Drug Target Review

APRIL 22, 2024

Despite excellent pharmacokinetic and stable antibody-linker connections, such ADCs have yet to receive market approval. How do the selection of linkers and conjugation sites impact the pharmacokinetics and therapeutic window of an ADC? This approach offers the advantage of using chemical modification.

Pharmacokinetics 75

Pharmacokinetics Drugs Organic Chemistry Engineering 75

The Pharma Data

JULY 2, 2025

Promising Results from Phase 1b Trial The Phase 1b study was a multicenter, randomized, double-blind, placebo-controlled clinical trial specifically designed to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of ARGX-119 in individuals with DOK7-related CMS. Peter Ulrichts, Ph.D.,

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DrugBank

OCTOBER 17, 2024

Data Science in Lead Optimization and Drug Design Data science accelerates the lead optimization and drug design process, transforming how molecules are engineered for therapeutic applications. These complex molecules require precise engineering to ensure optimal efficacy and safety.

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Drug Development Metabolic Stability Clinical Trials Drugs 98

Drug Hunter

MAY 18, 2023

From a childhood in a small village in China’s northeast Shandong province to her work examining the drug metabolism and pharmacokinetics (DMPK) of antibody-drug conjugates (ADCs) and Bicycle toxin conjugates ® (BTCs), Dian has always looked to forge something new. Dian recalls. But I didn’t want to take that as my fate.”

Small Molecule 131

Small Molecule DNA Pharmacokinetics Engineering 131

The Pharma Data

DECEMBER 17, 2020

Merck will select cancer targets and harness Janux’s proprietary Tumor Activated T Cell Engager (TRACTr) technology to engineer novel, T cell engager drug candidates. Previous technologies have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy.

Immune Response 52

Immune Response Pharmacokinetics Engineering Licensing 52

Drug Target Review

JUNE 12, 2023

What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties? ISM6331 is a Pan-TEAD inhibitor with novel scaffold with good IP space, discovered by Chemistry42.

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

Drug Target Review

OCTOBER 8, 2024

The OncoOne team is engineering antibodies to optimize pharmacokinetics, biodistribution, tumour retention, and target specificity. Pharmacokinetics and Dosimetry Studies for Optimization of Pretargeted Radioimmunotherapy in CEA-Expressing Advanced Lung Cancer Patients. Journal of Nuclear Medicine. 2016 May 26;57(10):1505–11.

Pharmacokinetics 52

Pharmacokinetics Engineering Treatment Science 52

The Pharma Data

JANUARY 17, 2021

Because the Jh mouse cannot produce ADA, there is no neutralizing or pharmacokinetic impact on the therapeutic or anaphylaxis risk. Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services.

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Immune Response Pharmacokinetics Engineering Licensing 40

DrugBaron

FEBRUARY 7, 2022

But because the synthetic effort is the engine of the program, much of that effort is wasted because the thinking came AFTER the compound generation. Most of these molecules however turn out to be rather poor in one way or another when they are tested – often in ways that could have easily been predicted from the burgeoning SAR.

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Small Molecule Synthetic Chemistry Pharma Companies Pharmacokinetics 100

The Pharma Data

NOVEMBER 18, 2020

SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties. This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels.

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Trials Engineering Pharmacokinetics Therapies 40

The Pharma Data

JULY 6, 2021

Population pharmacokinetic and pharmacodynamic modeling data to characterize the antithrombin (AT) lowering dynamics in hemophilia patients treated with fitusiran will be shared in a poster presentation. These data support the revised fitusiran dose and dosing regimen implemented in the ongoing adult and adolescent studies.

Therapies 52

Therapies Pharmacokinetics Treatment RNA 52

DrugBank

FEBRUARY 12, 2025

This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients. Animal Models In vivo studies in animal models assess drug activity, pharmacokinetics, and safety in a living organism.

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Cell Based Assays Drugs Pharmacokinetics Disease 52

The Pharma Data

OCTOBER 27, 2020

Be Bio plans to use their $52 million Series A to precisely engineer B cells to treat a range of diseases. million Series A gives it the capital to take their PRTX007 candidate into a short-term pharmacokinetic, pharmacodynamic and tolerability study, followed by a clinical proof-of-concept in an acute viral disease setting.

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Small Molecule Immune Response Clinical Development Therapies 52

The Pharma Data

AUGUST 9, 2021

Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

International 52

International Treatment Pharmacokinetics Therapies 52

New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] “Safety, tolerability, and pharmacokinetic evaluation of single- and multiple-ascending doses of a novel kappa opioid receptor antagonist LY2456302 and drug interaction with ethanol in healthy subjects” Journal of Clinical Pharmacology. nM vs. 24.0

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Molecular Design

MARCH 26, 2024

To this I’d add that we often don’t use the full-length proteins in design and recombinant proteins may have been engineered to make them easier to crystallize or more robust for soaking experiments. In drug discovery truth may also be a compound that, despite an excellent pharmacokinetic profile, chokes comprehensively in phase 2.]

Drugs 60

Drugs Pharmacokinetics Cell Based Assays Treatment 60

The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. chief executive officer of Teneobio.

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Production Clinical Trials Government Disease 52

Practical Cheminformatics

JANUARY 8, 2024

No member company will agree to use a representation that can potentially be reverse-engineered to reveal the chemical structures of its molecules. In addition to optimizing potency against a target of interest, we must design selective compounds with optimal pharmacokinetic profiles and a host of other desirable properties.

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The Pharma Data

JANUARY 4, 2021

Innate has been a pioneer in the understanding of natural killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. IPH6101/SAR443579 is a NKp46-based NK cell engager (NKCE) using Innate’s proprietary multispecific antibody format (Gauthier et al. Cell 2019 ).

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Drugs Cell Biology Pharmacokinetics Clinical Trials 40

The Pharma Data

NOVEMBER 22, 2020

The DARPin® platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. About Molecular Partners’ anti-COVID-19 program. DARPin® therapeutics have been clinically validated through to the registrational stage.

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Trials Clinical Trials Licensing Licensing 40

Alta Sciences

APRIL 17, 2024

We have significant expertise in analyzing pharmacokinetic, pharmacodynamic, and anti-drug antibody endpoints from the preclinical phase to clinical trials. ASO Resources Read this case study about resolving issues with matrix effect in ASO detection Read The Altascientist, “Antisense Oligonucleotides” 4. Asia, and Europe.

Drug Development 52

Drug Development Treatment Drugs FDA Approval 52

The Pharma Data

OCTOBER 27, 2020

In October 2020 , we completed a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. our initial phase 1 study of OreniPro , which has since been completed. We also recommenced startup activities for the ADVANCE CAPACITY study of ralinepag.

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FDA Production Licensing Licensing 40

Drug Target Review

JUNE 5, 2023

ZW191 is an antibody-drug conjugate (ADC) that is engineered to target folate receptor-⍺ (FR⍺), a protein that has limited expression in normal tissues but is often elevated on a variety of tumours including epithelial ovarian, endometrial, triple negative breast and lung adenocarcinoma.

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Treatment Pharmacokinetics Drugs Cell Biology 100

The Premier Consulting Blog

DECEMBER 16, 2024

Pharmacokinetics and pharmacodynamics :Pharmacokinetics (PK) assess how a drug is absorbed, distributed, metabolized, and excreted by the body. GEN – Genetic Engineering and Biotechnology News. For example, a narrow therapeutic window occurs when the difference between the effective dose and the toxic dose is small.

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Pharmacokinetics Clinical Trials Drug Development Pharmaceutical Companies 52

ASPET

JANUARY 22, 2024

Profiling NT-0796 in mice humanized with respect to CES-1 biology enables critical modeling of the pharmacokinetics and pharmacodynamics of this novel therapeutic candidate. To study pharmacodynamics of NT-0796 in vivo, a mouse line was engineered possessing more human-like traits with respect to carboxylesterase biology.

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Pharmacokinetics DNA Engineering International 100

DrugBank

FEBRUARY 26, 2025

Advances in genetic engineering have enabled researchers to enhance bacteriophage efficacy and overcome bacterial resistance mechanisms. Our platform offers an extensive database of drug interactions, molecular targets, and pharmacokinetics, providing researchers with the tools to identify and optimize effective compounds.

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Therapies Pharmaceutical Companies Pharmacokinetics Treatment 52

Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Read Biological Engineering mScarlet3: a brilliant and fast-maturing red fluorescent protein. CRISPRi-mediated tunable control of gene expression level with engineered single-guide RNA in Escherichia coli.

DNA 52

DNA RNA Engineering Licensing 52

The Pharma Data

DECEMBER 13, 2020

Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2. The companies filed in December 2019, and included analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data from two clinical trials.

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FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

APRIL 27, 2021

The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). About the Phase 1/2 Trial. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

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FDA Treatment Pharmaceutical Companies Therapies 52

DrugBank

FEBRUARY 5, 2025

Conversely, conjugation involves chemically attaching the drug to the nanoparticle surface, allowing for targeted delivery and improved pharmacokinetics. They can be engineered with different sizes, shapes, and surface chemistries, allowing for precise control over drug loading and release kinetics.

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Drugs Engineering Vaccine Treatment 52

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

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The Pharma Data

SEPTEMBER 15, 2020

With the depth and breadth of our current portfolio, the tremendous potential of our pipeline and scientific engine, and the power of our culture of innovation, we are poised to continue delivering meaningful value to patients by addressing some of the world’s most difficult health challenges.”.

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Drug Target Review

APRIL 25, 2025

19 Multi-organ CIVMs provide several new opportunities in ADME including in vitro bioavailability predictions, assessment of the effect of gut microbiome on hepatic drug metabolism, and prediction of the pharmacokinetic (PK) profile in humans in early pre-clinical stage. AAPS J 24 (2022). link] [5] Pike A, Williamson B, Harlfinger S, et al.

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Clinical Development Small Molecule Drugs FDA Approval 52

The Pharma Data

MARCH 26, 2021

Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection. About the Vir and GSK Collaboration.

Treatment 52

Treatment FDA Vaccine Trials 52

The Pharma Data

MAY 7, 2021

Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection. About the Vir and GSK Collaboration.

Treatment 40

Treatment Virus Vaccine Trials 40

New Drug Approvals

APRIL 21, 2025

“Bridgebio’s Attruby, to Treat Heart Condition ATTR-CM, Receives FDA Approval” Genetic Engineering and Biotechnology News. Retrieved 21 January 2025. Jump up to: a b LeMieux J (25 November 2024). 25 November 2024. . 9 (1): 115129. doi : 10.1002/cpdd.700. PMC 7003869. PMID 31172685. Epub 2013 May 28. Clin Pharmacol Drug Dev.

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