TILT Biotherapeutics Provides Update on International Clinical Trial Progress With Intravenous Delivery Regimen for Cancer Immunotherapies

TILT Biotherapeutics (TILT) recently announced it will be presenting data at the European Society of Medical Oncology Immuno-Oncology Congress (ESMO-IO) 2024. The oral presentation discloses the impact of different biological features on treatment efficacy in patients treated with the oncolytic virus Igrelimogene litadenorepvec or TILT-123(1). The study used single-cell sequencing analysis to identify immunological markers in peripheral blood mononuclear cells that were related with better outcomes, including higher baseline levels of cytotoxic effector cells. Additionally, TILT-123 treatment supported the formation of immunological memory. TILT will also present data relating to the fully intravenous dosing of TILT-123 (2). These findings have the potential to support future clinical development strategy.

In addition, TILT is progressing its plans for international Phase II trials of TILT-123 in ovarian cancer, to be administered intravenously, and expects Phase Ib clinical results by H2 2025.

TILT Biotherapeutics’ founder and CEO, Akseli Hemminki, said “This year we’ve made significant progress in the clinical development of TILT-123, and have now treated over 60 patients in five international trials, including our first patients in leading US cancer centres. Our data, presented at ESMO-IO this month, provides further support on the mechanism of action of our oncolytic immunotherapy. Our progress in IV administration, alongside our manufacturing process scale up work, supports our mission to make TILT-123 accessible to patients with hard-to-treat solid cancers.”

TILT-123, an oncolytic adenovirus armed with tumor necrosis factor alpha (TNFα) and interleukin-2 (IL-2), is designed to enhance the efficacy of T-cell therapies, including immune checkpoint blockade or adoptive cell transfer. TILT’s approach uses oncolytic viruses to selectively replicate in and lyse cancer cells, while simultaneously stimulating immune responses towards the tumor.

Reference

(1) ESMO-IO Abstract 353: “Single-cell profiling of peripheral blood mononuclear cells from patients treated with oncolytic adenovirus armed with TNFα and IL-2 revealed pre-existing immunity as a predictor of therapy outcomes”.

(2) ESMO-IO Abstract 458: “Effect of split intravenous dosing of oncolytic adenovirus TILT-123 on normal tissue versus tumor macrophages and virus bioavailability in patients with advanced solid tumors”.

TILT Biotherapeutics is a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary oncolytic adenoviruses armed with molecules including cytokines that can activate T cells and destroy cancer cells.

The company’s patented TILT technology can be delivered intravenously, locoregionally, or intratumorally. It modifies the tumor microenvironment and has a broader systemic effect. By making cold tumors hot, it eliminates cancer’s ability to evade immune responses, thereby enhancing T-cell therapies such as immune checkpoint inhibitors, tumor infiltrating lymphocyte (TIL) therapy, and CAR T therapies.

TILT’s lead asset, TILT-123 also known as Igrelimogene litadenorepvec, is a 5/3 chimeric serotype adenovirus armed with two human cytokines: TNF alpha and IL-2. Over sixty patients have been treated in five international trials sponsored by the company with promising initial efficacy responses observed in some of the patients.

The company’s pioneering approach has been recognized by industry leaders. It has two collaborations with MSD (Merck & Co., Inc., Rahway, NJ, USA) investigating TILT-123 in combination with KEYTRUDA (pembrolizumab) in ovarian cancer (NCT05271318) and in refractory non-small cell lung cancer (NCT06125197).  The company is also collaborating with Merck KGaA (Darmstadt, Germany) and investigating TILT-123 in combination with Bavencio (avelumab).

Based in Helsinki, Finland, and with an office in Boston, the company was established over a decade ago as a spin-out from the University of Helsinki. It has funding from Lifeline Ventures, Finnish Industry Investment (TESI), angel investors, Business Finland, the European Innovation Council, and the US Department of Defense.