ACE-86225106

SHANGHAI & INDIANAPOLIS--(BUSINESS WIRE)--Acerand Therapeutics, a clinical-stage biotechnology company focused on developing innovative therapies in oncology, metabolic diseases, and immunology, today announced updated results from its first-in-human Phase I/II study ACE-106-001 (NCT06380660) evaluating ACE-106 (ACE-86225106) in patients with advanced solid tumors. As of February 5, 2026, 57 heavily pretreated patients, with a median three prior lines of therapies, had received ACE-106. No dose-limiting toxicities or Grade 4–5 treatment-related adverse events (TRAEs) occurred. Grade 3 TRAEs occurred in 17.5% of patients, with no apparent evidence of dose-dependent toxicity. ACE-106 has also shown a safety profile that compares favorably with currently approved PARP inhibitors, including lower rates of hematologic toxicity. ACE-106 showed encouraging and durable antitumor activity across tumor types. Among evaluable homologous recombination repair-mutated (HRRm) patients, the objective response rate (ORR) was 32%, with a disease control rate (DCR) of 58%. Responses remain ongoing, and the median duration of response has not yet reached. In patients with HRRm metastatic castration-resistant prostate cancer (mCRPC), ACE-106 achieved an ORR of 50% and a PSA50 response rate of 37%, and a median progression-free survival (mPFS) of 7.4 months. In PARPi–naïve HRRm ovarian cancer, ACE-106 demonstrated an ORR of 67% and a DCR of 100%. Pharmacokinetic data supports once-daily dosing, with dose-proportional exposure and a favorable half-life. Based on these results, Acerand plans to initiate a randomized Phase II study evaluating ACE-106 in combination with an androgen receptor pathway inhibitor (ARPI) versus ARPI alone in prostate cancer. “These data reinforce ACE-106’s differentiated profile and support its potential as a best-in-class PARP1 inhibitor,” said Acerand. “We believe ACE-106 is well positioned for combination strategies and broader clinical development.” Detailed results will be presented at the AACR Annual Meeting 2026 (Abstract CT064). About ACE-106 (ACE-86225106) ACE-106 is a next-generation, highly selective PARP1 inhibitor designed to improve the therapeutic index relative to approved PARP inhibitors. About Acerand Therapeutics Acerand Therapeutics is a biotech company dedicated to discovering and developing novel small-molecule therapies for oncology and metabolic diseases. With research and development hubs in Shanghai, China, and Indianapolis, USA. http://www.acerand.com/