US-based clinical services company Rampart Health has reported positive initial data from the Phase II Abscopal 5001 clinical trial of its multiplex intra-tumoural immunotherapy (MITI) in metastatic cancer patients.

In the trial, 13 subjects were given a minimum of one intra-tumoural treatment of the MITI comprising cryo-ablation and subsequent dosing with PD-1 and CTLA-4 inhibitors and cyclophosphamide as intra-tumoural injections. 

A granulocyte-macrophage colony-stimulating factor was also given subcutaneously. 

The trial results showed that MITI was safe and well-tolerated without any grade IV or V side effects. 

A 77% disease control rate was observed in trial subjects with partial response, as well as a stable disease rate of 38.5%.

In 31% of the subjects, an abscopal effect or clearance of cancer at untreated metastatic sites was reported.

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By GlobalData

These effects included complete responses of lung metastases in a sarcoma patient and liver metastases in a bladder cancer patient.

Rampart Health CEO David Bostwick said: “Results of the Abscopal 5001 trial prospectively demonstrate the potential of our novel intra-tumoural treatment to handle one of the world’s most devastating and difficult diseases: metastatic cancer. 

“Our vision is to empower the patient’s immune system to destroy cancer by exploiting four processes: releasing by ablation the full complement of cancer-specific protein antigens; unmasking by immunotherapy all cancer-specific antigens to ensure optimal recognition by the immune system; unleashing the full force of the cancer-killing T-cells and other immune cells by activation and mobilisation; and blocking mechanisms that would dampen the anti-tumour effect.

“We were gratified by the high rates of disease control and abscopal effect, as well as the favourable adverse event profile compared with systemic immunotherapy. Remarkably, this therapy appeared to be applicable to many types of solid cancer.”

Rampart Health’s MITI treatment is intended to synergistically empower the immune system to destroy cancer.