Of the two patients dosed, both have now passed the trial's 36-day primary safety endpoint having received three administrations of TILT-123 at the lowest dose.
TILT-123's clinical trial (1) is a phase 1, open-label, dose-escalation study of the company's oncolytic adenovirus coding for Tumor Necrosis Factor Alpha (TNF alpha) and Interleukin 2.
In this 'TUNINTIL' trial, up to 15 patients with metastatic melanoma will receive three injections of TILT-123 as an initial monotherapy over one month, followed by multiple administrations of TILT-123 plus up to two administrations of tumor infiltrating lymphocytes.
TILT-123 has been engineered to encode two human immunostimulatory cytokines, Tumor Necrosis Factor (hTNFa) and human interleukin 2, in order to direct a powerful T cell response to selectively destroy cancer cells.
The TUNINTIL trial's primary objective is to evaluate the safety of TILT-123 and is designed to also deliver insights about the behavior of TILT-123 in humans, such as systemic tumor transduction and virus replication in the tumor, as well as immunological responses.
Overall, the trial has the potential to increase the efficacy of adoptive T-cell therapy, remove the need for toxic pre- and post-conditioning regimens, and deliver the combined anti-tumor benefits of armed oncolytic viruses and T-cell therapy.
The trial will examine both intra-venous and intra-tumoral delivery of TILT-123 and is due to complete in 2021.
TILT Biotherapeutics is a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary, best-in-class oncolytic adenoviruses armed with molecules including cytokines that can stimulate, or suppress, T cells.
The company's patented TILT technology, which can be delivered locally and systemically, modifies the tumor microenvironment and eliminates its ability to suppress immune responses to cancer, thereby enhancing T-cell therapies such as checkpoint inhibitors and CAR T therapies.
TILT's lead asset, TILT-123, is a 5/3 chimeric serotype adenovirus armed with two human cytokines; TNF alpha and IL-2. TILT-123 has demonstrated a 100% response rate in pre-clinical cancer models in vivo, and it is currently in Phase 1 clinical trials in combination with tumor infiltrating lymphocytes therapy in Europe.
Based in Helsinki, Finland, the company was established in 2013 as a spin-out from the University of Helsinki. It has funding from Lifeline Ventures, angel investors, Business Finland, and the European Innovation Council.
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