Delving into the Latest Updates on VK-2019 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

EBNA1

Mechanism

EBNA1 inhibitors(Epstein-Barr nuclear antigen 1 inhibitors)

Therapeutic Areas

NeoplasmsMouth and Tooth DiseasesOtorhinolaryngologic Diseases

Active Indication

Nasopharyngeal Neoplasms

Inactive Indication

Epstein-Barr virus associated Nasopharyngeal CarcinomaEpstein-Barr Virus InfectionsNasopharyngeal Carcinoma

Originator Organization

Cullinan Oncology LLC

Active Organization

The Wistar Institute

Inactive Organization

Cullinan Pearl Corp.Startup

Cullinan Oncology LLC

Aienkang Clinical Medical Research (Beijing) Co., Ltd.

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Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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I期-主要目的：确定复发或转移性NPC患者中VK-2019单药治疗（口服）的MTD和RP2D。评价和表征复发或转移性NPC成人患者中VK-2019单用的安全性特征。I期-次要目的：根据RECIST v1.1评价VK-2019单药的抗肿瘤活性。表征复发或转移性NPC成人患者中单药VK-2019的单次给药和稳态药代动力学特征。在复发或转移性NPC成人患者中，通过减少VK-2019单药的血浆EBV-DNA，评价抗EBV活性。2a期-主要目的：评价复发或转移性NPC成人患者中VK-2019单药治疗（口服）的初步疗效（ORR、DOR、DCR、PFS、生存率和OS）。确认复发或转移性NPC成人患者中VK-2019单药治疗(口服)的安全性和耐受性。2a期-次要目的：进一步表征复发或转移性NPC成人患者中与VK-2019单药治疗（口服）相关的选定PK参数。在复发或转移性NPC成人患者中，通过减少VK-2019单药治疗(口服)的血浆EBV-DNA，评价抗EBV活性。（因字数限制，本试验的探索性目的请见相关说明栏）

[Translation]

Phase I - Primary Objective: Determine the MTD and RP2D of VK-2019 monotherapy (oral) in patients with recurrent or metastatic NPC. Evaluate and characterize the safety profile of VK-2019 monotherapy in adult patients with recurrent or metastatic NPC. Phase I - Secondary Objectives: Evaluate the anti-tumor activity of VK-2019 monotherapy according to RECIST v1.1. Characterize the single-dose and steady-state pharmacokinetic profile of VK-2019 monotherapy in adult patients with recurrent or metastatic NPC. Evaluate anti-EBV activity by reducing plasma EBV-DNA of VK-2019 monotherapy in adult patients with recurrent or metastatic NPC. Phase 2a - Primary Objective: Evaluate the preliminary efficacy (ORR, DOR, DCR, PFS, survival, and OS) of VK-2019 monotherapy (oral) in adult patients with recurrent or metastatic NPC. Confirm the safety and tolerability of VK-2019 monotherapy (oral) in adult patients with recurrent or metastatic NPC. Phase 2a - Secondary Objective: Further characterize selected PK parameters associated with VK-2019 monotherapy (oral) in adult patients with recurrent or metastatic NPC. Evaluate anti-EBV activity by reducing plasma EBV-DNA with VK-2019 monotherapy (oral) in adult patients with recurrent or metastatic NPC. (Due to word count limitations, please see the relevant description column for the exploratory purpose of this trial)

Start Date27 Dec 2019

Sponsor / Collaborator

Aienkang Clinical Medical Research (Beijing) Co., Ltd.

NCT03682055 / TerminatedPhase 1/2

Phase 1/2a Open Label, Multicenter Clinical Trial of a Novel Small Molecule EBNA1 Inhibitor, VK 2019, in Patients With Epstein Barr Virus Positive Nasopharyngeal Cancer, With Pharmacokinetic and Pharmacodynamic Correlative Studies

VK-2019-001 is a 1/2a trial of the oral EBNA-1 targeting agent VK-2019 in patients with EBV-positive recurrent or metastatic NPC to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D), as well as to evaluate the PK profile of VK-2019.

Start Date04 Apr 2019

Sponsor / Collaborator

Cullinan Oncology LLC

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100 Clinical Results associated with VK-2019

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100 Translational Medicine associated with VK-2019

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100 Patents (Medical) associated with VK-2019

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1

Literatures (Medical) associated with VK-2019

01 Feb 2024·Biomedical Chromatography

Validation of a robust and rapid liquid chromatography tandem mass spectrometric method for the quantitative analysis of VK‐2019, a selective EBNA1 inhibitor

Article

Author: Davis, Michael T ; Rudek, Michelle A ; Messick, Troy E ; Anders, Nicole M ; Colevas, A Dimitrios

AbstractEBNA1 is an Epstein Barr virus (EBV) protein expressed in all EBV‐associated cancers. EBNA1 plays a critical role in the replication and maintenance of EBV episomes in latently infected cells. VK‐2019 was developed as a highly specific inhibitor of EBNA1 DNA binding activity and is currently in phase 1 development as a treatment for EBV‐associated carcinomas. A sensitive and reliable method was developed to quantify VK‐2019 in human plasma using liquid chromatography with tandem mass spectrometry to perform detailed pharmacokinetic studies. VK‐2019 was extracted from plasma using protein precipitation with acetonitrile. Separation of VK‐2019, two purported metabolites, and the internal standard, VK‐2019–d6, was achieved with a Zorbax XDB C18 column using a gradient flow over 6 min. VK‐2019 was detected using a SCIEX 4500 triple quadrupole mass spectrometer operating in positive electrospray ionization mode. The assay range was 0.5–500 ng/mL and proved to be accurate and precise. Dilutions of 1:10 were accurately quantified. VK‐2019 was stable in plasma at −70°C for approximately 18 months. The method was applied to assess the total plasma concentrations of VK‐2019 in a patient who received a single and multiple oral daily doses of 120 mg.

100 Deals associated with VK-2019

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nasopharyngeal Neoplasms	Phase 2	-	The Wistar Institute	-
Epstein-Barr Virus Infections	Phase 1	US	-	04 Apr 2019
Epstein-Barr Virus Infections	Phase 1	FR	-	04 Apr 2019
Nasopharyngeal Carcinoma	Phase 1	US	Cullinan Pearl Corp.Startup	11 Mar 2019
Epstein-Barr virus associated Nasopharyngeal Carcinoma	Preclinical	SG	Cullinan Oncology LLC	04 Apr 2019
Epstein-Barr virus associated Nasopharyngeal Carcinoma	Preclinical	US	-	04 Apr 2019
Epstein-Barr virus associated Nasopharyngeal Carcinoma	Preclinical	CN	Cullinan Oncology LLC	04 Apr 2019
Epstein-Barr Virus Infections	Preclinical	FR	-	04 Apr 2019
Epstein-Barr Virus Infections	Preclinical	US	-	04 Apr 2019
Nasopharyngeal Carcinoma	Preclinical	US	Cullinan Pearl Corp.Startup	11 Mar 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04925544 (ASCO2023) Manual	Phase 2	Epstein-Barr virus associated Nasopharyngeal Carcinoma	22	VK-2019	(vgnrnsdira) = sxxqpfglzv draofsdlxu (etinddgsut ) View more	Positive	31 May 2023