Mocaciclib

SEONGNAM, South Korea--(BUSINESS WIRE)--Qurient Co., Ltd. (KRX: 115180) today announced that the first patient has been dosed in a Phase 2 clinical study evaluating mocaciclib (Q901) in combination with fulvestrant for treatment of hormone receptor-positive (HR+) breast cancer. The trial specifically targets patients who have stopped responding to prior treatments containing CDK4/6 inhibitors. Mocaciclib is a highly selective and potent covalent inhibitor of cyclin-dependent kinase 7 (CDK7), developed to address significant unmet medical needs in advanced solid tumors, including treatment-resistant breast cancer. "Dosing the first HR-positive breast cancer patient with mocaciclib is an important step forward in our mission to provide new therapeutic options for patients who have exhausted standard-of-care treatments." The dosing of the first patient with CDK4/6 inhibitor-resistant HR+ breast cancer marks a significant milestone in development of mocaciclib as a new therapeutic option. While CDK4/6 inhibitors combined with endocrine therapy have proven highly effective for treatment of HR-positive, HER2-negative metastatic breast cancer, many patients eventually experience disease progression due to innate non-responsiveness or acquired resistance. Mocaciclib is being investigated as a targeted solution to overcome the refractory conditions through cell cycle control and transcriptional regulation of key refractory mechanisms, such as PTEN-PI3K/AKT pathway activation. "Dosing the first HR-positive breast cancer patient with mocaciclib is an important step forward in our mission to provide new therapeutic options for patients who have exhausted standard-of-care treatments," said Kiyean Nam, Ph.D., Chief Executive Officer of Qurient. "Because of its unique mechanism of action in cell cycle control and transcriptional regulation, mocaciclib holds promise for patients whose tumors have developed bypass mechanisms to evade CDK4/6 inhibition. We are highly encouraged by our latest findings in CDK7 biology and look forward to translating this science into meaningful clinical outcomes." Mechanism of Action Rationale in HR+ Breast Cancer Mocaciclib (Q901) provides a novel therapeutic strategy for HR+ breast cancer by targeting CDK7, a dual-function kinase essential for both cell cycle progression and transcriptional regulation: Master Regulation of the Cell Cycle (CAK Inhibition): CDK7 acts as the CDK-activating kinase (CAK), responsible for phosphorylating the T-loop of other key cell cycle kinases, including CDK1, CDK2, CDK4, and CDK6. In HR+ breast cancer, resistance to CDK4/6 inhibitors frequently occurs through the loss of retinoblastoma (RB) protein function or the over-activation of the Cyclin E-CDK2 axis. This allows cancer cells to bypass the CDK4/6 blockade and re-enter the S-phase of division. By potently inhibiting CDK7, mocaciclib suppresses the activation of CDK2 and other downstream kinases, effectively shutting down these alternative escape routes and halting tumor proliferation. Targeted Transcriptional Repression: Beyond cell cycle control, CDK7 is a core component of the transcription factor II H (TFIIH) complex. Mocaciclib selectively disrupts the transcription of heavily relied-upon oncogenic transcription factors (such as MYC and E2F) and suppresses the expression of genes that are activated by the PTEN-PI3K/AKT pathway, effectively neutralizing another mechanism of CDK4/6 inhibitor resistance. About Mocaciclib (Q901) Mocaciclib (Q901) is an intravenously administered, highly selective covalent CDK7 inhibitor currently advancing through Phase 1/2 clinical trials (NCT05394103). In addition to its potential as a monotherapy in HR+ breast cancer and other advanced solid tumors, mocaciclib has demonstrated profound synergy in preclinical models when used in combination with Topoisomerase 1 inhibitor-based antibody-drug conjugates (TOP1i-ADCs) and immune checkpoint inhibitors. About Qurient Qurient Co., Ltd. is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for oncology and inflammatory diseases. Utilizing a network-centric research and development model, Qurient successfully collaborates with top-tier research institutes and global pharmaceutical companies to translate innovative science into impactful medicines. Website: www.qurient.com Note: This press release contains forward-looking statements regarding the clinical potential of mocaciclib (Q901). These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially.

License agreement centered around technology enabling dual-payload ADC Unique combination of Synaffix's exatecan-based technology with Qurient's CDK7 inhibitor AMSTERDAM and SEONGNAM-SI, South Korea , Sept. 25, 2025 /PRNewswire/ -- Synaffix B.V. ("Synaffix"), a Lonza company (SWX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with potential best-in-class therapeutic index, today jointly announced that it has entered into a licensing agreement with Qurient Co., Ltd., a clinical-stage biopharmaceutical company based in South Korea, for the development of a dual-payload ADC. Dual-payload ADCs are designed to deliver two separate cytotoxic agents with distinct mechanisms of action to target cancer cells, aiming to enhance therapeutic efficacy and mitigate payload resistance. Their therapeutic promise can potentially expand the current range of effective treatments while minimizing toxicity to healthy tissues, especially in refractory cancer cases. The collaboration aims to develop a dual-payload ADC consisting of Synaffix's exatecan-based technology and Qurient's CDK7 inhibitor, aiming to target unmet medical needs in solid tumors. Under the terms of the agreement, Qurient will gain access to Lonza's clinical-stage, site-specific ADC technology platform powered by Synaffix services including GlycoConnect® antibody conjugation, HydraSpace® polar spacer, and exatecan-based linker-payload technologies, as well as Lonza's market-leading expertise and experience in developing and manufacturing bioconjugates. Lonza will manufacture components related to its proprietary Synaffix technologies, and Qurient will perform the research, development, manufacturing and commercialization of the ADC, and manufacturing of Qurient's CDK7 inhibitor. Peter van de Sande, Head of Synaffix, said: "This licensing collaboration with Qurient signifies the versatility of our industry-leading ADC platform technology. Enabling the development of a dual-payload ADC built with Synaffix technology reflects our drive to continue pioneering innovation in the field." Kiyean Nam, CEO at Qurient, said: "Dual-payload ADCs represent the next frontier in targeted antibody therapeutics, and we look forward to advancing this novel combination of our CDK7 inhibitor and Synaffix's SYNtecan™ linker-payload. The combination of our proprietary technology with Synaffix's industry-leading platform has the potential to be applicable to a wider range of targets and antibodies, and we look forward to exploring those possibilities in the future." Notes to Editors About Synaffix Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform based on GlycoConnect®, HydraSpace® and toxSYN® technologies, that together enable any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix. The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Synaffix holds granted patents to its technology. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its partner pipeline. Synaffix was fully acquired by Lonza in June 2023. For more information about Synaffix's ADC platform technology, please visit: About Lonza Lonza is one of the world's largest development and manufacturing organizations (CDMOs). Working across five continents, our global team of more than 19,000 colleagues works alongside pharma and biotech companies to turn their breakthrough innovations into viable therapies. We support our customers in bringing life-saving and life-enhancing treatments to patients worldwide with a combination of cutting-edge science, smart technology and lean manufacturing. Our company generated sales of CHF 3.6 billion with a CORE EBITDA of CHF 1.1 billion in Half-Year 2025. Find out more at About Qurient Co., Ltd. Qurient Co., Ltd. is a public clinical-stage biotechnology company headquartered in South Korea and listed on KOSDAQ, with a mission to develop innovative medicines and targeted therapies across oncology and infectious diseases. The company's pipeline includes mocaciclib (Q901), a CDK7 inhibitor targeting transcriptionally addicted cancers; adrixetinib (Q702), an AXL/MER/CSF1R inhibitor being explored for chronic graft-versus-host disease (cGvHD) and oncology indications; and telacebec (Q203), a first-in-class antibiotic in late-stage development for Tuberculosis, Buruli ulcer and other mycobacterial diseases. Qurient combines strong translational research expertise with global partnerships to advance programs from discovery through clinical development. By strategically focusing on high-unmet-need indications such as hard-to-treat cancers, drug-resistant mycobacteria, and immune-driven diseases, Qurient positions itself at the intersection of precision oncology and infectious disease innovation. For more information, please visit . SOURCE Synaffix WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED