Clinical Trials Appendices R&D Pipeline – New Molecular Entities(*)
Total Page:16
File Type:pdf, Size:1020Kb
Clinical Trials Appendices R&D Pipeline – New Molecular Entities(*) Phase 1 Phase 2 Phase 3 Registration (Total:16) (Total:13) (Total:8) (Total:3) SAR439794 SAR228810 SAR440340(**) ST400(8) isatuximab cemiplimab(**) TLR4 agonist Anti-protofibrillar AB mAb Anti-IL33 mAb ZFN Gene Editing Technology Anti-CD38 mAb PD-1 inhibitor mAb Peanut Allergy Alzheimer’s Disease Asthma Beta thalassemia 3L Relapsing Refractory MM (ICARIA) Advanced CSCC (U.S./EU) SAR408701 SAR442168(4) SAR156597 SAR422459 avalglucosidase alfa ZynquistaTM(**) n Maytansin-loaded anti-CEACAM5 mAb BTK inhibitor IL4/IL13 bi-specific mAb ABCA4 gene therapy Neo GAA Oral SGLT-1&2 inhibitor Solid Tumors Multiple Sclerosis Systemic Scleroderma Stargardt Disease Pompe Disease Type 1 Diabetes (U.S./EU) TM SAR439459 UshStat® GZ389988 SAR425899 venglustat Cablivi anti-TGFb mAb Myosin 7A gene therapy TRKA antagonist GLP-1/GCG dual agonist Oral GCS inhibitor Bivalent anti-vWF Nanobody Advanced Solid Tumors Usher Syndrome 1B Osteoarthritis Obesity/Overweight in T2D ADPKD(10) acquired Thrombotic Thrombocytopenic Purpura (EU) O REGN3767(1) SAR438335 Combination SAR407899 fitusiran Anti LAG-3 mAb GLP-1/GIP dual agonist ferroquine / OZ439(**) rho kinase siRNA targeting anti-thrombin Advanced Cancers Type 2 Diabetes Antimalarial Microvascular Angina Hemophilia A and B O (1) (5)(**) (11) REGN4659 SAR440181 ALX0171 HIV sutimlimab Anti-CTLA-4 mAb Myosin activation Anti RSV Nanobody Anti Complement C1s mAb Viral vector prime & rgp120 boost vaccine Cancer Dilated Cardiomyopathy Respiratory Syncitial Virus Cold Agglutinin Disease O REGN4018(1) SAR247799 R olipudase alfa SP0232(9) mAb(**) SAR341402 Anti MUC16-CD3 bispecific mAb S1P1 agonist rhASM Respiratory syncytial virus Rapid acting insulin Ovarian Cancer Cardiovascular indication Acid Sphingomyelinase Deficiency(6) Monoclonal Antibody Type 1/2 Diabetes O (7) (**) SAR439859 Herpes Simplex Virus Type 2 SAR339375 efpeglenatide n SERD miRNA-21 Long-acting GLP-1 agonist HSV-2 vaccine Metastatic Breast Cancer Alport Syndrome Type 2 Diabetes BIVV001(2) Respiratory syncytial virus mavacamten(12)(**) rFVIIIFc – vWF – XTEN(3) Infants Myosin inhibitor Hemophilia A Vaccines Obstructive Hypertrophic Cardiomyopathy R Registrational Study (other than Phase 3) O Opt-in rights products for which rights have not been exercised yet Immuno-inflammation MS & Neuro Oncology Diabetes (1) Regeneron product for which Sanofi has opt-in rights (8) Developed in collaboration with Sangamo Rare Diseases Cardiovascular & metabolism (2) Sanofi Product for which Sobi has opt-in rights (9) Also known as MEDI8897 (3) Recombinant Coagulation Factor VIII Fc – von Willebrand Factor – XTEN Fusion protein (10) Autosomal Dominant Polycystic Kidney Disease Rare Blood Disorders Vaccines (4) Also known as PRN2246 (11) Also Known as BIVV009 (5) Also known as MYK491 (12) Also known as SAR439152 and MYK461 (6) Also known as Niemann Pick type B (*) Data related to all studies published on clinicaltrials.gov 2 (7) Regulus product for which Sanofi has opt-in rights (**) Partnered and/or in collaboration – Sanofi may have limited or shared rights on some of these products Additional Indications(*) Phase 1 Phase 2 Phase 3 Registration (Total:6) (Total:16) (Total:20) (Total:5) SAR439459 + cemiplimab(**) dupilumab(**) cemiplimab(**) dupilumab(**) isatuximab dupilumab(**) Anti-IL4Rα mAb Anti-TGFb mAb + PD-1 inhibitor mAb PD-1 inhibitor mAb Anti-IL4Rα mAb Anti-CD38 mAb Anti-IL4Rα mAb Advanced Solid Tumors Eosinophilic Esophagitis 2L NSCLC Asthma 6 - 11 years old 1-3L Relapsing Refractory MM (IKEMA) Asthma 12y+ (U.S./EU) O cemiplimab(**) + REGN3767(1) dupilumab(**) venglustat dupilumab(**) Aubagio® Praluent®(**) PD-1 inhibitor mAb + anti LAG-3 mAb Anti-IL4Rα mAb Oral GCS inhibitor Anti-IL4Rα mAb teriflunomide alirocumab Advanced Cancers Grass Immunotherapy Fabry Disease Nasal Polyposis Relapsing Multiple Sclerosis - Pediatric CV events reduction (U.S.(4)/EU) O cemiplimab(**) + REGN4659(1) R sarilumab(**) venglustat Dupixent®(**) Lemtrada® VaxiGrip® QIV IM PD-1 inhibitor mAb + Anti-CTLA-4 mAb Anti-IL6R mAb Oral GCS inhibitor dupilumab alemtuzumab Quadrivalent inactivated NSCLC Polyarticular Juvenile Idiopathic Arthritis Gaucher Type 3 Atopic Dermatitis 12 – 17 years old Relapsing Remitting Multiple Sclerosis - Pediatric Influenza vaccine 6 - 35 months O cemiplimab(**) + REGN4018(1) sarilumab(**) venglustat Dupixent®(**) ZynquistaTM(**) n PR5i PD-1 inhibitor mAb + Anti-MUC16-CD3 bispecific Anti-IL6R mAb Oral GCS inhibitor dupilumab Oral SGLT-1&2 inhibitor DTP-HepB-Polio-Hib mAb - Ovarian Cancer Systemic Juvenile Arthritis Gaucher related Parkinson’s Disease Atopic Dermatitis 6 – 11 years old Type 2 Diabetes Pediatric hexavalent vaccines (U.S.) SAR439859 SAR440340(**) mavacamten(3)(**) Dupixent®(**) ZynquistaTM(**) Fluzone® 0.5 mL QIV SERD + Palbociclib Anti-IL33 mAb Myosin inhibitor dupilumab Oral SGLT-1&2 inhibitor Quadrivalent inactivated Metastatic Breast Cancer COPD Non-Obstructive Hypertrophic Cardiomyopathy Atopic Dermatitis 6 months - 5 years old Worsening Heart Failure in Diabetes Influenza vaccine 6 months+ (2) R (**) (**) ® sutimlimab cemiplimab Rabies VRVg cemiplimab Cerdelga Anti Complement C1s mAb PD-1 inhibitor mAb PD-1 inhibitor mAb eliglustat Purified vero rabies vaccine Immune Thrombocytopenia Advanced Basal Cell Carcinoma 1L NSCLC Gaucher Type 1, switch from ERT - Pediatric (**) (**) ®(**) isatuximab + cemiplimab Adacel+ cemiplimab Praluent Anti-CD38 mAb + PD-1 inhibitor mAb PD-1 inhibitor mAb + ipilimumab alirocumab Tdap booster Relapsing Refractory MM 1L NSCLC LDL-C reduction - Pediatric (**) isatuximab + cemiplimab(**) Shan 6 cemiplimab Fluzone® QIV HD PD-1 inhibitor mAb + platinum based Anti-CD38 mAb + PD-1 inhibitor mAb DTP-HepB-Polio-Hib Quadrivalent inactivated chemotherapy Advanced Malignancies Pediatric hexavalent vaccine Influenza vaccine - High dose 1L NSCLC cemiplimab(**) Men Quad TT PD-1 inhibitor mAb Advanced generation meningococcal 2L Cervical Cancer ACYW conjugate vaccine isatuximab Pediatric pentavalent vaccine Anti-CD38 mAb DTP-Polio-Hib R Registrational study (other than Phase 3) 1L Newly Diagnosed MM (IMROZ) Japan O Opt-in rights products for which rights have not been exercised yet Immuno-inflammation MS & Neuro (1) Regeneron product for which Sanofi has opt-in rights (2) Also known as BIVV009 Oncology Diabetes (3) Also known as SAR439152 and MYK461 Rare Diseases Cardiovascular & metabolism (4) U.S. filing pending acceptance by FDA 3 (*) Data related to all studies published on clinicaltrials.gov Vaccines (**) Partnered and/or in collaboration - Sanofi may have limited or shared rights on some of these products Rare Blood Disorders Expected Submission Timeline(1) avalglucosidase alfa GZ389988 ALX0171 Neo GAA TRKA antagonist Anti RSV Nanobody Pompe Disease Osteoarthritis Respiratory Syncitial Virus olipudase alfa SAR156597 SAR228810 SAR407899 rhASM IL4/IL13 bi-specific mAb Anti-protofibrillar AB mAb rho kinase (4) ASD Systemic Scleroderma Alzheimer’s Disease Microvascular Angina (**) fitusiran venglustat SAR440340 SAR422459 SP0232 mAbs(7)(**) siRNA inhibitor ABCA4 gene therapy Oral GCS inhibitor Anti-IL33 mAb Respiratory syncytial virus Hemophilia A/B ADPKD(6) Asthma Stargardt Disease NMEs isatuximab SAR341402 sutimlimab(5) efpeglenatide(**) Combination SAR425899 HIV anti-CD38 mAb Rapid acting insulin Anti Complement C1s mAb Long acting GLP1-R agonist ferroquine / OZ439(**) GLP-1/GCG dual agonist Viral vector prime & rgp120 3L RRMM (ICARIA) Type 1/2 Diabetes - EU(2) Cold Agglutinin Disease Type 2 Diabetes Antimalarial Obesity/Overweight in T2D boost vaccine 2018 2019 2020 2021 2022 and beyond sarilumab(**) Dupixent®(**) Dupixent®(**) ZynquistaTM(**)n Aubagio® isatuximab Dupixent®(**) SAR440340(**) venglustat Anti-IL6R mAb dupilumab dupilumab Anti-IL33 mAb dupilumab Oral SGLT-1&2 inhibitor Polyarticular Juvenile teriflunomide Anti-CD38 mAb (IMROZ) Oral GCS inhibitor AD 6 - 11 years old - (3) AD 6 months - 5 years old COPD (8) AD 12 – 17 years old Type 2 Diabetes – EU Idiopathic Arthritis Relapsing MS – Ped. 1L Newly Diagnosed MM GrPD cemiplimab(**) (**) Fluzone® QIV HD cemiplimab(**) Shan 6 sarilumab(**) ®(**) dupilumab PD-1 inhibitor mAb + platinum venglustat Praluent Anti-IL4Ra mAb Quadrivalent inactivated PD-1 inhibitor mAb DTP-HepB-Polio-Hib Anti-IL6R mAb Oral GCS inhibitor alirocumab Nasal Polyposis Adult Influenza vaccine - High dose 2L Cervical Cancer Pediatric hexavalent vaccine based chemotherapy Systemic Juvenile Arthritis Fabry Disease LDL-C reduction - Pediatric 1L NSCLC ZynquistaTM(**) cemiplimab(**) Men Quad TT isatuximab dupilumab(**) Oral SGLT-1&2 inhibitor venglustat Rabies VRVg PD-1 inhibitor mAb Adv. generation meningococcal Anti-CD38 mAb Anti-IL4Ra mAb Oral GCS inhibitor Purified vero rabies vaccine Advanced BCC U.S.: 2y+ & EU: Toddlers+ 1-3L RRMM (IKEMA) Worsening Heart Failure in Eosinophilic Esophagitis Indications Gaucher Type 3 Diabetes ® (**) (**) Cerdelga Pentacel® vIPV cemiplimab Adacel+ dupilumab PD-1 inhibitor mAb Anti-IL4Rα mAb eliglustat DTaP-IPV/Hib Tdap booster 1L NSCLC Asthma 6 - 11 years old Gaucher Type 1, switch from ERT – Pediatric EU Pediatric pentavalent vaccine DTP-Polio-Hib (Japan) Additional Immuno-inflammation MS & Neuro Oncology Diabetes Rare Diseases Cardiovascular & metabolism (1) Excluding Phase 1 - Data related to all studies published on clinicaltrials.gov (6) Autosomal Dominant Polycystic Kidney Disease (2) Submission strategy for the U.S. under evaluation (7) Also known as MEDI8897 Rare Blood Disorders