigate the use of epacadostat alongside Immunovaccine’s DPX-Survivac therapy and we look forward to evaluating its results.”