Agenus (AGEN) Commencement of Phase 1/2 Clinical Trial of anti-OX400 in Patients with Solid Tumors

November 30, 2016 8:53 AM EST

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Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, today announced that the first patient has been dosed in a Phase 1/2 clinical trial of the anti-OX40 agonist antibody INCAGN1949. The trial is being conducted by, and in collaboration with, Incyte Corporation.

The open-label, dose-escalation portion of the trial will evaluate the safety and tolerability of INCAGN1949 in patients with advanced or metastatic solid tumors and determine its pharmacologically active and/or maximum tolerated dose. Part 2 of the trial is planned to evaluate the recommended dose of INCAGN1949 in multiple tumor types.

"We are pleased with the progress of our fruitful alliance with Incyte and also anticipate advancing a number of Agenus programs outside of the Incyte collaboration, such as our PD-1 antagonist, AGEN2034, into clinical development in the coming months," said Garo H. Armen, Ph.D. Chairman and CEO of Agenus. "Our pipeline of proprietary and differentiated assets continues to offer opportunities for additional partnerships."

INCAGN1949 is an agonist antibody targeting OX40, otherwise known as CD134 or TNFRSF4. OX40 is a co-stimulatory receptor found on activated T cells. OX40 engagement has a two-pronged effect; it can stimulate proliferation of activated T cells that may promote tumor killing and inhibit the activity of regulatory T cells that mediate immune suppression. INCAGN1949 was discovered during an earlier collaboration with Ludwig Cancer Research. This antibody is being co-developed with Incyte.

"Immune checkpoint antibodies including those targeting PD-1/PD-L1 and CTLA-4 have shown clinical activity across multiple tumor types that supported their approval in a number of indications, but a significant proportion of patients are still in need of additional intervention," said Jean-Marie Cuillerot, M.D., VP and Global Head of Clinical Development. "OX40 is an important co-stimulatory checkpoint that contributes to the regulation of the immune anti-tumor response. We believe OX40 agonism provides a robust framework for combination therapy with a potential to make a meaningful difference to patients afflicted by this deadly disease."

Additional information about the trial can be found here.

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