The first patient has been enrolled in Targovax‘s pilot clinical trial for advanced or unresectable melanoma patients whose cancer progressed after treatment with checkpoint inhibitors.
The study is being conducted at Memorial Sloan Kettering Cancer Center in New York City.
The single center, Phase 1 ONCOS C824 study (NCT03003676) is evaluating the sequential administration of Targovax’s investigational drug ONCOS-102 followed by Keytruda (pembrolizumab) in 12 patients with advanced melanoma whose disease has progressed despite prior treatment with anti-PD-1 checkpoint inhibitors Keytruda or Opdivo (nivolumab).
The study will enroll six patients into each of its two cohorts: those who received prior anti-PD-1 monotherapy, or those who received a prior anti-PD-1 therapy in combination with Yervoy (ipilimumab).
The study’s primary endpoint is to determine the safety of the sequential treatment. Secondary endpoints include objective response rate, progression-free survival, and changes in blood and tumor immune parameters. Change in the size of each individual lesion will also be evaluated.
“This study will allow us to assess in more detail the immune activating properties of ONCOS-102 already observed in earlier studies,” Anne-Kirsti Aksnes, vice president of clinical development at Targovax, said in a press release. “The study also addresses a major medical need, as the majority of patients with advanced melanoma do not respond clinically to checkpoint inhibitors. Moreover, we are delighted to do this collaboration with one of the top cancer research centers in the world.”
ONCOS-102 is an adenovirus designed to replicate itself inside cancer cells only, leaving healthy cells unharmed. The excess replication leads to cancer cell death and the GM-CSF protein — encoded in the virus’ DNA — induces strong immune responses against cancer cells that were not infected by the virus.
Targovax is set to begin ONCOS-102 combination trials in several solid tumor indications, including mesothelioma in combination with standard of care chemotherapy; ovarian cancer in combination with an immune checkpoint inhibitor; and prostate cancer in combination with a dendritic cell vaccine.
The company is currently conducting a Phase 1b/2 trial (NCT02879669) evaluating ONCOS-102 in combination with Alimta (pemetrexed) and Platinol (cisplatin) in 30 patients with malignant mesothelioma.
In an earlier Phase 1 trial for solid tumors (NCT01598129), ONCOS-102 in combination with low-dose cyclophosphamide revealed treatment-induced tumor specific immune activation, which correlated with responses to treatment.
