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For more than 30 years, Cabling Installation & Maintenance has provided useful, practical information to professionals responsible for the specification, design, installation and management of structured cabling systems serving enterprise, data center and other environments. These professionals are challenged to stay informed of constantly evolving standards, system-design and installation approaches, product and system capabilities, technologies, as well as applications that rely on high-performance structured cabling systems. Our editors synthesize these complex issues into multiple information products. This portfolio of information products provides concrete detail that improves the efficiency of day-to-day operations, and equips cabling professionals with the perspective that enables strategic planning for networks’ optimum long-term performance.

Throughout our annual magazine, weekly email newsletters and 24/7/365 website, Cabling Installation & Maintenance digs into the essential topics our audience focuses on.

  • Design, Installation and Testing: We explain the bottom-up design of cabling systems, from case histories of actual projects to solutions for specific problems or aspects of the design process. We also look at specific installations using a case-history approach to highlight challenging problems, solutions and unique features. Additionally, we examine evolving test-and-measurement technologies and techniques designed to address the standards-governed and practical-use performance requirements of cabling systems.
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Cabling Installation & Maintenance is published by Endeavor Business Media, a division of EndeavorB2B.

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Kashiv Biosciences Announces Successful Phase 1 Study Results of ADL018, A Biosimilar Candidate to Xolair® (omalizumab)

By: via Business Wire
  • ADL018 (omalizumab biosimilar) is Kashiv’s next biosimilar candidate in pipeline, after receiving FDA approval for Releuko® and Fylnetra® in 2022.

Kashiv Biosciences, LLC (“Kashiv” or the “Company”) today announced that ADL018, a biosimilar candidate to Xolair® (omalizumab), completed a successful global Phase 1 clinical study in healthy volunteers.

“We are proud to announce positive Phase 1 results for our third biosimilar candidate, omalizumab. This is a significant step for Kashiv towards achieving its mission of developing high-quality, biosimilar products that are widely accessible and improve patients’ lives. We are looking forward to initiating dosing in the global Phase 3 study soon in chronic spontaneous urticaria (CSU) patients. In parallel, we are actively seeking commercial partners globally to maximize the potential of this drug,” said Dr. Sandeep Gupta, CEO of Kashiv. According to IQVIA®, worldwide and U.S. annual sales for Xolair® for the 12 months ended December 2022 were ~$4.0 billion and $2.8 billion, respectively.

In the Phase 1, randomized, double-blind, comparative pharmacokinetic (PK) study, subjects received either ADL018, EU-approved omalizumab, or US-licensed omalizumab via subcutaneous injection. The primary objective of this study was to demonstrate PK similarity by assessing the area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax) and compare the safety and tolerability. The secondary objectives were to investigate the pharmacodynamic (PD) activity (total and free IgE levels) and immunogenicity between three treatment groups.

“For all comparisons of primary endpoints (AUCinf and Cmax), the 90% confidence intervals (CIs) of the geometric least squares means ratio were fully contained within the pre-defined equivalence margin of 0.80-1.25. The IgE levels, safety profiles and immunogenicity were also comparable among the three treatment groups. The successful completion of this study further demonstrates the excellent capabilities of Kashiv R&D team in developing biosimilar and complex products,” stated Dr. Chandramauli Rawal, COO of Kashiv.

About ADL018

ADL018 is a monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® (omalizumab), an injectable prescription medicine approved to treat chronic spontaneous urticaria (CSU) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. Omalizumab is also approved to treat moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids; and chronic rhinosinusitis with nasal polyps in people 18 years of age and older.

ADL018 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as United States and European Union (EU)-approved omalizumab.

About Kashiv Biosciences, LLC

Kashiv Biosciences, LLC is a fully integrated biopharmaceutical company with global R&D, clinical, regulatory, and manufacturing capabilities for developing biosimilars and other complex products. The Company has a robust pipeline of seven biosimilars, and multiple 505(b)(2) and complex peptide generic products in development. Kashiv is headquartered in Piscataway, NJ with FDA-approved GMP manufacturing facilities in Chicago, IL and state-of-the-art R&D infrastructure in Ahmedabad, India.

For more information, visit www.kashivbiosciences.com.

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