Oncology company Coiled Therapeutics plc (AIM: COIL) reported on Monday that it has recorded improved clinical outcomes from its ongoing Phase I/II trial (NCT06136884) of AO-252, supporting a strategic shift towards targeted dose expansion in ovarian and prostate cancers.

The company said a transition to twice-daily dosing in Cohort 4b delivered an 80% clinical benefit rate, compared with 40% under once-daily dosing, with four out of five evaluable patients showing tumour stabilisation or regression. Treatment duration exceeded six months, outperforming the typical two to three months seen in heavily pre-treated populations. A leiomyosarcoma patient achieved stable disease after two cycles despite nine prior lines of therapy.

AO-252 continues to demonstrate a favourable safety profile, with no serious adverse events reported and maximum tolerated dose not yet reached, enabling further dose escalation. The study has enrolled 31 patients to date, with 21 evaluable for efficacy, and remains on track to complete dose escalation in H1 2026.

Emerging data also highlights AO-252's dual mechanism of action, combining direct cytotoxic effects with immune activation via the cGAS/STING pathway, supporting its potential use in combination regimens. Preclinical findings indicate synergy with immuno-oncology and antibody-drug conjugate therapies, with a combination study planned to commence in Q3 2026.

Pharmacokinetic analysis has identified gender-based exposure differences, informing dose optimisation, while a food-effect sub-study is expected to report in late Q2 2026. A next-generation formulation aimed at improving drug exposure is scheduled for mid-2026.

Following positive early signals, Coiled Therapeutics is advancing towards dose expansion cohorts with a target enrolment of 40 patients by Q3 2026, alongside continued engagement with key opinion leaders to refine clinical strategy. Further milestones include expansion cohort data readouts in H2 2026 and potential progression to Phase II registrational studies.