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

• 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 (AUC_inf) and maximum serum concentration (C_max) 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 (AUC_inf and C_max), 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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