In situ orthotopic bladder cancer (IOBC) model.
The In-situ Orthotopic Bladder Cancer (IOBC) Model is a unique animal model for bladder cancer in which tumor cells are implanted into the bladder through the urethra after damaging the bladder’s inner wall mucosa. This model allows real-time tracking of tumor size and survival through bioluminescence imaging. The in situ animal model of bladder cancer in rats has become a unique tumor model technology with independent intellectual property rights.
Unlike subcutaneous xenograft models, the in situ model more accurately simulates the early pathogenesis of clinical bladder tumors and the immune changes in the tumor microenvironment. It compensates for the high malignancy and inadequate reconstruction of the immune microenvironment in subcutaneous xenograft models. It is a reliable research model and essential tool for studying the mechanisms of tumor immunomodulation and evaluating the efficacy of immune-oncology drugs.
Based on this technology, it can be used for the development of bladder perfusion drugs, oral drugs, and intravenous drugs. Asieris is dedicated to the development of NMIBC therapeutic drugs guided by clinical value. Through diversified and multi-level collaboration models, such as independent research and development, collaborative development, licensing, and deep incubation, we continuously develop anti-tumor drugs for bladder cancer.
Based on Asieris’ existing commercialization team and business network, we will continue to seek products that are commercialized or near-commercialization in Asieris’ advantageous therapeutic areas (urological diseases and women’s health), with the aim of maximizing product potential and creating sustained value and growth momentum for Asieris and our partners.
A variety of innovative products, seeking global market partners
APL-2302
APL-1702
USP1 plays critical role in DNA damage repair pathways
APL-2302 is potentially a best-in-class USP1 inhibitor (USP1i) for the treatment of ovarian, prostate and breast cancers.
It is three-times more efficacious than the key competitor as a monotherapy in breast tumor models, also shows higher efficacy when used in combination with olaparib in PARPi-resistant tumor models with HRD (homologous recombination deficiency) or BRCA mutations.
Note: In vivo experiments have shown that APL-2302 exhibits better efficacy than its main competitors, whether used as monotherapy or in combination with olaparib or gemcitabine.
• It has high oral bioavailability (>75%) and dose-exposure linearity across species, predicting a similar PK (pharmacokinetic) profile in humans.
• In animal models, it has higher tumor-specific distribution than in plasma, providing an advantage over competing compounds.
• The FIH (First-In-Human) Phase I study to be initiated in 2025.
For more experimental data about APL-2302, please click here to view relevant information.
Currently seeking potential partners from around the world for further development.
APL-1702 is the world’s first-in-class non-surgical treatment for cervical HSIL with its efficacy proven in a randomized, double-blind, controlled international phase III trial.
Between November 2020 and July 2022, a total of 402 eligible patients from various countries, including China, Germany, the Netherlands, were randomized and enrolled in the international multi-center phase III clinical trial of APL-1702. Regarding the primary efficacy endpoint, the response rate in the APL-1702 treatment group was 89.4% higher than that in the placebo control group (41.1% vs. 21.7%, p = 0.0001),indicating a remarkable therapeutic effect. Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the APL-1702 treatment group compared to the control group (31.4% vs. 15.4%)1. The incidence of treatment-emergent adverse events (TEAEs) was comparable between the treatment group and the control group, with the majority being mild and self-healing without requiring intervention. The occurrence rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were both low in both groups.
• The response rate increased by 89.4% compared to the placebo control group, with a low incidence of adverse events;
• This product has clinical treatment value for the long-term management of precancerous lesions of cervical cancer, public health value for the prevention and control of cervical cancer, and social value for protecting women’s fertility.
• It heralds a potential paradigm shift in the treatment of precancerous cervical lesions.
• The New Drug Application (NDA) for product APL-1702 has been accepted by the National Medical Products Administration (NMPA) in May 2024.
Actively seeking collaborative opportunities for overseas market development.
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