TILT Biotherapeutics has revealed positive results from a Phase I trial investigating its candidate TILT-123 for the treatment of solid tumours.
The late-breaking data was presented at the Society for Immunotherapy of Cancer 2023 conference held in San Diego, US, from 1 to 5 November. TILT Biotherapeutics said the candidate demonstrated a good safety profile and promising anti-tumour activity, according to a 6 November press release.
The TUNIMO trial (NCT04695327) was a single-arm, open-label, multicentre trial assessing TILT-123 as a monotherapy in 20 patients with advanced solid tumours who have not responded to standard treatments. Patients received multiple administrations of the candidate, with a dose escalation occurring after safety data was ascertained. Enrolled patients had cancers, including sarcomas, melanoma, and ovarian cancer.
The primary endpoint measured safety by day 85, which was assessed by adverse events, vital signs, laboratory values, and electrocardiogram. Tumour responses, neutralising antibodies, biopsy analysis, and virus persistence in blood were included as secondary endpoints.
As per posters presented at the conference, the most frequent adverse events were fever, chills, and fatigue. TILT reported no dose-limiting toxicities.
Finland-based TILT Biotherapeutics stated that the tolerability is consistent with other oncolytic virus therapies and opens the door for potential combination therapies.
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For efficacy, 67% of patients experienced disease control by positron emission tomography (PET) criteria. The overall survival and progression-free survival rate in patients with disease control was more than 25% after approximately two years.
TILT-123 is an oncolytic virus encoding human tumour necrosis factor alpha (hTNFa) and human interleukin 2 (hIL-2) cytokines. The candidate works by inducing and enhancing the traffic of T-cells to the tumour microenvironment.
TILT-123 is also being investigated in combination with MSD’s Keytruda (pembrolizumab) in patients with ovarian cancer (NCT05271318) and Merck’s Bavencio (avelumab) in patients with solid tumours who have not responded to anti-PD-L1 inhibitors (NCT05222932).