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The Bispecific Approach Financial Strategy Coronavirus Licensing and Collaboration Briefs www.mednous.com Vol 15, No 3 March 2021 MedNous Σ Managing European Medical Innovation The Bispecific Approach Interviews with Merus, Genmab and NovalGen Plus Page 6 Gene Therapy Addressing the challenges Financial Strategy of gene therapy medicinal Why we should take products a second look at RNA By Paula Salmikangas and Björn Carlsson Page 28 therapeutics Company News By Gabriele Campi Centessa launched Page 5 Genmab gains traction Page 25 Coronavirus Clinical Research New treatments in Early efficacy for Libtayo HIV therapy shows promise the pipeline Page 19 By Peter Charlish Regulation and Policy Page 10 US and EU approve J&J vaccine Page 17 Licensing and Collaboration Briefs Subscribe Page 4 NOW See page 2 www.mednous.com more MedNous online...www.mednous.com...more MedNous online...www.mednous.com... EDITORIAL BOARD MedNous Editorial Board Editorial Dr Chris Bailey is director of development at the UK vaccine Executive Editor: William Ellington company, ImmunoBiology Ltd. During his earlier career at Beecham, Editor: Victoria English Celltech and Medeva, Dr Bailey worked in new product development Science Editor: Peter Charlish in the areas of vaccines, recombinant DNA products, gene therapies Associate Editors: Jane Morrison, Rosie Bannister and small molecules. Contributing Editors: Bruno Pagliara, Tim Farries, Dr Gabriele Dallmann has more than 25 years of experience in Karen Finn drug development and regulatory strategy and currently directs the Market Research: Janet Barrie Munich-based regulatory consultancy Biopharma Excellence. She is Production Editor and Art Director: Melissa Sterry specialised in biopharmaceuticals and has led training initiatives in Website Designer: Keith Jay that field. Until 2005, she was in charge of the approval of antibody Publisher: Evernow Publishing Ltd products at the Paul-Ehrlich-Institute in Germany. Registered in England & Wales under the number: Dr Miguel Forte is chief executive of Bone Therapeutics SA 6019186. Registered office: 264 Banbury Road, of Belgium and a visiting professor at the Lisbon and Aveiro Oxford, OX2 7DY, UK. VAT registration number: Universities in Portugal. He is also chair of the commercialisation 912 7394 21 committee of the International Society of Cellular Therapy. He holds Subscriptions an MD from the University of Lisbon and a PhD in immunology from An annual subscription, which includes unlimited the University of Birmingham, UK. access to the website and 10 issues per year of the Dr Thomas Lönngren is the former executive director of the print publication is: European Medicines Agency. Prior to this, he was deputy director • Company/Organisation rate of general at the Swedish Medical Products Agency. Dr Lönngren is £299 or €360 or $469 • Personal rate of £99 or €120 or $156 currently director of Pharma Executive Consulting AB, strategic advisor to NDA Group AB and a non-executive board member of To subscribe, please send an email to: Compass Pathways Ltd, London, Analytica Ltd, Brisbane and Global [email protected] Kinetics Corp, Melbourne. Or send a cheque to: Evernow Publishing Ltd, 39 Calabria Road, Professor Chris Mason, FRCS, FMedSci, is a co-founder and London N5 1HZ, UK chief scientific officer of AvroBio Inc, a clinical-stage gene therapy company located in Cambridge, Massachusetts, US. He also holds Or the Chair of Cell and Gene Therapy in the Advanced Centre for Evernow Publishing Ltd, PO Box 26 BPost Biochemical Engineering at University College London. Prof Mason is Bruxelles Livingstone, Rue Stevin 41-43, on a number of national and international committees, enabling the 1000 Brussels, Belgium clinical translation and commercialisation of cell and gene therapies. Tel: +44 (0)20 7704 1015 +32 (0)27 332 889 Dr Edwin Moses was chief executive officer of Ablynx NV until 2018 Email: [email protected] when the company was acquired by Sanofi SA. He has more than 25 years of experience in the life science and biotechnology sectors Advertising including board level positions, primarily as chairman, in over 15 MedNous welcomes advertising in the European companies. He is currently chairman of Sensorion SA, print publication. Achilles Therapeutics Ltd, LabGenius Ltd and Avantium NV. • Rates are: Quarter page; £100 Dr Jean-Claude Muller is a special advisor to a number of Half page; £200 international institutions, having previously been a senior vice Full page; £400 president in research and development at Sanofi SA. At Sanofi, he • For further information please call the editor was responsible for identifying strategic opportunities and potential at: Tel: +44 (0)20 7704 1015 breakthrough technologies. Dr Muller is the executive editor of Printer: MedNous is printed by Bookbinders of BtoBioInnovation, a biopharmaceutical blog. London Ltd, 33-37 Chambers Street, Hertford, Dr John Purves is a life science consultant and member of the Hertfordshire, SG14 1PL, United Kingdom Board of the International Alliance for Biological Standardisation Conditions of Supply (IABS). He previously worked for 14 years at the European Medicines MedNous is published 10 times per year by Evernow Agency as head of the biotechnology and biological products Publishing Ltd. Copyright © 2021 by Evernow sector and subsequently, as head of the sector for the quality of Publishing Ltd. All rights reserved. No part of this medicines. Prior to joining the EMA, Dr Purves was manager of issue can be reproduced or transmitted in any form the biotechnology and biological unit at the UK Medicines and or by any means, electronic or mechanical, including Healthcare products Regulatory Agency. photocopying, for public or private use, or by any Dr J Fraser Wright is Professor of Paediatrics at Stanford information storage or retrieval system, without the University School of Medicine, and Principal at Wright Biologics prior written permission of the publisher. Consulting, having previously been chief technology officer at Spark ISSN 1757-9937 (Print) Therapeutics Inc where he was also a co-founder. He is an expert in @mednous the field of gene therapy, viral vectors and monoclonal antibodies, contributing to the clinical development of Luxturna and Kymriah, gene therapy products that were licensed in 2017. 2 March 2021 MedNous www.mednous.com ©2021 Evernow Publishing Ltd EDITORIAL Letter from the Editor Contents 3 Editorial One agent, two targets 4 Finance, Grants and Deals When Eli Lilly and Co announced in January that it had 5 RNA Therapeutics signed a licensing deal with Merus NV of the Netherlands RNA Modulation: Gabriele Campi – Why we should take to research and develop up to three bispecific antibodies for a second look at RNA technology cancer, MedNous decided to take another look. As products, 6-9 Bispecific Antibodies bispecifics are not new, but they are also not common. What Three companies, multiple strategies – Bispecific could be attracting the interest of this US pharma company to antibody development gains momentum the sector? Under the deal, Lilly has agreed to pay Merus $40 million 10-15 Coronavirus upfront as well as milestone payments of up to $540 million Covid-19: new treatments in the pipeline per project, bringing the potential milestones up to $1.6 COVID-19 Collaborations billion. The projects will all focus on the development of 16-17 Regulation and Policy bispecific molecules that redirect T cells to a cancer as a way US & European Regulatory Actions of killing cancer cells. J&J vaccine cleared for use Bispecific antibodies are antibodies that bind to two DMD drug approved in US different types of antigen at the same time. Two bispecifics New bone marrow therapy have been approved by a regulator to treat cancer, and Spinal muscular atrophy drug recommended one has been approved for haemophilia. One of the cancer drugs was withdrawn from the market by its developer for 18-19 Clinical Research commercial reasons. This leaves the other, blinatumomab, as Initiation of US & European Clinical Trials the cancer representative. Blinatumomab was developed by Clinical Trials: a round-up of recent advances the German company Micromet and is currently marketed to and setbacks treat four types of leukaemia. Micromet, in the meantime, has 20 Research News become part of Amgen Inc. Antimalarial drug for cancer Blinatumomab is effective, but it has limitations. One New findings about fungi of these is a short half-life which means that it has to be Strategy for treating ALS administered to patients by continuous infusion. In a bid to improve on the concept and to expand the uses of the drug, 21-23 Company News – Financing pharma companies have been investigating follow-on products. Evox completes financing These include products for haematologic malignancies as Funding for eye treatments well as for solid tumours. There are now about 100 projects European Biotech Financings in clinical development, many of them originated by small 24-27 Company News biotech companies. As illustrated by the deal between Lilly A new chapter for argenx and Merus, however, a number of large pharma companies AZ sees higher revenue have also entered the fray. Launch of Centessa In an article starting on page 6, we interview three AZ withdraws Imfinzi indication companies active in the bispecific antibody space: Merus, Genmab A/S of Denmark and NovalGen Ltd of the UK. Genmab gains traction Courtesy of our contributing editor, Bruno Pagliara, we also Non-insulins lift Novo provide a table with a representative sample of products in Exscientia completes financing round clinical development. This table shows that there are several Imcyse extends financing products in Phase 3 and one product, developed by Johnson & Merck withdraws lung indication for Keytruda Johnson, that has been submitted for review to the Food and Round-up of European biopharmaceutical company news Drug Administration. Our interviewees argue that the next 28-29 Cell and Gene Therapy few years will see a significant expansion in the use of these Commentary: Paula Salmikangas and Björn Carlsson – therapies. Addressing the challenges of GTMPs Elsewhere in this issue, Gabriele Campi explains why RNA 30-31 Appointments and Company Index therapeutics are attracting more interest from investors.
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