Q901 / Qurient, Lead Discovery Center - LARVOL DELTA

Curient anticancer drug Q901, international non-proprietary name 'mocaciclib' confirmed (HIT News) - "Qurient announced on the 12th that the International Nonproprietary Name (INN) of its innovative anticancer drug Q901 has been finalized as 'mocaciclib'. This decision is the result of simultaneous approval from the World Health Organization (WHO) and the United States Association of Nomenclature (USAN) Council."

Commercial • Oncology

Dongkoo Bio acquires exclusive domestic rights to Curient's 'Telacebec' [Google translation] (Biospectator) - "DongKoo Bio announced on the 18th that it signed a letter of intent with Qurient, a new drug development biotech company and its largest shareholder, for the domestic supply, distribution, and sales of 'Telacebec'...According to this letter of intent, Dongkoo Biopharmaceutical will be in charge of domestic distribution and sales of Telacebec. In addition, Dongkoo Biopharmaceutical will be granted priority negotiation rights in the Korean and Southeast Asian markets for the CDK7 inhibitor 'Q901' and the Axl/Mer/CSF1R triple inhibitor 'Q702', which are being developed by Qurient as anticancer drugs."

Commercial • Hematological Malignancies • Infectious Disease • Oncology • Solid Tumor

Qurient, CDK7 Inhibitor Anticancer Drug 'Q901' Shows Potential for Brain Tumor Efficacy [Google translation] (Medipana) - "Qurient...announced on the 12th that it has signed a joint research and development agreement with researchers at the Dana-Farber Cancer Center at Harvard University and the University of Colorado School of Medicine to verify the efficacy of the CDK7 inhibitor anticancer drug 'Q901' in brain tumors and has begun full-scale research....Q901 has already been proven to be safe and effective in other types of cancer, and the driving force behind its interest is that it is a new drug candidate that can enter clinical trials for brain tumors right away through this joint research."

Licensing / partnership • Brain Cancer • Oncology • Solid Tumor

Curient stock price is booming... Why have foreigners been buying for 7 consecutive trading days? [Google translation] (Pinpoint News) - "The stock price of Curient, a company specializing in innovative new drug development, is showing an exceptionally strong performance...According to the Korea Exchange on the 12th, as of 9:55 am on the same day, it closed at 3,960 won, up 9.09%...The stock price is trying to break out of the deep bottom and break through the 60-day moving average. Foreigners are on a buying streak for 7 consecutive trading days...Expectations for improved performance appear to be driving up the stock price as the immunotherapy drug adrixetinib (Q702) received IND approval for a clinical trial for acute myeloid leukemia....The anticancer pipeline includes the immunotherapy Q702 and the anticancer drug Q901 targeting cell cycle regulators, and a joint development agreement has been signed with MSD."

Stock price • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

A first-in-human trial of selective CDK7 inhibitor Q901, in patients with advanced solid tumors: Interim results of a phase I study (QRNT-009). (ASCO 2024) - P1/2 | "Preliminary data from QRNT-009 study showed that selective CDK7 inhibitor Q901 is well tolerated. Preliminary antitumor activity and pharmacodynamic observations are encouraging. Dose escalation is ongoing to identify MTD or recommended dose for further studies."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Castration-Resistant Prostate Cancer • Colorectal Cancer • Endometrial Cancer • Fatigue • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Disorders • Hepatology • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • CA 19-9 • CDK1

[ASCO 2024] Qurient “Proven sufficient safety for combined use of Q901 and ADC” [Google translation] (Hankyung) - P1/2 | N=130 | NCT05394103 | Sponsor: Qurient Co., Ltd. | "Qurient CEO Nam Ki-yeon, who met at the American Society of Clinical Oncology (ASCO) in Chicago on the 3rd (local time), said that interest and questions have poured in since the announcement of the clinical results of Q901, Qurient's core pipeline. On the 1st, Qurient announced on-site that the interim results of the clinical trial of Q901, a CDK7 inhibitor, demonstrated tolerability and safety in all dose ranges regardless of carcinoma...The results announced this time also partially demonstrated the efficacy of Q901. Of the 18 patients who responded to the drug, 5 had stable disease (SD) and 1 had partial response (PR). Qurient is currently administering the 5th cohort at a dose of 126mg/m2. The recommended dose for phase 2 clinical trials is expected to be determined soon."

P1/2 data • Trial status • Oncology • Solid Tumor

Qurient Therapeutics Enters CRADA with the National Cancer Institute to Collaborate on a Phase 1/2 Clinical Study of Q901 in Combination with TROP2-ADC (Businesswire) - "Qurient...entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to evaluate Qurient’s proprietary CDK7 inhibitor, Q901, in combination with an antibody drug conjugate (ADC) targeting tumor-associated calcium signal transducer 2 (TROP2) with topoisomerase 1 inhibitor payload for the treatment of small cell lung cancer (SCLC) and other relapsed solid tumors....Under this CRADA, NCI and Qurient will collaborate on an NCI-sponsored Phase 1/2 clinical study of Q901 in combination with the TROP2-ADC in SCLC and other relapsed solid tumors, starting from combination dose escalation and evaluating the safety, efficacy, and potential synergy of this novel combination."

Licensing / partnership • New P1/2 trial • Small Cell Lung Cancer

Functional dissection of CDK7 in transcription using a highly selective CDK7 inhibitor Q901 (AACR 2024) - "CDK7 binding exclusively to the genes that were downregulated by Q901, without any detectable binding to upregulated genes. Despite the universal role of general transcription machinery in transcription, the data demonstrated that the highly selective inhibition of CDK7 in transcription of various oncogenic pathways underlies the potent in vitro and in vivo anti-cancer efficacy of this specific CDK7 inhibitor."

Breast Cancer • Oncology • Solid Tumor • CDK9

Qurient announces new mechanism of action for ‘Q901’ at AACR 2024 [Google translation] (HIT News) - "Qurient...announced on the 8th that it will disclose the mechanism of action and pharmacological background of 'Q901 (development code name)' in cancer cell transcription regulation at the American Association for Cancer Research (AACR) on April 9 (local time)....At this conference, the cancer killing mechanism of Q901 through regulation of oncogenic gene transcription and its superiority compared to other CDK7 inhibitors will be presented....Based on these advantages, the purpose of this announcement is to reveal the anticancer mechanism of Q901 for the first time. In addition, the synergistic effect of the combination therapy of antibody drug conjugate (ADC) and Q901 will also be revealed."

Preclinical • Breast Cancer • Oncology • Solid Tumor

Qurient accelerates development of anticancer drug ‘Q901’… Following the US, phase 1/2 is also underway in Korea. [Google translation] (News1 Korea) - "Qurient...has begun recruiting patients for domestic phase 1/2 clinical trials for its targeted anti-cancer drug ‘Q901’. Q901 monotherapy and combination therapy with immune checkpoint inhibitors are being studied for patients with advanced solid cancer. According to the Ministry of Food and Drug Safety on the 19th, Qurient recently began recruiting patients for the Q901 phase 1/2 clinical trial....We plan to conduct a joint study to evaluate the efficacy of Q901 and its synergy with standard treatments in small cell lung cancer."

Trial status • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A phase I/II multicenter, open-label, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study of Q901 administered via intravenous infusion in adult patients with selected advanced solid tumors with a cohort expansion at the recommended phase II dose (ESMO 2023) - P1/2 | "Cohort 1 will recruit HR+ HER2- breast cancer patients receiving Q901 combined with fulvestrant, who have received at prior endocrine and CDK4/6 targeted treatment, along with up to two additional prior lines of systemic anticancer therapy. Cohort 2 consists of extensive-stage SCLC patients treated with Q901 monotherapy after failing first-line standard of care. Each cohort will enroll up to 20 patients to assess safety and activity in selected cancer types."

Clinical • Metastases • P1/2 data • P2 data • PK/PD data • Breast Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • CDK4 • HER-2

Qurient “Q901 slows down ADC resistance through combined use of ‘TOP1’ inhibitor” [Google translation] (Hankyung) - "In this study, NCI used the TOP1 inhibitor ‘Topotecan’ and the CDK7 inhibitor ‘THZ1’ in combination. The results of the study showed that topotecan induced cell death by producing TOP1-induced DNA cleavage and DNA-protein cross-linking (TOP1-DPC), which requires protein degradation by the ubiquitin-proteasome pathway (UPP). THZ1 induced ubiquitin-mediated proteasomal degradation of RNA polymerase II (Pol II degradation) and blocked UPP-mediated TOP1-DPC degradation....Based on these research results, NCI selected Qurient's 'Q901' among the CDK7 inhibitors under clinical development and began joint development."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Qurient "New anti-cancer drug 'Q901' confirmed improvement in clinical prognosis in phase 1 clinical trial" [Google trnaslation] (HIT News) - P1/2 | N=130 | NCT05394103 | Sponsor: Qurient Co., Ltd. | "Qurient...announced on the 14th that it had confirmed results showing improved clinical prognosis during a phase 1 clinical dose escalation trial of its anti-fertility drug 'Q901 (development code name)'....In particular, Qurient reported that it confirmed partial response efficacy in patients with terminal pancreatic cancer in the lowest dose group. According to Qurient, patient '202-003' was a terminal-stage pancreatic cancer patient whose CA19-9 (normal 37 ng/ml or lower), an indicator of pancreatic cancer, increased by more than 4,500, but showed a stable clinical prognosis, decreasing to the 200s after 4 months of Q901 administration."

P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

K-Bio to participate in ESMO2023… Latest cancer treatment and diagnosis technology unveiled in Europe (E-Today) - "ABL Bio announces the interim results of the phase 1 clinical trial of ABL111, a dual antibody anticancer drug being jointly developed with I-MAB, a Nasdaq-listed company....Qurient plans to present a poster introducing the clinical trial of ‘Q901’, a CDK7-inhibiting anticancer drug. Qurient wanted to introduce the clinical design of Q901, which is in the early stages of clinical trials, but announced that it plans to disclose the interim results of this clinical trial at an international oncology conference early next year as anticancer efficacy has been confirmed even at the lowest dose."

P1 data • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Qurient presents posters of two new anti-cancer drugs at an international academic conference [Google translation] (HIT News) - "Qurient...plans to present the research results of new anti-cancer drugs 'Q901...and 'Adlixetinib' currently under clinical development at the European Society for Oncology (ESMO) and the American Society for Immuno-Oncology (SITC) said on the 23rd. Qurient plans to present a poster introducing the phase 1/2 clinical trial of Q901, a CDK7 inhibitor anti-cancer drug, at the European Society of Oncology (ESMO) to be held in Madrid, Spain in October. The company initially intended to participate in this conference to introduce the clinical design of Q901, which is in the early stages of clinical trials, but since the anticancer efficacy has been confirmed from the lowest dose, the interim results of this clinical trial will be disclosed at an international oncology conference early next year. In November, the American Society of Immuno-Oncology (SITC) will present phase 1 clinical data of the immuno-oncology drug 'Adlixetinib (Q702)'."

Clinical protocol • P1 data • P1/2 data • Oncology • Solid Tumor

S.Korea's Qurient, US National Cancer Institute to develop anti-cancer drug (KED Global) - "South Korea's Qurient Co. announced on Monday that it signed a research and development agreement with the US government agency National Cancer Institute (NCI) regarding the investigational anti-cancer compound 'Q901'. Under this agreement, Qurient and NCI will jointly evaluate the efficacy of Q901 in synergy with standard treatment regimens for small cell lung cancer (SCLC)."

Licensing / partnership • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Qurient "Anti-cancer drug candidate Q901, 'synthesized synthetic lethality' announced a new mechanism [Google translation] (Yakup Shinmoon) - "Qurient announced on the 19th that it announced the results of a study on the expansion of indications for Q901, a new anticancer drug, at the American Association for Cancer Research (AACR)....It is noteworthy that Q901 showed a good combination effect with Lynparza by inhibiting double-stranded DNA damage repair, a mechanism complementary to Lynparza....In the research results of Q901 announced this time, the sustained effect of the drug was revealed through the combination of not only PARP inhibitors such as Lynparza, but also various types of anticancer drugs that show anticancer effects by inducing DNA damage in cancer cells, securing a bridgehead for expanding various indications....Meanwhile, Qurient is currently conducting phase 1/2 clinical trials of Q901 in the US, and recently submitted an IND to the Ministry of Food and Drug Safety (MFDS) to add a clinical site in Korea."

Preclinical • Trial status • Oncology • Solid Tumor

Evaluation of the potential combination regimens for q901, a clinical stage selective cdk7 inhibitor, as a DNA damage repair inhibitor (AACR 2023) - P1/2 | "The non-clinical data demonstrate that Q901 not only has a potential as a single agent,but can also be used in combination with other therapeutic strategies to develop next-generation cancer therapeutics to potentially address unmet medical needs."

Clinical • IO biomarker • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Estrogen Receptor Positive Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Kidney Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • BRCA • ER

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Qurient Co., Ltd. | N=70 ➔ 130

Enrollment change • Metastases • Gastrointestinal Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2

Qurient Announces Dosing of First Patient in Q901 Phase 1/2 Clinical Study for the Treatment of Patients with Solid Tumors (Businesswire) - "Qurient Co. Ltd...announced that the first patient has been dosed in the Phase 1/2 dose-escalation and expansion study of Q901 in patients with advanced solid tumors....The Q901 Phase 1/2 study (NCT05394103) is being conducted at six investigative sites in the U.S., and approximately 70 patients with advanced solid tumors are scheduled to be enrolled....'We look forward to the eventual completion of this Phase 1/2 study, which will guide the further development of Q901 both as monotherapy and in combination with other standard of care therapies that could benefit from genomic instability triggered by Q901'."

Trial status • Oncology • Solid Tumor

Qurient, MSD to co-research combination therapy for advanced solid cancer (Korea Biomedical Review) - "Qurient said it entered into a joint development agreement with MSD (Merck in the U.S.) for clinical research on the combination therapy of Q901, a selective CDK7 inhibitor, and MSD’s Keytruda, an anti-programmed cell death protein1 (PD-1) immunotherapy. Under the accord, the two companies will conduct phase 1 and 2 clinical trials to evaluate the safety and efficacy of Q901 plus Keytruda comobo in the U.S. for certain advanced solid cancer patients."

Licensing / partnership • Oncology • Solid Tumor

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Qurient Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: Qurient Co., Ltd.

New P1/2 trial • Gastrointestinal Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2

Q901; a highly selective covalent cdk7 inhibitor inducing substantial anti-tumor effect in a broad spectrum of solid tumor lineages (AACR 2022) - "Taken together, these data support the clinical development of Q901 for solid tumor indications. Q901 is progressing to IND-enabling studies to support the start of Phase 1 oncology clinical trials in early 2022."

Oncology • Solid Tumor • CDK7

Qurient Announces U.S. FDA Clearance of IND Application for Q901, a Novel Cancer Therapy (Businesswire) - "Qurient...announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for Q901, a small molecule oncology drug candidate targeting cyclin dependent kinase 7 (CDK7). The company plans to enroll up to 70 patients with advanced solid tumors in a Phase 1/2 clinical study taking place in the United States. The goal of the study will be to determine the maximum tolerated dose, dose-limiting toxicities, and the recommended Phase 2 dose of Q901."

IND • New P1/2 trial • Oncology • Solid Tumor