Selecta Biosciences has dosed the first patient in a Phase I clinical trial evaluating the safety and tolerability of SEL-403 in combination with LMB-100 for the treatment of mesothelioma.
The trial seeks to enrol up to 18 patients with malignant pleural or peritoneal mesothelioma who have undergone at least one regimen of chemotherapy.
It is being carried out under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health in the US.
In the trial, patients will receive up to four treatment cycles, each featuring an initial dose of SVP-Rapamycin in combination with LMB-100 on day one followed by two doses of LMB-100 alone on days three and five.
The trial expects to provide data on pharmacokinetics, anti-drug antibody (ADA) levels, as well as an objective response rate assessment.
The trial's senior investigator Raffit Hassan said: “Mesothelioma remains one of the deadliest and most challenging-to-treat forms of cancer.
“Recombinant immunotoxins hold the potential to induce marked anti-tumour activity if anti-drug antibodies are prevented and sufficient cycles of therapy can be administered.”
Selecta is currently developing SEL-403 that features SVP-Rapamycin, the company’s proprietary, clinical-stage anti-drug antibody (ADA) prevention and immune tolerance technology.
LMB-100 is a recombinant immunotoxin that targets mesothelin, a protein expressed in almost all mesotheliomas and pancreatic adenocarcinomas, and a high percentage of other malignancies, such as lung, breast and ovarian cancers.