Delving into the Latest Updates on Pegarginase(Bio-Cancer Treatment International Ltd.) with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

PEG-arginase, PEGylated recombinant human arginase, Pegarginase

+ [4]

Target

ARG

Action-

Mechanism

Arginase replacements

Therapeutic Areas

NeoplasmsHemic and Lymphatic Diseases

Active Indication

Acute Myeloid Leukemia

Inactive Indication

Adenocarcinoma of prostateAdvanced Hepatocellular CarcinomaAdvanced Malignant Solid Neoplasm+ [4]

Originator Organization

Bio-Cancer Treatment International Limited.

Active Organization

Bio-Cancer Treatment International Limited.

Inactive Organization

Oncotherapeutics, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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PARC is an international phase I/II trial evaluating the safety and activity of pegylated recombinant human arginase (BCT-100) in children and young people with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade gliomas (brain cancers).
Currently the outcomes for these patients are poor and the therapeutic options are limited with a significant toxicity burden. Therefore new treatments which work in different ways to standard chemotherapy are urgently needed. Research has shown that arginine (a nutrient) is important in the survival of cancer cells. BCT-100 is a drug which can deplete arginine levels and starve cancer cells - a completely new approach. BCT-100 has been tested in adults and shown to be active with almost no side-effects. This trial will test whether this dose of BCT-100 is also safe and active in children with relapsed/refractory leukaemia, neuroblastoma, sarcoma and high grade glioma. The trial will also study how BCT-100 is broken down in the body and look for new biological markers of treatment response. Up to 64 children with relapsed cancers will be recruited over 2 years.

Start Date28 Aug 2018

Sponsor / Collaborator

University of Birmingham

NCT02899286

/ Unknown statusPhase 2

A Phase II Open-label Study of the Efficacy and Safety of Recombinant Human Arginase 1 (PEG-BCT-100) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

To evaluate the efficacy of PEG-BCT-100 in patients with relapsed or refractory acute myeloid leukemia (AML) in terms of remission rate.

Start Date01 Sep 2016

Sponsor / Collaborator

Bio-Cancer Treatment International Limited.

NCT02285101

/ CompletedPhase 1

Recombinant Human Arginase 1 (rhArg1) in Patients With Advanced Arginine Auxotrophic Solid Tumors: Dose Escalation, Safety and PK/PD

The goal of this clinical research study is to evaluate the safety of PEG-BCT- 100 given as an infusion to treat patients who bear advanced solid tumors that are dependent on arginine (melanoma, renal cell carcinoma, prostate cancer and hepatocellular carcinoma), and who have progressed after receiving approved or established therapies. This is a Phase 1 study; PEG-BCT-100 is an enzyme that degrades arginine and is an investigational drug.

Start Date01 Nov 2014

Sponsor / Collaborator

Bio-Cancer Treatment International Limited.

[+1]

100 Clinical Results associated with Pegarginase(Bio-Cancer Treatment International Ltd.)

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100 Translational Medicine associated with Pegarginase(Bio-Cancer Treatment International Ltd.)

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100 Patents (Medical) associated with Pegarginase(Bio-Cancer Treatment International Ltd.)

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29

Literatures (Medical) associated with Pegarginase(Bio-Cancer Treatment International Ltd.)

09 Oct 2023·EMBO reports

Arginine dependency is a therapeutically exploitable vulnerability in chronic myeloid leukaemic stem cells

Article

Author: Prasad, Bodhayan ; Tardito, Saverio ; Rattigan, Kevin M ; Vande Voorde, Johan ; Mussai, Francis ; Zerbst, Désirée ; Brabcova, Zuzana ; Kalkman, Eric R ; Helgason, G Vignir ; Dunn, Karen ; Scott, Mary T ; Ianniciello, Angela ; Zarou, Martha M ; Shokry, Engy ; Copland, Mhairi ; Cheng, Paul ; Sumpton, David ; Sarnello, Daniele

AbstractTo fuel accelerated proliferation, leukaemic cells undergo metabolic deregulation, which can result in specific nutrient dependencies. Here, we perform an amino acid drop‐out screen and apply pre‐clinical models of chronic phase chronic myeloid leukaemia (CML) to identify arginine as a nutrient essential for primary human CML cells. Analysis of the Microarray Innovations in Leukaemia (MILE) dataset uncovers reduced ASS1 levels in CML compared to most other leukaemia types. Stable isotope tracing reveals repressed activity of all urea cycle enzymes in patient‐derived CML CD34+ cells, rendering them arginine auxotrophic. Thus, arginine deprivation completely blocks proliferation of CML CD34+ cells and induces significantly higher levels of apoptosis when compared to arginine‐deprived cell lines. Similarly, primary CML cells, but not normal CD34+ samples, are particularly sensitive to treatment with the arginine‐depleting enzyme, BCT‐100, which induces apoptosis and reduces clonogenicity. Moreover, BCT‐100 is highly efficacious in a patient‐derived xenograft model, causing > 90% reduction in the number of human leukaemic stem cells (LSCs). These findings indicate arginine depletion to be a promising and novel strategy to eradicate therapy resistant LSCs.

01 Oct 2023·European Journal of Pharmacology

Intranasal EP4 agonist and arginase-1 therapy in a murine model of asthma

Article

Author: Gercke, Philipp ; Lautenschlager, Nikoleta ; Vedder, Nora ; Kolahian, Saeed ; van Geffen, Chiel ; Renz, Harald

Research findings evermore suggest a crucial role of myeloid-derived suppressor cells (MDSCs) in chronic lung diseases including asthma. Previously, we showed that intravenous (IV) treatment with a prostaglandin E2 receptor 4 (EP4) agonist, L-902,688, promoted MDSC suppressive activity. IV therapy with L-902,688 and BCT-100, a human pegylated arginase-1, ameliorated lung inflammatory features in a murine model of asthma. Here, we further investigate the potential therapeutic approach by studying the local therapy effects on the lungs after intranasal (IN) application. Using a two-week model of house dust mite (HDM)-induced murine asthma, the effect of IN treatment with L-902,688 or BCT-100 on in vivo lung function, inflammatory features of asthma and MDSC generation and activation was studied. Our experiments demonstrated increased suppressive activity of pulmonary MDSCs after induction of allergic airway disease. IN treatment with L-902,688 and BCT-100 further enhanced the immunosuppressive activity of pulmonary MDSCs. Additionally, treatment with BCT-100 reduced pulmonary T cell numbers. Asthmatic mice that received IN L-902,688 showed improved in vivo lung function. In conclusion, our results underline the potential of modulating MDSCs systemically or locally as a future therapeutic option in airway inflammatory diseases such as asthma.

01 Oct 2022·3 Biotech

Human arginase 1, a Jack of all trades?

Review

Author: Anakha, J ; Pande, Abhay H ; Jawalekar, Snehal Sainath ; Kawathe, Priyanka S ; Datta, Sayantap ; Banerjee, Uttam Chand

Arginine, a conditionally essential amino acid, plays a crucial role in several metabolic and signalling pathways. Arginine metabolism in the body can be significantly increased under stress or during certain pathological conditions. Depletion of circulating arginine by administering arginine-hydrolysing enzyme has been shown to mitigate varied pathophysiological conditions ranging from cancer, inflammatory conditions, and microbial infection. This review provides an overview of such intriguing expanse of potential applications of recombinant human arginase 1 for different pathological conditions and its status of development.

100 Deals associated with Pegarginase(Bio-Cancer Treatment International Ltd.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	United Kingdom	Bio-Cancer Treatment International Limited.	10 Aug 2022
Refractory acute myeloid leukemia	Discovery	Hong Kong	Bio-Cancer Treatment International Limited.	01 Sep 2016
Relapsing acute myeloid leukemia	Discovery	Hong Kong	Bio-Cancer Treatment International Limited.	01 Sep 2016
Adenocarcinoma of prostate	Discovery	United States	Oncotherapeutics, Inc.	01 Nov 2014
Adenocarcinoma of prostate	Discovery	United States	Bio-Cancer Treatment International Limited.	01 Nov 2014
Advanced Malignant Solid Neoplasm	Discovery	United States	Bio-Cancer Treatment International Limited.	01 Nov 2014
Melanoma	Discovery	United States	Oncotherapeutics, Inc.	01 Nov 2014
Melanoma	Discovery	United States	Bio-Cancer Treatment International Limited.	01 Nov 2014
Advanced Hepatocellular Carcinoma	Discovery	Hong Kong	Bio-Cancer Treatment International Limited.	01 Apr 2014
Metastatic hepatocellular carcinoma	Discovery	Hong Kong	Bio-Cancer Treatment International Limited.	01 Apr 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01092091 (BCT-100-002, Pubmed \| Invest New Drugs) Manual	Phase 2	Hepatocellular Carcinoma ASS Negative	27	PEG-BCT-100	(hhdhiahtqa) = uzxlvwomdf jxwulqcwev (xfdeagkwty, 5.9 - 6.0) View more	Positive	01 Oct 2021
WCLC2016	Not Applicable	Malignant Pleural Mesothelioma	-	BCT-100	bvwgmmquei(nianmowgrh) = snlwsawdno brjtvseuoa (jnquspyvgv )	-	07 Dec 2016
SNO2015	Not Applicable	Glioma ASS1 \| ASL \| OTC	5	PEG-BCT-100 (rhArg1peg5000)	zkvmzewstt(owjedkgvbp) = vscsqnwdfb kwoqxwvqcb (vkaldobqkj )	-	09 Nov 2015
SNO2015	Not Applicable	Glioma ASS1 \| ASL \| OTC	5	PEG-BCT-100 (Control (full culture medium))	zkvmzewstt(owjedkgvbp) = ggkuzjxpte kwoqxwvqcb (vkaldobqkj )	-	09 Nov 2015
ASCO2010	Phase 1	Advanced Hepatocellular Carcinoma	15	Recombinant human arginase I (rhArgI)	yonnxsslnm(gyssxenejs) = DLT was Gr 3 prolonged elevation of bilirubin in 2 patients at 2500 U/kg evxlmgwbfo (xipnaendku ) View more	-	20 May 2010

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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