BIO-11006 / BioMarck - LARVOL DELTA

BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital | N=10 ➔ 0 | Active, not recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Ewing Sarcoma • Lung Cancer • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Patent landscape highlighting therapeutic implications of peptides targeting myristoylated alanine-rich protein kinase-C substrate (MARCKS). (PubMed, Expert Opin Ther Pat) - "Unlike PKC inhibitors, MARCKS-targeting drug (BIO-11006) has shown early success in clinical trials involving lung diseases...Thus, there is a need to amalgamate and translate such a trend into therapeutic intervention. Our review article provides an overview of such recent advances, and we believe that our compilation will fetch the interest of researchers around the globe to develop MARCKS-targeting peptides in future for human diseases."

Journal • Review • Asthma • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases • MARCKS

BIO-11006 for Osteosarcoma and Ewing's Sarcoma Lung Metastases (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Nov 2024 | Trial primary completion date: Nov 2022 ➔ Nov 2023

Enrollment closed • Trial completion date • Trial primary completion date • Ewing Sarcoma • Lung Cancer • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Peptide Inhibitors of MARCKS Suppress Endotoxin Induced Uveitis in Rats. (PubMed, J Ocul Pharmacol Ther) - "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...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...No effect was seen with topical administration. MARCKS inhibitor peptides were effective in reducing the severity of ocular inflammation and cellular influx in EIU."

Journal • Preclinical • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Uveitis

[VIRTUAL] A Phase II, Placebo‑Controlled, Multicenter Pilot Study to Evaluate the Safety and Efficacy of BIO­‑11006 Inhalation Solution in Patients with Acute Respiratory Distress Syndrome (ATS 2021) - "In this safety and feasibility trial of BIO-11006 in ARDS there were few SAE's that were felt to be possibly related to the BIO-11006, and none led to subject discontinuation. Although study numbers are small and definitive conclusions about clinical outcomes are not possible, there may be faster improvement in oxygenation and delayed mortality observed with the BIO-11006 compared to placebo."

Clinical • P2 data • Acute Respiratory Distress Syndrome • Chronic Obstructive Pulmonary Disease • Hematological Disorders • Hypertension • Immunology • Infectious Disease • Neutropenia • Pneumonia • Pulmonary Arterial Hypertension • Respiratory Diseases • Septic Shock

[VIRTUAL] An Inhaled MARCKS (Myristoylated Alanine-Rich C Kinase Substrate) - Inhibitory Drug, BIO-11006, Elicited a Statistically-Significant Result (p= 0.02) in Overall Response Rate (ORR) After 3 Months Compared to Standard of Care Chemotherapy in a Phase 2 Trial of Late Stage Non Small Cell Lung Cancer (NSCLC) (ATS-I 2020) - "The current trial was a randomized, controlled, multicenter Phase 2 study to evaluate safety and efficacy of BIO-11006 in Stage IIIB NSCLC patients who were not candidates for immunotherapy, and who were also receiving Pemetrexed and Carboplatin as standard of care (SOC: Pemetrexed [500 mg/meter square] and Carboplatin [AUC6, Calvert's formula] administered every three weeks for three months). This compares favorably to myelosuppression, liver and renal toxicity associated with other commonly-used agents. Inhalation of a MARCKS-inhibitory peptide appears as a promising therapy for NSCLC."

Late-breaking abstract • P2 data • Hepatitis B • Hepatitis C Virus • Immunology • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Thoracic Cancer • Tuberculosis

Biomarck Pharmaceuticals to present expanded analysis of BIO-11006 clinical data in treatment of non-small cell lung cancer at the American Thoracic Society 2020 International Conference (Businesswire) - P2, N=60; NCT03472053; Sponsor: BioMarck Pharmaceuticals, Ltd; "Biomarck Pharmaceuticals, Ltd...announced new data from a Phase 2 study of its novel anti-MARCKS peptide BIO-11006 in non-small cell lung cancer (NSCLC)...inhaled BIO-11006 decreases metastasis and tumor progression, and increases the overall response rate and survival in patients with advanced NSCLC....'It is entirely possible that, by blocking inflammation and the cytokine storm in the tumor microenvironment of metastatic lung cancer and of the injured lung in ARDS, BIO-11006 is acting, at least in part, through this similar mechanism of action.'"

Cytokine storm • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Novel Therapies to Inhibit Mucus Synthesis and Secretion in Airway Hypersecretory Diseases. (PubMed) - Pharmacology - "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."

Journal • Asthma • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation

Biomarck announces the start of a phase 2 clinical trial of BIO-11006 for Non-Small Cell Lung Cancer (NSCLC) (PRNewswire) - "Biomarck Pharmaceuticals, Ltd today announced that a Phase 2 clinical study in advanced NSCLC has commenced. This study at 10 sites in India compares standard of care therapy (SOC; pemetrexed and carboplatin) alone to SOC plus BIO-11006. This trial will evaluate the safety and efficacy of Biomarck's novel, patented, MARCKS protein inhibitor in a controlled trial."

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

An Inhaled MARCKS (Myristoylated Alanine-Rich C Kinase Substrate) - Inhibitory Drug, BIO-11006, Elicited a Statistically-Significant Result (p= 0.02) in Overall Response Rate (ORR) After 3 Months Compared to Standard of Care Chemotherapy in a Phase 2 Trial of Late Stage Non Small Cell Lung Cancer (NSCLC) (ATS 2020) - "The current trial was a randomized, controlled, multicenter Phase 2 study to evaluate safety and efficacy of BIO-11006 in Stage IIIB NSCLC patients who were not candidates for immunotherapy, and who were also receiving Pemetrexed and Carboplatin as standard of care (SOC: Pemetrexed [500 mg/meter square] and Carboplatin [AUC6, Calvert's formula] administered every three weeks for three months). This compares favorably to myelosuppression, liver and renal toxicity associated with other commonly-used agents. Inhalation of a MARCKS-inhibitory peptide appears as a promising therapy for NSCLC."

P2 data

Biomarck announces statistically significant results from the phase 2 controlled clinical study in non small cell lung cancer (NSCLC) (PRNewswire) - P2, N=60; NCT03472053; Sponsor: BioMarck Pharmaceuticals, Ltd; "Biomarck Pharmaceuticals, Ltd...announced that statistical significance (p=0.02) was achieved in improvement of Overall Response Rate (ORR) in the BIO-11006/SOC group compared to standard of care alone at 3 months in the Phase 2 study in NSCLC. This study compares standard of care alone, (pemetrexed/carboplatin; SOC) to SOC plus BIO-11006 in 60 patients with stage 4, NSCLC."

P2 data

A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=60; Active, not recruiting; Sponsor: BioMarck Pharmaceuticals, Ltd.; Trial completion date: Jun 2019 ➔ Dec 2019; Trial primary completion date: Jan 2019 ➔ Nov 2019

Clinical • Trial completion date • Trial primary completion date