Acerand Therapeutics has reported updated findings from its first-in-human Phase I/II study ACE-106-001 of ACE-106 (ACE-86225106), targeting patients with advanced solid tumours.
As of 5 February 2026, 57 patients with pretreatment histories, having undergone a median of three prior therapy lines, have been administered ACE-106.
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No dose-limiting toxicities or Grade 4–5 treatment-related adverse events were observed. Grade 3 treatment-related adverse events appeared in 17.5% of patients, with no signs of dose-related toxicity.
The data indicate a safety record favourable compared to existing polyadenosine diphosphate-ribose polymerase (PARP) inhibitors, especially considering a lower incidence of haematologic toxicity.
ACE-106 demonstrated notable anti-tumour activity across different tumour types. Among evaluable patients with homologous recombination repair mutation (HRRm), the objective response rate registered at 32%, and the disease control rate at 58%.
Ongoing responses meant the median duration of response is yet to be established.
In the HRRm metastatic castration-resistant prostate cancer subgroup, ACE-106 achieved an objective response rate of 50%, a PSA50 response rate of 37%, and a median progression-free survival of 7.4 months.
The PARPi–naïve HRRm ovarian cancer group saw an objective response rate of 67% and a disease control rate of 100%.
Pharmacokinetic analysis supported once-daily dosing with dose-proportional exposure and a favourable half-life.
Based on these outcomes, Acerand Therapeutics plans to launch a randomised Phase II study that compares ACE-106 combined with an androgen receptor pathway inhibitor to ARPI alone in prostate cancer.
The company indicated that the results strengthen ACE-106’s distinct profile and support its potential as a leading PARP1 inhibitor.
Acerand Therapeutics also mentioned that the therapy is suitably placed for use in combination approaches and for broader clinical development.
