The clinical trial will evaluate Leap’s TRX518 in combination with Bavencio (avelumab), approved by the FDA last year for metastatic Merkel cell carcinoma, and cyclophosphamide chemotherapy.
According to Leap Therapeutics representative, Doug Onsi, It will be conducted by Leap Therapeutics with the use of a contract research organization (CRO). Per the agreement, the trial will be conducted in advanced solid tumors in patient populations who have relapsed/refractory ovarian, breast, and prostate cancers.
“The clinical trial will be led by Jedd Wochok from Memorial-Sloan Kettering Cancer Center and is based on the preclinical work that members of his lab presented at the American Association for Cancer Research Annual Meeting earlier this year,” said Onsi.
TRX518 was developed by Leap as a humanized glucocortid-induced TNFR family related gene agonist monoclonal antibody, said to improve an anti-tumor response in the immune system.
“We believe that the use of TRX518 could enhance the activity of an immune checkpoint inhibitor like Bavencio [avelumab]. The checkpoint inhibitors, like Bavencio have been described as taking the brake off of the immune system so that the immune cells can target the tumor, and the agonist antibodies, like TRX518, are described as stepping on the gas pedal to accelerate the immune system’s activity to target cancer,” said Onsi.
TRX518 has demonstrated positive results in early clinical activity in combination with immune checkpoint inhibitors and is believed to be enhanced by the addition of cyclophosphamide chemotherapy, suggested Onsi.
According to Jessica Smith, global media relations of Pfizer, Merck KGaA and Pfizer are in a partnership to jointly develop and commercialize Avelumab, which the companies refer to as the ‘Avelumab Alliance’.
“If the study is successful it could lead to additional studies and collaboration. The clinical collaboration announced between Leap and the Avelumab Alliance does not contain rights to each other’s compounds,” said Smith.
Enrollment in the study is set to occur in Q1 of next year.