Antibodies to watch in 2019
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The Royal Swedish Academy of Sciences. Scientific background on the Nobel Prize in Chemistry 2018: directed evolution of enzymes and binding proteins. https://www.nobelprize.org/uploads/2018/10/advanced-chemistryprize-2018.pdf
The Royal Swedish Academy of Sciences. The Nobel Prize in Physiology or Medicine 2018. NobelPrize.org. Nobel Media AB 2018. Fri. [accessed 2018 Oct 26]. https://www.nobelprize.org/prizes/medicine/2018/summary/.
US Food and Drug Administration. FDA approves novel preventive treatment for migraine. May 17, 2018 press release. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm608120.htm?utm_campaign=05172018_PR_FDA%20approves%20migraine%20prevention%20treatment&utm_medium=email&utm_source=Eloqua.
Teva Pharmaceutical Industries Ltd. Teva announces U.S. approval of AJOVY™ (fremanezumab-vfrm) injection, the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults. September 14, 2018 press release. http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2367592.
Lilly E and Company. Lilly’s Emgality™ (galcanezumab-gnlm) receives U.S. FDA approval for the preventive treatment of migraine in adults. September 27, 2018 press release. https://investor.lilly.com/news-releases/news-release-details/lillys-emgalitytm-galcanezumab-gnlm-receives-us-fda-approval.
Kyowa Hakko Kirin Co. Ltd, Kyowa Kirin International PLC, Ultragenyx Pharmaceutical Inc. Kyowa Kirin and Ultragenyx Announce Crysvita® (burosumab) receives conditional marketing authorisation in Europe for the treatment of X–linked hypophosphatemia in children. February 23, 2018 press release. www.kyowa-kirin.com/news_releases/2018/pdf/e20180223_01.pdf.
US Food and Drug Administration. FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia. April 17, 2018 press release. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm604810.htm
Shire plc. Shire announces FDA approval of TAKHZYRO™ (lanadelumab-flyo), a first-of-its-kind mAb preventive treatment for hereditary angioedema. August 23, 2018 press release. https://www.shire.com/en/newsroom/2018/august/4fhgmy
Sanofi. Cablivi™ (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura (aTTP). September 3, 2018 press release. http://www.news.sanofi.us/2018-09-03-Cablivi-TM-caplacizumab-approved-in-Europe-for-adults-with-acquired-thrombotic-thrombocytopenic-purpura-aTTP
Scully M, 2017, 59th Annual Meeting of the American Society of Hematology
US Food and Drug Administration. FDA approves treatment for two rare types of non-Hodgkin lymphoma. August 8, 2018 press release. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616176.htm
Regeneron Pharmaceuticals, Inc. FDA approves Libtayo® (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma. September 28, 2018 press release. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-libtayor-cemiplimab-rwlc-first-and-only-treatment
US Food and Drug Administration. FDA approves new HIV treatment for patients who have limited treatment options. March 6, 2018 press release. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm
US Food and Drug Administration. TROGARZO™ (ibalizumab-uiyk) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf
US Food and Drug Administration. FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease. November 20, 2018 press release. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626263.htm.
Immunomedics. Corporate overview. September 2018. https://www.immunomedics.com/wp-content/uploads/2018/09/Corporate-Presentation-September-2018.pdf
Alexion Pharmaceuticals. FDA accepts priority review of ALXN1210 as a treatment for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the US. August 20, 2018 press release. http://ir.alexion.com/news-releases/news-release-details/fda-accepts-priority-review-alxn1210-treatment-patients
Alexion Pharmaceuticals. Alexion announces positive top-line results showing successful phase 3 clinical study of ALXN1210 in complement inhibitor treatment-naïve patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). March 15, 2018 press release. https://news.alexion.com/press-release/product-news/alexion-announces-positive-top-line-results-showing-successful-phase-3-cl.
AbbVie. AbbVie submits biologics license application to U.S. FDA for investigational treatment risankizumab for moderate to severe plaque psoriasis. April 25, 2018 press release. https://news.abbvie.com/news/abbvie-submits-biologics-license-application-to-us-fda-for-investigational-treatment-risankizumab-for-moderate-to-severe-plaque-psoriasis.htm.
Amgen and UCB. Amgen and UCB provide update on regulatory status of EVENITY™ (romosozumab) in the US. July 16, 2017. https://www.amgen.com/media/news-releases/2017/07/amgen-and-ucb-provide-update-on-regulatory-status-of-evenity-romosozumab-in-the-us/.
Amgen and UCB. Amgen and UCB resubmit biologics license application (BLA) for EVENITY™ (romosozumab) to the US FDA. July 12, 2018 press release. https://www.amgen.com/media/news-releases/2018/07/amgen-and-ucb-resubmit-biologics-license-application-bla-for-evenity-romosozumab-to-the-us-fda/.
Beigene Ltd. BeiGene announces acceptance of new drug application for anti-PD-1 antibody tislelizumab in Hodgkin’s lymphoma in China. August 31, 2018 press release. http://ir.beigene.com/phoenix.zhtml?c=254246&p=irol-newsArticle&ID=2365642.
Innovent Biologics (Suzhou) Co. Ltd. Innovent biologics announces the study result of its anti-PD-1 antibody in Hodgkin lymphoma May 17, 2018 press release. http://innoventbio.com/en/#/news/102.
LSK BioPharma, Jiangsu Hengrui Medicine. LSK Biopharma and Jiangsu Hengrui medicine announce global clinical collaboration to evaluate the combination of anti-angiogenesis and immuno-oncology therapy for patients with advanced Hepatocellular Carcinoma (HCC). October 21, 2018 press release. http://lskbiopharma.com/lsk-biopharma-and-jiangsu-hengrui-medicine-announce-global-clinical-collaboration-to-evaluate-the-combination-of-anti-angiogenesis-and-immuno-oncology-therapy-for-patients-with-advanced-hepatocellular/.
Wang C, Liu Y, Nie J, Shen L, Yang Q, Han W Safety and efficacy of decitabine-primed anti-PD-1 (SHR-1210) treatment in patients with relapsed/refractory classical Hodgkin lymphoma. 2018 American Society of Clinical Oncology meeting abstract. https://meetinglibrary.asco.org/record/162336/abstract.
Zhou C, Gao G, Wu F, Chen X, Li W, Xiong A, Su C, Cai W, Ren S, Jiang T, et al. A phase Ib study of SHR-1210 plus apatinib for heavily previously treated advanced non-squamous non-small cell lung cancer (NSCLC) patients. 2018 American Society of Clinical Oncology meeting abstract. https://meetinglibrary.asco.org/record/160803/abstract.
CytoDyn Inc. CytoDyn’s PRO 140 (leronlimab) HIV monotherapy trial results show 92% responder’s rate at 700 mg dose. November 13, 2018 press release. https://www.cytodyn.com/media/press-releases/detail/297/cytodyns-pro-140-leronlimab-hiv-monotherapy-trial.
Novartis. New analysis of Novartis phase III brolucizumab (RTH258) data reinforces superior reduction of retinal fluid, a key marker of disease activity in nAMD. September 22, 2018 press release. https://www.novartis.com/news/media-releases/new-analysis-novartis-phase-iii-brolucizumab-rth258-data-reinforces-superior-reduction-retinal-fluid-key-marker-disease-activity-namd.
Novartis. Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD. October 27, 2018 press release. https://www.novartis.com/news/media-releases/two-year-data-novartis-brolucizumab-reaffirm-superiority-versus-aflibercept-reducing-retinal-fluid-patients-namd.
Alder Biopharmaceuticals. Alder BioPharmaceuticals® reports third quarter 2018 financial and operating results. November 5, 2018 press release. https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-reports-third-quarter-2018-financial.
Alder Biopharmaceuticals. Transforming the prevention treatment paradigm for migraine patients. November 5, 2018 corporate presentation. https://investor.alderbio.com/index.php/encrypt/files?file=nasdaq_kms/assets/2018/11/06/3-08-52/Corporate%20Deck%20November%205th%20FINAL%20FINAL.pdf&file_alias=18416.
Alder Biopharmaceuticals. Alder BioPharmaceuticals® presents new one-year data for eptinezumab from PROMISE 1 phase 3 trial demonstrating long-term efficacy in episodic migraine. June 29, 2018 press release. https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-presents-new-one-year-data-eptinezumab.
Alder Biopharmaceuticals. Alder BioPharmaceuticals® presents new six-month data for eptinezumab demonstrating improvement in efficacy in PROMISE 2 phase 3 trial for chronic migraine. June 29, 2018 press release. https://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-presents-new-six-month-data.
Horizon Pharma. An overview of Thyroid Eye Disease (TED) and teprotumumab clinical data. October 4, 2018 corporate presentation. http://ir.horizon-pharma.com/static-files/c153d2c9-fae6-4e3b-ab18-7e8485e2c2d4.
Novartis. Novartis analysis shows crizanlizumab (SEG101) increased the number of patients free of sickle cell pain crises vs placebo during SUSTAIN study. October 9, 2018 press release. https://www.novartis.com/news/media-releases/novartis-analysis-shows-crizanlizumab-seg101-increased-number-patients-free-sickle-cell-pain-crises-vs-placebo-during-sustain-study
Chugai Pharmaceutical Co., Ltd. Chugai presents results from phase III study of satralizumab in NMOSD at ECTRIMS 2018. October 15, 2018 press release. https://www.chugai-pharm.co.jp/english/news/detail/20181015120001_561.html.
Pfizer Inc., Eli Lilly and Company. Pfizer and Lilly announce positive top-line results from phase 3 trial of tanezumab for the treatment of Osteoarthritis (OA) pain. July 18, 2018 press release. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_lilly_announce_positive_top_line_results_from_phase_3_trial_of_tanezumab_for_the_treatment_of_osteoarthritis_oa_pain.
Eli Lilly and Company. Form 10-Q quarterly report for the quarter ended June 30, 2018. https://www.sec.gov/Archives/edgar/data/59478/000005947818000188/lly-6302018x10q.htm.
Sehn LH, 2018, 23rd Congress of the European Hematology Association
Roche. Roche virtual late stage pipeline event 2018. September 13, 2018 corporate presentation. https://www.roche.com/dam/jcr:8142e2f9-9525-4a8f-ad1f-d5f605e36991/en/irp20180913.pdf
Sanofi. Q3 2018 results. October 31, 2018 corporate presentation, slides 38, 41. https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/en/investors/docs/Q-R/Q3_2018_Final_Slides.pdf?la=fr&hash=1746EC206B1D3AEB873C251D8512A5F62C28AE10
Novartis AG Q2 2018 Results. July 18, 2018 investor presentation, slides 36, 37, 81. https://www.novartis.com/sites/www.novartis.com/files/q2-2018-ir-presentation.pdf.
Novartis. Q2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative products. July 18, 2017 press release. https://www.novartis.com/news/media-releases/q2-results-confirm-full-year-guidance-strong-pipeline-results-underpin-potential.
Morphosys. MorphoSys reports updated data from L-MIND study of MOR208 plus lenalidomide in aggressive lymphoma (r/r DLBCL). March 13, 2018. https://www.morphosys.com/media-investors/media-center/morphosys-reports-updated-data-from-l-mind-study-of-mor208-plus.
Morphosys. MorphoSys AG announces third quarter 2018 results. November 5, 2018. https://www.morphosys.com/media-investors/media-center/morphosys-ag-announces-third-quarter-2018-results.
Biggers K, 2008, Curr Opin Mol Ther, 10, 176
Sesen Bio. Sesen Bio announces vicinium granted fast track designation by FDA for treatment of non-muscle invasive bladder cancer. August 09, 2018 press release. https://sesenbio.gcs-web.com/news-releases/news-release-details/sesen-bio-announces-vicinium-granted-fast-track-designation-fda.
Sesen Bio. Phase 3 registration trial for non-muscle invasive bladder cancer achieves 42% complete response rate at three months in carcinoma in situ patients. May 21, 2018 press release. https://sesenbio.gcs-web.com/news-releases/news-release-details/phase-3-registration-trial-non-muscle-invasive-bladder-cancer.
Sesen Bio. Sesen Bio reports third quarter 2018 financial results and planned VISTA trial readouts. November 8, 2018 press release. https://sesenbio.gcs-web.com/news-releases/news-release-details/sesen-bio-reports-third-quarter-2018-financial-results-and.
TESARO, Inc. TESARO announces data presentations at ESMO 2018 congress. October 20, 2018. http://ir.tesarobio.com/news-releases/news-release-details/tesaro-announces-data-presentations-esmo-2018-congress-0.
Seattle Genetics, Inc. Seattle Genetics and Astellas announce updated enfortumab vedotin phase 1 data in metastatic urothelial cancer at 2017 ASCO annual meeting. June 5, 2017 press release. http://investor.seattlegenetics.com/news-releases/news-release-details/seattle-genetics-and-astellas-announce-updated-enfortumab.
Seattle Genetics, Inc. Seattle Genetics and Astellas announce progress in enfortumab vedotin urothelial cancer clinical development program. October 25, 2018 press release. http://investor.seattlegenetics.com/news-releases/news-release-details/seattle-genetics-reports-third-quarter-2018-financial-results.
TG Therapeutics. TG therapeutics announces update regarding UNITY-CLL phase 3 trial. September 25, 2018 press release. http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-update-regarding-unity-cll-phase-3.
AbbVie. AbbVie announces results from phase 2 study evaluating rovalpituzumab tesirine (Rova-T) for third-line treatment of patients with DLL3-expressing relapsed/refractory small cell lung cancer. March 22, 2018 press release. https://news.abbvie.com/news/abbvie-announces-results-from-phase-2-study-evaluating-rovalpituzumab-tesirine-rova-t-for-third-line-treatment-patients-with-dll3-expressing-relapsedrefractory-small-cell-lung-cancer.htm.