AZTherapies, Inc.

Treg Cell-based Therapies refer to therapeutic approaches that utilize regulatory T cells (Tregs) to modulate the immune system. Innovations in cell expansion and engineering techniques have greatly enhanced the ability to isolate, expand, and deliver functional Tregs. Ex vivo expansion technologies and genetic engineering (such as CAR-Tregs) have opened up new possibilities for enhancing the stability, specificity, and effectiveness of Treg therapies. LAS VEGAS, Oct. 28, 2024 /PRNewswire/ -- DelveInsight's ' Treg Cell-based Therapies Pipeline Insight 2024 ' report provides comprehensive global coverage of available, marketed, and pipeline Treg cell-based therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Treg cell-based therapies pipeline domain. Key Takeaways from the Treg Cell-based Therapies Pipeline Report DelveInsight's Treg cell-based therapies pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for various indications. Key Treg cell-based therapies companies such as Orca Bio, Nektar Therapeutics, Quell Therapeutics, Cugene, Sangamo Therapeutics, Abata Therapeutics, HCW Biologics, GentiBio, Tr1X, PolTREG, Cellenkos, VT BIO, Miltenyi Biotec GmbH, KSQ Therapeutics, TeraImmune, Tract Therapeutics, and others are evaluating new Treg cell-based therapies to improve the treatment landscape. Promising Treg cell-based therapies in the pipeline in various stages of development include Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others. In October 2024, Quell Therapeutics hired eXmoor Pharma to make supplies of its pipeline of novel immunosuppressive cell therapies—called CAR-Tregs—at its new cell and gene therapy facility. Quell recently teamed with fellow U.K.-based eXmoor in a strategic partnership that will see the contractor make its candidate autoimmune disease cell therapies for early-phase clinical studies. In September 2024, Abata Therapeutics announced that ABA-101, an autologous regulatory T-cell (Treg) therapy for the treatment of patients with progressive multiple sclerosis (MS), has received fast-track designation from the US FDA. In September 2024, PolTREG S.A. announced that China's National Intellectual Property Administration, PRC (CNIPA) had issued a notification to grant a patent for the intrathecal administration of the company's cellular therapies in patients with multiple sclerosis (MS). The intrathecal administration is an established method used to deliver therapy across the blood-brain barrier via injection into the subarachnoid space. In June 2024, Orca Bio announced that it had completed enrollment in the pivotal Precision-T Phase III clinical study. The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD). In March 2024, PolTREG announced that the company is planning to launch Phase II trials testing its Tregs therapy — the T-cell-based treatment PTG-007 in people with multiple sclerosis (MS). In February 2024, Cellenkos announced encouraging safety data from its innovative CK0803 neurotrophic T regulatory (Treg) cell therapy, being developed to help treat individuals with Amyotrophic Lateral Sclerosis (ALS). The company was given the green light to move ahead following a review of safety data by the Data Safety Monitoring Board (DSMB). In August 2023, BlueRock Therapeutics LP, a wholly owned, independently operated subsidiary of Bayer AG, and bit.bio, the company coding human cells for novel cures announced a collaboration and option agreement for the discovery and manufacture of iPSC-derived regulatory T cells (Tregs) for use in creating therapeutics. Request a sample and discover the recent advances in Treg cell-based therapies @ Treg Cell-based Therapies Pipeline Outlook The Treg cell-based therapies pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Treg cell-based therapies, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Treg cell-based therapies pipeline landscape. Treg Cell-based Therapies Overview Treg cell-based therapies represent a promising frontier in immunotherapy, focusing on harnessing regulatory T cells (Tregs) to modulate the immune response in various clinical settings. Tregs play a crucial role in maintaining immune homeostasis and preventing autoimmune reactions by suppressing excessive immune responses. In the context of autoimmune diseases, these therapies aim to restore balance by expanding or enhancing Tregs to dampen inappropriate immune activity. For instance, in diseases like type 1 diabetes or multiple sclerosis, Treg cell-based treatments seek to prevent or slow disease progression by reestablishing immune tolerance. Beyond autoimmune disorders, Treg cell-based therapies are also being explored in cancer treatment. Tumors often exploit Tregs to evade immune detection, and by manipulating these cells, it's possible to enhance the anti-tumor immune response. Strategies include expanding Tregs ex vivo and reinfusing them to boost their numbers or modifying them to more effectively target tumor-associated antigens. These approaches hold the potential to improve the efficacy of existing immunotherapies and offer new avenues for treating cancers that are currently resistant to conventional treatments. Find out more about Treg cell-based therapies @ Treg Cell-based Therapies in Development A snapshot of the Treg Cell-based Therapies Pipeline Drugs mentioned in the report: Learn more about the emerging Treg cell-based therapies @ Treg Cell-based Therapies Clinical Trials Treg Cell-based Therapies Therapeutics Assessment The Treg cell-based therapies pipeline report proffers an integral view of the emerging Treg cell-based therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Treg Cell-based Therapies Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intravenous, Subcutaneous, Oral, Intramuscular Therapeutics Assessment By Molecule Type: Monoclonal antibody, Small molecule, Peptide Therapeutics Assessment By Mechanism of Action: Immunologic cytotoxicity, T lymphocyte replacements, Interleukin 2 replacements, Cell replacements Key Treg Cell-based Therapies Companies: Orca Bio, Nektar Therapeutics, Quell Therapeutics, Cugene, Sangamo Therapeutics, Abata Therapeutics, HCW Biologics, GentiBio, Tr1X, PolTREG, Cellenkos, VT BIO, Miltenyi Biotec GmbH, KSQ Therapeutics, TeraImmune, Tract Therapeutics, and others. Key Treg Cell-based Therapies in Pipeline: Orca-T, NKTR-358, QEL-001, CUG-252, TX200, ABA-101, HCW9302, GNTI-122, TRX-103, PTG-020, CK-0804, VT-301, TR-004, KSQ 001, TI-620, TRK 001, and others. Dive deep into rich insights for Treg cell-based therapies assessment, visit @ Treg Cell-based Therapies Therapeutics Assessment Table of Contents For further information on the Treg cell-based therapies pipeline therapeutics, reach out @ Treg Cell-based Therapies Pipeline Landscape Related Reports Type 1 Diabetes Market Type 1 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 1 diabetes companies, including Histogen , Novo Nordisk, Prevention Bio, among others. 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LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

GDANSK, Poland I September 26, 2024 I PolTREG S.A. (Warsaw Stock Exchange: PTG), a clinical-stage biotechnology company developing cellular therapies for a range of autoimmune diseases, today announces it has launched a study with CAR-Treg cells in a humanized mouse model of neuroinflammatory disease. Data from the study are anticipated by March 30, 2025, and will help determine the pathway to clinical evaluation. The study will measure safety and efficacy of the CAR-Treg cell therapy, which will be administered systemically as well as intrathecally. PolTREG’s CAR-Treg cells are manufactured using the same technology platform as its lead product PTG-007, a polyclonal Treg cell therapy, for which PolTREG has gathered over a decade of clinical safety and efficacy data, largely in type-1 diabetes (T1D) patients. “This first preclinical study of our CAR-Treg cell therapy program to treat neurodegenerative disease is a significant milestone for PolTREG. This may be our first CAR-Treg cell therapy candidate, but we expect it to benefit tremendously from the experience our team built up during more than a decade in manufacturing, developing and treating patients with PTG-007. This lengthy track record gives us several competitive advantages, as the next-generation engineered Tregs that we are adding to our pipeline come from the same platform, and show a large degree of bioequivalence with PTG-007. Because of our proprietary technology and expertise, we expect to be able to develop our engineered therapies with greater ease than others in this field,” said Prof Piotr Trzonkowski, Chief Executive Officer of PolTREG. PolTREG’s CAR-Treg cells are derived from its PTG-007 Treg cells, an advanced autologous polyclonal product candidate for which the company has gathered 12 years of patient safety and efficacy data in Type 1 diabetes (T1D), using its leading technological and wholly owned GMP manufacturing facility in Poland. To the best of its knowledge, PolTREG is the only company in possession of such expertise, giving it potential technical, clinical safety and efficacy advantages in the autoimmune therapy field. In an exploratory Phase 1/2a safety study in relapsing-remitting multiple sclerosis (MS), patients who had received intrathecal administration of PTG-007 showed no increase in existing lesions in the brain, and almost no new lesions, a far superior result compared to those who had received the therapy intravenously, and a surprisingly positive signal for a small study of just 14 patients. To read the 2021 results of the study, click on this link. On successful completion of preclinical testing of the CAR-Treg, PolTREG expects to initiate, as early as next year, the first-in-human trial of the engineered candidate to treat MS and amyotrophic lateral sclerosis (ALS). The company also is developing two additional modalities of engineered Treg cell therapies, Antigen-specific Tregs and T-cell receptor (TCR) Tregs for autoimmune diseases, which are in early, proof-of-concept preclinical stages. PolTREG receives three new patents Separately, the United States Patent and Trademark Office (USPTO) has granted AZTherapies, a private, late-stage clinical biopharmaceutical company developing treatments for neurological conditions, from Boston, Massachusetts, a patent for the use of CAR-Treg therapy in autoimmune neurodegenerative diseases. PolTREG holds the exclusive global license to the therapy for all indications. Also in September, the Japanese Patent Office issued a patent for PolTREG’s method of producing antigen-specific Treg cells, under the product name PTG-020. Earlier in the month, PolTREG had already announced in a press release that the Chinese Patent Office issued a patent for PolTREG’s method of administering Treg cell therapy in MS directly into the central nervous system (intrathecal administration). About PolTREG PolTREG is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. The company will launch Phase 2 trials for PTG-007 to treat Multiple Sclerosis (MS) in the second half of 2024, for RRMS and PPMS. PolTREG also has engineered Tregs, including CAR-Tregs, antigen-specific Tregs and TCR-Tregs, in the preclinical stage. PolTREG has completed four clinical trials with more than 100 patients treated with Tregs. For more information please visit www.poltreg.com. SOURCE: PolTREG

The rising demand for wireless brain sensors is largely driven by the growing occurrence of neurological disorders, including dementia and epilepsy. Furthermore, the increasing cases of traumatic brain injuries worldwide and the expanding elderly population are significant factors contributing to the wireless brain sensors market's growth from 2024 to 2030. LAS VEGAS, Aug. 26, 2024 /PRNewswire/ -- DelveInsight's Wireless Brain Sensors Market Insights report provides the current and forecast market analysis, individual leading wireless brain sensors companies' market shares, challenges, wireless brain sensors market drivers, barriers, trends, and key market wireless brain sensors companies in the market. Key Takeaways from the Wireless Brain Sensors Market Report As per DelveInsight estimates, North America is anticipated to dominate the global wireless brain sensors market during the forecast period. In the product type segment of the wireless brain sensors market, the devices category had a significant revenue share in the wireless brain sensors market in 2023. Notable wireless brain sensors companies such as NeuroSky, Advanced Brain Monitoring Inc., Koninklijke Philips N.V., Natus Medical Incorporated, NeuroWave Systems Inc., EMOTIV, BrainScope, InteraXon Inc., Cadwell Industries Inc., Neuroelectrics, Neuronetrix Solutions, LLC, Muse, and several others, are currently operating in the wireless brain sensors market. In May 2021, Neuroelectrics, a leader in brain stimulation technology development, raised USD 17.5 million in a Series A round led by Morningside Ventures. To read more about the latest highlights related to the wireless brain sensors market, get a snapshot of the key highlights entailed in the Global Wireless Brain Sensors Market Report Wireless Brain Sensors Overview Wireless brain sensors are a cutting-edge technology in the field of neuroengineering, designed to monitor brain activity without the need for cumbersome wires. These sensors can transmit data in real-time to external devices, enabling continuous monitoring of neural activity in a less invasive manner than traditional wired systems. They are often used in research to study brain functions, diagnose neurological disorders, and monitor patients with conditions such as epilepsy or Parkinson's disease. The wireless nature of these sensors allows for greater freedom of movement for patients, making long-term monitoring more feasible and less intrusive. The development of wireless brain sensors also opens new possibilities in brain-computer interface (BCI) technology. BCIs allow direct communication between the brain and external devices, which can be revolutionary for individuals with severe motor impairments. By using wireless brain sensors, these interfaces can become more practical and comfortable, paving the way for advancements in assistive technologies, such as controlling prosthetic limbs or computers through thought alone. Moreover, the miniaturization and increased sophistication of these sensors continue to improve their accuracy and reliability, making them a promising tool for both clinical applications and scientific research. Wireless Brain Sensors Market Insights North America dominated the wireless brain sensors market in 2023 among all regions, primarily due to the high incidence of neurological disorders. Contributing factors include favorable reimbursement policies, extensive research and development efforts, and a highly viable market for product development and launches. According to the Centers for Disease Control and Prevention (CDC) in 2023, 6.7 million Americans are living with Alzheimer's disease, a number expected to nearly triple to 14 million by 2060. Additionally, a May 2023 report by the United States Census Bureau indicated that the U.S. population aged 65 and over grew nearly five times faster than the total population from 1920 to 2020, reaching 55.8 million or 16.8% of the U.S. population in 2020. Aging naturally leads to changes in the brain, such as cell shrinkage and reduced blood flow, which can impair cognitive function and increase the risk of dementia. This underscores the significant need for the detection and diagnosis of such conditions, thereby boosting the demand for wireless brain sensors in the United States and, consequently, in North America. Moreover, key product launches and approvals in the region are further driving market growth. For instance, in February 2022, Masimo received FDA approval for the SedLine Pediatric EEG Sensor, extending its benefits to all patients aged one year and older in the United States. In summary, the combination of these factors and the ongoing introduction of new products and approvals are pivotal in driving North America's wireless brain sensors market during the forecast period. To know more about why North America is leading the market growth in the wireless brain sensors market, get a snapshot of the Wireless Brain Sensors Market Outlook Wireless Brain Sensors Market Dynamics The wireless brain sensors market is witnessing significant growth, driven by advancements in neurotechnology and a rising prevalence of neurological disorders. These sensors are pivotal in monitoring brain activity in a non-invasive manner, providing critical data for diagnosing and managing conditions like epilepsy, Parkinson's disease, and brain injuries. The increasing geriatric population, which is more susceptible to neurological ailments, further fuels the demand for innovative diagnostic and therapeutic solutions, propelling the expansion of this market. One of the primary market dynamics is technological innovation. The integration of wireless technology with brain sensors has revolutionized patient care by enabling continuous, real-time monitoring without the need for cumbersome wires. This enhances patient comfort and compliance, particularly in long-term monitoring scenarios. Moreover, advancements in miniaturization and biocompatibility of sensors have improved their safety and efficacy, broadening their application range from clinical settings to home healthcare environments. Companies are investing heavily in research and development to introduce more sophisticated, accurate, and user-friendly devices, which in turn accelerates market growth. Regulatory support and funding also play a crucial role in shaping the wireless brain sensors market. Governments and healthcare organizations worldwide are recognizing the potential of these sensors in improving patient outcomes and reducing healthcare costs. Consequently, there is an i ncrease in funding for research initiatives and favorable regulatory frameworks that streamline the approval process for new devices. This supportive environment encourages more companies to enter the market and innovate, fostering competitive dynamics and pushing the boundaries of what is technologically possible. However, challenges such as high costs and concerns regarding data privacy and security can impact wireless brain sensors market dynamics. The development and production of advanced wireless brain sensors involve significant investment, making them expensive and potentially limiting their accessibility. Additionally, as these devices generate and transmit sensitive neurological data, ensuring robust cybersecurity measures is paramount to protect patient information from breaches and misuse. Addressing these issues is critical for maintaining market momentum and gaining widespread acceptance among both healthcare providers and patients. In conclusion, the wireless brain sensors market is poised for robust growth, driven by technological advancements, an aging population, and supportive regulatory frameworks. While challenges such as high costs and data security need to be managed, the overall outlook remains positive. Continuous innovation and strategic collaborations among industry players are expected to further enhance the capabilities and accessibility of wireless brain sensors, ultimately transforming the landscape of neurological care and improving patient outcomes. Get a sneak peek at the wireless brain sensors market dynamics @ Wireless Brain Sensors Market Dynamics Analysis Wireless Brain Sensors Market Assessment Wireless Brain Sensors Market Segmentation Wireless Brain Sensors Market Segmentation By Product Type: Devices and Accessories Wireless Brain Sensors Market Segmentation By Application: Traumatic Brain Injury (TBI), Dementia, Epilepsy, and Others Wireless Brain Sensors Market Segmentation By End Users: Hospitals, Clinics, and Others Wireless Brain Sensors Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the wireless brain sensors market are set to emerge as the trendsetter explore @ Wireless Brain Sensors Companies Table of Contents Interested in knowing the wireless brain sensors market by 2030? 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About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP