ACM Biolabs Reports Favorable Safety Signals and Early Pharmacodynamics from Intramuscular Administration of ACM-CpG in Patients with Advanced Solid Tumors

SINGAPORE, Oct. 22, 2025 /PRNewswire/ -- ACM Biolabs, a clinical-stage biotechnology company developing next-generation nanoparticle-based immunotherapies, today announced encouraging early clinical findings from its ongoing Phase 1 study of ACM-CpG, a TLR9 agonist formulated with ACM's proprietary polymersome platform through a strategic collaboration with the National Cancer Centre Singapore (NCCS).

Preclinical experiments show that the ACM nanoparticle formulation fundamentally alters CpG's mechanism of action, enabling myeloid modulation through comprehensive TLR9 engagement in immunologically "cold" tumors. The ongoing Phase 1 trial (NCT06587295)^[i] is enrolling patients with advanced solid tumors at NCCS to assess the safety, tolerability, and pharmacodynamic effects of ACM-CpG.

Early clinical data indicate that these preclinical findings are translating into humans. In patients with advanced solid tumors, intramuscular administration of ACM-CpG - at weekly or biweekly doses as low as 0.25mg CpG – has demonstrated robust systemic immune activation as evidenced through immune biomarker data. The therapy shows a highly favorable safety and tolerability profile and to date, no dose-limiting toxicities have been observed.

"TLR9 has long been recognized as a validated immunologic target, but its therapeutic potential has been limited by delivery and safety limitations," said Dr. Madhavan Nallani, CEO of ACM Biolabs. "Our intramuscular nanoparticle delivery enables systemic immune activation with an excellent safety profile, creating opportunities not only for combination approaches but also for targeted monotherapy in patient populations with few treatment options. Over time, this platform can also support additional routes of administration allowing us to tailor treatment strategies to diverse tumor settings and address significant unmet medical needs."

"The safety profile and clear pharmacodynamic activity we have observed so far are very encouraging, with two out of the three patients enrolled at the 0.25mg dose level having ongoing disease control for eight months with monotherapy alone." said Dr. Amit Jain, Senior Consultant, Division of Medical Oncology, National Cancer Centre Singapore. "We look forward to exploring ways to optimize its delivery and maximize its therapeutic potential for patients with advanced cancers."

The collaboration is supported in part by funding from Singapore's Industry Alignment Fund – Pre-Positioning (IAF-PP), which fosters strategic collaborations between industry and research institutes. This study is evaluating ACM-CpG in patients with advanced head and neck, lung, bladder, and kidney cancers and is designed to establish proof of mechanism to support global clinical development.

About ACM Biolabs Pte Ltd

ACM Biolabs is headquartered in Singapore, with subsidiaries in Basel, Switzerland, and Sydney, Australia.   It is a clinical-stage biotechnology company developing targeted vaccines and immunotherapies using its proprietary polymer-lipid hybrid nanoparticle delivery platform. The company's pipeline includes candidates across oncology, infectious diseases, and inflammation, with a focus on precision immune modulation and next-generation drug delivery.