Hangzhou, China, Oct 29, 2024 Hangzhou Adcoris Biopharma (Adcoris) announced that its innovative new generation of antibody-drug conjugate ACR246 has been completed first-in-human dosing in Phase Ia trial (NCT06238401) in Beijing Cancer Hospital under the direction of Professor Lin Shen (the leading PI).
The Phase Ia study is evaluating ACR246 in patients with advanced solid tumors. The primary objectives of this multicenter, dose-escalation and optimization Phase Ia study aim to investigate the safety, tolerability and RP2D. The secondary objectives of this study include to characterize pharmacokinetics, immunogenicity and preliminary efficacy.
ACR246 targets 5T4, an oncofetal antigen that is highly expressed in many solid tumors and cancer-initiating cells meanwhile has no or limited expression in normal adult tissues. ACR246 bearing eight of TOP1 inhibitor payloads per ADC is developed based on Adcoris’ cutting-edge MuSCTM ADC technology platform and is the first-in-class to enter into clinical trial.
The trial will be conducted in three oncology hospitals: Peking University affiliated Beijing Cancer Hospital (Beijing, China), Shandong First Medical University affiliated Cancer Hospital of Shandong (Ji’nan, China) and Zhejiang Cancer Hospital (Hangzhou, China). Phase Ia dose-escalation will determine the DLT and MTD for further optimization.
“Cancer treatment remains a highly clinical niche, and a tremendous burden on patients, their families, and caregivers,” said Lin Shen, MD, Deputy Dean of Peking University Cancer Hospital and the leading PI of ACR246 Phase I trial. “ADCs are beginning to show great potential as a significantly important treatment modality in replacing conventional chemotherapy for many solid tumors indications. I am very impressed with the preclinical data that ACR246 demonstrated in numerous CDX and PDX models. We are looking forward to the results of this first-in-human clinical trial.”
“The initiation of this Phase I trial is a critical step forward in our mission to developing a variety of ADC products for unmet medical needs, and ACR246 is the 2nd ADC program in clinical stage at Adcoris”, said Zhenwei Miao, PhD, Chairman of Adcoris, who has almost 20 years’ experiences in advancing multiple ADC products to the market or late-stage clinical trials. “This milestone reflects our team’s perceptive capability of developing innovative cutting-edge technology platform, as a result, that was employed to this first-in-class of TOP1-inhibitor payload anti-5T4 ADC. We are optimistic about the potential of ACR246 to make a significant impact on cancer patients with safety and efficacy proved in the clinic. We are grateful to the investigators and participating patients who make this possible.”
About ACR246
ACR246 is a potentially first-to-market anti-5T4 ADC with a novel TOP1 inhibitor payload and a stable and tumor microenvironment (TME) cleavable linker. 5T4 is an oncofetal antigen (also known as trophoblast glycoprotein, TPBG) that has high expression in many solid tumors including NSCLC, breast, ovarian, esophageal, colorectal, prostate, urothelial, soft tissue sarcoma, etc., but no or limited expression in normal adult tissues. ACR246 may have broad therapeutic benefits in a wide range of solid tumors. The preclinical studies has demonstrated that ACR246 was highly potent and significantly superior to a reference anti-5T4 Dxd-ADC in many tumor CDX models. ACR246 has the potential to treat multiple solid tumors.
About Adcoris
Adcoris is a clinical stage biopharmaceutical company focusing on developing the next generation antibody-drug conjugate (ADC) and antibody conjugate beyond cytotoxic payload (AXC) therapeutics to address the unmet needs in oncology and autoimmune disease. Our state-of-the-art proprietary technology platform is based on internally developed three pillars of ADC technologies: proprietary and highly active payloads (PHAP™); cleavable, flexible and stable linkers (CLEF™), multifunctional site-specific conjugation (MuSC™). We can accelerate the development of ADC and AXC from target to IND enabling within 15 months. We have built a robust product pipeline including first-in-class (FIC) and first-in-generation (FIG) ADC and AXC in various development stages, including one completed phase-1 clinical study, one currently in phase-1 and several near IND-enabling. Adcoris is looking to collaborate with industry partners to codevelop our promising ADC candidates and deliver better and faster outcomes for patients.