Daiichi Sankyo and Sarah Cannon Research Institute closed a strategic oncology development collaboration under which the CRO will provide comprehensive clinical development services and operational delivery to several of Daiichi Sankyo’s translational development programs. The collaboration will enable rapid patient enrollment to clinical trials through Sarah Cannon’s extensive research network across the U.S. and UK, which serves thousands of patients annually in clinical trials, as well as through Daiichi Sankyo’s clinical network in Japan.
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Sanofi and Denali to collaborate on neurological and inflammatory diseases
The development of candidate molecules with the potential to treat multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and systemic inflammatory diseases is at the center of the collaboration signed by Sanofi and Denali Therapeutics, the last company due to receive $125 million upfront payment and future milestone payments that could exceed $1 billion.
The two lead molecules (DNL747 and DNL758) target the critical signaling protein RIPK1 in the TNF receptor pathway, which regulates inflammation and cell death.
A collaboration on epigenetic targets for Boehringer
Boehringer Ingelheim signed a global collaboration with Epizyme to jointly research and develop novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets, i.e. enzymes within the helicase and histone acetyltransferase (HAT) families that when dysregulated have been linked to the development of cancers. The collaboration will focus on lung and other solid tumor cancers in patients with defined mutations, sub-populations that currently lack precision medicine treatments.
Epizyme will receive an upfront payment of $15 million and an additional $5 million in research funding in 2019; the company is also eligible to receive more than $280 million in additional payments for research, development, regulatory and commercial milestones.
Research collaboration on metabolic diseases for Novo Nordisk
A research collaboration has been signed between Embark Biotech and Novo Nordisk to discover novel treatments for obesity and its associated metabolic pathologies. Embark Biotech is a recent spin-out from the Center for Basic Metabolic Research at University of Copenhagen; its technological platform focuses on receptors that stimulate energy expenditure without triggering the sympathetic nervous system (the ‘fight-or-flight’ response). The aim of the collaboration is to develop novel drug candidates that help people with obesity lose weight by burning off excess energy instead of storing it as fat.
Immuno-oncology agreement for Lilly
Eli Lilly and NextCure have signed a multi-year collaboration for the discovery and development of immuno-oncology therapies based on NextCure’s proprietary FIND-IO™ platform. The two companies will each receive options to exclusively license antibodies resulting from the collaboration. Upon the terms of the agreement, NextCure will receive an upfront payment of $25 million; Lilly also made an additional $15 million equity investment in NextCure.
The FIND-IO™ platform aims to identify novel cell surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites. Established primary cell lines from immune lineages include T cells, NK cells, macrophages, myeloid-derived suppressor cells, dendritic cells, as well as cancer cells.
AstraZeneca and Cancer Research UK to collaborate on genetic screening
A new Functional Genomics Centre of excellence that will use CRISPR technology, big data and clinical insights to discover new targets and disease pathways in oncology is the goal of a collaboration signed between AstraZeneca and Cancer Research UK. The Centre will use CRISPR technology to study the biology of cancer in order to create biological models more reflective of the human disease. It will be located at the Milner Therapeutics Institute at the University of Cambridge. According to the company, AstraZeneca and Cancer Research UK will have independent use of the Centre’s facilities.
A separate collaboration has been also signed by AZ with Innovative Genomics Institute (IGI) to use CRISPR to uncover genes and disease pathway mechanisms involved in DNA Damage Response (DDR), one of AstraZeneca’s four key platforms in oncology.
GSK to acquire Tesaro
GlaxoSmithKline announced the definitive agreement to acquire the oncology-focused biopharmaceutical company Tesaro for an aggregate cash value of approximately $5.1 billion. Tesaro’s major marketed product, Zejula (niraparib), is an oral poly-ADP ribose polymerase (PARP) inhibitor currently approved for use in ovarian cancer. Clinical trials are ongoing to assess its use in “all-comers” patient populations, as a monotherapy and in combinations; it is currently under investigation also as a possible treatment in lung, breast and prostate cancer. Tesaro’s pipeline includes also antibodies directed against PD-1, TIM-3 and LAG-3 targets.
Collaboration on blood cancers for Cilag
Janssen affiliate Cilag GmbH International entered a worldwide collaboration and license agreement with argenx BVBA and argenx SE focused on the investigational antibody cusatuzumab (ARGX-110) for use in blood cancers. The antibody targets CD70 immune receptors implicated in numerous cancers, including hematological malignancies. The first-in-class antibody is currently in Phase 1/2 clinical trials to evaluate its safety, tolerability and efficacy in the treatment of acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). According to the company, the deal has a total value of $ 300 million; a separate equity investment by Johnson & Johnson Innovation (JJDC) will be made in argenx SE.
Daniel O’Day to switch from Roche to Gilead
Roche CEO and member of the Corporate Executive Committee, Daniel O’Day, will step down its role as of 31 December 2018. He will provide support to the company for a smooth transition until the end of February 2019, to then become the new Chairman of the Board and Chief Executive Officer of Gilead Sciences, effective March 1, 2019. O’Day has held the position in Roche since 2012, and prior to that led Roche Diagnostics.
The new CEO of Roche starting 1 January 2019 will be William (Bill) Anderson, currently CEO of Genentech; he will be based in Basel, report to Severin Schwan, Roche Group CEO and become a member of the Corporate Executive Committee. Bill Anderson joined the Group in 2006 as lead of the Immunology Business Unit in Genentech, to then took responsibility for Oncology Sales and Marketing. In 2013, he was appointed Head of Global Product Strategy based in Basel, and became CEO of Genentech in 2017. Bill Anderson holds Master of Science degrees in Management and Chemical Engineering from Massachusetts Institute of Technology.
IP’s agreement for Pfizer and AbbVie
The global intellectual property matters for Pfizer’s proposed adalimumab biosimilar has been solved with the signature of licensing agreements with AbbVie, which granted Pfizer a non-exclusive patent license for the use and sale of the product in many countries around the world. All litigation pending between the parties will be withdrawn. The financial details of the agreements have been kept confidential. According to the company, in US the license period will begin on November 20, 2023, while in Europe the launch of the new biosimilar may occur after its approval by the European Medicines Agency.