The researchers are doing this study to find out whether the combination of ruxolitinib and ulixertinib is a safe and effective treatment for people with myelofibrosis. The researchers will test different doses of ulixertinib to find the highest dose that causes few or mild side effects in participants when given in combination with ruxolitinib.

Start Date07 Jan 2025

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+2]

NCT06411821

/ RecruitingPhase 2IIT

Phase 2 Trial of Ulixertinib for Patients With Histiocytic Neoplasms

The researchers are doing this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.

Start Date07 May 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT05985954

/ RecruitingPhase 1IIT

Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

To find the recommended dose of ulixertinib that can be given in combination with cetuximab and/or encorafenib to patients with unresectable/metastatic CRC and who have received EGFR or BRAF-directed therapy in the past.

Start Date18 Jan 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

100 Clinical Results associated with Ulixertinib

100 Translational Medicine associated with Ulixertinib

100 Patents (Medical) associated with Ulixertinib

164

Literatures (Medical) associated with Ulixertinib

01 May 2025·CTS-Clinical and Translational Science

Experimental Insights and Recommendations for Successfully Performing Cerebral Microdialysis With Hydrophobic Drug Candidates

Review

Author: Sundheimer, Julia K. ; Pfister, Stefan M. ; Longuespée, Rémi ; Maaß, Kendra K. ; Benzel, Julia ; Burhenne, Jürgen ; Sauter, Max ; Pajtler, Kristian W.

ABSTRACT:

Cerebral microdialysis in rodents represents a robust and versatile technique for quantifying the pharmacologically relevant unbound fraction of drugs in the brain. When this unbound fraction is simultaneously determined in plasma, it facilitates the calculation of the corresponding unbound plasma‐to‐brain partition coefficient (Kp,uu) for a given compound in vivo. This coefficient is critical for understanding the penetration and distribution of drugs across the blood–brain barrier (BBB). However, obtaining valid and accurate microdialysis data can be particularly challenging for hydrophobic drugs due to their pronounced non‐specific interactions with the components of the microdialysis system. The present study reports the outcomes of comprehensive microdialysis investigations in rodents, focusing on three hydrophobic compounds: actinomycin D, selinexor, and ulixertinib. These compounds exhibited varying degrees of non‐specific binding to the surfaces of the microdialysis apparatus, leading to low recovery rates and substantial carry‐over effects. To diminish these limitations, strategies such as surface coating and the use of optimized materials were employed to enhance the reliability of the microdialysis system. To ensure the robustness and reproducibility of microdialysis‐related research outcomes, our experimental findings were supplemented with a narrative literature review. This review encompassed keyword‐driven PubMed‐indexed publications on microdialysis from 1970 to 2024, providing a broader context for the challenges and solutions associated with the technique. By integrating empirical results with practical recommendations, this study offers a comprehensive resource aimed at advancing the application of cerebral microdialysis in preclinical drug development, particularly for compounds with challenging physicochemical properties.

08 Apr 2025·ACS Nano

Vertically Aligned Nanowires for Longitudinal Intracellular Sampling

Article

Author: Ko, Jina ; Allen, Mark G. ; Lee, Daeyeon ; Roh, Yoon Ho ; Reynolds, David Eun ; Huynh, Emily ; Vallapureddy, Phoebe ; Tran, Hong Huy ; Chintapula, Uday ; Xu, Xiaowei

Cells are diverse systems with unique molecular profiles that support vital functions, such as energy production and nutrient absorption. Advances in omics have provided valuable insights into these cellular processes, but many of these tools rely on cell lysis, limiting the ability to track dynamic changes over time. To overcome this, methods for longitudinal profiling of living cells have emerged; however, challenges such as low throughput and genetic manipulation still need to be addressed. Nanomaterials, particularly nanowires, offer a promising solution due to their size, high aspect ratios, low cost, simplicity, and potential for high-throughput manufacturing. Here, we present a nanowire-based platform for longitudinal mRNA profiling in living cells using vertically aligned nickel nanowire arrays for efficient mRNA extraction with minimal cellular disruption. We demonstrate its ability to track enhanced green fluorescent protein expression and transcriptomic changes from drug responses in the same cells over time, showcasing the platform's potential for dynamic cellular analysis.

01 Apr 2025·JCO Precision Oncology

Identification and Validation of Gastric Adenocarcinoma Prognosis Features Based on Neutrophil-Related Genes

Article

Author: Tang, Qiuling ; Han, Xiaole ; Cheng, Chaojie ; Tang, Jianjun

PURPOSE:

The aim of this study was to investigate the effect of neutrophil-related genes (NRGs) on prognosis and tumor microenvironment (TME) of patients with gastric adenocarcinoma (GA), to provide a new reference for prognosis evaluation and related mechanism research of GA.

METHODS:

The gene expression data and clinical information of patients with GA were collected from The Cancer Genome Atlas database. NRG data are from the literature. Differential NRGs were obtained by difference analysis and regression analysis for the construction of the prognostic model, which was validated using the GSE84426 data set. The independent prognostic effect of risk score was analyzed by constructing a nomogram. The single-sample gene set enrichment analysis and CIBERSORT methods were used to evaluate differences in TME between a high-risk group (HRG) and a low-risk group (LRG) and to evaluate the differences in response to immunotherapy and sensitivity to different drugs in high and low risk score groups.

RESULTS:

We established a prognostic model on the basis of seven NRGs (NHLRC3, PTPRJ, RTEL1, ST6GALNAC2, HRNR, HP, and MCEMP1) and validated its predictive value. Multivariable Cox regression analysis further demonstrated that the model remained an independent prognostic factor for overall survival, and a nomogram was constructed for clinical practice. Differential analysis of immune cell infiltration levels showed that macrophages, mast cells, and neutrophils were highly infiltrated in HRG compared with LRG. Compared with HRG, LRG was more sensitive to immunotherapy and more sensitive to candidates such as axitinib, cisplatin, and ulixertinib.

CONCLUSION:

In summary, on the basis of expression levels of NRGs, a new prognostic model was established. NHLRC3, PTPRJ, RTEL1, ST6GALNAC2, HRNR, HP, and MCEMP1 were valid candidate biomarkers that may help personalize prognostic predictions and serve as references for clinical studies.

News (Medical) associated with Ulixertinib

12 Sep 2022

·www.prnewswire.com

BioMed Valley Discoveries Announces First Patient Dosed in Phase II Combination Trial with Ulixertinib (BVD-523), its First-in-Class and Best-in-Class ERK Inhibitor, in Combination with Hydroxychloroquine

KANSAS CITY, Mo., Sept. 12, 2022 /PRNewswire/ -- BioMed Valley Discoveries (BVD) announced that the first patient has been dosed in a phase II clinical trial of ulixertinib (BVD-523) in combination with hydroxychloroquine (HCQ). Ulixertinib is a first-in-class and best-in-class ERK inhibitor, with this clinical trial focusing on patients with advanced gastrointestinal malignancies and mutations in the MAPK pathway. This study builds upon the finding of the phase I study of the combination, which was completed at Huntsman Cancer Institute at the University of Utah. "Combining an ERK inhibitor with an autophagy inhibitor is anticipated to take advantage of the finding that tumors may become addicted to autophagy for survival in context of MAPK inhibition" said Brent Kreider, Ph.D., President of BioMed Valley Discoveries. "Given the favorable safety profile and efficacy seen with ulixertinib monotherapy, we believe that the combination with hydroxychloroquine has the potential to provide significant benefit to patients with advanced gastrointestinal malignancies." The Phase II efforts build on a successful Phase Ib evaluating ulixertinib monotherapy as a novel targeted cancer treatment in cohorts of patients with genetic alterations that result in aberrant MAPK pathway signaling. Results from phase Ib demonstrated ulixertinib has an acceptable safety profile and early evidence of clinical activity against a wide range of RAS/MAPK pathway-driven cancers, including atypical alterations in BRAF. In addition to targeting the terminal node of the RAS/MAPK pathway, ulixertinib's highly selective kinase inhibition profile is expected to provide potential impact across a number of tumor types in both monotherapy and combination. Previous efforts have also established a recommended phase 2 dose in combination with palbociclib, with additional combination efforts ongoing. About ulixertinib (BVD-523): Ulixertinib is a first-in class and best-in class small molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug. ERK kinases are downstream components of the mitogen-activated protein kinase (MAPK) signaling cascade (RAS-RAF-MEK-ERK). Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway. About the study: This is an open-label, multicenter, prospective phase II basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients recruited must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages and includes pancreatic, colorectal, esophageal, gastric and cholangiocarcinomas . (Clinicaltrials.gov Number NCT05221320). About BioMed Valley Discoveries (BVD): BioMed Valley Discoveries is a clinical stage biotechnology company focused on addressing unmet medical needs in a variety of therapeutic and diagnostic areas. In addition to the ERK inhibitor, BVD's portfolio includes an oncolytic bacteria that has completed enrollment for a Phase I study, and two early-stage antibodies targeting the tumor microenvironment. Operating since 2007, BioMed Valley Discoveries was established by Jim Stowers Jr., founder of the asset management firm American Century Investments, and his wife Virginia, to advance new medical innovations to improve the lives of patients with difficult-to-treat diseases. BVD is owned by a supporting organization of the Stowers Institute for Medical Research, a non-profit, basic biomedical research organization. Since 2000, the endowment of the Stowers Institute has received over $1.7 billion in dividend payments from American Century. The Institute has invested a portion of its endowment in BVD, whose profits accrue to the benefit of the Institute. For more information, visit . Media Contact Joe Chiodo, Head of Media Relations 724-462-8529 [email protected] SOURCE BioMed Valley Discoveries

AntibodyCollaborateFirst in ClassSmall molecular drug

06 Jan 2021

·www.biospace.com

Theralink® Technologies Issues Letter to Shareholders

DENVER, Jan. 6, 2021 /PRNewswire/ -- Theralink Technologies (OTC: OBMP) ("Theralink" or the "Company"), a molecular profiling company specializing in patented, biomarker assay services that target multiple areas of oncology, today issued a letter to shareholders from its President and CEO, Mick Ruxin, M.D., providing a 2020 year-end recap and vision for the path ahead in 2021. Dear Shareholders: 2020 was a transformative year for Theralink Technologies. In June, we successfully closed OncBioMune Pharmaceuticals' asset purchase of Avant Diagnostics and changed the corporate name to Theralink® Technologies Inc. In September, Theralink emerged as a proteomics-based, molecular profiling and precision medicine company targeting multiple areas of oncology and drug development. Going forward we will continue to work on several other key aspects of our evolution as a public company, including our stock symbol change and updated financial statements with the SEC, which we anticipate to all be completed during the first half of 2021. In addition to my appointment as President and CEO, we have added experienced professionals to our leadership team through three key hires. We welcomed Kris Weinberg as Director of Commercial Oncology Markets, Michael Fanelli as Senior Director of Biopharma Commercial Operations and Tom Chilcott as Chief Financial Officer, who all bring extensive experience in their respective fields and have hit the ground running as part of our team. Over the past six-months, we have worked diligently to lay the foundation for our growth in 2021. Notably, we received Clinical Laboratory Improvement Amendments (CLIA) certification for our Golden, Colorado laboratory, which took two years to achieve. CLIA certification enables us to expand our testing capabilities and we will soon begin receiving, testing and billing for patient's breast cancer tumor specimens. As part of our growth strategy ahead, we have established several strategic agreements: In July, we announced a multi-year strategic agreement with VieCure™, the developer of the proprietary VieCure™ platform, a real-time decision-support system that combines clinical knowledge with patient data to assist oncologists in generating personalized treatment plans and managing a patient's care throughout his or her cancer therapy. Through our agreement, VieCure's physician network has access to Theralink's generation of testing for cancer patients, extending VieCure™'s genomics platform to now include phosphoprotein and protein-based information. We believe that the potential reach of their physician network leveraging our assay is substantial. In September, we announced our translational research collaboration with BioMed Valley Discoveries (BVD) to provide Laser Capture Microdissection (LCM) and Reverse Phase Protein Array (RPPA) services to assist BVD with translational research. We believe that this research could potentially improve treatment outcomes and quality of life for all cancer patients. In November 2020, we announced our agreement with Perthera, a market leader in Precision Oncology technology and services whose platform has been utilized by over 250 cancer care sites. The alliance was formed to facilitate and accelerate access to Theralink's 32 phosphoprotein panel, the Theralink® assay, across Perthera's wide reach in the U.S. for breast cancer patients and the oncologists who treat them. With many key milestones under our belt for 2020, there remains no shortage of opportunity as we head into 2021. In addition to the signing of our translational research collaboration with BioMed Valley Discoveries in September 2020, we have successfully signed multiple other biopharma collaboration agreements to date, all of which are generating revenue. In 2021, we not only expect to expand these existing relationships, but we will also continue to sign multiple other collaborative agreements. Thank you for your continued support and commitment. The Theralink team looks forward to a prosperous 2021! Sincerely, Mick Ruxin, M.D. President and CEO Corporate Milestones: OncBioMune Pharmaceuticals closed the asset purchase of Avant Diagnostics in June 2020 - link In September 2020, the Company received Clinical Laboratory Improvement Amendments (CLIA) certification for its Golden, Colorado laboratory, retroactively effective as of January 8, 2020 – link As of Thursday, September 24, 2020 the Company completed its corporate name change to Theralink Technologies, Inc. – link Enhanced Leadership: In June 2020, we appointed Mick Ruxin, M.D. as President & CEO and Jeffrey Busch as Chairman of the Board – link Also In June 2020, we appointed Kris Weinberg as Director, Oncology Commercial Markets. Mr. Weinberg has 20 years of experience in the commercial aspects of cancer molecular diagnostics, leading the launch and adoption of oncology assays including OncoType Dx and Guardant 360. Prior to TheraLink, he was commercial lead for TGen's CLIA NGS laboratory (Ashion) and Natera's oncology division. Also, Mr. Weinberg has previous public company experience at IMPATH, Genomic Health and Guardant Health. In July 2020, we appointed Michael Fanelli as Senior Director of Biopharma Commercial Operations – link In September 2020, we appointed Thomas E. Chilcott, III CPA as Chief Financial Officer – link Strategic Agreements: In July 2020, the Company signed a mutli-year strategic agreement with VieCure™ to enhance personalized cancer treatment in community oncology settings – link In September 2020, the Company announced its translational research collaboration with BioMed Valley Discoveries (BVD) to provide Laser Capture Microdissection (LCM) and Reverse Phase Protein Array (RPPA) services to assist BVD with translational research pertaining to first-in-class and best-in-class ERK 1/2 Inhibitor – Ulixertinib (BVD-523) – link In November 2020, the Company announced its agreement with Perthera, a market leader in Precision Oncology technology and services. The alliance was formed to facilitate and accelerate access to Theralink's 32 phosphoprotein panel, the Theralink assay, across the U.S. for breast cancer patients – link About Theralink Technologies, Inc. Theralink® Technologies is a proteomics-based, molecular profiling and precision medicine company with a CLIA-certified laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink's technology targets multiple areas of oncology and drug development. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array (RPPA) assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity. For more information, please visit . Forward-Looking Statements Certain statements contained in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, anything relating or referring to future financial results, patient enrollment and plans for future business development activities, and are thus prospective. Forward-looking statements are inherently subject to risks and uncertainties some of which cannot be predicted or quantified based on current expectations. Such risks and uncertainties include, without limitation, the risks and uncertainties set forth from time to time in reports filed by Theralink Technologies with the Securities and Exchange Commission. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business and although the company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. Consequently, future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward the forward-looking statements contained herein. The company undertakes no obligation to publicly release statements made to reflect events or circumstances after the date hereof. Company Codes: OTC-PINK:OBMP

CollaborateFinancial StatementFirst in Class

100 Deals associated with Ulixertinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11038	-	-	DB13930

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Post-essential thrombocythemia myelofibrosis	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 Jan 2025
Post-polycythemia vera myelofibrosis	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 Jan 2025
Diffuse Large B-Cell Lymphoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 May 2024
Hematologic Neoplasms	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 May 2024
Histiocytoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	07 May 2024
Adenocarcinoma of Esophagus	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022
Adenocarcinoma of large intestine	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022
Esophageal Squamous Cell Carcinoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022
Gastroesophageal junction adenocarcinoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022
Intrahepatic Cholangiocarcinoma	Phase 2	United States	BioMed Valley Discoveries, Inc.	26 May 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04488003 (CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	104	Ulixertinib	clsjshbtph = dtqntnewya soemrbywye (orbhdtjaxt, cerbdtzahp - traiwhsmtu) View more	-	04 Jun 2024
NCT03698994 (CTgov)	Phase 2	Refractory Soft Tissue Sarcoma \| Refractory Histiocytic and Dendritic Cell Neoplasm \| Recurrent Medulloblastoma ... View more	20	Pharmacokinetic Study+Ulixertinib	bltajptwcv = zawxsujwnn gwwuanrijh (zgdnhjbjum, jhixepiqpg - cgaurcwwjy) View more	-	16 May 2023
NCT02608229 (Pubmed \| Oncologist) Manual	Phase 1	Pancreatic adenocarcinoma metastatic	18	Albumin-Bound Paclitaxel+Gemcitabine+Ulixertinib	sznwkudbwl(ojbsgjaiir) = ulixertinib 450 mg BID brpbfpdmck (pjlzdqtyjq )	Positive	25 Nov 2022
NCT02465060 (EAY131-Z1L, AACR2022) Manual	Phase 1	Neoplasms BRAF Fusion	35	BVD-523FB	zxuogcpvmu(qdkdxstybl) = kuiytwzpmb hkzqwxxrya (dwylldhsws ) View more	Positive	15 Jun 2022
NCT04566393 (ULI-EAP-100, ASCO2022) Manual	Not Applicable	HR-positive/HER2-low Solid Tumors MAPK Mutation	48	ulixertinib	nqlextmlsg(reoapcahnk) = vpcspsktue kmotcrofbq (tndtogkhqe ) View more	Positive	02 Jun 2022
NCT03698994 (ASCO2022) Manual	Phase 2	Neoplasms MAPK Mutation	20	overall	wsgpcjajoa(vfrjdfzhcs) = jtlpujwlok klvtylpasw (pkhfnmtpqu, 17 - 58) View more	Positive	02 Jun 2022
NCT03698994 (ASCO2022) Manual	Phase 2	Neoplasms MAPK Mutation	20	Ulixertinib 260 mg/m2 (DL1)	zqbcynkgyy(hknrduqdhu) = rzcjlwriyx tisuhhuyuz (xcwutdbzbx )	Positive	02 Jun 2022
NCT03417739 (CTgov)	Phase 2	Uveal Melanoma	13	BVD-523	mgxwmqcyvj = qwpyjydbyt dmhrbycqsb (rduqccywew, gglcfpezde - yadoaccqdz) View more	-	11 Nov 2021
NCT03454035 (ASCO2021)	Phase 1	HR-positive/HER2-low Solid Tumors	26	Ulixertinib 300mg BID + Palbociclib 75mg daily	emzoiopmnp(oqigprsqod) = seavlvwrir ljplkazpcj (ittkjqbgpd, 1.87 - notdetermined)	-	28 May 2021
NCT01781429 (Pubmed \| Invest New Drugs)	Phase 1	Advanced cancer	135	Ulixertinib	gwuatyuwzk(uxubgttpgp) = The most common dAEs included acneiform rash (45/135, 33%), maculopapular rash (36/135, 27%), and pruritus (34/135, 25%). Grade 3 dAEs were observed in 19% (25/135) of patients; no grade 4 or 5 dAEs were seen. vbrwzkgxdr (rlgfnwsgst )	-	03 Jan 2021
NCT03417739 (ASCO2020)	Phase 2	Uveal Melanoma	25	Ulixertinib (BVD-523)	hrqkbzcyby(wfjgdvzhcb) = Grade 3 and 4 toxicities associated with therapy were consistent with BVD-523 and other ERK inhibitors and included LFT elevation, hyponatremia, pruritis, amylase elevation, anemia and rash. lwlfojlbml (imqnflktua )	Negative	25 May 2020

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