Immune Checkpoint Inhibitors (PD-1 & PD-L1 Targeting Drugs): Analysis of Clinical Trial Results (Featuring Insightful Summaries of Recently Published Trial Results, Contemporary Pipeline Review, Clinical Trial Analysis, Clinical Publications Analysis, and

Immune Checkpoint Inhibitors (PD-1 & PD-L1 Targeting Drugs): Analysis of Clinical Trial Results (Featuring Insightful Summaries of Recently Published Trial Results, Contemporary Pipeline Review, Clinical Trial Analysis, Clinical Publications Analysis, and Estimated Time to Market Analysis for Novel Drug Candidates)

Cancer is one of the leading causes of death, worldwide. In 2020 alone, over 19 million new cases of the disease (affecting different organs) and close 10 million associated fatalities, were reported worldwide. Over the next couple of decades, experts believe that the global cancer burden is likely to increase by almost 50%. Currently, a variety of therapeutic measures are available for the treatment of different types of cancers; of these, surgery, chemotherapy, and radiation therapy, are considered the current standards of care. However, the efficacy of the aforementioned procedures has been shown to be severely limited, especially in treating advanced-stage cancers that have metastasized beyond their respective points of origin. Additionally, the non-specific and highly toxic nature of both chemotherapy and radiation therapy is known to significantly deteriorate quality of life. Over the last couple of decades, several targeted, anti-cancer therapies have been developed, and many are already available in the market. Of these, immune checkpoint directed therapies, which are designed to prevent malignantly transformed cells from evading immune surveillance, have demonstrated a lot of potential in treating a variety of cancer types.

The programmed cell death protein 1 receptor (PD-1) receptor, and programmed death ligand 1 (PD-L1) are known to negatively regulate T-cell-mediated immune responses. Multiple studies have shown that the activation of PD-1 / PD-L1 signaling is a mechanism used by tumors to evade a T-cell based immunological response. This led to the development of the hypothesis that PD-1 / PD-L1 blockade may prove to be an effective form of anti-cancer therapy that is capable of harnessing the key mediators of the adaptive human immune system. KEYTRUDA® (pembrolizumab), the first PD-1 targeting anti-cancer therapy was approved by the FDA in September 2014 for the treatment of patients suffering from advanced / unresectable melanoma who were no longer responding to other forms of treatment. Later, in the same year, OPDIVO® (nivolumab), another PD-1 targeting therapy, was approved by the FDA. These immune checkpoint inhibitors soon demonstrated the fact that they were both viable and potent therapeutic options and had the ability to substantially prolong the lives of patients suffering from advanced stage tumors. As a result, till date, there are seven approved drugs against PD-1 and PD-L1, and several more under development. Drug developers are now capitalizing on the success of PD-1 blockade in several different types of malignancies, and also researching alternative areas of application. Consequently, this field of research is abuzz with activity both at the clinical and preclinical levels. This report provides a deeper perspective on some of the recently published results from completed and ongoing clinical research activity.

SCOPE OF THE REPORT
The “Immune Checkpoint Inhibitors (PD-1 & PD-L1 Targeting Drugs): Analysis of Clinical Trial Results” report provides detailed information on the contemporary R&D efforts related to an important segment of the immune checkpoint inhibitors market, specifically the drugs / drug candidates that have been developed to target the PD-1 and PD-L1 molecules. It offers a technical perspective of the innovation in this domain, in terms of products in the pipeline, clinical research activity, and trend of scientific publications (focused on clinical trial results). The information in this report has been presented across two deliverables, featuring an interactive MS Excel sheet and a MS PowerPoint pack, which summarizes the key takeaways from the project, and insights drawn from the curated data. The report features the following details:
 Detailed summaries of published clinical research results, featuring key insights related to completed and ongoing trials of PD-1 and PD-L1 inhibitors. For each trial, we have provided an elaborate [A] overview (including details of the related publication, and names of the journal and authors, trial ID, mentioned phase of development, sponsor(s), target indications, important study-related dates and locations of hospitals / centers involved), and also collated and presented information on the [B] clinical study design (featuring study type, primary purpose, total enrollment, allocation, intervention model, type of masking used, among others, along with information on the participant screening process, treatment plan and follow-up plan), [C] key research outcomes (based on information available in the dedicated trial related webpage), [D] reported results (segregated across both primary and secondary endpoints, featuring important participant and key parameter assessment related details, and key insights mentioned in the affiliated publication(s)) and [E] treatment related adverse events (including both treatment- and immune related events, segregated across different grades of severity).
 A review of the current market landscape of PD-1 & PD-L1 targeting immune checkpoint therapies, providing information on phase of development, type of molecule, biological target, and mechanism of action. In addition, the section includes details on the key developers of PD-1 / PD-L1 based drugs, along with information on their respective year of establishment, company size, and location of headquarters.
 A clinical trial analysis, offering information on trial registration year, phase of development, enrolled patient population, study design, key sponsors (and their respective collaborators), popular target therapeutic area, and geography. The insights from this analysis are organized to provide an informed perspective on the historical and recent pace of innovation in this domain.
 An insightful publication analysis, taking into account only clinical trial results that have been published in peer-reviewed, scientific journals. The analysis highlights key trends observed across the aforementioned articles, including those related to year of publication, biological target, target therapeutic areas(s), key journals (in terms of number of articles published in this domain and impact factor of the journal), and popular authors (taking into consideration only the first authors of the mentioned publications). The insights from this analysis are organized to provide an informed perspective on the historical and recent trends of publishing activity, in this field of research.
 An informed perspective concerning the likely time of launch for all the PD-1 / PD-L1 targeting drugs candidates that have not yet been approved. This analysis takes into consideration the current phase of development, time required for regulatory submissions and review, and other parameters that are expected to drive the transition from the clinic to the market.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary research and analyzed using proprietary methods / tools, in order to develop a detailed perspective on the current market landscape and the R&D scenario, across different global regions. As much as possible, the collated data has been checked for accuracy from multiple, reliable sources of information.

The secondary sources of information include
 Company websites & annual reports
 Global & region-specific clinical trial registries
 Biomedical and life sciences literature
 Notes from regulatory authorities
 Industry databases
 Press releases
 Scientific news articles
 Industry analysts’ views (as expressed on related news articles and other informative publications)

The insights presented are solely based on our knowledge, research and understanding of the relevant market, as inferred from publicly available sources of information.

DELIVERABLE OUTLINES
Excel Deliverables
Section I is a dashboard, featuring a pictorial summary of the key inclusions of the report.

Section II is a tabular representation of the contemporary PD-1 / PD-L1 inhibitors pipeline, including details on their respective developers.

Section III features data from clinicaltrials.gov which was used for a historical clinical trial analysis of studies featuring PD-1 and PD-L1 inhibitors.

Section IV includes a list of clinical trial result-related publications, sourced from PubMed, which was further analyzed to identify articles focused on singular clinical trials. The latter types of publications were shortlisted, linked to the corresponding clinical study-related information, and used for the trials results analysis.

Section V is a tabular representation of the clinical trials for which detailed publications of results are available in PubMed.

Section VI features the input data used for the estimated time to launch analysis.

Section VII includes a set of appendices, featuring pivot tables and other inputs that drive the interactive elements in the summary dashboard.

PowerPoint Deliverable: Key Section Outlines
Section I is an executive summary of all the key takeaways from the report.

Section II features a detailed analysis of all clinical trial (phase I, phase II and phase III) results, which have been published in reputed, scientific journals in the period between 2020 and 2021, related to PD-1 / PD-L1 targeting drugs. The insights generated were categorized into the following sections: general trial related details, pictorial representation of study design and treatment plan, participant-related information, primary and secondary study related outcomes, tools used for patient selection and statistical analysis of clinical data, key inputs from study endpoints, and observed adverse events.

Section III features a detailed review of the current market landscape of PD-1 & PD-L1 targeting immune checkpoint therapies, offering insights on phase of development, type of molecule, biological target, and mechanism of action. In addition, the section includes details on the key developers of PD-1 / PD-L1 based drugs, along with information on their respective year of establishment, company size, and location of headquarters.

Section IV presents the clinical trial analysis, offering inputs related to key trends associated with trial registration year, phase of development, enrolled patient population, study design, key sponsors (and their respective collaborators), popular target therapeutic area, and geography. The insights from this analysis are organized to provide an informed perspective on the historical and recent pace of innovation and clinical research activity in this domain.

Section V provides insight from a detailed publication analysis, taking into account only clinical trial results that have been published in peer-reviewed, scientific journals. It also features our independent opinion related to trends observed across the aforementioned articles, including those related to year of publication, biological target, target therapeutic areas(s), key journals (in terms of number of articles published in this domain and impact factor of the journal), and popular authors (taking into consideration only the first authors of the mentioned publications).

Section VI offers an informed perspective concerning the likely time of launch for all the PD-1 / PD-L1 targeting drugs candidates that have not yet been approved. This analysis takes into consideration the current phase of development, time required for regulatory submissions and review, and other parameters that are expected to drive the transition from the clinic to the market.

Section VII provides a proprietary perspective on the future of immune checkpoint inhibitors, primarily focusing on drugs that target the PD-1 receptor and its ligand, PD-L1. This part of the report highlights what can be expected in terms of likely product launches, future application areas, potential for being used in combination with other drugs / therapies and estimated size of the PD-1 / PD-L1 therapies market.

Section VIII is an appendix, featuring a list of tables (representing numerical data from the charts and graphs in the deliverable) and a list of companies and organizations captured during the course of the study.

LIST OF COMPANIES / LIST OF COMPANIES AND ORGANIZATIONS

1. 4-Antibody AG
2. Abbott
3. AbbVie
4. AbClon
5. Abeome
6. ABL Bio
7. Abpro
8. Acerta Pharma
9. Acrus Biosciences
10. Actinium Pharmaceuticals
11. Adaptive Biotechnologies
12. Adimab
13. AdoRx Therapeutics
14. Aduro Biotech
15. Advaxis
16. Agenus
17. Agios Pharmaceuticals
18. AgonOX
19. Alexion Pharmaceuticals
20. Allergan
21. Alligator Bioscience
22. Alpine Immune Sciences
23. ALX Oncology
24. Ambrx
25. American Society of Clinical Oncology
26. Amgen
27. Amplimmune
28. AnaptysBio
29. Angel Therapeutics
30. Anvil Biosciences (The company has been acquired)
31. Apexigen
32. Apogenix
33. Aptevo Therapeutics
34. Arch Oncology
35. Arcus Biosciences
36. arGEN-X
37. ArQule
38. Astellas Pharma
39. Astex Pharmaceuticals
40. AstraZeneca
41. Atridia
42. Aurigene
43. Aurigene Discovery Technologies
44. Avacta Life Sciences
45. Azienda Ospedaliera Universitaria Senese
46. Bach BioSciences
47. Bayer
48. BeiGene
49. BinDeBio Group
50. BIOCAD
51. Biodextris
52. Bio-Matrix Scientific Group
53. BioNTech
54. Bio-Techne
55. BioWa
56. Black Belt Therapeutics
57. BliNK Biomedical
58. bluebird bio
59. Boehringer Ingelheim
60. Boston Medical Center
61. Brigham and Women's Hospital
62. Bristol Myers Squibb
63. Bristol-Myers Squibb
64. Calithera Biosciences
65. CALIXAR
66. Canadian Cancer Trials Group
67. CASI Pharmaceuticals
68. Catalent Biologics
69. Celgene
70. Cell Genesys
71. Celldex Therapeutics
72. Center for Applied Medical Research
73. Centre Georges Francois Leclerc
74. Centro Nacional de Investigaciones Oncologicas CARLOS III
75. Centrose
76. Changhai Hospital
77. Checkpoint Therapeutics
78. China National Biotec Group
79. City of Hope Medical Center
80. CleveXel Pharma
81. Clinical Research Institute
82. Columbia University
83. Columbia University Irving Medical Center
84. Compass Therapeutics
85. Compugen
86. Corvus Pharmaceuticals
87. CoStim Pharmaceuticals
88. Crescendo Biologics
89. CStone Pharmaceuticals
90. CureTech
91. Curis
92. D5Pharma
93. Daiichi Sankyo
94. Dana-Farber Cancer Institute
95. Distributed Bio
96. DNAtrix
97. Domain Therapeutics
98. Dova Pharmaceuticals
99. Dualogics
100. Eddingpharm
101. Eisai
102. Eli Lilly
103. Elpiscience Biopharma
104. ELSALYS BIOTECH
105. EMulate Therapeutics
106. EpicentRx
107. European Thoracic Oncology Platform
108. Facet Biotech
109. FF Pharmaceuticals
110. Five Prime Therapeutics
111. Fondazione IRCCS Istituto Nazionale dei Tumori
112. Forty Seven
113. Fred Hutchinson Cancer Research Center
114. F-star
115. Gateway Biologics
116. Genentech
117. Genmab
118. Genomics Medicine Ireland
119. Genosco
120. Georgia Health Sciences University
121. GERCOR - Multidisciplinary Oncology Cooperative Group
122. GigaGen
123. Gilead Sciences
124. Glaxosmithkline
125. Glenmark
126. Glycotope
127. Grupo Espanol de Investigacion en Sarcomas
128. Gustave Roussy Institute
129. Hanmi Pharmaceutical
130. HanX Biopharmaceuticals
131. HealthCare Ventures
132. Heat Biologics
133. Hoffmann-La Roche
134. Hospices Civils de Lyon
135. Hrain Biotechnology
136. Hummingbird Bioscience
137. IDM
138. IGM Biosciences
139. I-Mab Biopharma
140. Immatics
141. ImmuneOncia Therapeutics
142. ImmuneOnco Biopharmaceuticals
143. ImmuNext
144. Immutep
145. Imperial College London
146. Impetis Biosciences
147. Incyte
148. Inhibrx
149. Innate Pharma
150. Innovent Biologics
151. Institute for Research in Biomedicine
152. InteRNA Technologies
153. International Myeloma Foundation
154. IO Biotech
155. iOnctura
156. iTeos Therapeutics
157. Janssen Pharmaceuticals
158. Jiangsu HengRui Medicine
159. Jiangxi Qingfeng Pharmaceutical
160. JN Biosciences
161. Johns Hopkins University
162. Johnson & Johnson
163. Jounce Therapeutics
164. Juventas Cell Therapy
165. KAHR Medical
166. Kiniksa Pharmaceuticals
167. Kite Pharma
168. Kleo Pharmaceuticals
169. Kymab
170. Kyowa Hakko Kirin
171. Lankenau Institute for Medical Research (LIMR)
172. Laureate Pharma
173. Leap Therapeutics
174. Lee's Pharma
175. LG Chem
176. LifeArc
177. Lonza Biologics
178. Ludwig Cancer Research
179. Lynkcell
180. M.D. Anderson Cancer Center
181. Macrocure
182. MacroGenics
183. Marino Biotechnology
184. Masonic Cancer Center
185. Massachusetts General Hospital
186. Medarex
187. MedImmune
188. Medivation
189. Merck
190. Merck KGaA
191. Merck Serono
192. Merck Sharp & Dohme
193. Merus
194. Millennium Pharmaceuticals
195. Moderna
196. Molecular Partners
197. MolMed
198. Momenta Pharmaceuticals
199. Morphiex
200. MorphoSys
201. Mount Sinai Innovation Partners
202. MRC Technology
203. Nanjing Chia Tai Tianqing
204. National Cancer Center Hospital East
205. National Cancer Institute
206. National Heart, Lung, and Blood Institute
207. National Institute of Allergy and Infectious Diseases
208. National Institute of Biomedical Imaging and Bioengineering
209. National Institute of Dental and Craniofacial Research
210. National Institute of Diabetes and Digestive and Kidney Diseases
211. National Institute of Neurological Disorders
212. NavarraBiomed-Biomedical Research Centre
213. Navigen
214. Nektar Therapeutics
215. Neon Therapeutics
216. NewLink Genetics
217. NextCure
218. Northwestern University
219. Novartis
220. Novartis Pharmaceuticals
221. Novimmune
222. Novo Nordisk
223. Numab Therapeutics
224. Ogeda
225. OncoArendi Therapeutics
226. Oncotelic
227. Oncothyreon
228. Ono Pharmaceutical
229. Onyx (subsidiary of Amgen)
230. Orega Biotech
231. ORIC Pharmaceuticals
232. OSE Immunotherapeutics
233. Oslo University Hospital
234. Palobiofarma
235. Pandion Therapeutics
236. Paradigm Shift Therapeutics
237. Parker Institute for Cancer Immunotherapy
238. Pascal Biosciences
239. PDL Biopharma
240. Peking University
241. Peking University People's Hospital
242. Peloton Therapeutics
243. PeptiDream
244. PersonGen BioTherapeutics (Suzhou)
245. Pfizer
246. PharmAbcine
247. Pieris Pharmaceuticals
248. Pierre Fabre
249. Pinze Lifetechnology
250. Polaris Group
251. Potenza Therapeutics
252. Prima BioMed
253. PsiOxus Therapeutics
254. Recipharm Cobra Biologics
255. Regeneron Pharmaceuticals
256. Regis Technologies
257. Roche
258. Royal Marsden NHS Foundation Trust
259. Rubius Therapeutics
260. Samsung Biologics
261. Samsung Medical Center
262. Sanofi
263. Sanquin
264. Seattle Genetics
265. Servier
266. Shanghai GeneChem
267. Shanghai Junshi Bioscience
268. Shattuck Labs
269. Shire
270. Sorrento Therapeutics
271. Spring Bioscience
272. Stanford University
273. Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
274. Surface Oncology
275. Sutro Biopharma
276. Swedish Orphan Biovitrum
277. Symphogen
278. Synthon International Holding
279. Syros Pharmaceuticals
280. Taizhou Hanzhong biomedical
281. Takeda Pharmaceutical
282. Tarus Therapeutics
283. Tempest Therapeutics
284. TESARO
285. TG Therapeutics
286. The First Affiliated Hospital with Nanjing Medical University
287. The National Cancer Institute, Mexico
288. The Netherlands Cancer Institute
289. The University of Texas MD Anderson Cancer Center
290. Tianjin Medical University Cancer Institute and Hospital
291. ToleroTech
292. Tottori University
293. TRACON Pharmaceuticals
294. Trellis Biosciences
295. TRIGR Therapeutics
296. Trillium Therapeutics
297. Tsinghua University
298. Union Stem Cell & Gene Engineering
299. University Health Network, Toronto
300. University Medical Center Hamburg-Eppendorf
301. University of Birmingham
302. University of California, Berkeley
303. University of California, Los Angeles
304. University of California, San Diego
305. University of California, San Francisco
306. University of Cologne
307. University of Iowa Pharmaceutical Services
308. University of Louisville
309. University of Minnesota
310. University of Texas
311. Vall d’Hebron Institute of Oncology
312. Valo Therapeutics
313. Ventana Medical Systems
314. Viela Bio
315. ViraTherapeutics
316. Vivoryon Therapeutics
317. Washington University
318. Waterstone Hanxbio
319. Weill Medical College of Cornell University
320. Xencor
321. XOMA
322. Yale Cancer Center
323. Yale University
324. Y-Biologics
325. Y-mAbs Therapeutics
326. Yuhan Pharmaceuticals
327. Zai Lab
328. Zymeworks


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