Roche Template

Roche Template

Changes to the development pipeline Q3 2020 update New to phase I New to phase II New to phase III New to registration 7 NMEs: 2 NMEs: 4 NMEs: 1 NME: RG6091 UBE3A LNA - Angelman syndrome RG7992 FGFR1 x KLB - NASH RG6107 crovalimab - PNH RG6396 Gavreto (pralsetinib) - RET fusion- RG6286 NME - colorectal cancer CHU Oncolytic Type 5 adenovirus - esophageal RG6413+RG6412 REGN-COV2 - SARS-CoV-2 positive NSCLC RG6315 NME - systemic sclerosis cancer prophylaxis RG6330 KRAS G12C - KRAS-mutant solid tumors RG6171 SERD(3) ER+/HER2 - metastatic breast 2 AIs: RG6418 NLRP3 inhibitor - inflammation 5 AIs: cancer RG3648 Xolair - asthma home use 4D-MT 4D-R125 - X-linked retinitis pigmentosa RG6171 SERD(3) - neoadjuvant HR+ breast 7 AIs: RG6396 Gavreto (pralsetinitb) - RET-mutant CHU CD137 agonist switch antibody - solid tumors cancer RG6058 tiragolumab+Tecentriq - stage III medullary thyroid cancer (MTC) RG6413+RG6412 REGN-COV2 - COVID-19+ unresectable 1L NSCLC 2 AIs: adult – ambulatory RG6058 tiragolumab+Tecentriq - locally adv RG7440 ipatasertib+Tecentriq - prostate cancer RG6413+RG6412 REGN-COV2 - COVID-19+ esophageal cancer previously treated with androgen receptor-targeted adult – hospitalized RG6321 PDS with ranibizumab - diabetic therapy retinopathy RG7446 Tecentriq+Venclexta - maintenance 1L RG7159 Gazyva - lupus nephritis ES-SCLC RG7601 Venclexta - 1L MDS RG7446 Tecentriq+cabozantinib - adv RCC RG7446 Tecentriq+cabozantinib - 2L NSCLC Removed from phase I Removed from phase II Removed from phase III Approvals 2 NMEs: 2 AIs: 3 AIs: 3 NMEs approved in US RG6000 DLK inhibitor - ALS RG7421 Cotellic+Tecentriq+/- taxane - TNBC RG7413 etrolizumab - ulceritis colitis RG7916 Evrysdi - SMA RG7861 anti-S.aureus - infectious diseases RG7596 Polivy - r/r FL* RG7446 Tecentriq+paclitaxel - 1L TNBC RG6168 Enspryng - NMOSD RG7446 Tecentriq+ chemo + Avastin - ovarian RG6396 Gavreto - RET fusion positive NSCLC cancer 1 NME approved in EU RG6268 Rozlytrek - ROS1+ NSCLC 1 AI approved in US RG7421 Cotellic+Zelboraf+Tecentriq - 1L+ BRAFm melanoma 1 AI approved in EU RG6268 Rozlytrek - NTRK+ tumor-agnostic Status as of October 15, 2020 * FL cohort removed, DLBCL continues 1 Roche Group development pipeline Phase I (45 NMEs + 17 AIs) Phase II (21 NMEs + 14 AIs) RG6026 glofitamab combos heme tumors RG7769 PD1 x TIM3 solid tumors RG6171 SERD (3) neoadjuvant HR+ BC RG6058 tiragolumab combos heme & solid tumors RG7802 cibisatamab ± T solid tumors RG6180 iNeST* + pembrolizumab malignant melanoma RG6076 CD19-4-1BBL heme tumors RG7827 FAP-4-1BBL + T solid tumors RG6357 SPK-8011 hemophilia A RG6115 TLR7 agonist (4) HCC RG7828 mosunetuzumab combos heme tumors RG6358 SPK-8016 hemophilia A with inhibitors to factor VIII RG6139 PD1 x LAG3 solid tumors RG7876 selicrelumab combos solid tumors tiragolumab + T NSCLC RG6058 RG6160 FcRH5 x CD3 r/r MM CHU FIXa x FX hemophilia tiragolumab + T cervical cancer RG6171 SERD (3) ER+/HER2- mBC 1L CHU glypican-3 x CD3 solid tumors RG7446 Tecentriq SC NSCLC RG6180 iNeST*± T solid tumors CHU codrituzumab HCC Venclexta + fulvestrant 2L HR+BC RG7601 RG6185 belvarafenib (pan-RAF inh)+Cotellic solid tumors CHU CD137 switch antibody solid tumors Venclexta + carfilzomib r/r MM t(11:14) RG6194 HER2 x CD3 BC CHU - .. solid tumors & endometriosis CHU Oncolytic Type 5 adenovirus esophageal cancer RG6279 PD1-IL2v solid tumors SQZ PBMC vaccine solid tumors RG6149 ST2 MAb asthma RG6286 NME colorectal cancer RG6151 - asthma RG6173 anti-tryptase asthma RG6290 MAGE-A4 ImmTAC solid tumors RG6244 - asthma rhPTX-2 (PRM-151) myelofibrosis RG6354 RG6292 CD25 MAb solid tumors RG6287 - IBD rhPTX-2 (PRM-151) . idiopathic pulmonary fibrosis RG6296 BCMA x CD16a r/r MM RG6418 NLRP3 inh inflammation RG7845 fenebrutinib RA RG6323 IL15/IL15Ra-Fc solid tumors RG6315 NME systemic sclerosis RG7880 IL22-Fc inflammatory diseases RG6330 KRAS G12C solid tumors RG7835 IgG–IL2 autoimmune diseases RG6149/RG7880 ST2 MAb or IL22-Fc COVID-19 pneumonia ipatasertib + Taxane + T TNBC RG6084 - HBV NOV TLR4 MAb autoimmune diseases RG7440 ipatasertib + rucaparib mCRPC, solid tumors RG6346 HBV siRNA HBV RG7854+RG7907 TLR7 ago(3) + CpAM (2) HBV ipatasertib .prostate cancer, pretreated RG6091 UBE3A LNA Angelman syndrome RG6413+ REGN-COV2 nAbs . COVID-19+ adult-ambulatory Morpheus platform solid tumors RG6102 brain shuttle gantenerumab Alzheimer’s RG6412 REGN-COV2 nAbs COVID-19+ adult-hospitalised T + Avastin + Cotellic 2/3L CRC RG6237 - neuromuscular disorders RG7992 FGFR1 x KLB MAb NASH T ± Avastin ± chemo HCC, GC, PaC RG7637 - . neurodevelopmental disorders IONIS ASO factor B IgA nephropathy T + anti-CD20 combos heme tumors RG7816 GABA Aa5 PAM autism RG6100 semorinemab Alzheimer’s RG7446 T + K/HP HER2+ BC RG6179 - DME RG6356 microdystrophin (SRP-9001) DMD T + rucaparib ovarian cancer RG6247 4D-R110 choroideremia RG7412 crenezumab familial Alzheimer’s healthy pts T + CD47 MAb r/r AML RG7921 - nAMD RG7906 ralmitaront schizophrenia T + Venclexta maintenance 1L ES-SCLC 4D-MT 4D-R125 X-linked retinitis pigmentosa RG7935 prasinezumab Parkinson's RG7461 simlukafusp alfa combos solid tumors CHU PTH1 recep. ago hypoparathyroidism RG6147 - geographic atrophy Venclexta + AMG176 AML CHU - hyperphosphatemia RG6367 SPK-7001 choroideremia RG7601 Venclexta ± azacitidine r/r MDS RG7774 - retinal disease New Molecular Entity (NME) CardioMetabolism Venclexta + gilteritinib r/r AML Additional Indication (AI) Neuroscience IONIS ASO factor B geographic atrophy *Individualized Neoantigen Specific Immunotherapy; T=Tecentriq Oncology / Hematology Ophthalmology RG-No - Roche/Genentech SQZ - SQZ Biotechnology managed Immunology Other CHU - Chugai managed NOV - Novimmune managed 2 Status as of October 15, 2020 Infectious Diseases IONIS – IONIS managed 4D-MT - 4D-MT managed Roche Group development pipeline Phase III (12 NMEs + 34 AIs) Registration (5 NMEs + 11 AIs) RG6013 Hemlibra mild to moderate hemophilia A RG7446/ Tecentriq bTMB-high RG6264 Phesgo 1 Perjeta + Herceptin FDC SC HER2+ BC 1L NSCLC tiragolumab + T + chemo 1L SCLC RG6268 or entrectinib ROS1+ Gavreto (pralsetinib) 1 RET+ NSCLC RG6396 tiragolumab + T 1L PD-L1+ NSCLC Venclexta r/r MM t(11:14) Gavreto (pralsetinib) 2 RET+ MTC RG6058 RG7601 tiragolumab + T locally advanced esophageal cancer Venclexta + azacitidine 1L MDS Tecentriq Dx+ 1 1L sq + non-sq NSCLC RG7446 tiragolumab + T .stage III unresectable 1L NSCLC RG7853 Alecensa ALK+ NSCLC adj Tecentriq+ Avastin 1 1L HCC RG6107 crovalimab PNH RG1569 Actemra COVID-19 pneumonia RG7601 Venclexta + azacitidine 1L AML RG6114 mPI3K alpha inh 1L HR+ mBC RG1569 Actemra + remdesivir COVID-19 pneumonia RG7853 Alecensa 1LNSCLC Dx+ RG6171 SERD (3) ER+/HER2- mBC RG3648 Xolair food allergy Xolair 3 nasal polyps RG3648 ipatasertib + abiraterone 1L CRPC RG7159 Gazyva lupus nephritis Xolair 2 asthma home use ipatasertib + chemo 1L TNBC/HR+ BC RG7413 etrolizumab Crohn’s Xofluza 1 influenza RG7440 ipatasertib + fulvestrant + palbociclib 1L HR+ mBC Xofluza influenza, hospitalized pts Xofluza 1 influenza, high risk RG6152 ipatasertib + Tecentriq + taxane 1L TNBC RG6152 Xofluza influenza, pediatric (0-1 year) Xofluza influenza post exposure prophylaxis RG7596 Polivy 1L DLBCL Xofluza influenza direct transmission Xofluza 2 influenza, pediatric (1-12 yrs) RG6413+ 3 Tecentriq NSCLC adj REGN-COV2 nABs SARS-CoV2 prophylaxis RG1594 Ocrevus short infusion RMS & PPMS RG6412 Tecentriq NMIBC, high risk RG6168 Enspryng (satralizumab) 1 NMOSD RG1450 gantenerumab Alzheimer’s Tecentriq RCC adj RG7916 Evrysdi (risdiplam) 1 SMA RG6042 tominersen Huntington’s Tecentriq + cabozantinib advanced RCC port delivery system with ranibizumab . wAMD Tecentriq + cabozantinib 2L NSCLC 1 RG6321 port delivery system with ranibizumab . DME Approved in US, filed in EU T ± chemo SCCHN adj RG7446 port delivery system with ranibizumab DR 2 Filed in US Tecentriq HER2+ BC neoadj faricimab DME 3 T + capecitabine or carbo/gem 1L TNBC RG7716 Filed in US, approved in EU faricimab wAMD T + paclitaxel TNBC adj New Molecular Entity (NME) CardioMetabolism T + nab-paclitaxel TNBC neoadj Additional Indication (AI) Neuroscience T + Avastin HCC adj Oncology / Hematology Ophthalmology Immunology Other T ± chemo 1L mUC Infectious Diseases T=Tecentriq 3 Status as of October 15, 2020 NME submissions and their additional indications Projects in phase II and III Port Delivery System tiragolumab + TLR7 ago (3) RG7907+ RG6321 with ranibizumab RG6058 Tecentriq (T) + CpAM (2) RG7854 wAMD 1L PD-L1+ cervical ca HBV Xofluza ✓ rhPTX-2 RG6413+ REGN-COV2 Crovalimab tiragolumab + T FGFR1 x KLB MAb RG6152 influenza, pediatric RG6107 RG6058 RG7992 RG6354 (PRM-151) SARS-CoV2 prophylaxis PNH 1L PD-L1+ NSCLC NASH (1-12 yrs) RG6412 IPF Xofluza ✓ REGN-COV2 tiragolumab + T rhPTX-2 RG6413+ tominersen ralmitaront RG6152 influenza post-exposure COVID-19+ RG6042 RG6058 locally adv esophageal RG7906 RG6354 (PRM-151) RG6412 Huntington’s schizophrenia prophylaxis adult-ambulatory cancer myelofibrosis REGN-COV2 tiragolumab + T microdystrophin Evrysdi (risdiplam) RG6413+ gantenerumab ST2 MAb RG7916 COVID-19+ RG1450 RG6058 Stage III unresectable 1L RG6356 SRP-9001 RG6149 SMA (EU) RG6412 Alzheimer‘s asthma adult-hospitalized NSCLC DMD Gavreto Xofluza semorinemab etrolizumab mPI3K alpha inh Anti-tryptase RG6396 (pralsetinib) ✓ RG6152 influenza, pediatric RG7413 RG6114 RG6100 (Tau MAb ) RG6173 Crohn’s 1L HR+ BC asthma RET+ NSCLC (0-1 year) Alzheimer’s Gavreto Xofluza Xofluza iNeST** prasinezumab fenebrutinib RG6396 (pralsetinib) ✓* RG6152 RG6152 RG6180 RG7935 RG7845 influenza, hospitalized direct transmission

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    96 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us