AG01 / A&G Pharma - LARVOL DELTA

On-going phase 1A clinical trial of A01, a chimerized monoclonal antibody to Progranulin/Glycoprotein 88 (GP88) in patients with advanced malignancy. (SABCS 2023) - P1a | "A first-in-human, first-in-class phase 1 safety and efficacy clinical study of AG01 in patients with solid tumors and advanced disease with special focus on patients with breast, lung and ovarian cancers has been initiated and is on-going at the University of Maryland Greenebaum Cancer Center...The presentation will provide an update on the number of patients enrolled in this on-going phase 1A trial. Supported by grants R44CA162629 and R44CA224718 from the National Cancer Institute to GS."

Clinical • Metastases • P1 data • Breast Cancer • Oncology

Development of fully human anti-progranulin monoclonal antibodies as inhibitors of triple negative breast cancer cell growth and tumor formation. (SABCS 2023) - "In vivo dose response of AG01 in MDAMB-231 tumor bearing mice will be provided... PGRN/GP88 represents a therapeutic target for TNBC with two companion diagnostics (tissue test and ELISA to measure GP88 circulating levels). The use of the TC transgenic mice allows for the rapid development of fully human high affinity monoclonal antibodies bypassing the need for chimerization or humanization of mouse monoclonal antibodies. The development of fully human anti-progranulin antibodies provides novel targeted therapeutic option for TNBC."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

On-going phase 1A clinical trial for AG01 an first-in-class anti-progranulin (GP88) monoclonal antibody in patients with advanced malignancies (AACR 2023) - P1a | "The IND application has been filed and cleared by the Food and Drug Administration. A first-in-human, first-in-class phase 1 safety and efficacy clinical study of AG01 in patients with solid tumors and advanced disease with special focus on patients with breast, lung and ovarian cancers has been initiated and is on-going at the University of Maryland Greenebaum Cancer Center."

Clinical • Metastases • P1 data • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

Anti-progranulin (GP88) antibody AG01 inhibitory effect on the growth of triple negative breast cancer cells (SABCS 2021) - "TNBC is a disease with poor prognosis in need of novel targeted therapeutic solutions. PGRN/GP88 represents a therapeutic target for TNBC with two companion diagnostics (tissue test and ELISA to measure GP88 circulating levels). Blocking PGRN/GP88 with AG01 antibody treatment will provide novel targeted therapeutic option for TNBC which could address the issue of toxicity, and unresponsiveness associated with SOC."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Accuracy and Reliability of AG501 Articulograph for Mandibular Movement Analysis: A Quantitative Descriptive Study. (PubMed, Sensors (Basel)) - "Bland-Altman analysis of agreement between the AG501 and a millimetre ruler used to measure the distance between the sensors revealed limits of agreement between 0.5 mm and -0.9 mm. The results suggest that EMA AG501 is valid for three-dimensional analysis of mandibular biomechanics allowing natural movements."

Journal

Antibiotics Act with vB_AbaP_AGC01 Phage against Acinetobacter baumannii in Human Heat-Inactivated Plasma Blood and Galleria mellonella Models. (PubMed, Int J Mol Sci) - "The AGC01 is able to significantly reduce the A. baumannii cell count in a human heat-inactivated plasma blood model (HIP-B), both alone and in combination with antibiotics (gentamicin (GEN), ciprofloxacin (CIP), and meropenem (MER)). Hence, AGC01 represents a novel candidate for phage therapy. Additionally, our study suggests that phages and antibiotics can act synergistically for greater antimicrobial effect when used as combination therapy."

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Mebendazole induces apoptosis via C-MYC inactivation in malignant ascites cell line (AGP01). (PubMed, Toxicol In Vitro) - "MBZ induced lower cell viability in AGP01 cells compared AGP01 shRNA MYC in the same concentration. Therefore, our results show the evidence of C-MYC gene as one of the pathways by which MBZ induces cell death in gastric cancer cells."

Journal • Preclinical

A Novel Three-Dimensional Analysis of Tongue Movement During Water and Saliva Deglutition: A Preliminary Study on Swallowing Patterns. (PubMed, Dysphagia) - "Fourteen participants (25.36 ± 4.85 years) were evaluated, and the movements of anterior, middle, and posterior portions of the tongue were recorded using AG501 3D-electromagnetic articulograph...The movement of the tongue portions was influenced by the volume and the element to be swallowed. The amplitude of the movement was directly proportional to the volume of water swallowed."

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New prognostic markers revealed by RNA-Seq transcriptome analysis after MYC silencing in a metastatic gastric cancer cell line. (PubMed, Oncotarget) - "Metastatic GC cells (AGP01) characterized by MYC amplification, were transfected with siRNAs targeting MYC...Overall survival rate of patients with overexpressed CIAPIN1 or UXT was significantly lower (P < 0.0001). In conclusion, CIAPIN1 and UXT may serve as potential molecular markers for GC prognosis."

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A Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults (clinicaltrials.gov) - P=N/A; N=60; Active, not recruiting; Sponsor: Vedic Lifesciences Pvt. Ltd.; Trial completion date: Sep 2019 ➔ Dec 2019

Clinical • Trial completion date

Characterization of Telomerase (hTERT) in Solid and Hematopoietic Cancer Cell Lines Reveals Different Expression Patterns. (PubMed, Anticancer Res) - "In leukemia cell lines, hTERT gene overexpression was shown to be a potential target for pharmacological assays for drugs aiming to inhibit telomerase activity and control cell proliferation in oncohematological diseases."

Journal

Diversification of Bw4 Specificity and Recognition of a Nonclassical MHC Class I Molecule Implicated in Maternal-Fetal Tolerance by Killer Cell Ig-like Receptors of the Rhesus Macaque. (PubMed, J Immunol) - "...In contrast, Mamu-KIR3DL05 recognizes Mamu-A and Mamu-A-related molecules, including Mamu-A1*002 and -A3*13, Mamu-B*036, the product of a recombinant Mamu-B allele with α1 and α2 domain sequences derived from a MHC-A gene, and Mamu-AG*01, a nonclassical molecule expressed on placental trophoblasts that originated from an ancestral duplication of a MHC-A gene. These results reveal an expansion of the lineage II KIRs in macaques that recognize Bw4 ligands and identify a nonclassical molecule implicated in placental development and pregnancy as a ligand for Mamu-KIR3DL05. In addition to offering new insights into KIR-MHC class I coevolution, these findings provide an important foundation for investigating the role of NK cells in the rhesus macaque as an animal model for infectious diseases and reproductive biology."

Journal

A Study to Evaluate ALN-AGT01 in Patients With Hypertension (clinicaltrials.gov) - P1; N=168; Recruiting; Sponsor: Alnylam Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults (clinicaltrials.gov) - P=N/A; N=60; Active, not recruiting; Sponsor: Vedic Lifesciences Pvt. Ltd.; Trial completion date: May 2019 ➔ Sep 2019; Trial primary completion date: Apr 2019 ➔ Aug 2019

Clinical • Trial completion date • Trial primary completion date

A Study to Evaluate ALN-AGT01 in Patients With Hypertension (clinicaltrials.gov) - P1; N=168; Not yet recruiting; Sponsor: Alnylam Pharmaceuticals

Clinical • New P1 trial

STUDY OF THE ANTITUMORAL ACTIVITY OF CRIZOTINIB ASSOCIATED WITH MEBENDAZOLE IN VITRO MODELS OF GASTRIC CANCER (IGCC 2019) - "Objectives: The present study evaluated the cytotoxic and genotoxicity potential of Crizotinib in combination with Mebendazole in a metastatic gastric cancer cell line AGP01. Conclusions The Crizotinib and MBZ drugs have excellent anticancer activity against the gastric cancer mestatic cell line AGP01. This may represent a new strategy for the treatment of this tumor type."

Preclinical

ASSOCIATION OF IDARUBICIN AND MEBENDAZOLE ENHANCES CELLULAR DEATH AND CELL CYCLE ARREST IN A METASTATIC GASTRIC CANCER CELL LINE (IGCC 2019) - "Objectives: The present study evaluated the cytotoxic potential of Idarubicin (IDA) in combination with Mebendazole (MBZ) in a metastatic gastric cancer cell line, AGP01, originated from malignant ascites. Conclusions The MBZ and IDA drugs have excellent anticancer activity against the AGP01 gastric cancer cell line. These results may represent a new strategy for the treatment of this tumor type, because of the inefficient response to chemo and chemoresistance."

Preclinical

EVALUATION OF THE ANTINEOPLASTIC ACTIVITY OF METFORMIN COMBINED WITH THE ANTHELMINTIC MEBENDAZOLE IN A METASTATIC GASTRIC CANCER CELL LINE (IGCC 2019) - "Objectives: Investigate the antineoplastic activity of Metformin (MET) and Mebendazole (MBZ) as single agents and their performances in association in a human metastatic gastric adenocarcinoma lineage (AGP01). Conclusions These data confirm the antiproliferative effect of the drugs in the human metastatic gastric adenocarcinoma lineage. Both drugs had good antineoplastic effects, and the combination of them allowed a considerable reduction of the concentrations, providing similar effects against cancer cells."

Preclinical

Piwi like RNA-mediated gene silencing 1 gene as a possible major player in gastric cancer. (PubMed, World J Gastroenterol) - "Taken together, these data reinforce the idea that PIWIL1 plays a crucial role in the signaling pathway of gastric cancer, regulating several genes involved in migration and invasion processes; therefore, its use as a therapeutic target may generate promising results in the treatment of gastric cancer."

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