TILT Biotherapeutics announced the presentation of clinical data on TILT-123 at the European Society of Medical Oncology (ESMO) Congress 2024, highlighting its potential as a fully intravenous therapy for advanced solid cancers. The Phase I clinical trial (NCT04695327) evaluated TILT-123 monotherapy, demonstrating safety, tumor transduction, and immunological effects in metastases.
Phase I Trial Results
The Phase I study included six patients with diverse advanced solid cancers, including three rectal carcinomas, gastric intestinal type carcinoma, pancreatic ductal adenocarcinoma, and liposarcoma. TILT-123 was administered intravenously twice daily, initially twice a week and subsequently at 3-week intervals. Imaging data revealed disease control in 33% of patients according to RECIST1.1 criteria and 66% based on PET-based criteria at data cutoff.
TILT-123 Mechanism of Action
TILT-123, also known as Igrelimogene litadenorepvec, is an oncolytic adenovirus engineered to express tumor necrosis factor alpha (TNFα) and interleukin-2 (IL-2). This therapeutic approach aims to enhance the efficacy of T-cell therapies by selectively replicating in and lysing cancer cells, while simultaneously stimulating immune responses towards the tumor. The intravenous delivery regimen seeks to improve systemic accessibility and therapeutic impact.
Management Perspective
Akseli Hemminki, founder and CEO of TILT Biotherapeutics, commented, "This data presented at ESMO 2024 provides additional validation on the potential of TILT-123 as fully intravenous therapy in very difficult to treat patient population. I am also proud of our progress with two other studies investigating the fully intravenous regimen of TILT-123. We are moving according to our plan towards Phase II and making good clinical progress."
Ongoing and Future Studies
TILT Biotherapeutics is advancing TILT-123 through multiple clinical trials, including collaborations with MSD (Merck & Co., Inc., Rahway, NJ, USA) to investigate TILT-123 in combination with KEYTRUDA® (pembrolizumab) in ovarian cancer (NCT05271318) and refractory non-small cell lung cancer (NCT06125197). Additionally, the company is collaborating with Merck KGaA (Darmstadt, Germany) to study TILT-123 in combination with Bavencio® (avelumab).
