Delving into the Latest Updates on Individualised cancer vaccine (Immunovative Therapies) with Synapse

Overview

Basic Info

Drug Type

Personalized antigen vaccine, Synthetic peptide vaccine, Therapeutic vaccine

Synonyms

CRCLAlloVax

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsDigestive System DisordersHemic and Lymphatic Diseases

Active Indication-

Inactive Indication

Advanced Hepatocellular CarcinomaHematologic NeoplasmsHepatocellular Carcinoma+ [2]

Originator Organization

Immunovative Therapies Ltd.

Active Organization-

Inactive Organization

Immunovative Therapies Ltd.

Tauriga Sciences, Inc.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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The purpose of this study is to determine the safety and tumor debulking efficacy of personalized anti-cancer vaccine AlloVax(TM) in Subjects with confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who cannot be treated with surgery, chemotherapy or radiation. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of CRCL and AlloStim(TM) is designed to provide cross-reactivity of alloantigen specific recognition with tumor-specific recognition. All the key components necessary to develop tumor-specific immunity by creating the inflammatory environment necessary to overcome the HNC immunosuppressive environment, breaking tumor immune tolerance, and provision of specific HNC antigens for generation of a specific adaptive anti-tumor response.

Start Date01 Jan 2016

Sponsor / Collaborator

Immunovative Therapies Ltd.

100 Clinical Results associated with Individualised cancer vaccine (Immunovative Therapies)

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100 Translational Medicine associated with Individualised cancer vaccine (Immunovative Therapies)

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100 Patents (Medical) associated with Individualised cancer vaccine (Immunovative Therapies)

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38

Literatures (Medical) associated with Individualised cancer vaccine (Immunovative Therapies)

01 Mar 2022·The Journal of Clinical PharmacologyQ3 · MEDICINE

Population Pharmacokinetics of TAK‐931, a Cell Division Cycle 7 Kinase Inhibitor, in Patients With Advanced Solid Tumors

Q3 · MEDICINE

Article

Author: Zhou, Xiaofei ; Diderichsen, Paul Matthias ; Gupta, Neeraj ; Ouerdani, Aziz

AbstractA population pharmacokinetic (PK) analysis was conducted to characterize sources of interpatient variability on the PK of TAK‐931, a cell division cycle 7 kinase inhibitor, in adult patients with advanced solid tumors using data from 198 patients who received oral TAK‐931 over the range of 30 to 150 mg once daily in multiple dosing schedules in 2 phase 1 and 1 phase 2 clinical studies. A 2‐compartment model with 2 transit compartments describing the absorption and first‐order linear elimination adequately described the PK of TAK‐931. The apparent oral clearance (CL/F) of TAK‐931 was estimated to be 38 L/h, and the terminal half‐life was estimated to be approximately 6 hours. Creatinine clearance (CrCL) was identified as a covariate on CL/F, and body weight as a covariate on CL/F, apparent central volume of distribution, and apparent intercompartmental clearance. Simulations using the final model indicated that the effect of CrCL (≥35 mL/min) or body weight (29.8‐127 kg) on TAK‐931 systemic exposures was not considered clinically meaningful, suggesting that no dose adjustments were necessary to account for body weight or renal function (CrCL ≥35 mL/min). Sex, age (36‐88 years), race, and mild hepatic impairment had no impact on the CL/F of TAK‐931. Taken together, the population PK analysis supports the same starting dose of TAK‐931 in Asian and Western cancer patients in a global setting.

03 Jan 2022·Japanese Journal of Clinical OncologyQ4 · MEDICINE

Association of renal function with the safety and efficacy of cisplatin plus S-1 therapy and docetaxel plus cisplatin plus S-1 therapy in patients with advanced gastric cancer: an exploratory analysis of JCOG1013

Q4 · MEDICINE

Article

Author: Machida, Nozomu ; Yoshikawa, Takaki ; Terashima, Masanori ; Hironaka, Shuichi ; Boku, Narikazu ; Sadachi, Ryo ; Iwasa, Satoru ; Sasako, Mitsuru ; Yamada, Yasuhide

AbstractBackgroundAlthough cisplatin and 5-chloro-2,4-dihydropyrimidine (dihydropyrimidine dehydrogenase inhibitor contained in S-1) are excreted into the urine, it remains unknown how creatinine clearance (CrCl) affects the safety and efficacy of cisplatin plus S-1 and docetaxel plus cisplatin plus S-1 in patients with advanced gastric cancer.MethodsAmong the 741 participants in JCOG1013 comparing cisplatin plus S-1 with docetaxel plus cisplatin plus S-1, 723 with serum creatinine levels ≤1.2 mg/dL were categorized into A1 (CrCl ≥ 80 mL/min), A2 (60 ≤ CrCl <80) and A3 (CrCl < 60) in the cisplatin plus S-1 arm and similarly B1, B2 and B3 in the docetaxel plus cisplatin plus S-1 arm. The initial dose modification by CrCl was pre-specified in the docetaxel plus cisplatin plus S-1 arm but not in the cisplatin plus S-1 arm.ResultsThe numbers of patients categorized as A1/A2/A3 and B1/B2/B3 were 169/136/57 and 170/138/53, respectively. In the cisplatin plus S-1 arm, a lower CrCl was associated with higher incidences of grade 4 leukopenia (P = 0.006), neutropenia (P = 0.002), and grade 3/4 anorexia (P = 0.004) and febrile neutropenia (P = 0.049), whereas there was no association in the docetaxel plus cisplatin plus S-1 arm. No significant differences were observed according to CrCl in the overall survival [median: 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.886) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.719)], progression-free survival [median: 7.1/6.8/6.2 months in A1/A2/A3 (P = 0.884) and 7.5/7.2/7.8 months in B1/B2/B3 (P = 0.851)] and response rates [58.9/57.8/46.9% in A1/A2/A3 (P = 0.311) and 62.0/61.5/51.5% in B1/B2/B3 (P = 0.362)].ConclusionsRenal impairment was associated with severe adverse events in cisplatin plus S-1 therapy but not with the efficacy in cisplatin plus S-1 and docetaxel plus cisplatin plus S-1 therapy.

01 Feb 2020·Journal of Critical CareQ3 · MEDICINE

Population pharmacokinetic model of Vancomycin based on therapeutic drug monitoring data in critically ill septic patients

Q3 · MEDICINE

Article

Author: Kovacevic, Pedja ; Kovacevic, Tijana ; Vucicevic, Katarina ; Avram, Sanja ; Miljkovic, Branislava ; Jovanovic, Marija ; Dragic, Sasa ; Momcicevic, Danica

PURPOSEThe present study aimed to establish a population pharmacokinetic model of vancomycin, including adult critically ill septic patients, with normal and impaired renal function.MATERIALS AND METHODSA prospective analysis of 146 concentrations from 73 adult critically ill septic patients treated with 1-h intravenous infusion of vancomycin were included in the study. A nonlinear mixed effects modeling (NONMEM) approach was applied for data analysis and evaluation of the final model. The influence of creatinine clearance calculated by the Cockcroft-Gault equation (CrCl), and other potential covariates on vancomycin clearance (CL) were evaluated.RESULTSThe final one-compartment pharmacokinetic model includes the effect of CrCl on CL. Population pharmacokinetic values for a typical subject were estimated at 0.024 l/h for CL dependent on renal function (CLCrCl), 1.93 l/h for residual portion of CL (not dependent on renal function), and 0.511 l/kg for volume of distribution (V). According to the final model, for patients with CrCl = 120 ml/min, the median vancomycin total CL is 4.81 l/h, while CrCl-dependent fraction accounts for approximately 60% of CL.CONCLUSIONSThe developed population vancomycin model may be used in estimating individual CL for adult critically ill septic patients, and could be applied for individualizing dosage regimens taking into account the continuous effect of CrCl.

100 Deals associated with Individualised cancer vaccine (Immunovative Therapies)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 2	Thailand	Immunovative Therapies Ltd.	01 Dec 2016
Advanced Hepatocellular Carcinoma	Phase 2	Thailand	Immunovative Therapies Ltd.	01 Jul 2016
Squamous cell carcinoma of head and neck metastatic	Phase 2	Thailand	Immunovative Therapies Ltd.	01 Jan 2016
Hepatocellular Carcinoma	Phase 2	Israel	Immunovative Therapies Ltd.	01 Dec 2013
Hematologic Neoplasms	Phase 2	Israel	Immunovative Therapies Ltd.	-
Hematologic Neoplasms	Phase 2	United States	Tauriga Sciences, Inc.	-