Table of Content

1. Bispecific Antibodies: The Next Generation Antibody Therapeutics
1.1 History of Bispecific Antibodies
1.2 Overview to Bispecific Antibodies


2. Advantages of Bispecific Antibody Over Monoclonal Antibody


3. BiTE (Bispecific T Cell Engager) - New Era in Cancer Immunotherapy


4. Structure & Design of BiTE
4.1 Construction of Single Chain Variable Fragment Antibodies
4.2 Bispecific scFv Antibody Expression & Production


5. BiTE Antibody - Mode of Action
5.1 Redirected Target Cell Lysis by BiTE
5.2 T-Cell Activation by BiTE
5.3 Lytic Synapse Formation by BiTE


6. Blinatumomab (Blincyto): The First Approved BiTE Antibody
6.1 Clinical Trials, Approval & Patenting
6.2 Design & Mechanism of Action
6.3 Adverse Drug Reactions & Management


7. Global BiTE Antibody Clinical Trials Indicators
7.1 By Phase
7.2 By Company
7.3 By Country
7.4 By Indication
7.5 By Patient Segment


8. Global BiTE Clinical Pipeline By Company, Indication & Phase
8.1 Preclinical
8.2 Phase-I


9. Global BiTE Antibody Market Overview
9.1 Current Market Scenario
9.2 Blincyto Reimbursement Policy


10. Blincyto - Dosage & Market Sales Analysis
10.1 Dosage of Blincyto in B-ALL
10.2 Current Market Sales Analysis


11. Clinical Pipeline of Bispecific T-Cell Engagers


12. Bridging T-Cells to Tumors: CAR vs BiTEs


13. BiTE: Ongoing Research & Development
13.1 BiTe Based Immunotherapy Treatment for Relapsed Refractory Multiple Myeloma
13.2 Novel DLL3 Targeted BiTE shows Antitumor Activity in Small Cell Lung Cancer
13.3 Preliminary Efficacy of AMG 160 in Metastatic Castration – Resistant Prostate
Cancer


14. Global Bispecific T-Cell Engagers Market Dynamics
14.1 Favorable Market Parameters
14.2 Commercialization Challenges


15. Global BiTE Market Future Prospects


16. Competitive Landscape
16.1 Amgen
16.2 Bayers
16.3 Micromet
16.4 Psioxus Therapeutics
16.5 Y Biologics



List of Figures


Figure 1-1: Evolution of Bispecific Antibodies
Figure 1-2: Bispecific Antibodies Structure
Figure 1-3: Formats of Bispecific Antibodies

Figure 2-1: Advantages of Bispecific Antibody over Monoclonal Antibody

Figure 3-1: Structure of Bispecific T-Cell Engagers
Figure 3-2: General Mechanism of BiTE

Figure 4-1: Construction of scFv Antibodies
Figure 4-2: Antibodies Expression & Production in E. coli
Figure 4-3: Expression & Production of Antibodies in CHO System
Figure 4-4: Various Expression Systems for Antibodies

Figure 5-1: Redirected Target T Cell Lysis
Figure 5-2: Synapse Formation by BiTE

Figure 6-1: Blincyto – FDA Approval Year by Indication
Figure 6-2: History of Clinical Trials
Figure 6-3: Blincyto – Patent Approval & Expires Year
Figure 6-4: Design of Blinatumomab
Figure 6-5: Mechanism of Action of Blinatumomab

Figure 7-1: Global - BiTE Antibody Clinical Trials by Phase, 2020 -2025
Figure 7-2: Global - BiTE Antibody Clinical Trials by Company, 2020 -2025
Figure 7-3: Global - BiTE Antibody Clinical Trials by Country, 2020 -2025
Figure 7-4: Global - BiTE Antibody Clinical Trials by Indication, 2020 -2025
Figure 7-5: Global - BiTE Antibody Clinical Trials by Patient Segment, 2020 -2025

Figure 9-1: Global – BiTE Under Development
Figure 9-2: Global – BiTE Market (US$ Million), 2016-2020
Figure 9-3: US – BiTE Market (US$ Million), 2016-2020
Figure 9-4: Global (Excluding US) – BiTE Market (US$ Million), 2016-2020
Figure 9-5: Global – BiTE Market Growth Rate (CAGR %), 2016-2020
Figure 9-6: Global – BiTE Market Future Estimates (US$ Million), 2021 - 2025
Figure 9-7: Global – Avastin & Herceptin Market (US$ Billion), 2017-2019
Figure 9-8: Blincyto - Total Treatment Cost & Reimbursement
Figure 9-9: Blincyto – In Pocket & Out of Pocket Expenditure

Figure 10-1: Induction & Consolidation Cycles in MRD +ve B-ALL
Figure 10-2: Treatment Interval (weeks) Per Cycle
Figure 10-3: Induction, Consolidation & Continued Therapy Cycles in R/R B-ALL
Figure 10-4: Blincyto - Recommended Dose for R/R B-ALL
Figure 10-5: Global - Blincyto Quarterly Sales by Region (US$ Million), Q1’2019
Figure 10-6: Blincyto – Quarterly Sales by Region (%), Q1’2019
Figure 10-7: Global – Blincyto Quarterly Sales (US$ Million), Q1’2018 & Q1’2019
Figure 10-8: Global - Blincyto Sales by Region (US$ Million) Q2’2019
Figure 10-9: Global – Blincyto Sales (US$ Million), Q2’2018 & Q2’2019
Figure 10-10: Global - Blincyto Sales by Region (US$ Million), Q3’2019
Figure 10-11: Global - Blincyto Sales by Region (%), Q3’2019
Figure 10-12: Global – Blincyto Sales (US$ Million), Q3’2018 & Q3’2019
Figure 10-13: Global – Blincyto Sales by Region (US$ Million), Q4’2019
Figure 10-14: Blincyto –Sales Value by Region (%), Q4’2019
Figure 10-15: Global – Blincyto Sales (US$ Million), Q4’2018 & Q4’2019
Figure 10-16: Global – Blincyto Sales (US$ Million), 2017 – 2020
Figure 10-17: Global - Blincyto Sales by Region (%), Q1’2020
Figure 10-18: Global - Blincyto Sales by Region (%), Q2’2020
Figure 10-19: Global - Blincyto Sales by Region (%), Q3’2020
Figure 10-20: Global - Blincyto Sales by Region (%), Q4’2020
Figure 10-21: Global – Blincyto Sales (US$ Millions), Q1’2020 - Q4’2020

Figure 11-1: BiTE in Clinical Trials
Figure 11-2: Combinational Therapies with Blincyto in Clinical Trials
Figure 11-3: HLE BiTE in Clinical Trials

Figure 12-1: BiTE Antibodies
Figure 12-2: Structure of CAR T-Cell
Figure 12-3: Comparison between Bite & CAR T-Cell

Figure 13-1: AMG420 – Clinical Trial Response of Patients
Figure 13-2: Clinical Trials for RRMM
Figure 13-3: AMG757 – Phase 1 Patient Response
Figure 13-4: AMG757 - Cytokine Release Syndrome in Patients
Figure 14-1: Favorable Parameters
Figure 14-2: Commercialization Challenges

Figure 15-1: Global – Cancer Immunotherapy Market Size (US$ Billion), 2020-2025