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Thermo Fisher Scientific Signs Agreement with Lilly Oncology for Companion Diagnostic to be Used with RET Inhibitor
2019-09-10

MONDAY, SEPTEMBER 09, 2019

Thermo Fisher Scientific today announced an agreement with Eli Lilly and Company for development of a companion diagnostic that will use the U.S Food and Drug Administration-approved, next-generation sequencing-based Oncomine Dx Target Test to identify certain non-small cell lung cancer (NSCLC) and thyroid cancer patients who may be treated with Lilly's investigational therapy, LOXO-292. Specifically, the test would be used with patients whose tumors harbor a rearranged during transfection (RET) alteration. RET variants are found in about two percent of NSCLC, about 60 percent of medullary thyroid cancer (MTC) and up to approximately 20 percent of other thyroid cancers.

LOXO-292 is a highly selective and potent oral RET inhibitor being studied by Lilly in a Phase 1/2 clinical trial for the treatment of advanced cancers that harbor activating alterations of the RET kinase. Changes in the RET kinase, including fusions and mutations, can cause uncontrolled cell growth leading to tumor development. Cancers driven by such alterations are mostly dependent on this singularly activated pathway, making them highly susceptible to small molecule inhibitors.

"One of the biggest barriers to realizing the full power of precision medicine in oncology is having access to high-quality testing, such as next-generation sequencing-based tests, that identify a broad range of clinically actionable alterations, can be performed locally and allow treating institutions to participate in this important step in the evolving treatment paradigm," said Anne White, president of Lilly Oncology. "With this agreement, we believe that more patients will gain access to high-quality tumor profiling, identifying those with RET alterations potentially suitable for LOXO-292 therapy, in addition to other alterations suitable for treatment with other therapies."

Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific said: "We are pleased to enter into this agreement with Lilly and leverage our Oncomine platform as a means to quickly identify cancer patients who may benefit from this breakthrough therapy, even in cases of limited sample availability. We are committed to working with our global pharmaceutical partners to help bring forth next-generation sequencing-based companion diagnostics and best-in-class therapies that can have a profound impact on treating cancer patients."

Under the terms of the agreement, Thermo Fisher will retain the rights to commercialize the test in all markets, including the United States, Europe and Japan. Once validation is complete, Thermo Fisher will submit a supplemental premarket approval (sPMA) application to the U.S. Food and Drug Administration (FDA) to broaden the clinical claims of its Oncomine Dx Target Test.

The NGS test, which received FDA approval in 2017, simultaneously screens tumor samples for multiple gene variants associated with NSCLC, a subset of which are utilized to identify patients who may be eligible for several approved targeted therapies. It is covered in the United States by the Centers for Medicare & Medicaid Services and a majority of the largest commercial U.S. health plans. Oncomine Dx Target Test is also approved for reimbursement by the Japan Ministry of Health, Labor and Welfare (MHLW).

2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/ will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.

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Gotham Therapeutics Establishes Advanced Oncology Profiling Cascade with ProQinase to Progress its Portfolio of Epitranscriptomic Drug CandidatesWEDNESDAY, OCTOBER 30, 2019Gotham Therapeutics, a biotechnology company developing a novel drug class targeting RNA-modifying proteins, and ProQinase, an early stage drug-discovery company, recently acquired by Malvern/PA-based Reaction Biology Corp., today announced that they have established an array of advanced biochemical and cellular assays to characterize epitranscriptomic-directed compounds.“Establishing tailored target engagement, cell biology, phenotypic, and in-vivo assays to evaluate compounds originating from our three most advanced epitranscriptomic programs in parallel is a crucial next step to develop our broad pipeline towards the clinic,” said Dr. Gerhard Müller, Chief Scientific Officer of Gotham Therapeutics. “By pursuing the full range of the reader-writer-eraser continuum, we are able to focus on targets with the most compelling links to disease and advance those programs in tandem.”“Combining our high proficiency in providing customized solutions as early stage drug-discovery services, including tailor-made biochemical and cell-based assays, with Gotham’s expertise in epitranscriptomics, we were able to establish in a very short time a set of customized enzymatic and cellular assays for compounds addressing three different mRNA-modifying targets,” said Dr. Sebastian Dempe, Chief Executive Officer of ProQinase. “We look forward to supporting Gotham as the company advances its programs into lead optimization and to continued work with the Gotham team assisting the company to advance its broad pipeline in a time-effective manner.”In addition to establishing a tailor-made profiling cascade for compounds from its three most advanced programs, Gotham has also made progress in strengthening its drug discovery engine and developing its candidate base. Gotham previously completed the gene-to-lead phase for its drug discovery project targeting the METTL3/METTL14 complex and established a robust discovery process as a platform for future projects. The company has also generated a library of high-quality compounds tailor-made for accelerated hit generation and hit-to-lead expansion against large parts of the epitranscriptomic target space. This library includes a collection of over 2,000 analogues covering over 80 distinct chemotypes that will be used to further accelerate Gotham’s drug discovery efforts as it expands its pipeline.The original link:https://www.pharmafocusasia.com/news/gotham-therapeutics-establishes-advanced-oncology-profiling-cascade-with-proqinase-to-progress-its-portfolio-of-epitranscriptomic-drug-candidates2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact:AnnPhone: 021-65650305Email:Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934

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HistoIndex Announces Global Partnerships To Expand AI-Based Digital Pathology PlatformMONDAY, OCTOBER 28, 2019HistoIndex announces the expansion of its AI-based digital pathology platform towards large-scale NASH preclinical programs for pharmaceutical and biotech companies to achieve quantifiable and reproducible data on therapeutic responses in NASH animal models, and to aid CROs as well as research agencies in validating new models mimicking the NASH disease.Published preclinical studies have demonstrated the use of HistoIndex's fully quantifiable Second Harmonic Generation (SHG) technology as a highly accurate stain-free method that can monitor the efficacy of various therapeutic agents, by quantifying more than 450 NASH-associated parameters in fibrosis, inflammation, ballooning and steatosis. The information of these NASH-associated parameters gathered from the entire liver tissue, provides comprehensive insights on the mechanism of action of the therapeutic agent.  As a drug discovery tool, HistoIndex's SHG-enabled digital pathology platform will allow pharmaceutical and biotech companies to select promising lead candidates for further optimization and make informed decisions in the management of their NASH drug development pipeline.In addition to ongoing NASH clinical trials, HistoIndex is currently involved in multiple preclinical studies, most of which are conducted by major pharmaceutical and biotech companies, medical universities, CROs and research agencies. Notably, HistoIndex has recently entered into a collaboration with the A*STAR's Genome Institute of Singapore (GIS) to validate their in vivo and in vitro NASH models based on Asian-centric clinical data. Says Professor Patrick Tan, Executive Director of the Genome Institute of Singapore (GIS), "At GIS, we conduct our preclinical studies on fatty liver involving data from animal models based on patient-derived transcriptomic data. This has a high translational potential as it helps us to pinpoint new therapeutic targets and their validation. Therefore, using a fully quantitative, reliable and objective pathological evaluation such as HistoIndex's AI-based digital pathology platform is essential to the success of our efforts in therapeutic target discovery."HistoIndex is also a partner with globally-renowned CRO, WuXi Apptec, in advancing their NASH preclinical programs with advanced R&D and smart imaging analysis capabilities. Published study data will be available for discussions during networking opportunities throughout AASLD's The Liver Meeting® in November 2019.  "We are very excited to extend our AI-based SHG platform to preclinical studies to help companies with drug discovery programs select promising lead candidates for further optimization and subsequent clinical development," says Dr Poon Thong Yuen, Chief Executive Officer of HistoIndex. "Our SHG image analysis platform has already been used to analyze the efficacy of a series of promising drug candidates for NASH within various animal models commonly-used by the industry, and we believe these preclinical partnerships will help drive the adoption of our platform significantly."information source:pharma focus AsiaThe original link:https:https://www.pharmafocusasia.com/news/histoindex-announces-global-partnerships-to-expand-ai-based-digital-pathology-platform2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact:AnnPhone: 021-65650305Email:Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934

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FRIDAY, OCTOBER 25, 2019AZTherapies, Inc., a biopharmaceutical company developing therapeutics to extend brain health, today announced the acquisition of Smith Therapeutics, a private biopharmaceutical company with a shared goal of targeting neuroinflammation to treat neurodegenerative disease. Smith Therapeutics’ Founder and Chief Executive Officer Philip Ashton-Rickardt, Ph.D., has joined the senior leadership team at AZTherapies as Senior Vice President of Immunology. Financial terms of the acquisition were not disclosed.Smith Therapeutics’ proprietary research platform focuses on the use of modified T cells to restore a healthy balance of inflammatory and regulatory cells in the brain. To date, Smith has successfully engineered immunosuppressive T regulatory (Treg) cells with Chimeric Antigen Receptors (CARs) targeting brain glial cells. Previous research has demonstrated the ability of Tregs to dampen microglial activity and reduce neuroinflammation in models of neurodegeneration, suggesting their potential utility in the treatment of diseases including Progressive Supranuclear Palsy (PSP), Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, Amyotrophic Lateral Sclerosis (ALS), and others.“This acquisition represents a meaningful step forward for us as we continue to strengthen our leadership position in the development of therapies targeting neuroinflammation to stop or slow the progression of neurodegenerative diseases,” said David R. Elmaleh, Ph.D., Founder, CEO, and Chairman of AZTherapies. “We are excited to be working with Philip as we add this cutting-edge technology to our portfolio of innovative programs. An esteemed immunologist and inventor of the technology, Philip brings unparalleled expertise to the company and we look forward to advancing this CAR-Treg program further into IND-enabling studies and into clinical development as rapidly as possible.”Dr. Ashton-Rickardt commented on the acquisition and his appointment: “Our shared rationale of targeting neuroinflammation as the root cause of neurodegenerative disease makes this acquisition a great strategic fit for us. With AZTherapies’ expertise in drug development and clinical trial execution, we believe that together, we are well positioned to advance our CAR-Treg technology and fundamentally change neurodegenerative disease progression.”Prior to launching Smith Therapeutics in 2017, Dr. Ashton-Rickardt was Chair in Immunology at Imperial College London, Visiting Professor, Brigham and Women’s Hospital, Harvard Medical School, and Associate Professor in the Department of Pathology at the University of Chicago. His work has been recognized by his peers through the award of tenure from The University of Chicago and by his fellow citizens as a recipient of the Early Career Award for Scientists and Engineers from President Bill Clinton. He has published more than 65 peer-reviewed papers in more than 30 academic journals (including Cell, Science, Immunity, and Nature Immunology), has served as an editor for several academic journals, and has been a member of grant review boards globally. Dr. Ashton-Rickardt received a B.Sc. in Biochemistry from the University of London, King’s College with honors, a Ph.D. in Molecular Biology from the University of Edinburgh, and completed post-doctoral work at the University of Edinburgh and the Massachusetts Institute of Technology in Molecular Biology and Molecular Immunology, respectively.information source:pharma focus AsiaThe original link:https:https://www.pharmafocusasia.com/news/aztherapies-strengthens-neuroinflammation-targeted-pipeline-through-acquisition-of-smith-therapeutics2019 Asia-pacific pharma IP Leader Summit: http://en.zenseegroup.com/p/510934/will be held in Beijing  on November 14-15, and will attract more than 500 industry experts from domestic and foreign pharmaceutical companies, biotechnology companies, governments, associations, law firms, intellectual property agents and other companies to attend.Official registration and consultation channels:Contact:AnnPhone: 021-65650305Email:Marketing@zenseegroup.comhttp://en.zenseegroup.com/p/510934

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