[Translation] An open, two-period, fixed-sequence clinical trial to evaluate the effects of itraconazole, rifampicin, and omeprazole on the pharmacokinetics of KL590586 capsules in healthy subjects

主要目的：评估健康受试者中伊曲康唑、利福平和奥美拉唑分别对KL590586胶囊药代动力学的影响。。次要目的：评估KL590586胶囊分别与伊曲康唑、利福平和奥美拉唑联用在健康受试者中的安全性和耐受性。

[Translation]

Primary objective: To evaluate the effects of itraconazole, rifampicin and omeprazole on the pharmacokinetics of KL590586 capsules in healthy subjects. . Secondary objective: To evaluate the safety and tolerability of KL590586 capsules in combination with itraconazole, rifampicin and omeprazole in healthy subjects.

Start Date18 Mar 2024

Sponsor / Collaborator

Sichuan Kelun Botai Biomedicine Co., Ltd.

CTR20232730 / CompletedPhase 1

KL590586在中国成年男性健康受试者体内的物质平衡和生物转化研究

[Translation] Study on the substance balance and biotransformation of KL590586 in healthy adult male subjects in China

主要目的：（1）定量分析健康受试者口服[14C] KL590586后排泄物中的总放射性，获得人体放射性回收率和主要排泄途径；（2）考察健康受试者口服[14C] KL590586后全血与血浆总放射性的分配比，以及全血和血浆中总放射性的药代动力学特征；（3）鉴定健康受试者口服[14C] KL590586后在血浆、尿液和粪便中的主要代谢产物，确定主要生物转化途径。次要目的：（1）采用已验证的LC-MS/MS方法定量分析血浆中KL590586及其代谢产物（如适用）的浓度，获得血浆中KL590586及其代谢产物（如适用）的药动学参数；（2）观察健康受试者单次口服[14C] KL590586后的安全性。

[Translation]

Main objectives: (1) To quantitatively analyze the total radioactivity in the excreta after oral administration of [14C] KL590586 to healthy subjects, and to obtain the human radioactivity recovery rate and the main excretion pathway; (2) To investigate the distribution ratio of total radioactivity in whole blood and plasma after oral administration of [14C] KL590586 to healthy subjects, as well as the pharmacokinetic characteristics of total radioactivity in whole blood and plasma; (3) To identify the main metabolites of [14C] KL590586 in plasma, urine and feces after oral administration of healthy subjects, and to determine the main biotransformation pathways. Secondary objectives: (1) To quantitatively analyze the concentration of KL590586 and its metabolites (if applicable) in plasma using a validated LC-MS/MS method, and to obtain the pharmacokinetic parameters of KL590586 and its metabolites (if applicable) in plasma; (2) To observe the safety of healthy subjects after a single oral administration of [14C] KL590586.

Start Date29 Aug 2023

Sponsor / Collaborator

Sichuan Kelun Botai Biomedicine Co., Ltd.

ChiCTR2300074552 / SuspendedPhase 1IIT

To evaluate the randomized, open-label, two-cycle, double-cross food effects of KL590586 capsules in healthy subjects in a phase I clinical trial

Start Date21 Aug 2023

Sponsor / Collaborator-

100 Clinical Results associated with Lunbotinib

100 Translational Medicine associated with Lunbotinib

100 Patents (Medical) associated with Lunbotinib

166

Literatures (Medical) associated with Lunbotinib

01 Dec 2024·Journal of Computer-Aided Molecular Design

Identifying and characterising promising small molecule inhibitors of kinesin spindle protein using ligand-based virtual screening, molecular docking, molecular dynamics and MM‑GBSA calculations

Article

Author: Elseginy, Samia A

AbstractThe kinesin spindle protein (Eg5) is a mitotic protein that plays an essential role in the formation of the bipolar spindles during the mitotic phase. Eg5 protein controls the segregation of the chromosomes in mitosis which renders it a vital target for cancer treatment. In this study our approach to identifying novel scaffold for Eg5 inhibitors is based on targeting the novel allosteric pocket (α4/α6/L11). Extensive computational techniques were applied using ligand-based virtual screening and molecular docking by two approaches, MOE and AutoDock, to screen a library of commercial compounds. We identified compound 8-(3-(1H-imidazol-1-ylpropylamino)-3-methyl-7-((naphthalen-3-yl)methyl)-1H-purine-2, 6 (3H,7H)-dione (compound 5) as a novel scaffold for Eg5 inhibitors. This compound inhibited cancer cell Eg5 ATPase at 2.37 ± 0.15 µM. The molecular dynamics simulations revealed that the identified compound formed stable interactions in the allosteric pocket (α4/α6/L11) of the receptor, indicating its potential as a novel Eg5 inhibitor.Graphical Abstract

11 Jan 2024·Journal of Medicinal ChemistryQ1 · MEDICINE

Discovery of (2S)-N-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-3-(6-(4-cyanophenyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)-2-hydroxy-2-methylpropanamide as a Highly Potent and Selective Topical Androgen Receptor Antagonist for Androgenetic Alopecia Treatment

Q1 · MEDICINE

Article

Author: Lu, Tao ; Fu, Lingsheng ; Zhang, Yan ; Pei, Sheng ; Chen, Yadong ; Fan, Yawen ; Tang, Feng ; Zhao, Siqi ; Lai, Qianlong ; Jiao, Yu ; Peng, Shaoping ; Xie, Shaofei ; Zhang, Wenqiang ; Tang, Renhong ; Chen, Zhuolin ; Zhou, Xiaoyu ; Luo, Yi ; Feng, Yunrui ; Li, Hongmei

Androgenetic alopecia (AGA) is the most prevalent form of progressive hair loss disorder in both men and women, significantly impacting their appearance and overall quality of life. Overactivation of the AR signaling pathway in dermal papilla cells (DPCs) plays a crucial role in the development and progression of AGA. Considering the severe systemic side effects associated with oral AR antagonists, the idea of developing of topical AR antagonists with rapid metabolic deactivation properties emerged as a promising approach. Herein, through systematic structural optimization, we successfully identified compound 30a as a potent and selective AR antagonist with favorable pharmacokinetic properties, resulting in high skin exposure and low plasma exposure following topical administration. Importantly, in both hair-growth and AGA mouse models, compound 30a showed potent hair-growth-promoting effects without any noticeable toxicity. These findings suggest that compound 30a holds significant potential as a topical AR antagonist for treating AGA patients.

12 Dec 2023·ACS Omega

Efficient Protocol for Novel Hybrid Pyrimidines Synthesis: Antiproliferative Activity, DFT Analyses, and Molecular Docking Studies

Article

Author: Alserhani, Mjd Saleh Morezeq ; Hussein, Modather F ; Althobaiti, Ibrahim O ; Arafa, Wael A A ; Ghoneim, Amira A ; Ibrahim, Hamada Mohamed ; Mourad, Asmaa K

An efficient, microwave/ultrasound-irradiated synthesis of novel chromenopyrimidines has been established. 2-Amino-5-oxo-4-(thiophen-2-yl)-5,6,7,8-tetrahydro-4H-chromene-3-carbonitrile (1) underwent cyclization reactions with various assorted reagents under sustainable conditions to afford a family of fused pyrimidine derivatives. The proposed structures of the designed fused pyrimidines were confirmed by several spectral techniques. Moreover, the targeted pyrimidines were estimated for their in vitro cytotoxic activities toward three carcinoma cell lines: breast (MCF7), hepatocyte (HepG2), and lung (A549) cancer cell lines, as well as one noncancerous cell line (MCF-10A). Structure-activity relationship (SAR) analyses revealed that derivatives 3 and 7 exhibited the highest potency in inhibiting the growth of cancer cells tested in vitro. Particularly, 3-amino-4-imino-5-(thiophen-2-yl)-3,4,5,7,8,9-hexahydro-6H-chromeno[2,3-d]pyrimidin-6-one (3) displayed a robust impact with IC₅₀ values ranging from 2.02 to 1.61 μM. Interestingly, compound 3 was observed to have low cytotoxicity toward noncancerous cell (MCF-10A) compared to the standard drug (Doxorubicin). Further, quantum chemical computations of the designed molecules utilizing density functional theory (DFT) were conducted and shown to be compatible with the observed antiproliferative properties. Thorough docking investigations revealed that the assembled compounds possess exceptionally low binding energies toward our three selected proteins: 4b3z-Lung, HepG2-2JW2, and 6ENV-MCV-7. Based on these intriguing results, compound 3 could be further evaluated for preclinical screening, potentially paving the way for its utilization as a promising cancer treatment.

News (Medical) associated with Lunbotinib

13 Sep 2024

·www.businesswire.com

Guardant Health to Share Data at ESMO 2024 Further Demonstrating Strong Performance of Its Precision Oncology Technology in Multiple Advanced Tumor Types

PALO ALTO, Calif.--( BUSINESS WIRE )--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present data from several studies utilizing Guardant technology to advance precision oncology at the European Society for Medical Oncology Congress (ESMO) in Barcelona, Spain, Sept. 13-17, 2024. Data on the Guardant Reveal™ minimal residual disease test in locally advanced rectal cancer patients enrolled in the NO-CUT trial will be presented in a proffered paper session during Presidential Symposium III. Other presentations will include findings from studies evaluating Guardant360® for therapy selection in advanced breast cancer and other solid tumors, and the Guardant Infinity™ platform for response monitoring in advanced non-small cell lung cancer (NSCLC). “Our latest data featured at ESMO further highlight the value of Guardant’s technology in precision oncology and the critical role liquid biopsy can play in informing therapy selection and treatment management across multiple tumor types,” said Craig Eagle, M.D., chief medical officer at Guardant Health. “We look forward to sharing how Guardant tests can contribute to improved outcomes across all stages of cancer care.” Complete list of Guardant Health and collaborator presentations at ESMO 2024 Abstract Title (Hall 6, unless otherwise noted) Product Saturday, September 14 | 9:00 - 17:00 1295P EP0031 a next-generation selective RET inhibitor (SRI): Correlation of molecular and clinical responses in patients with RET alteration positive solid tumours naïve to or following prior SRI Guardant Infinity Sunday, September 15 | 9:00 - 17:00 127P Clinical utility of circulating tumor DNA (ctDNA) next generation sequencing (NGS) to inform treatment decisions for patients (pts) with advanced solid tumors Guardant 360 Monday, September 16 | 9:00 - 17:00 418P Concordance of PI3K-AKT pathway alterations between tumor and ctDNA in metastatic breast cancer Guardant 360 419P Prevalence of gene rearrangement on ctDNA NGS and its targetability in patients with advanced breast cancer Guardant 360 Monday, September 16 | 17:04 – 17:16 509O Total neoadjuvant treatment (TNT) with non-operative management (NOM) for proficient mismatch repair locally advanced rectal cancer (pMMR LARC): first results of NO-CUT Trial Proffered Paper Session: Presidential Symposium III: Eyes to the future, Barcelona Auditorium, Hall 2 Guardant Reveal The full abstracts for Guardant Health and a list of all abstracts being presented at the ESMO Congress can be found on the ESMO website . For information and updates from the conference, follow Guardant Health on LinkedIn , X (Twitter) and Facebook or visit Guardant on-site at booth #510. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook . Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2023, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

ASCOClinical Study

01 May 2024

·www.prnewswire.com

Ellipses' next generation selective RET inhibitor EP0031/A400 cleared to start Phase 2

Drug has successfully completed US Food and Drug Administration's End of Phase 1 data review LONDON, May 1, 2024 /PRNewswire/ -- Ellipses Pharma Limited ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today the U.S. Food and Drug Administration (FDA) has confirmed the company's next generation selective RET inhibitor (SRI), EP0031/A400, is clear to progress into Phase 2 clinical development. EP0031/A400 is a potential treatment of RET-altered tumours and clinical data in studies to date has shown promising efficacy in patients with NSCLC, thyroid and other solid tumours. Durable responses have been seen in patients who were naive to, or who had been pre-treated with, 1st generation SRIs including in patients with brain metastases1. The latest clinical data from the Ellipses Phase 1 study will be presented at ASCO in Chicago on June 3rd 2024. EP0031 is being developed jointly by Ellipses in a global clinical phase 1/2 trial under the name EP0031 (NCT05443126) and Sichuan-Kelun Biotech in China under the names KL590586/A400 (NCT05265091). Modular Phase 1 studies have been conducted in the US, Europe and China and a registrational Phase 2 trial in China is ongoing. The FDA granted Orphan Drug Designation to EP0031/A400 in November 2023 and in March of this year granted it Fast Track Designation, which facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Professor Sir Christopher Evans, Chairman, Ellipses, said: "We are greatly encouraged with the progress to date of EP0031/A400 and look forward to rapidly generating Phase 2 data, which will be another key step towards bringing this treatment to patients." Dr Rajan Jethwa, Chief Executive Officer, Ellipses, commented: "We are excited to announce another important clinical milestone as we continue to drive the development of EP0031 towards an NDA as a potential next-generation treatment for people living with RET-altered NSCLC and other cancers." Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses commented: "At every stage our belief has been reinforced that EP0031/A400 can be a transformational treatment for patients with RET fusion-positive NSCLC, which remains a progressive and fatal condition for hundreds of thousands of patients worldwide, despite available treatment options." About EP0031 In March 2021, Kelun-Biotech granted Ellipses an exclusive licence for EP0031 (A400) in certain territories including the US and Europe, with Kelun-Biotech retaining certain rights in Greater China. An Investigational New Drug Application (IND) application for EP0031 (A400) was approved by China's National Medicinal Products Administration in June 2021 and a registrational Phase 2 trial is ongoing in China. In June 2022, the U.S. Food and Drug Administration approved the EP0031 Phase 1/2 study IND application in the US. About RET altered malignancies Activating RET mutations and rearrangements have been identified as actionable drivers of oncogenesis in numerous tumour types and are most prevalent in non-small cell lung and thyroid cancer. It is estimated that RET mutations and rearrangements may be responsible for ~2% of all solid tumours. After the successful development of first generation SRIs and an increasing understanding of escape mechanisms to these agents, there is an unmet need to develop new treatments that can address acquired resistance, including the development of next-generation SRIs. About Ellipses Pharma Limited Ellipses is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients. About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialisation and global collaboration of innovative drugs. The company focuses on major disease areas such as solid tumours, autoimmune, inflammatory and metabolic diseases. At present, the company has 33 on-going innovative projects for medical needs in selected major disease areas such as solid tumours, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical stage and multiple global trials conducted in several regions such as China, Europe, and the United States. For more information, please visit . Logo - SOURCE Ellipses Pharma

Orphan DrugPhase 2Fast TrackPhase 1IND

06 Jun 2023

·www.pharmaceutical-technology.com

ASCO 2023: Ellipses Pharma advances plans for RET inhibitor following encouraging results

Aidan McNamee The audience at the 2-23 ASCO Annual Meeting. Positive results have motivated Eclipse to accelerate its RET inhibitor pipeline. Credit: Photo by © ASCO/Todd Buchanan 2023. Chicago, Illinois-based Ellipses Pharma has announced its intention to accelerate the global clinical development of its selective RET inhibitor EP0031/A400. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. Following the publication of clinical data from its Phase I study of the inhibitor at the American Society of Clinical Oncology (ASCO) conference, Ellipses was motivated to accelerate clinical development due to what it believes are “very encouraging” results. The ASCO Annual Meeting is being held 2–6 June in Chicago. Recommended Reports Reports LOA and PTSR Model - Ensartinib Hydrochloride in Sarcomas GlobalData Reports LOA and PTSR Model - Ropidoxuridine in Sarcomas GlobalData View all Companies Intelligence Ellipses Pharma Ltd View all According to the company, RET mutations and fusions may be responsible for roughly 2% of all solid tumours. This includes 2% of non-small cell lung cancer (NSCLC) and 60-80% of medullary thyroid cancers. Ellipses reported preliminary efficacy and safety data for the 109 patients enrolled in the trial. For the RET-altered tumour population, patients receiving doses of 40-120mg had an objective response rate (ORR) of 60%, and a disease control rate of 90%. Two patient cohorts were highlighted in particular. The first, patients, with previously untreated RET-fusion positive advanced NSCLC, had an ORR of 80.8%. Another cohort of patients with RET-fusion positive NSCLC who had received treatment like chemo-immunotherapy, had an ORR of 69.7%. In both cases, DCR of over 96% were reported. Dr. Tobias Arkenau, Global Head of Drug Development & CMO at Ellipses, said the data gives Ellipses the backing to advance their pipeline. The company was also eager to highlight observed evidence of clinical activity in patients with brain metastases. It also saw similar for patients who had previously been treated with first-generation SRIs, who currently have limited available treatment options. The cohorts were part of a global, modular phase I/II trial in patients with advanced RET-altered tumours (add NCT). Data released at this point will be augmented by the results of ongoing trials in the US, EU, and UK Kelun-Biotech, Ellipses’ partner in developing the RET inhibitor, is conducting clinical investigations in China for patients with RET-altered cancers. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. 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Phase 1ASCOClinical ResultImmunotherapy

100 Deals associated with Lunbotinib

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	CN	Sichuan Kelun Pharmacy Institute Co., Ltd.	01 Jun 2021
RET Mutation-Positive Medullary Thyroid Cancer	IND Approval	CN	Sichuan Kelun Botai Biomedicine Co., Ltd.	24 Jul 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05443126 (Phase-1 dose escalation and expansion study of EP0031, ASCO2024)	Phase 1/2	Non-Small Cell Lung Cancer	27	EP0031 60mg QD	(uxxgbyfqdn) = No DLTs were observed pwoyemhdte (rdkkrsmvdm ) View more	Positive	24 May 2024
	Phase 1/2	Non-Small Cell Lung Cancer	27	EP0031 90mg QD		Positive	24 May 2024
NCT05265091 (KL400-I/Ⅱ-01, ASCO2023) Manual	Phase 1	RET mutation Solid Tumors RET Fusion	87	KL590586	(pbbjuqptxx) = Not reached yoipwimylq (jwemnrcedo ) View more	Positive	31 May 2023

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