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Immunotherapy – a Novel Facet of Modern Therapeutics Immunotherapy – a Novel Facet of Modern Therapeutics Sujata P Sujata P. Sawarkar Vandana S. Nikam Shariq Syed Editors Immunotherapy – A Novel Facet of Modern Therapeutics Immunotherapy – A Novel Facet of Modern Therapeutics Sujata P. Sawarkar • Vandana S. Nikam • Shariq Syed Editors Immunotherapy – A Novel Facet of Modern Therapeutics Editors Sujata P. Sawarkar Vandana S. Nikam Department of Pharmaceutics Department of Pharmacology, STES’s Smt. SVKM’s Dr. Bhanuben Kashibai Navale College of Pharmacy Nanavati College of Pharmacy S. P. Pune University Mumbai, Maharashtra, India Pune, Maharashtra, India Shariq Syed School of Pharmacy Anjuman-I-Islam’s, Kalsekar Technical Campus Mumbai, Maharashtra, India ISBN 978-981-15-9037-5 ISBN 978-981-15-9038-2 (eBook) https://doi.org/10.1007/978-981-15-9038-2 # Springer Nature Singapore Pte Ltd. 2021 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore Contents 1 Immunotherapy: A Concept .............................. 1 Vritika Kulwal and Sujata Sawarkar 2 Immunotherapy in Cancer: Immune Checkpoint Inhibitors; Changing Oncology Treatment Paradigm .................... 21 Shariq Syed 3 Vaccines as Immunotherapy .............................. 31 Pratik Ogale, Vandana S. Nikam, Manish Gautam, Sunil Gairola, and S. S. Jadhav 4 Immunotherapy for Autoimmune Diseases ................... 63 Aniket Mali, Apurva Sawant, Anagha Mahadik, and Sujit Nair 5 Immunotherapy in Neurodegenerative Disorders .............. 117 Dipanjali Kamthe, Netra Gosavi, and Vandana S. Nikam 6 Companion Diagnostics and Clinical Biomarkers for Immunotherapy ....................................... 137 Vandana S. Nikam 7 Novel Drug Delivery Systems for Immunotherapeutics .......... 153 Krishna Baxi, Munira Momin, and Sujata Sawarkar 8 Discovery, Screening Methods, Design Considerations, and Scale-up Aspects of Immunotherapeutic Drugs ............ 173 Pratiksha Palahe and Vinal Pardhi 9 Pharmacokinetics, Pharmacodynamics, and Toxicology Aspects of Immunotherapeutics .................................. 195 Preeti Kulkarni, Parsshava Mehta, Bharati Shriyan, Kalpita Gawit, Vikram Gota, and Minal Ghante v vi Contents 10 Regulatory Affairs and Intellectual Property Rights in Immunotherapeutics .................................... 215 Kedar Suvarnapathaki, Sanjay D. Sawant, and Indu Nambiar 11 Future Immunotherapy Challenges and Perspectives ........... 247 Amrita Date, Vandana S. Nikam, Shariq Syed, and Sujata P. Sawarkar About the Editors Sujata P. Sawarkar is Professor and Head of Department, Pharmaceutics, SVKM’s Dr. Bhanuben Nanavati College of Pharmacy, India. Before joining academics Dr. Sujata Sawarkar was associated with major pharmaceutical companies in India at managerial position, in the field of Research and Development, formulation development of conventional and novel dosage forms for regulated and domestic market. Several oral solid dosage forms and sterile products developed by her team have received approval in US and EU and have been commercialized. She has about total 22 years of research and teaching experience. Her research interests include Formulation Development of novel drug delivery and targeted systems based on nanotechnology for oral, ophthalmic, colonic and vaginal delivery, development of evaluation techniques for novel drug delivery systems, Translational research. Dr. Sujata Sawarkar has been Executive Member of Controlled Release Society (India Chapter) since 2014 and Secretary of Controlled Release Society (India Chapter) CRS IC for 2017-2019. She has been invited reviewer for Indian Drugs, AAPS PharmSciTech, International Journal of Nanomedicine Dove Press, Drug Design, Development and Therapy, Journal of Bioequivalence & Bioavailability, European Journal of Pharmaceutics and Biopharmaceutics and Journal of Cosmetic Dermatology. Dr. Sujata Sawarkar has received research project grants worth about 85 lakhs rupees (8.5 million INR i.e. about 1.19 million USD) from Industry and Government funding agency. She has presented about 50 research papers in national and international conferences like CRS Inc. and AAPS. She has several papers published in peer reviewed journals like AAPS PharmSciTech, International Journal of Pharmaceutics, Critical Reviews in Therapeutic Drug Carrier systems, Drug Development and Translational Research, Frontiers in Pharmacology, Expert Opin- ion on Drug Delivery. She has coauthored 5 book chapters and two books. Dr. Sujata Sawarkar has been awarded IDMA award for reviewer, Research and Industry Outcome by SVKM’s Dr. Bhanuben Nanavati College of Pharmacy in 2018 and 2020, Received Travel Grant from Controlled Release Society and All India Council of Technical Education for attending and presenting paper at 42nd and 46th Annual Meeting & Exposition of the Controlled Release Society in July 2015 and July 2019 respectively. She has several papers published in peer-reviewed journals like AAPS PharmSciTech, International Journal of Pharmaceutics. She has co-authored 2 book chapters and one book. vii viii About the Editors Vandana S. Nikam is presently Associate Professor and Head of Department, Pharmacology, at STES’s Smt. Kashibai Navale College of Pharmacy, S. P. Pune University, India. Before her present association, she was a Post-Doctoral Fellow at Max Planck Institute for Heart and Lung Research, Bad Nauheim, Germany. Dr. Nikam has pursued her Master’s degree in Molecular Bioengineering from the Technical University of Graz, Austria and a Doctoral degree from School of Medicine, University of Giessen, Giessen, Germany. Dr. Nikam’s research interests and expertise include stem cells, tissue remodeling and regeneration, toxicology, understanding molecular and cellular biology of underlying diseases. She has received an honorarium from United Therapeutic, NC, USA, Fellowship award for Master of Science in Molecular Bioeng. (M.Sc.) from Technical University of Graz, Austria and received the scholarship from Afro- Asiatische Institute, Graz, Austria. She has several papers published in peer-reviewed journals like British Journal of Pharmacology, Eur Respir J, AAPS PharmSciTech, J Proteome Res, Am J Respir Cell Mol Biol and Pneumologie. She attended and presented her research work at several international conferences like American Thoracic Society Meeting (ATS) 2006, 2009, Symposium of the Austrian Pharmacological Society (APHAR) 2004, European Respiratory Society (ERS) 2006, Austrian Academy of Sciences Proceedings 2008, American Association for Cancer Research (AACR) Annual Meeting, 2013. Shariq Syed is presently Interim Dean and Associate Professor at AIKTC School of Pharmacy and Advisor to Board, Medley Pharmaceuticals. Earlier, he has served as Senior Research Investigator, Bristol Myers-Squibb, USA (2007-2012). At Bristol Myer Squibb, he was part of Ipilimumab drug development team, and has collaborated with Dr. James Allison, immunologist and Nobel Laureate of the year 2018. At Bristol Myer Squibb, he was responsible for all key aspects of Clinical Pharmacology in Oncology therapeutic area for large and small molecule drugs/ compounds, Co-lead Clinical Pharmacology development of Brivanib®, a novel Kinase inhibitor for Liver cancer and contributed to NDA submission package of Yervoy®, a breakthrough therapy in immune-oncology approved for skin cancer. Dr. Shariq’s research interest and expertise include Clinical Pharmacology, Pharma- cokinetics, understanding drug exposure-response relationship (PK-PD) in early Proof of concept (POC) trials. He has received Pharma Ratan Young Achiever Award for his contribution tothe field of Immuno-oncology and award from Rho-Chi Honor society (Honor Society in Pharmaceutical Sciences). He is an invited reviewer of the European Journal of Drug Metabolism and Pharmacokinetics, Current Clinical Pharmacology. He is a member of American Association of Phar- maceutical Scientists, elected member of American College of Clinical Pharmacol- ogy, elected Member of American Society of Clinical Pharmacology and Therapeutics, a member of the Indian Society of Clinical Research. He has published several research articles in peer-reviewed international journals. Immunotherapy: A Concept 1 Vritika Kulwal and Sujata Sawarkar Abstract Immunotherapy has emerged as a promising
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