Solutions
Protheragen is a premier, full-service solutions provider dedicated to advancing the development of drugs and therapies for autoimmune diseases. We offer a comprehensive suite of services, including preclinical studies and disease model development services, to provide seamless support for your projects. Additionally, our extensive collection of human specimens, sourced from both healthy individuals and patients with autoimmune diseases, serves as a valuable resource to accelerate your drug and therapy development efforts in this specialized field.
Fig.1 Schematic diagram of the stages of autoimmune disease. (Pisetsky D. S., 2023)
Overview of Autoimmune and Inflammation Diseases
Autoimmune and inflammatory diseases represent a wide array of conditions where the immune system mistakenly targets the body’s own tissues, causing chronic inflammation and tissue damage. These disorders can impact nearly any organ system, though they are more commonly seen in women, with a few exceptions like Guillain-Barré syndrome and ankylosing spondylitis. The development of these diseases is driven by a complex interaction between genetic predisposition and environmental factors. Genetic elements, particularly HLA genes, shape the immune response, while environmental triggers such as infections, smoking, diet, and gut microbiota imbalances can set off the disease. Inflammatory mediators like TNF-α, IL-6, and IL-17 are key players in the disease’s progression.
Targets of Autoimmune and Inflammation Disease Therapeutics
The development of effective therapeutics for autoimmune and inflammatory diseases necessitates a thorough comprehension of the underlying mechanisms. Several key targets have been identified as promising candidates for therapeutic intervention.
Cytokines
Cytokines are small proteins that play a crucial role in regulating the immune response. They are produced by various immune cells and act as signaling molecules to modulate inflammation and immune cell activity. In autoimmune and inflammation diseases, certain cytokines are often overproduced, leading to excessive inflammation and tissue damage.
Intracellular Signaling Pathways
Intracellular signaling pathways are involved in the regulation of immune cell activation and function. Dysregulation of these pathways can contribute to the development of autoimmune and inflammation diseases. Targeting specific signaling molecules or pathways has the potential to modulate the immune response and reduce inflammation.
B Cells and T Cells
B cells and T cells are two major types of immune cells that play a central role in the immune response. In autoimmune diseases, B cells can produce autoantibodies that attack the body's own tissues, while T cells can directly attack and damage tissues. Targeting B cells and T cells has emerged as a promising therapeutic approach for autoimmune and inflammation diseases.
Other Targets
In addition to the above-mentioned targets, several other molecules and pathways have been identified as potential therapeutic targets for autoimmune and inflammation diseases. These include chemokines, which are involved in immune cell migration, and adhesion molecules, which are involved in immune cell interactions.
Therapeutics Development for Autoimmune and Inflammation Diseases
Therapeutic advancements for autoimmune and inflammatory diseases have primarily centered on targeting key inflammatory mediators. Both biologics and small-molecule inhibitors have been developed to effectively modulate these pathways. Monoclonal antibodies that target TNF-α (such as Infliximab and Adalimumab), IL-6 (such as Tocilizumab), and IL-17 (such as Secukinumab) are now widely used. These biologics have transformed autoimmune disease therapeutics by offering highly specific targeted therapies. Small molecule inhibitors, including JAK inhibitors (such as Tofacitinib) and small molecule TNF-α inhibitors (such as PF-06650833), provide an alternative to biologics, often with more convenient dosing schedules. Additionally, emerging approaches like siRNA and CRISPR/Cas9 are being investigated for their potential in treating autoimmune diseases.
Table 1. The antibodies that could be used to treat autoimmune diseases (AIDs). (Xiang, Y., et al., 2023)
|
Class |
Name |
Target |
Type |
Major indication |
Research stage |
|---|---|---|---|---|---|
TNF inhibitor |
Infliximab |
TNF-α |
mAb |
RA, CD, UC, AS, psoriasis |
marketed |
Golimumab |
TNF |
mAb |
RA, psoriatic arthritis, AS, UC |
marketed |
|
Etanercept |
TNF |
fusion protein |
AS, psoriasis, juvenile idiopathic arthritis, RA |
marketed |
|
Certolizumab pegol |
TNF |
mAb |
CD, RA, AS |
marketed |
|
Adalimumab |
TNF |
mAb |
RA, AS, CD, UC, psoriasis |
marketed |
|
Ozoralizumab |
TNF-α |
nanobody |
RA |
marketed |
|
IL-6 inhibitor |
Tocilizumab |
IL-6R |
mAb |
RA, juvenile idiopathic arthritis, CD, SLE, SSc |
marketed |
Sarilumab |
IL-6R |
mAb |
RA |
marketed |
|
Clazakizumab |
IL-6 |
mAb |
RA |
phase III |
|
Siltukumab |
IL-6 |
mAb |
RA, SLE |
phase III |
|
Olokizumab |
IL-6 |
mAb |
RA |
phase III |
|
ALX-0061 |
IL-6R, HAS |
nanobody |
RA |
phase II |
|
IL-1 inhibitor |
Anakinra |
IL-1R |
recombinant IL-1Ra |
RA, NOMID |
marketed |
Rilonacept |
IL-1β |
fusion protein |
recurrent pericarditis, CAPS, sJIA |
marketed |
|
Canakinumab |
IL-1β |
mAb |
CAPS, sJIA |
marketed |
|
Gevokizumab |
IL-1β |
mAb |
autoinflammatory diseases |
marketed |
|
IL-17 inhibitor |
Secukinumab |
IL-17A |
mAb |
PsA, AS, psoriasis, PSO, axSpA |
marketed |
Ixekizumab |
IL-17A or IL-17A/F |
mAb |
PsA, AS, psoriasis, PSO, axSpA |
marketed |
|
Brodalumab |
IL-17R |
mAb |
Psoriasis, PsA |
marketed |
|
Bimekizumab |
IL-17A, IL-17F |
mAb |
PSO, PsA, AS, axSpA |
marketed |
|
Sonelokimab |
IL-17A/F |
nanobody |
PsA, PSO |
phase II |
|
Netakimab |
IL-17A |
mAb |
PSO, AS |
phase III |
|
Vunakizumab |
IL-17A |
mAb |
PSO |
phase III |
|
CNT06785 |
IL-17A |
mAb |
RA |
phase II |
|
COVA322 |
TNF; IL-17A |
FynomAb |
PsA |
phase I |
|
ABT-122 |
TNF; IL-17A |
mutant immunoglobulin (DVD-Ig™) molecule |
RA, PsA |
phase II |
|
CJM112 |
IL-17A |
mAb |
PSO |
phase I |
|
IL-12/23 inhibitor |
Ustekinumab |
IL-12/23 p40 |
mAb |
CD, UC, PsA, PSO |
marketed |
Guselkumab |
IL-23 p19 |
mAb |
PsA, PSO, IBD |
marketed |
|
Tildrakizumab |
IL-23 p19 |
mAb |
PSO, PsA |
marketed |
|
Risankizumab |
IL-23 |
mAb |
PSO, PsA, CD |
marketed |
|
Mirikizumab |
IL-23 p19 |
mAb |
UC |
marketed |
Disclaimer: Protheragen focuses on providing preclinical research services. This table is for information exchange purposes only. This table is not a treatment plan recommendation. For guidance on treatment options, please visit a regular hospital.
Diversified Disease Solutions
At Protheragen, we provide comprehensive end-to-end solutions to expedite advancements in the realm of rare movement and neurological disorders. Backed by a team of seasoned experts and cutting-edge technology, we are steadfast in delivering holistic support for our clients’ research endeavors, seamlessly bridging the transition from early discovery to preclinical validation.
Diagnostic Development Services
At Protheragen, we recognize the critical role of accurate diagnostics in the management of autoimmune and inflammatory diseases. Our diagnostic development services encompass a broad spectrum of capabilities, including biomarker development and diagnostic kit development. We specialize in identifying and validating novel biomarkers that can serve as early indicators of disease onset, progression, and therapeutic response. By utilizing advanced technologies such as next-generation sequencing and multiplex assays, we ensure that our biomarkers are highly specific and sensitive. Our diagnostic kit development services are designed to translate these biomarkers into practical tools, providing reliable and rapid diagnostic solutions.
- Biochemistry Diagnostic Kits
- Immunodiagnostic Kits
- Molecular Diagnostic kits
- Customized Diagnostic kits
- Genomics-based Biomarker
- Transcriptomics-based Biomarker
- Proteomics-based Biomarker
- Metabolomics-based Biomarker
Therapeutics Development Services
Protheragen excels in the development of innovative therapeutics for autoimmune and inflammatory diseases, offering a diverse range of services to meet the evolving needs of our clients. Our therapeutics development services include small-molecule drug development, therapeutic antibody development, and cell therapy development. By integrating these diverse approaches, Protheragen is committed to advancing the frontiers of therapeutic innovation for autoimmune and inflammatory diseases.
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- Polyclonal Antibody Development
- Monoclonal Antibody Development
- Bispecific Antibody (BsAb) Development
- Antibody-Drug Conjugates Development
- Single Domain Antibody Development
-
- Autologous Cell Therapy Development
- Allogeneic Cell Therapy Development
- iPSC-Derived Cell Therapy Development
-
- DNA-based Therapy Development
- RNA-based Therapy Development
- CRISPR/Cas9-based Therapy Development
-
- Lactobacillus Rhamnosus
- Bifidobacterium Adolescentis
- Lactobacillus
- Saccharomyces Boulardii
-
- Fusion Protein Development
- Recombinant Protein Development
Autoimmune Disease Model Development Services
Protheragen offers a comprehensive suite of autoimmune disease model development services, including cell-based models, animal models, and organoid models. Our cell-based models utilize primary and immortalized cell lines to recapitulate key aspects of the disease, allowing for high-throughput screening of drug candidates. Our animal models, ranging from genetically modified mice to large animal models, provide in vivo validation of therapeutic efficacy and safety. Additionally, our organoid models, which are derived from patient tissues, offer a highly physiologically relevant platform for studying disease mechanisms and testing personalized therapies. By providing a diverse array of disease models, Protheragen ensures that our clients have access to the most advanced tools for accelerating their research and development efforts.
-
Cell-based Model Development
- Cell Line Development
- Primary Cell Development
- iPSC Development
-
Organoid Model Development
- ASC-derived Organoid
- ESC-derived Organoid
- iPSC-derived Organoid
- Patient-derived Organoid
-
Animal Model Development
- Genetically Engineering Model
- Humanized Animal Model
- Induced Disease Model
- Surgery Model
Customized Solutions
From early-stage target identification to preclinical development, Protheragen offers a comprehensive suite of services tailored to meet the unique needs of each client. Our commitment to innovation and excellence ensures that we stay at the leading edge of autoimmune and inflammation disease research, driving forward the development of next-generation therapeutics.
Preclinical Research Services
Preclinical research forms the cornerstone of successful therapeutic development, and Protheragen offers a comprehensive suite of preclinical research services to support our clients' needs. Our services include drug safety evaluation, pharmacokinetics studies, and efficacy testing. Our drug safety evaluation services utilize a combination of in vitro and in vivo assays to assess the potential toxicities of drug candidates, ensuring that only safe and effective compounds proceed to clinical trials. Our pharmacokinetics studies provide detailed insights into the absorption, distribution, metabolism, and excretion of drugs, enabling the optimization of dosing regimens and improving therapeutic efficacy. By integrating these preclinical research services, Protheragen is committed to providing our clients with the highest quality data to support their therapeutic development programs and accelerate the path to clinical success.
- General Toxicity Evaluation
- Genetic Toxicity Evaluation
- Developmental and Reproductive Toxicity Evaluation
- Immunotoxicity Evaluation
- Safety Pharmacology Evaluation
- Toxicokinetic Evaluation
-
In Vitro Pharmacokinetics Study Services
-In Vitro Physicochemical Studies
-In Vitro Metabolism Studies
-In Vitro Permeability and Transporter Studies -
In Vivo Pharmacokinetics Study Services
-Bioavailability Studies
-Quantitative Tissue
-Drug Excretion Studies
Human Biospecimen Products
Protheragen’s biofluid catalog spans an extensive range of sample types, from whole blood and serum/plasma to urine, cerebrospinal fluid, saliva, and more. This comprehensive selection provides researchers with the flexibility to address a vast array of disease indications. Whether you are unraveling the pathogenesis of autoimmune diseases, identifying novel therapeutic targets in oncology, or exploring the microbiome's role in infectious diseases, our human biofluid products are designed to be the essential key that unlocks your next scientific breakthrough.
Product Features
- Diverse Collection Sites: Our network of collection sites allows for a rapid and efficient response to client needs, ensuring a diverse and representative sample pool.
- Ethical Sourcing: We are committed to ethical sourcing practices, ensuring that all samples are acquired with respect for donor privacy and dignity, in compliance with relevant standards and regulations.
- Preservation Expertise: Our cryopreservation and stabilization techniques ensure the long-term viability and integrity of our biospecimens, enabling high-quality analysis and reproducible results.
FAQs
-
What makes Protheragen's approach to autoimmune and inflammatory disease therapeutics unique compared to other companies?
Protheragen's unique approach lies in our comprehensive and multidisciplinary strategy. We integrate cutting-edge research across genomics, proteomics, and immunology with practical therapeutic development. Our services are designed to address the full spectrum of autoimmune and inflammatory diseases, from early-stage research to preclinical development. By offering a diverse range of solutions, including biomarker discovery, disease model development, and innovative therapeutics, we provide a holistic approach that sets us apart from other companies.
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What role do biomarkers play in Protheragen's diagnostic development services for autoimmune and inflammatory diseases?
Biomarkers are a cornerstone of Protheragen's diagnostic development services. They serve as critical indicators of disease presence, progression, and response to treatment. By identifying and validating highly specific and sensitive biomarkers, we can develop diagnostic tools that enable early detection, accurate diagnosis, and personalized therapeutic plans. Our biomarker development leverages advanced technologies such as next-generation sequencing and multiplex assays to ensure the highest level of accuracy and reliability.
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How does Protheragen ensure the relevance and accuracy of its disease models for autoimmune and inflammatory research?
Protheragen ensures the relevance and accuracy of our disease models through a combination of advanced technologies and rigorous validation processes. Our cell-based models use primary human cells and tissues to closely mimic the disease environment. Our animal models are carefully selected and genetically engineered to reflect key aspects of human autoimmune and inflammatory diseases. Additionally, our organoid models, derived from patient tissues, provide a highly physiologically relevant platform for studying disease mechanisms and testing potential therapies. Each model undergoes thorough validation to ensure it accurately reflects the disease pathology and therapeutic response.
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Can Protheragen assist with the development of novel cell therapies for autoimmune and inflammatory diseases?
Absolutely. Protheragen specializes in cell therapy development services, focusing on innovative approaches to modulate the immune system for treating autoimmune and inflammatory diseases. We have expertise in developing CAR-T cells, regulatory T cells, and other cellular therapies that can target specific immune pathways involved in these diseases. Our cell therapy development services include cell engineering, preclinical testing, and optimization of therapeutic efficacy and safety. By leveraging our advanced technologies and extensive experience, we help clients bring novel cell therapies from concept to clinical application.
Contact
Please feel free to contact us for information about our services or to ask any questions you may have in your autoimmune disease therapy development.