INCAGN1949 is an investigational immune checkpoint antibody to potentially treat cancer, beginning early testing in patients with advanced solid tumors.

It is being developed by Agenus in collaboration with Incyte.

How INCAGN1949 works

INCAGN1949 is an antibody that targets OX40 (also known as CD134 or TNFRSF4), leading to an anti-tumor immune response. OX40 is a receptor protein found on activated immune cells called T-cells that can enhance the magnitude and durability of T-cell response. By specifically binding to OX40, INCAGN1949 is able to enhance the effect of OX40 and promote tumor-specific cellular immunity via two different mechanisms: by stimulating the proliferation of activated T-cells that promote tumor killing, and by inhibiting the activity of other T-cells, known as regulatory T-cells, that mediate immune suppression.

INCAGN1949 in clinical trials

INCAGN1949 as a single agent has shown significant antitumor activity and was well-tolerated at all doses tested in preclinical studies in non-human primates. Researchers report that the compound may also be combined with other antibodies that modulate the immune response, targeted therapies, and vaccines.

A Phase 1/2 treatment safety and tolerability study (NCT02923349) is currently recruiting about 150 patients with advanced or metastatic solid tumors in the U.S., Spain, Switzerland, and the U.K. The open-label, dose-escalation portion of the study will assess the safety and tolerability of INCAGN1949 in these people. The second part will evaluate the recommended dose of INCAGN1949 in enrolled patients. Its estimated completion date is February 2019; enrollment information is available by clicking on the trial’s identification number.

Another Phase 1/2 study (NCT03241173) is aimed at determining the safety, tolerability, and efficacy of INCAGN1949 when given in combination with the immune checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab), either alone or in combination, in people with advanced or metastatic tumors. Measures of both potential side effects related to the treatment (safety and tolerability) and objective response rate (efficacy) are the trial’s primary endpoints.

This study is expected to soon begin enrolling eligible patients, and to finish in November 2021. It aims to recruit 651 patients at sites that are also in the U.S., Spain, Switzerland and the U.K.


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