Shanghai, China, October 24, 2024 – Asieris Pharmaceuticals (688176.SH), a leading global biopharmaceutical company dedicated to advancing innovative therapies for genitourinary tumors and women health with significant unmet medical needs, announces that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of APL-2302（Ubiquitin-specific protease 1, USP1 inhibitor）for the treatment of advanced solid tumor.
APL-2302 is a novel USP1 inhibitor with completely independent intellectual property rights, which plays its anti-tumor role through a “synthetic lethality” mechanism. The results of the non-clinical pharmacodynamics (PD) studies show that APL-2302 is an active USP1 inhibitor. Monotherapy and combination therapy of APL-2302 showed excellent tumor suppression efficacy in vitro and in vivo. It is expected to provide a new treatment option for patients with advanced solid tumors, including breast cancer, ovarian cancer, prostate cancer, and other specific solid tumors with certain biomarkers (such as BRCA mutation).
This is a Phase I/IIa, open-label, multi-center, dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of ASN-3186 in patients with advanced solid tumors.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, stated, “We are pleased that the IND for APL-2302 has been approved by FDA. The non-clinical data for APL-2302 is promising, and we are eagerly generating the clinical data for this candidate drug, further demonstrating its safety and efficacy, addressing the actual clinical treatment needs to benefit more patients. We will promptly submit IND application to the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) to actively promote the initiation of this clinical trial on a global scale. “
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient’s dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.
