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Article ; Online: Translational Pharmacokinetic/Pharmacodynamic Model for mRNA-3927, an Investigational Therapeutic for the Treatment of Propionic Acidemia.

Attarwala, Husain / Lumley, Matthew / Liang, Min / Ivaturi, Vijay / Senn, Joe

2022 Volume 33, Issue 2, Page(s) 141–147

Abstract: Propionic acidemia (PA) is an ultrarare disorder caused by deficiency of the mitochondrial enzyme, propionyl-CoA carboxylase (PCC), composed of PCCA and PCCB subunits. An enzyme replacement therapy is being developed using dual messenger RNA (mRNA) ... ...

Abstract	Propionic acidemia (PA) is an ultrarare disorder caused by deficiency of the mitochondrial enzyme, propionyl-CoA carboxylase (PCC), composed of PCCA and PCCB subunits. An enzyme replacement therapy is being developed using dual messenger RNA (mRNA) therapy composed of lipid nanoparticles (LNPs) encapsulating mRNAs encoding PCCA and PCCB subunits of the PCC enzyme. We herein report on development of a translational semimechanistic pharmacokinetic (PK) and PK/pharmacodynamic (PD) model to quantify the relationship between the mRNA components of mRNA-3927 (an LNP encapsulating PCCA and PCCB mRNAs) and dose levels; PCCA/B mRNA PK and PD responses were assessed as circulating levels of primary disease markers 2-methyl citrate, 3-hydroxypropionate, and propionyl carnitine normalized to acetyl carnitine (C3/C2 ratio) to inform the first-in-human dose range and regimen selection. The translational PK/PD model was developed using preclinical data available in mice with PA, Sprague Dawley rats, and cynomolgus monkeys at dose levels ranging from 0.2 to 9 mg/kg. PCCA/B mRNA PK in mice, rats, and monkeys was adequately described using allometric scaling of volume and clearance parameters. The interspecies preclinical model was scaled allometrically to humans to predict the dose-response relationship in adult and pediatric patients with PA to guide selection of dose range and regimen for the Phase 1 clinical trial (ClinicalTrials.gov Identifier NCT04159103).
MeSH term(s)	Adult ; Humans ; Child ; Mice ; Rats ; Animals ; Propionic Acidemia/drug therapy ; Propionic Acidemia/genetics ; Mutation ; RNA, Messenger/genetics ; Rats, Sprague-Dawley ; Methylmalonyl-CoA Decarboxylase/genetics
Chemical Substances	RNA, Messenger ; Methylmalonyl-CoA Decarboxylase (EC 7.2.4.3)
Language	English
Publishing date	2022-12-27
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2639888-6
ISSN	2159-3345 ; 2159-3337
ISSN (online)	2159-3345
ISSN	2159-3337
DOI	10.1089/nat.2022.0036
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Article ; Online: Translational kinetic-pharmacodynamics of mRNA-6231, an investigational mRNA therapeutic encoding mutein interleukin-2.

Liric Rajlic, Ivana / Guglieri-Lopez, Beatriz / Rangoonwala, Nabeel / Ivaturi, Vijay / Van, Linh / Mori, Simone / Wipke, Brian / Burdette, Douglas / Attarwala, Husain

CPT: pharmacometrics & systems pharmacology

2024

Abstract: Regulatory T cells ( ... ...

Abstract	Regulatory T cells (T
Language	English
Publishing date	2024-04-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	2697010-7
ISSN	2163-8306 ; 2163-8306
ISSN (online)	2163-8306
ISSN	2163-8306
DOI	10.1002/psp4.13142
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Article ; Online: TGN1412: From Discovery to Disaster.

Attarwala, H

Journal of young pharmacists : JYP

2010 Volume 2, Issue 3, Page(s) 332–336

Abstract: After a drug is confirmed as safe and efficacious in preclinical studies, it is tested in healthy human volunteers for first in man trials. In 2006, a phase I clinical study was conducted for a CD28 superagonist antibody TGN1412 in six human volunteers. ... ...

Abstract	After a drug is confirmed as safe and efficacious in preclinical studies, it is tested in healthy human volunteers for first in man trials. In 2006, a phase I clinical study was conducted for a CD28 superagonist antibody TGN1412 in six human volunteers. After very first infusion of a dose 500 times smaller than that found safe in animal studies, all six human volunteers faced life-threatening conditions involving multiorgan failure for which they were moved to intensive care unit. After this particular incident, a lot was changed over how first in man trials are approved by regulatory authorities and the way clinical trials are conducted. This review primarily deals with preclinical studies conducted by TeGenero, results of which encouraged them to test the antibody on human subjects, reasons why this drug failed in human trial and aftermath of this drug trial. In addition, another drug-Fialuridine which failed in phase 2 clinical trial leading to death of five human subjects is briefly reviewed.
Language	English
Publishing date	2010-10-29
Publishing country	India
Document type	Journal Article
ZDB-ID	2503424-8
ISSN	0975-1505 ; 0975-1505
ISSN (online)	0975-1505
ISSN	0975-1505
DOI	10.4103/0975-1483.66810
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Article ; Online: Role of antibodies in cancer targeting.

Attarwala, Husain

Journal of natural science, biology, and medicine

2011 Volume 1, Issue 1, Page(s) 53–56

Abstract: The development of chemotherapeutic agents capable of specifically eliminating tumor cells has been a great challenge since these agents cannot differentiate between normal body cells and tumor cells. Enhanced elimination of cancer cells without ... ...

Abstract	The development of chemotherapeutic agents capable of specifically eliminating tumor cells has been a great challenge since these agents cannot differentiate between normal body cells and tumor cells. Enhanced elimination of cancer cells without affecting normal body cells can be achieved by developing strategies which can enable drug targeting. With recent advances in antibody engineering strategies, the development of different antibody-associated tumor-targeted delivery systems for chemotherapy, chemoprevention, and early cancer diagnosis has become possible. In this review, the role of antibodies for cancer diagnosis, chemoprevention, and chemotherapy will be discussed with an emphasis on recent advances in antibody engineering.
Language	English
Publishing date	2011-09-30
Publishing country	India
Document type	Journal Article
ZDB-ID	2638867-4
ISSN	2229-7707 ; 0976-9668
ISSN (online)	2229-7707
ISSN	0976-9668
DOI	10.4103/0976-9668.71675
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Article ; Online: Comparative Genomic Insights into Bacterial Induction of Larval Settlement and Metamorphosis in the Upside-Down Jellyfish

Ohdera, Aki / Attarwala, Khushboo / Wu, Victoria / Henry, Rubain / Laird, Henry / Hofmann, Dietrich K / Fitt, William K / Medina, Mónica

mSphere

2023 Volume 8, Issue 3, Page(s) e0031522

Abstract: Bacteria are important mediators of the larval transition from pelagic to benthic environments for marine organisms. Bacteria can therefore dictate species distribution and success of an individual. Despite the importance of marine bacteria to animal ... ...

Abstract	Bacteria are important mediators of the larval transition from pelagic to benthic environments for marine organisms. Bacteria can therefore dictate species distribution and success of an individual. Despite the importance of marine bacteria to animal ecology, the identity of inductive microbes for many invertebrates are unknown. Here, we report the first successful isolation of bacteria from natural substrates capable of inducing settlement and metamorphosis of the planula larvae stage of a true jellyfish, the upside-down jellyfish
MeSH term(s)	Animals ; Larva ; Ecosystem ; Invertebrates ; Scyphozoa ; Genomics ; Bacteria/metabolism
Language	English
Publishing date	2023-05-08
Publishing country	United States
Document type	Journal Article
ISSN	2379-5042
ISSN (online)	2379-5042
DOI	10.1128/msphere.00315-22
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Article ; Online: Rational Design and In Vivo Characterization of mRNA-Encoded Broadly Neutralizing Antibody Combinations against HIV-1.

Narayanan, Elisabeth / Falcone, Samantha / Elbashir, Sayda M / Attarwala, Husain / Hassett, Kimberly / Seaman, Michael S / Carfi, Andrea / Himansu, Sunny

Antibodies (Basel, Switzerland)

2022 Volume 11, Issue 4

Abstract: Monoclonal antibodies have been used successfully as recombinant protein therapy; however, for HIV, multiple broadly neutralizing antibodies may be necessary. We used the mRNA-LNP platform for in vivo co-expression of 3 broadly neutralizing antibodies, ... ...

Abstract	Monoclonal antibodies have been used successfully as recombinant protein therapy; however, for HIV, multiple broadly neutralizing antibodies may be necessary. We used the mRNA-LNP platform for in vivo co-expression of 3 broadly neutralizing antibodies, PGDM1400, PGT121, and N6, directed against the HIV-1 envelope protein. mRNA-encoded HIV-1 antibodies were engineered as single-chain Fc (scFv-Fc) to overcome heavy- and light-chain mismatch. In vitro neutralization breadth and potency of the constructs were compared to their parental IgG form. We assessed the ability of these scFv-Fcs to be expressed individually and in combination in vivo, and neutralization and pharmacokinetics were compared to the corresponding full-length IgGs. Single-chain PGDM1400 and PGT121 exhibited neutralization potency comparable to parental IgG, achieving peak systemic concentrations ≥ 30.81 μg/mL in mice; full-length N6 IgG achieved a peak concentration of 974 μg/mL, but did not tolerate single-chain conversion. The mRNA combination encoding full-length N6 IgG and single-chain PGDM1400 and PGT121 was efficiently expressed in mice, achieving high systemic concentration and desired neutralization potency. Analysis of mice sera demonstrated each antibody contributed towards neutralization of multiple HIV-1 pseudoviruses. Together, these data show that the mRNA-LNP platform provides a promising approach for antibody-based HIV treatment and is well-suited for development of combination therapeutics.
Language	English
Publishing date	2022-10-24
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2661514-9
ISSN	2073-4468 ; 2073-4468
ISSN (online)	2073-4468
ISSN	2073-4468
DOI	10.3390/antib11040067
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Article ; Online: Oral nucleic acid therapy using multicompartmental delivery systems.

Attarwala, Husain / Han, Murui / Kim, Jonghan / Amiji, Mansoor

Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology

2017 Volume 10, Issue 2

Abstract: Nucleic acid-based therapeutics has the potential for treating numerous diseases by correcting abnormal expression of specific genes. Lack of safe and efficacious delivery strategies poses a major obstacle limiting clinical advancement of nucleic acid ... ...

Abstract	Nucleic acid-based therapeutics has the potential for treating numerous diseases by correcting abnormal expression of specific genes. Lack of safe and efficacious delivery strategies poses a major obstacle limiting clinical advancement of nucleic acid therapeutics. Oral route of drug administration has greater delivery challenges, because the administered genes or oligonucleotides have to bypass degrading environment of the gastrointestinal (GI) tract in addition to overcoming other cellular barriers preventing nucleic acid delivery. For efficient oral nucleic acid delivery, vector should be such that it can protect encapsulated material during transit through the GI tract, facilitate efficient uptake and intracellular trafficking at desired target sites, along with being safe and well tolerated. In this review, we have discussed multicompartmental systems for overcoming extracellular and intracellular barriers to oral delivery of nucleic acids. A nanoparticles-in-microsphere oral system-based multicompartmental system was developed and tested for in vivo gene and small interfering RNA delivery for treating colitis in mice. This system has shown efficient transgene expression or gene silencing when delivered orally along with favorable downstream anti-inflammatory effects, when tested in a mouse model of intestinal bowel disease. WIREs Nanomed Nanobiotechnol 2018, 10:e1478. doi: 10.1002/wnan.1478 This article is categorized under: Biology-Inspired Nanomaterials > Nucleic Acid-Based Structures Nanotechnology Approaches to Biology > Nanoscale Systems in Biology Therapeutic Approaches and Drug Discovery > Emerging Technologies.
MeSH term(s)	Administration, Oral ; Animals ; Drug Delivery Systems ; Gastrointestinal Tract/chemistry ; Gastrointestinal Tract/metabolism ; Genetic Therapy ; Humans ; Mice ; Nucleic Acids/administration & dosage ; Nucleic Acids/pharmacokinetics ; Nucleic Acids/therapeutic use ; Transfection
Chemical Substances	Nucleic Acids
Language	English
Publishing date	2017-05-24
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2502698-7
ISSN	1939-0041 ; 1939-5116
ISSN (online)	1939-0041
ISSN	1939-5116
DOI	10.1002/wnan.1478
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Article ; Online: Cosilencing Intestinal Transglutaminase-2 and Interleukin-15 Using Gelatin-Based Nanoparticles in an in Vitro Model of Celiac Disease.

Attarwala, Husain / Clausen, Valerie / Chaturvedi, Prasoon / Amiji, Mansoor M

Molecular pharmaceutics

2017 Volume 14, Issue 9, Page(s) 3036–3044

Abstract: ... microscopy showed rapid internalization of gelatin nanoparticles within 2 h of dosing, with cytosolic ... at 72 h post siRNA treatment for both TG2 and IL-15 genes, which corresponded to ∼200 copies of RISC ...

Abstract	In this study, we have developed a type B gelatin nanoparticle based siRNA delivery system for silencing of intestinal transglutaminase-2 (TG2) and interleukin-15 (IL-15) genes in cultured human intestinal epithelial cells (Caco-2) and murine alveolar macrophage cells (J774A.1). Small interfering RNA (siRNA) targeting the TG2 or IL-15 gene was encapsulated within gelatin nanoparticles using ethanol-water solvent displacement method. Size, charge, and morphology of gelatin nanoparticles were evaluated using a Zetasizer instrument and transmission electron microscopy. siRNA encapsulation efficiency was determined using an siRNA specific stem-loop quantitative polymerase chain reaction (qPCR) assay. Cellular uptake of siRNA-containing gelatin nanoparticles was determined using fluorescent microscopy and stem-loop qPCR assay. siRNA loading in the RISC (RNA-induced silencing complex) was determined by immunoprecipitation of argonaute 2 (AGO2) protein followed by stem-loop qPCR for siRNA quantification. Gene expression analysis of TG2, IL-15, and the proinflammatory cytokines, tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), was performed using qPCR assays. Efficacy of silencing TG2 and IL-15 knockdown was evaluated in an in vitro model of celiac disease by utilizing immunogenic α-gliadin peptide p31-43 in cultured J774A.1 cells. siRNA-containing gelatin nanoparticles were spherical in shape with mean particle size and charge of 217 ± 8.39 nm and -6.2 ± 0.95 mV, respectively. siRNA loading efficiency within gelatin nanoparticles was found to be 89.3 ± 3.05%. Evaluations of cellular uptake using fluorescent microscopy showed rapid internalization of gelatin nanoparticles within 2 h of dosing, with cytosolic localization of delivered siRNA in Caco-2 cells. Gelatin nanoparticles showed greater intracellular siRNA exposure with a longer half-life, when compared to Lipofectamine-mediated siRNA delivery. Approximately 0.1% of total intracellular siRNA was associated in the RISC complex. A maximum knockdown of 60% was observed at 72 h post siRNA treatment for both TG2 and IL-15 genes, which corresponded to ∼200 copies of RISC associated siRNA. Further, efficacy of gelatin nanoparticle mediated knockdown of TG2 and IL-15 mRNA was tested in an in vitro model of celiac disease. Significant suppression in the levels of proinflammatory cytokines (TNF-α and IFN-γ) was observed in p31-43 stimulated J774A.1 cells upon either IL-15 or IL-15 + TG2 siRNA treatment. The results from this study indicate that gelatin nanoparticle mediated TG2 and IL-15 siRNA gene silencing is a very promising approach for the treatment of celiac disease.
MeSH term(s)	Animals ; Caco-2 Cells ; Celiac Disease/genetics ; Cell Line ; GTP-Binding Proteins/genetics ; GTP-Binding Proteins/metabolism ; Gelatin/chemistry ; Gene Silencing ; Humans ; Interferon-gamma/metabolism ; Interleukin-15/genetics ; Interleukin-15/metabolism ; Intestines/enzymology ; Intestines/metabolism ; Mice ; Nanoparticles/chemistry ; RNA, Small Interfering/metabolism ; Transglutaminases/genetics ; Transglutaminases/metabolism ; Tumor Necrosis Factor-alpha/metabolism
Chemical Substances	Interleukin-15 ; RNA, Small Interfering ; Tumor Necrosis Factor-alpha ; Interferon-gamma (82115-62-6) ; Gelatin (9000-70-8) ; transglutaminase 2 (EC 2.3.2.-) ; Transglutaminases (EC 2.3.2.13) ; GTP-Binding Proteins (EC 3.6.1.-)
Language	English
Publishing date	2017-08-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	2138405-8
ISSN	1543-8392 ; 1543-8384
ISSN (online)	1543-8392
ISSN	1543-8384
DOI	10.1021/acs.molpharmaceut.7b00233
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Article ; Online: Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure-Response Analyses in the Phase 3 APOLLO Trial in Patients With Hereditary Transthyretin-Mediated (hATTR) Amyloidosis.

Zhang, Xiaoping / Goel, Varun / Attarwala, Husain / Sweetser, Marianne T / Clausen, Valerie A / Robbie, Gabriel J

Journal of clinical pharmacology

2019 Volume 60, Issue 1, Page(s) 37–49

Abstract: Hereditary transthyretin-mediated (hATTR) amyloidosis is an inherited, rapidly progressive, life-threatening disease caused by deposition of abnormal transthyretin protein. Patisiran is an RNA interference therapeutic comprising a novel, small ... ...

Abstract	Hereditary transthyretin-mediated (hATTR) amyloidosis is an inherited, rapidly progressive, life-threatening disease caused by deposition of abnormal transthyretin protein. Patisiran is an RNA interference therapeutic comprising a novel, small interfering ribonucleic acid (ALN-18328) formulated in a lipid nanoparticle targeted to inhibit hepatic transthyretin protein synthesis. The lipid nanoparticle also contains 2 novel lipid excipients (DLin-MC3-DMA and PEG
MeSH term(s)	Administration, Intravenous ; Aged ; Amyloid Neuropathies, Familial/blood ; Amyloid Neuropathies, Familial/complications ; Amyloid Neuropathies, Familial/drug therapy ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Humans ; Liposomes/administration & dosage ; Liposomes/therapeutic use ; Liver/metabolism ; Male ; Middle Aged ; Nanoparticles/administration & dosage ; Nanoparticles/therapeutic use ; Polyneuropathies/drug therapy ; Polyneuropathies/etiology ; Prealbumin/antagonists & inhibitors ; Prealbumin/metabolism ; RNA, Small Interfering/administration & dosage ; RNA, Small Interfering/pharmacokinetics ; RNA, Small Interfering/therapeutic use ; RNAi Therapeutics ; Treatment Outcome
Chemical Substances	Lipid Nanoparticles ; Liposomes ; Prealbumin ; RNA, Small Interfering ; patisiran (50FKX8CB2Y)
Language	English
Publishing date	2019-07-19
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.1480
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Article: Embryonic Hypotaurine Levels Contribute to Strain-Dependent Susceptibility in Mouse Models of Valproate-Induced Neural Tube Defects.

Steele, John W / Lin, Ying Linda / Chen, Nellie / Wlodarczyk, Bogdan J / Chen, Qiuying / Attarwala, Nabeel / Venkatesalu, Madhu / Cabrera, Robert M / Gross, Steven S / Finnell, Richard H

Frontiers in cell and developmental biology

2022 Volume 10, Page(s) 832492

Abstract: Valproic acid (VPA, valproate, Depakote) is a commonly used anti-seizure medication (ASM) in the treatment of epilepsy and a variety of other neurological disorders. While VPA and other ASMs are efficacious for management of seizures, they also increase ... ...

Abstract	Valproic acid (VPA, valproate, Depakote) is a commonly used anti-seizure medication (ASM) in the treatment of epilepsy and a variety of other neurological disorders. While VPA and other ASMs are efficacious for management of seizures, they also increase the risk for adverse pregnancy outcomes, including neural tube defects (NTDs). Thus, the utility of these drugs during pregnancy and in women of childbearing potential presents a continuing public health challenge. Elucidating the underlying genetic or metabolic risk factors for VPA-affected pregnancies may lead to development of non-teratogenic ASMs, novel prevention strategies, or more targeted methods for managing epileptic pregnancies. To address this challenge, we performed unbiased, whole embryo metabolomic screening of E8.5 mouse embryos from two inbred strains with differential susceptibility to VPA-induced NTDs. We identified metabolites of differential abundance between the two strains, both in response to VPA exposure and in the vehicle controls. Notable enriched pathways included lipid metabolism, carnitine metabolism, and several amino acid pathways, especially cysteine and methionine metabolism. There also was increased abundance of ω-oxidation products of VPA in the more NTD-sensitive strain, suggesting differential metabolism of the drug. Finally, we found significantly reduced levels of hypotaurine in the susceptible strain regardless of VPA status. Based on this information, we hypothesized that maternal supplementation with L-carnitine (400 mg/kg), coenzyme A (200 mg/kg), or hypotaurine (350 mg/kg) would reduce VPA-induced NTDs in the sensitive strain and found that administration of hypotaurine prior to VPA exposure significantly reduced the occurrence of NTDs by close to one-third compared to controls. L-carnitine and coenzyme A reduced resorption rates but did not significantly reduce NTD risk in the sensitive strain. These results suggest that genetic variants or environmental exposures influencing embryonic hypotaurine status may be factors in determining risk for adverse pregnancy outcomes when managing the health care needs of pregnant women exposed to VPA or other ASMs.
Language	English
Publishing date	2022-02-21
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2737824-X
ISSN	2296-634X
ISSN	2296-634X
DOI	10.3389/fcell.2022.832492
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