The FDA awarded the Fast Track status for the investigation of a botensilimab (AGEN1181) and balstilimab (AGEN2034) combination.
The combination therapy has been approved to treat non-microsatellite instability-high (non-MSI-H)/deficient mismatch repair metastatic colorectal cancer patients, with no signs of active liver involvement.
The designation covers patients who are heavily pre-treated and show resistance or intolerance to fluoropyrimidine, irinotecan and oxaliplatin.
Agenus chief medical officer Dr Steven O’Day stated: “We are pleased that the FDA has granted Fast Track designation for the combination of botensilimab with balstilimab in patients with non-MSI-H colorectal cancer, recognising the high unmet medical need in this population.
“The Fast Track designation offers important benefits, including the potential eligibility for a Priority Review, and we will be working with the FDA and all key stakeholders to rapidly advance the botensilimab/balstilimab combination in colorectal cancer as well as other solid tumour indications.”
A new multifunctional CTLA-4 investigational antibody, botensilimab has been designed for expanding the clinical benefits to cold tumours which did not respond to standard of care or investigational treatments.
In a Phase Ib clinical trial involving more than 350 participants, it showed clinical responses in nine solid tumour cancers either alone or along with balstilimab.