Delving into the Latest Updates on BIO-11006 with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Target

MARCKS

Mechanism

MARCKS inhibitors(Myristoylated alanine-rich C-kinase substrate inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesOther Diseases

Active Indication-

Inactive Indication

Advanced Lung Non-Small Cell CarcinomaInflammationNon-small cell lung cancer stage IIIB+ [2]

Originator Organization

BioMarck Pharmaceuticals Ltd.

Active Organization-

Inactive Organization

BioMarck Pharmaceuticals Ltd.

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC46H75N13O15

InChIKeyKCSNGWMKFYVMKF-HGYIIGRXSA-N

CAS Registry901117-03-1

Sequence Code 59919

This is a Phase 2 study of an investigational drug, BIO-11006, for the treatment of lung metastases in pediatric patients with advanced osteosarcoma or Ewing's sarcoma. This study will enroll up to 10 patients aged between 5 and 21 at Nicklaus Children's Hospital in Miami, FL. Patients will receive BIO-11006 in addition to chemotherapy consisting of gemcitabine and docetaxel. This study will test the hypothesis that BIO-11006 will enhance the effect of the gemcitabine and docetaxel chemotherapy to treat lung metastases in osteosarcoma and Ewing's sarcoma.

Start Date04 Oct 2019

Sponsor / Collaborator

Nicklaus Children's Hospital

NCT03472053

/ CompletedPhase 2

A Randomized Study of the Safety and Efficacy of BIO-11006 in Treatment of Advanced Non-Small Cell Lung Cancer in Patients Who Are Not Candidates for Curative Surgery and/or Radiation and Who Are Receiving Pemetrexed and Carboplatin

This Phase 2 is a randomized study in advanced Non-Small Cell lung cancer patients to evaluate safety and efficacy of aerosolized BIO-11006 in conjunction with chemotherapy.

Start Date01 Feb 2018

Sponsor / Collaborator

BioMarck Pharmaceuticals Ltd.

CTRI/2018/01/011152

/ CompletedPhase 2

A Randomized Study of the Safety and Efficacy of BIO-11006 in the Treatment of Advanced Nonâ??Small Cell Lung Cancer in Patients who Are not Candidates for Curative Surgery and/or Radiation and who Are Receiving Pemetrexed and Carboplatin.

Start Date12 Jan 2018

Sponsor / Collaborator

BioMarck Pharmaceuticals Ltd.

100 Clinical Results associated with BIO-11006

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100 Translational Medicine associated with BIO-11006

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100 Patents (Medical) associated with BIO-11006

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5

Literatures (Medical) associated with BIO-11006

01 Apr 2022·Journal of Ocular Pharmacology and TherapeuticsQ4 · MEDICINE

Peptide Inhibitors of MARCKS Suppress Endotoxin Induced Uveitis in Rats

Q4 · MEDICINE

Article

Author: Stonex, Tara ; Gilger, Brian C. ; Adler, Kenneth B. ; Salmon, Jacklyn H.

Purpose: To determine if inhibition of Myristoylated Alanine Rich C Kinase Substrate (MARCKS) protein, using novel MARCKS inhibitor peptides, will reduce the severity of endotoxin-induced uveitis (EIU) in rats. Methods: EIU was induced in Lewis rats using subcutaneous administration of lipopolysaccharide. In the first phase of the study, 3 different novel MARCKS inhibitor peptides that mimic the N-terminal region of MARCKS (BIO-11006, or lower molecular weight analogs BIO-91201 or BIO-91202; Biomarck Pharmaceuticals, Ltd., Newtown, PA) were administered intravitreally (IVT) at 50 and 100 μM. In the second phase, BIO-91201 was administered IVT at 10, 50, and 100 μM and topically at the 100 μM concentration. The efficacy of MARCKS inhibitor peptides was assessed by clinical examination using slit lamp biomicroscopy, optical coherence tomography (OCT) anterior chamber cell counts, histopathology, and aqueous humor cytokine analysis. Results: Clinical scores were significantly reduced 24 h following uveitis induction in the first phase of the study in the following treatment groups: BIO-11006 50 μM IVT and 100 μM IVT, BIO-91201 50 μM IVT, and BIO-91202 100 μM IVT (P < 0.05). OCT anterior chamber cell counts were significantly reduced in the first phase of the study in all treatment groups (P < 0.001). OCT anterior chamber cell counts and histopathology scores were significantly reduced in the second phase of the study in the BIO-91201 50 μM IVT group (P < 0.05). No effect was seen with topical administration. Conclusion: MARCKS inhibitor peptides were effective in reducing the severity of ocular inflammation and cellular influx in EIU.

01 Nov 2016·American Journal of Respiratory Cell and Molecular BiologyQ1 · MEDICINE

An Inhaled Inhibitor of Myristoylated Alanine-Rich C Kinase Substrate Reverses LPS-Induced Acute Lung Injury in Mice

Q1 · MEDICINE

Article

Author: Parikh, Indu ; Yin, Qi ; Park, Joungjoa ; Crews, Anne L. ; Fang, Shijing ; Adler, Kenneth B.

Intratracheal instillation of bacterial LPS is a well-established model of acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS). Because the myristoylated alanine-rich C kinase substrate (MARCKS) protein is involved in neutrophil migration and proinflammatory cytokine production, we examined whether an aerosolized peptide that inhibits MARCKS function could attenuate LPS-induced lung injury in mice. The peptide, BIO-11006, was delivered at 50 μM via inhalation either just before intratracheal instillation of 5 μg of LPS into Balb/C mice, or 4, 12, 24, or 36 hours after LPS instillation. Effects of BIO-11006 were evaluated via analysis of mouse disease-related behavior, lung histology, bronchoalveolar lavage fluid total protein, neutrophil counts and percentages, cytokine (KC [CXCl1, mouse IL-8 equivalent] and TNF-α) expression, and activation of NF-κB in lung tissue. Treatment with aerosolized BIO-11006 at 0, 4, 12, 24, and even 36 hours after LPS instillation reversed the disease process: mouse behavior returned to normal after two treatments 12 hours apart with the inhaled peptide after LPS injury, whereas control LPS-instilled animals treated with PBS only remained moribund. Histological appearance of inflammation, bronchoalveolar lavage fluid protein levels, leukocyte and neutrophil numbers, KC and TNF-α gene and protein expression, and NF-κB activation were all significantly attenuated by inhaled BIO-11006 at all time points. These results implicate MARCKS protein in the pathogenesis of ALI/ARDS and suggest that MARCKS-inhibitory peptide(s), delivered by inhalation, could represent a new and potent therapeutic treatment for ALI/ARDS, even if administered well after the disease process has begun.

01 Jan 2016·PharmacologyQ4 · MEDICINE

Novel Therapies to Inhibit Mucus Synthesis and Secretion in Airway Hypersecretory Diseases

Q4 · MEDICINE

Review

Author: Ha, Emily V. S. ; Rogers, Duncan F.

Background: In asthma and chronic obstructive pulmonary disease (COPD), airway mucus hypersecretion contributes to impaired mucociliary clearance, mucostasis and, potentially, the development of mucus plugging of the airways. Summary: Excess mucus production can be targeted via therapies that focus on inhibition mucin synthesis, via reducing expression of mucin (MUC) genes, and/or inhibition of mucin secretion into the airways. Key Messages: This review discusses a number of therapeutic approaches to reduce airway mucus in asthma and COPD, including the use of synthetic and natural products. In particular, it highlights areas where clinical trials of inhibitors of particular target molecules are lacking. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors are an example of a targeted therapy that has been researched to reduce mucus synthesis, as have inhibitors of EGFR's downstream signalling pathways, for example, mitogen-activated protein kinase-13 and hypoxia inducible factor-1. However, their efficacy and safety profiles are currently not up to the mark. There is clinical potential in Bio-11006, which reduces mucus secretion via the inhibition of myristoylated alanine-rich C-kinase substrate and is currently in Phase IIb trial.

100 Deals associated with BIO-11006

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14886

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 2	IN	BioMarck Pharmaceuticals Ltd.	01 Feb 2018
Non-small cell lung cancer stage IIIB	Phase 2	IN	BioMarck Pharmaceuticals Ltd.	01 Feb 2018
Respiratory Distress Syndrome, Adult	Phase 2	US	BioMarck Pharmaceuticals Ltd.	05 Aug 2017
Inflammation	Phase 2	US	BioMarck Pharmaceuticals Ltd.	01 Jun 2008
Pulmonary Disease, Chronic Obstructive	Phase 2	US	BioMarck Pharmaceuticals Ltd.	01 Jun 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03202394 (BusinessWire) Manual	Phase 2	Respiratory Distress Syndrome, Adult	38	BIO 11006	(injzqlgksf) = no significant increase bzetjrfwmm (ztmekvsdpc )	Positive	23 Apr 2020
NCT03472053 (Biospace) Manual	Phase 2	Non-Small Cell Lung Cancer	60	Standard of Care+BIO 11006	(qmfibqzdvu): P-Value = 0.02 View more	Positive	10 Jul 2019
NCT03472053 (Biospace) Manual	Phase 2	Non-Small Cell Lung Cancer	60	Standard of Care	(qmfibqzdvu): P-Value = 0.02 View more	Positive	10 Jul 2019