Clinical Trials Appendix Q1 2020 Results Update Movement Since Q4 2019 Update

Total Page:16

File Type:pdf, Size:1020Kb

Clinical Trials Appendix Q1 2020 Results Update Movement Since Q4 2019 Update Clinical trials appendix Q1 2020 results update Movement since Q4 2019 update New to Phase I New to Phase II New to Pivotal trial New to registration NME Lifecycle management AZD2373 Enhertu# DESTINY-Gastric02 Podocyte health nephropathy HER2 targeting antibody drug conjugate HER2- positive gastric cancer that cannot be surgically AZD7648# removed or has spread DNAPK haematological and solid tumours IPH5201# CD39 solid tumours Removed from Phase I Removed from Phase II Removed from Phase III Removed from registration NME NME NME MEDI3902 Imfinzi# + tremelimumab DANUBE Koselugo# (selumetinib) SPRINT¶ 1 Psl/PcrV bispecific mAb prevention of nosocomial PD-L1 mAb + CTLA-4 mAb 1st-line bladder MEK inhibitor paediatric neurofibromatosis type-1 Pseudomonas aeruginosa pneumonia cancer Lifecycle management Imfinzi# + SoC CASPIAN 1 PD-L1 mAb + SoC 1st-line extensive-stage small cell lung cancer 2 ¶ Registrational Phase II/III trial # Partnered and/or in collaboration 1 Submission approved Q1 2020 new molecular entity (NME)1 pipeline Phase I Phase II Phase III Under review 20 new molecular entities 25 new molecular entities 7 new molecular entities 0 new molecular entities AZD0466 capivasertib+chemotherapy Imfinzi#+RT (platform) CLOVER adavosertib# Imfinzi#+oleclumab BCL2/xL haematological and solid CAPItello-290 PD-L1+RT HNSCC NSCLC SCLC Wee1 ovarian cancer, solid tumours PD-L1+CD73 solid tumours tumours AKT+chemotherapy mTNBC 1L AZD2811 Imfinzi#+/-tremelimumab+chemo AZD1390 Imfinzi#+tremelimumab Imfinzi#+tremelimumab Aurora solid tumours, haematological POSEIDON glioblastoma PD-L1+CTLA-4 solid tumours PD-L1+CTLA-4 gastric cancer malignancies PD-L1+/-CTLA-4+SoC 1L NSCLC Imfinzi#+tremelimumab+chemo Imfinzi#+tremelimumab Imfinzi#+/-tremelimumab+CRT AZD4573 AZD4635 PD-L1+CTLA-4 1L PDAC oesophageal PD-L1+CTLA-4 biliary tract ADRIATIC CDK9 haematological malignancies A2aR inhibitor prostate cancer SCLC oesophageal PD-L1+/-CTLA-4+CRT LS-SCLC AZD5153 Imfinzi+Koselugo (selumetinib)# AZD9833 Imfinzi+Lynparza# BAYOU Imfinzi#+tremelimumab HIMALAYA BRD4 haematological and solid PD-L1+MEK solid tumours SERD ER+ breast PD-L1+PARP bladder PD-L1+CTLA-4 1L HCC tumours AZD5991 IPH5201# capivasertib# Lynparza#+adavosertib# Imfinzi#+tremelimumab KESTREL MCL1 haematological malignancies CD39 solid tumours AKT breast PARP+Wee1 solid tumours PD-L1+CTLA-4 1L HNSCC AZD7648# Imfinzi#+tremelimumab+SoC NILE MEDI1191 capivasertib# Lynparza#+AZD6738 VIOLETTE DNAPK solid and haematological PD-L1+CTLA-4+SoC 1L urothelial IL12 mRNA solid tumours AKT prostate PARP+ATR breast tumours cancer Imfinzi# (platform) COAST Lynparza#+Imfinzi MEDIOLA Lynparza#+Imfinzi#+bevacizumab AZD9496 MEDI2228 PD-L1+multiple novel ONC therapies PARP+PD-L1 ovarian breast gastric DUO-O SERD ER+ breast BCMA ADC multiple myeloma NSCLC SCLC PARP+PD-L1+VEGF 1L ovarian MEDI5083 Imfinzi# (platform) NeoCOAST Calquence+ceralasertib MEDI5752 CD40 ligand fusion protein solid PD-L1++multiple novel ONC therapies BTK+ATR haematological tumours PD-1/CTLA-4 solid tumours tumours NSCLC Calquence+danvatirsen MEDI5395 Imfinzi#+AZD4635 oleclumab+AZD4635 BTK+STAT3 haematological rNDV GMCSF solid tumours PD-L1+A2aR prostate cancer CD73+A2aR prostate cancer malignancies Imfinzi#+AZD5069 or Imfinzi#+ oleclumab+chemo or Imfinzi#+ Imfinzi#+adavosertib# oleclumab+Tagrisso danvatirsen# PD-L1+(CXCR2 or oleclumab+chemo CD73+chemo or PD-L1+Wee1 solid tumours CD73+EGFR EGFRm NSCLC STAT3) HNSCC bladder NSCLC PD-L1+CD73+chemo pancreatic Imfinzi#+Lynparza# ORION Tagrisso combo# TATTON PD-L1+PARP 1L mNSCLC EGFR+PD-L1/MEK/MET NSCLC Tagrisso+savolitinib# SAVANNAH Imfinzi#+MEDI0457# EGFR+MET advanced EGFRm PD-L1+DNA HPV vaccine HNSCC NSCLC 1 Includes novel combinations and additional indications for assets Imfinzi#+monalizumab# where the lead is not yet launched PD-L1+NKG2a solid tumours 3 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial Oncology Precision medicine approach being explored Q1 2020 new molecular entity (NME)1 pipeline Phase I Phase II Phase III Under review 17 new molecular entities 20 new molecular entities 4 new molecular entities 0 new molecular entities cotadutide AZD0284 AZD8233 abediterol# anifrolumab# TULIP GLP-1/glucagon type-2 diabetes / RORg psoriasis / respiratory hypercholesterolemia cardiovascular LABA asthma / COPD Type I IFN receptor SLE obesity / NASH nirsevimab# AZD0449 AZD9977 anifrolumab# MEDI3506 RSV mAb-YTE passive RSV Inhaled JAK inhibitor asthma MCR cardiovascular Type I IFN receptor SLE SC Diabetic kidney disease immunisation AZD1402# MEDI0618# anifrolumab# MEDI3506 PT027 inhaled IL-4Ra asthma PAR2 antagonist mAb OA pain Type I IFN receptor lupus nephritis IL33 AD / COPD ICS/SABA asthma AZD2373 MEDI1341# AZD4831 MEDI5884# tezepelumab# NAVIGATOR SOURCE Podocyte health nephropathy alpha synuclein parkinson's disease MPO HFpEF cholesterol modulation cardiovascular TSLP severe uncontrolled asthma AZD2693 MEDI1814# AZD5718 MEDI6012 nonalcoholic steatohepatitis amyloidβ alzheimer's disease FLAP coronary artery disease LCAT cardiovascular AZD4041# MEDI7352 MEDI5117# China velsecorat (AZD7594) orexin 1 receptor antagonist opioid use NGF/TNF OA pain / painful diabetic IL6 YTE rheumatoid arthritis Inhaled SGRM asthma / COPD disorder neuropathy AZD5634 MEDI6570 AZD7986# suvratoxumab inhaled ENaC cystic fibrosis LOX-1 CV disease DPP1 COPD α-Toxin Staphylococcus pneumonia AZD6615 MEDI7219 AZD8601# tezepelumab# hypercholesterolemia CV disease anti-diabetic type-2 diabetes VEGF-A cardiovascular TSLP atopic dermatitis AZD8154 navafenterol (AZD8871)# tezepelumab# Inhaled PI3Kgd asthma MABA COPD TSLP COPD AZD9567 verinurad SGRM RA / respiratory URAT-1 chronic kidney disease 1 Includes novel combinations and additional indications for assets where the lead is not yet launched Precision medicine approach being explored 4 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial BioPharmaceuticals Q1 2020 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under review 1 Project 9 Projects 24 Projects 1 Project Imfinzi#+CRT PACIFIC-5 (China) Imfinzi#+azacitidine# Enhertu# Calquence# Lynparza# PROfound PD-L1+CRT locally-advanced stage III PD-L1+azacitidine MDS ADC NSCLC BTK inhibitor 1st line MCL PARP prostate cancer NSCLC Imfinzi#+CTx neoadjuvant AEGEAN Enhertu# DESTINY-CRC-01 Calquence# PD-L1+CTx locally-advanced stage I-III ADC colorectal cancer BTK inhibitor r/r CLL, high risk NSCLC Calquence#+venetoclax+ Imfinzi#+CTx NIAGARA Enhertu# DESTINY-Gastric02 obinutuzumab PD-L1+CTx muscle invasive bladder ADC gastric BTK+BCL-2+anti-CD20 1st line CLL cancer Imfinzi# Enhertu# DESTINY-Breast02 Imfinzi#+CTx TOPAZ-1 PD-L1 solid tumours ADC breast PD-L1+CTx 1L biliary tract cancer Imfinzi# (platform) BEGONIA Enhertu# DESTINY-Breast03 Imfinzi#+VEGF EMERALD-2 PD-L1 1L mTNBC ADC breast PD-L1+VEGF adjuvant HCC Imfinzi# (platform) MAGELLAN Enhertu# DESTINY-Breast04 Imfinzi#+VEGF+TACE EMERALD-1 PD-L1 1L mNSCLC ADC breast PD-L1+VEGF+TACE locoregional HCC Imfinzi+FOLFOX+bevacizumab (platform) Enhertu¶# DESTINY-Gastric01 Lynparza# OlympiA COLUMBIA1 PD-L1+chemo+VEGF+multiple ADC gastric PARP gBRCA adjuvant breast novel ONC therapies 1L MSS-CRC Imfinzi# CALLA Lynparza# (basket) MK-7339-002 / LYNK002 PD-L1 adj. locally advanced cervical Lynparza# SOLO-3 PARP HRRm cancer PARP BRCAm PSR ovarian cancer Lynparza#+cediranib CONCERTO Imfinzi# PEARL Lynparza+abiraterone# PROpel PARP+VEGF recurrent Pt-R ovarian PD-L1 1L metastatic NSCLC PARP+NHA prostate cancer Imfinzi# post-SBRT PACIFIC-4 Tagrisso ADAURA PD-L1 post-SBRT stage I/II NSCLC EGFR adj. EGFRm NSCLC Imfinzi# POTOMAC Tagrisso LAURA PD-L1 non muscle invasive bladder EGFRm locally advanced unresectable cancer NSCLC Imfinzi#+CRT PACIFIC-2 Tagrisso+chemo FLAURA2 PD-L1+CRT NSCLC EGFR+chemo 1L adv EGFRm NSCLC 1 Includes significant LCM projects and parallel indications for assets beyond Phase III 5 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial Oncology Precision medicine approach being explored Q1 2020 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under review 0 Projects 2 Projects 10 Projects 4 Projects Breztri Brilinta/Brilique HESTIA Brilinta/Brilique THEMIS LABA/LAMA/ICS asthma P2Y12 paeds w/ sickle cell P2Y12 diabetes & CAD outcomes roxadustat# Brilinta/Brilique THALES Farxiga/Forxiga DAPA-HF HIF-PH inhibitor chemo induced P2Y12 stroke SGLT2 HFrEF anaemia Farxiga/Forxiga Dapa-CKD Nexium (CN only) SGLT2 CKD stress ulcer prophylaxis Farxiga/Forxiga DELIVER Symbicort SYGMA SGLT2 HFpEF as needed in mild asthma Farxiga/Forxiga DETERMINE- Preserved SGLT2 HFpEF Farxiga/Forxiga DETERMINE-Reduced SGLT2 HFrEF Fasenra MANDARA IL-5R EGPA Fasenra# OSTRO, ORCHID IL-5R nasal polyposis Fasenra# RESOLUTE IL-5R COPD roxadustat# HIFPH anaemia MDS 1 Includes significant LCM projects and parallel indications for assets beyond Phase III 6 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial BioPharmaceuticals Precision medicine approach being explored Estimated key regulatory submission acceptances PT027 asthma tezepelumab asthma NAVIGATOR Imfinzi + tremelimumab HCC Imfinzi + tremelimumab + CRT LDS-SCLC Fasenra severe asthma (China) HIMALAYA ADRIATIC anifrolumab SLE Imfinzi + tremelimumab HNSCC Imfinzi + tremelimumab+ SoC urothelial nirsevimab passive RSV immunisation TULIP KESTREL NILE Imfinzi +/- tremelimumab SCLC Enhertu Imfinzi +/- tremelimumab NSCLC capivasertb + CTx 1L mTNBC Lynparza +Imfinzi + bevacizumab ovarian NME CASPIAN (China) DESTINY-Breast01 (EU) POSEIDON CAPItello-290
Recommended publications
  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
    [Show full text]
  • Perioperative Systemic Treatment for Muscle-Invasive Bladder Cancer: Current Evidence and Future Perspectives
    International Journal of Molecular Sciences Review Perioperative Systemic Treatment for Muscle-Invasive Bladder Cancer: Current Evidence and Future Perspectives In-Ho Kim 1 and Hyo-Jin Lee 2,* 1 Department of Internal Medicine, Division of Medical Oncology, Seoul St. Mary’s Hospital, The Catholic University of Korea College of Medicine, Seoul 06591, Korea; [email protected] 2 Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon 35015, Korea * Correspondence: [email protected]; Tel.: +82-42-280-8369; Fax: +82-42-257-5753 Abstract: Radical cystectomy is the primary treatment for muscle-invasive bladder cancer; however, approximately 50% of patients develop metastatic disease within 2 years of diagnosis, which re- sults in dismal prognosis. Therefore, systemic treatment is important to improve the prognosis of muscle-invasive bladder cancer. Currently, several guidelines recommend cisplatin-based neoad- juvant chemotherapy before radical cystectomy, and adjuvant chemotherapy is recommended in patients who have not received neoadjuvant chemotherapy. Immune checkpoint inhibitors have recently become the standard treatment option for metastatic urothelial carcinoma. Owing to their clinical benefits, several immune checkpoint inhibitors, with or without other agents (including other immunotherapy, cytotoxic chemotherapy, and emerging agents such as antibody drug conjugates), are being extensively investigated in perioperative settings. Several studies for perioperative im- munotherapy have shown that immune checkpoint inhibitors have promising efficacy with relatively low toxicity, and have explored the predictive molecular biomarkers. Herein, we review the current evidence and discuss the future perspectives of perioperative systemic treatment for muscle-invasive Citation: Kim, I.-H.; Lee, H.-J. bladder cancer. Perioperative Systemic Treatment for Muscle-Invasive Bladder Cancer: Keywords: bladder cancer; immunotherapy; perioperative systemic treatment Current Evidence and Future Perspectives.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]
  • NETTER, Jr., Robert, C. Et Al.; Dann, Dorf- (21) International Application
    ll ( (51) International Patent Classification: (74) Agent: NETTER, Jr., Robert, C. et al.; Dann, Dorf- C07K 16/28 (2006.01) man, Herrell and Skillman, 1601 Market Street, Suite 2400, Philadelphia, PA 19103-2307 (US). (21) International Application Number: PCT/US2020/030354 (81) Designated States (unless otherwise indicated, for every kind of national protection av ailable) . AE, AG, AL, AM, (22) International Filing Date: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 29 April 2020 (29.04.2020) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, (25) Filing Language: English DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, (26) Publication Language: English KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, (30) Priority Data: MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/840,465 30 April 2019 (30.04.2019) US OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, (71) Applicants: INSTITUTE FOR CANCER RESEARCH TT, TZ, UA, UG, US, UZ, VC, VN, WS, ZA, ZM, ZW. D/B/A THE RESEARCH INSTITUTE OF FOX CHASE CANCER CENTER [US/US]; 333 Cottman Av¬ (84) Designated States (unless otherwise indicated, for every enue, Philadelphia, PA 191 11-2497 (US). UNIVERSTIY kind of regional protection available) . ARIPO (BW, GH, OF KANSAS [US/US]; 245 Strong Hall, 1450 Jayhawk GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, Boulevard, Lawrence, KS 66045 (US).
    [Show full text]
  • 2018 Medicines in Development for Cancer
    2018 Medicines in Development for Cancer Bladder Cancer Product Name Sponsor Indication Development Phase ABI-009 AADi Bioscience non-muscle invasive bladder cancer Phase I/II (nab-rapamycin/mTOR inhibitor) Los Angeles, CA www.aadibio.com ALT-801 Altor BioScience non-muscle invasive bladder cancer Phase I/II (tumor antigen-specific T-cell Miramar, FL www.altorbioscience.com receptor linked to IL-2) NantKwest Culver City, CA ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase II (IL-15 superagonist protein complex) Miramar, FL (BCG naïve) (Fast Track), www.altorbioscience.com NantKwest non-muscle invasive bladder cancer Culver City, CA (BCG unresponsive) (Fast Track) B-701 BioClin Therapeutics 2L locally advanced or metastatic Phase I/II (anti-FGFR3 mAb) San Ramon, CA bladder cancer www.bioclintherapeutics.com Bavencio® EMD Serono 1L urothelial cancer Phase III avelumab Rockland, MA www.emdserono.com (anti-PD-L1 inhibitor) Pfizer www.pfizer.com New York, NY BC-819 BioCanCell Therapeutics non-muscle invasive bladder cancer Phase II (gene therapy) Cambridge, MA (Fast Track) www.biocancell.com Medicines in Development: Cancer ǀ 2018 1 Bladder Cancer Product Name Sponsor Indication Development Phase Capzola® Spectrum Pharmaceuticals non-muscle invasive bladder cancer application submitted apaziquone Henderson, NV (Fast Track) www.sppirx.com Cavatak® Viralytics bladder cancer (+pembrolizumab) Phase I coxsackievirus Sydney, Australia www.viralytics.com CG0070 Cold Genesys non-muscle invasive bladder cancer Phase II (oncolytic immunotherapy)
    [Show full text]
  • (INN) for Biological and Biotechnological Substances
    WHO/EMP/RHT/TSN/2019.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 WHO/EMP/RHT/TSN/2019.1 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 International Nonproprietary Names (INN) Programme Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances (a review) FORMER DOCUMENT NUMBER: INN Working Document 05.179 © World Health Organization 2019 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
    [Show full text]
  • H1 2020 Results
    H1 2020 results Roadshows and conferences Forward-looking statements disclaimer In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter ’the Group’) provides the following cautionary statement: this document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected revenues, margins, earnings per share or other financial or other measures. Although the Group believes its expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements. The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond the Group’s control, include, among other things: the risk of failure or delay in delivery of pipeline or launch of new medicines; the risk of failure to meet regulatory or ethical requirements
    [Show full text]
  • H1 2021 Results Clinical Trials Appendix PDF 2769KB
    Clinical trials appendix Q2 2021 results update Movement since Q1 2021 update New to Phase I New to Phase II New to Pivotal trial New to registration NME NME NME AZD1402# AZD2816¶# (next generation COVID-19 vaccine) tezepelumab# NAVIGATOR [US, EU & JP] 1 Inhaled IL4Ra asthma SARS-CoV-2 prevention of COVID-19 TSLP mAb severe, uncontrolled asthma AZD9977 + Farxiga Additional indication Lifecycle management # MCR + SGLT2 inhibitor heart failure with CKD capivasertib + fulvestrant + palbociclib CAPItello-292 Fasenra# OSTRO [US] 1 AKT inhibitor + fulvestrant + CDK4/6 inhibitor 1st- line triplet in early IL5R mAb nasal polyps zibotentan + Farxiga3 ZENITH-CKD relapse/ET resistant locally advanced (inoperable) or metastatic breast cancer ETA antagonist + SGLT2 CKD Lifecycle Management Enhertu# DESTINY-Breast09 HER2 targeting antibody drug conjugate 1st-line HER2-postitive breast cancer Enhertu# DESTINY-Gastric04 HER2 targeting antibody drug conjugate 2nd-line HER2-positive gastric cancer Lokelma DIALIZE-Outcomes potassium binder CV outcomes in patients on chronic hemodialysis with hyperkalemia tezepelumab# WAYPOINT TSLP mAb nasal polyposis Removed from Phase I Removed from Phase II Removed from Phase III Removed from registration Additional indication Lifecycle management Lifecycle management Imfinzi + Lynparza# BAYOU Lynparza# SOLO-3 Farxiga3 DAPA-CKD [US] 2 PD-L1 mAb + PARP inhibitor 1st-line unresectable PARP inhibitor gBRCA PSR ovarian cancer SGLT2 inhibitor renal outcomes and CV mortality in stage IV bladder cancer patients with CKD tezepelumab#
    [Show full text]
  • Astrazeneca Deals – Key Highlights
    COMPANY OVERVIEW NOVEMBER 2020 NASDAQ: IPHA EURONEXT PARIS: IPH Forward Looking Statements This document has been prepared by Innate Pharma S.A. (the “Company”) solely for This presentation discusses product candidates that are under clinical development the purposes of a presentation to investors concerning the Company. This document and which have not yet been approved for marketing by the U.S. Food and Drug is not to be reproduced by any person, nor to be distributed. Administration or the European Medicines Agency. No representation is made as to the safety or effectiveness of these product candidates for the use for which such This document contains forward-looking statements. The use of certain words, product candidates are being studied. including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its The information contained herein has not been independently verified. No expectations are based on reasonable assumptions, these forward-looking representation, warranty or undertaking, express or implied, is made as to, and no statements are subject to various risks and uncertainties, which could cause the reliance should be placed on, the fairness, accuracy, completeness or correctness of Company’s actual results or financial condition to differ materially from those the information or opinions contained herein. The Company is under no obligation to anticipated. These risks and uncertainties include, among other things, the keep current the information contained in this presentation and any opinion uncertainties inherent in research and development, including related to safety, expressed is subject to change without notice. progression of and results from its ongoing and planned clinical trials and preclinical The Company shall not bear any liability whatsoever for any loss arising from any use studies, review and approvals by regulatory authorities of its product candidates, the of this document or its contents or otherwise arising in connection therewith.
    [Show full text]
  • Filed by Astrazeneca PLC This Communication Is Filed Pursuant to Rule 425 Under the United States Securities Act of 1933 Subject Company: Alexion Pharmaceuticals, Inc
    Filed by AstraZeneca PLC This communication is filed pursuant to Rule 425 under the United States Securities Act of 1933 Subject Company: Alexion Pharmaceuticals, Inc. (Commission File No. 000-27756) Date: February 11, 2021 The following presentation was made available by AstraZeneca PLC on its website on February 11, 2021 FY2020results Conference call and webcast for investors and analysts 11 February 2021 Forward-looking statements In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter ‘the Group’) provides the following cautionary statement: this document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected revenues, margins, earnings per share or other financial or other measures. Although the Group believes its expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements. The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions
    [Show full text]
  • A61K9/51 (2006.01) — with International Search Report (Art
    ) ( 2 (51) International Patent Classification: Published: A61K9/51 (2006.01) — with international search report (Art. 21(3)) (21) International Application Number: — before the expiration of the time limit for amending the PCT/US20 19/033 875 claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) (22) International Filing Date: 24 May 2019 (24.05.2019) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/676,169 24 May 2018 (24.05.2018) US (71) Applicant: ELEKTROFI, INC. [US/US]; 75 Kneeland Street, 14th Floor, Boston, MA 021 11 (US). (72) Inventors: COFFMAN, Chase; 86 Worcester Street, Unit 3, Boston, MA 021 18 (US). CHARLES, Lyndon; 600 Main St Apt 3, Medford, MA 02155 (US). BROWN, Paul; 156 W 6th St, Unit 2, Boston, MA 02127 (US). DADON, Daniel, Benjamin; 2 Garden Court, Apt. 1, Cambridge, MA 02138 (US). LIU, Lisa; 111 Bartlett Street, Apt 2, Somerville, MA 02145 (US). SHADBAR, Sadiqua; 1307 Commonwealth Avenue, Apt 9, Allston, MA 02135 (US). SUDRIK, Chaitanya; 7 1 Elm Street, Apartment #2, Cam¬ bridge, MA 02139 (US). (74) Agent: BELLIVEAU, Michael J. et al.; Clark & Elbing LLP, 101 Federal Street, 15th Floor, Boston, MA 021 10 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available) : AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
    [Show full text]
  • The State-Of-The-Art of Phase II/III Clinical Trials for Targeted Pancreatic Cancer Therapies
    Journal of Clinical Medicine Review The State-of-the-Art of Phase II/III Clinical Trials for Targeted Pancreatic Cancer Therapies Andres Garcia-Sampedro , Gabriella Gaggia , Alexander Ney , Ismahan Mahamed and Pilar Acedo * Institute for Liver and Digestive Health, Royal Free Hospital Campus, University College London, London NW3 2QG, UK; [email protected] (A.G.-S.); [email protected] (G.G.); [email protected] (A.N.); [email protected] (I.M.) * Correspondence: [email protected] Abstract: Pancreatic cancer is a devastating disease with very poor prognosis. Currently, surgery followed by adjuvant chemotherapy represents the only curative option which, unfortunately, is only available for a small group of patients. The majority of pancreatic cancer cases are diagnosed at advanced or metastatic stage when surgical resection is not possible and treatment options are lim- ited. Thus, novel and more effective therapeutic strategies are urgently needed. Molecular profiling together with targeted therapies against key hallmarks of pancreatic cancer appear as a promising ap- proach that could overcome the limitations of conventional chemo- and radio-therapy. In this review, we focus on the latest personalised and multimodal targeted therapies currently undergoing phase II or III clinical trials. We discuss the most promising findings of agents targeting surface receptors, angiogenesis, DNA damage and cell cycle arrest, key signalling pathways, immunotherapies, and the tumour microenvironment. Keywords: pancreatic cancer; PDAC; clinical trials; targeted therapies; immunotherapy; cancer vaccines; tumour microenvironment Citation: Garcia-Sampedro, A.; Gaggia, G.; Ney, A.; Mahamed, I.; Acedo, P. The State-of-the-Art of Phase II/III Clinical Trials for 1.
    [Show full text]