AGENUS INC (AGEN)
Agenus Inc. is a clinical-stage biotechnology firm operating globally, dedicated to the discovery and development of immuno-oncology therapies. The company's innovative technological arsenal includes Retrocyte Display, a sophisticated antibody expression platform designed to identify fully human and humanized monoclonal antibodies, alongside other proprietary display technologies. Agenus is also actively involved in vaccine development programs, featuring the Prophage vaccine candidate and QS-21 Stimulon, a widely recognized saponin-based vaccine adjuvant. Its robust and diverse pipeline of therapeutic candidates targets various immune checkpoints and cancer pathways. Notable assets in clinical development include: Balstilimab: An anti-PD-1 antagonist that has successfully completed Phase II trials for the treatment of second-line cervical cancer. AGEN1181: A monospecific anti-CTLA-4 antibody currently undergoing Phase 1/2 clinical evaluation. AGEN2373: An anti-CD137 monospecific antibody in Phase 1 clinical trials. AGEN1423: A bi-functional anti-CD73/TGFß TRAP antibody, engineered to modulate the tumor microenvironment, which has concluded Phase 1 studies. AGEN1777: An anti-TIGIT bispecific antibody. AGEN1327: A human monoclonal antibody. INCAGN1876: An anti-GITR monospecific antibody. INCAGN1949: An anti-OX40 monospecific antibody. INCAGN2390: An anti-TIM-3 monospecific antibody. INCAGN2385: An anti-LAG-3 monospecific antibody. MK-4830: A monospecific antibody engineered to target ILT4. AGENT 797: An iNKT cell therapy, currently in Phase 1 for solid tumors, multiple myeloma, and viral ARDS, with ongoing clinical investigation for hematological malignancies and multiple myeloma/B cell indications. AGEN1884: A first-generation anti-CTLA-4 monospecific antibody. Agenus Inc. utilizes a portfolio of trademarks, including ASV, AutoSynVax, EVAMPLIX, MiNK, PSV, PhosPhoSynVax, Prophage, Retrocyte Display, and Stimulon, alongside its own company name. Strategic alliances are maintained with partners such as Incyte Corporation, Merck Sharpe & Dohme, Recepta Biopharma SA, and Gilead Sciences, Inc. Established in 1994, the company originally operated as Antigenics Inc. before rebranding to Agenus Inc. in January 2011. Its corporate headquarters are situated in Lexington, Massachusetts.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
Agenus Inc.
- Cash runway at this date: -2mo
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
autologous human tumor-derived HSPPC-96
Renal Cell Carcinoma
NCT00033904Enrollment650StartJun 2000Primary CompletionApr 2007CompletionApr 2007 - Phase 3Completed
Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
HSPPC-96 or Oncophage
Malignant Melanoma
NCT00039000Enrollment350StartMar 2002Primary CompletionDec 2005CompletionDec 2005 - Phase 3Terminated
Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney Cancer
HSPPC-96
Kidney Cancer, Renal Cell Carcinoma
NCT00126178Enrollment600StartMay 2005Primary CompletionMar 2006CompletionMar 2006 - Phase 3Withdrawn
Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)
Balstilimab (BAL), Topotecan
Advanced Cancer, Metastatic Cervical Cancer
NCT04943627Enrollment0StartAug 2021Primary CompletionOct 2021CompletionOct 2021 - Phase 2Terminated
AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™
Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
Leukemia, Myeloid, Chronic
NCT00058747Enrollment40StartMar 2003Primary CompletionApr 2006CompletionApr 2006 - Phase 2Completed
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
autologous human tumor-derived HSPPC-96
Lymphoma, Follicular, Lymphoma, Small Lymphocytic
NCT00081809Enrollment35StartMar 2000Primary CompletionJun 2005CompletionJun 2005 - Phase 2Terminated
Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
autologous human tumor-derived HSPPC-96
Renal Cell Carcinoma
NCT00082459Enrollment40StartJul 2002Primary CompletionDec 2005CompletionDec 2005 - Phase 2Completed
Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer
HSPPC-96
Non-Small-Cell Lung Carcinoma, Lung Cancer +1
NCT00098085Enrollment20StartSep 2003Primary CompletionNov 2007Completion- - Phase 2Terminated
Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
HSPPC-96
Renal Cell Carcinoma
NCT01147536Enrollment12StartJan 2010Primary CompletionJun 2012CompletionJun 2012 - Phase 2Completed
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
HerpV and QS-21, Placebo
Herpes Simplex Type 2
NCT01687595Enrollment80StartOct 2012Primary CompletionSep 2013CompletionJan 2015 - Phase 2Terminated
Study of AGEN1884 With Pembrolizumab in 1L NSCLC
AGEN1884 in combination with pembrolizumab
NSCLC Stage IV
NCT03411473Enrollment2StartOct 2017Primary CompletionMay 2018CompletionMar 2019 - Phase 2Terminated
RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer
AGEN2034, AGEN1884
Cervical Cancer
NCT03894215Enrollment211StartJun 2019Primary CompletionMar 2025CompletionMar 2025 - Phase 2Withdrawn
AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma
AGEN2034, AGEN1884
Angiosarcoma
NCT04607200Enrollment0StartFeb 2021est.Primary CompletionSep 2021CompletionSep 2021 - Phase 2Withdrawn
A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer
Balstilimab, Balstilimab + Zalifrelimab
Cervical Cancer
NCT05033132Enrollment0StartOct 2021Primary CompletionDec 2024est.CompletionDec 2024est. - Phase 2Terminated
A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma
Botensilimab, Balstilimab
Advanced Melanoma
NCT05529316Enrollment150StartDec 2022Primary CompletionApr 2026CompletionApr 2026 - Phase 2Active, not recruiting
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Botensilimab, Balstilimab
Metastatic Colorectal Cancer
NCT05608044Enrollment234StartNov 2022Primary CompletionSep 2027est.CompletionSep 2029est. - Phase 2Completed
A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
Botensilimab, Gemcitabine
Metastatic Pancreatic Ductal Adenocarcinoma
NCT05630183Enrollment81StartMar 2023Primary CompletionJan 2026CompletionJan 2026 - Phase 1/2Completed
AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Participants With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy
Zalifrelimab
Advanced Solid Cancers, Advanced Solid Cancers Refractory to PD-1 and PD-L1 Therapies
NCT02694822Enrollment89StartApr 2016Primary CompletionMar 2022CompletionMar 2022 - Phase 1/2Completed
A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
AGEN2034
Advanced Cancer, Cervical Cancer
NCT03104699Enrollment211StartApr 2017Primary CompletionJun 2022CompletionJun 2022 - Phase 1/2Completed
A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)
Zalifrelimab, Balstilimab
Cervical Cancer
NCT03495882Enrollment175StartDec 2017Primary CompletionJul 2022CompletionJul 2022 - Phase 1Completed
Trial Evaluating Safety, Tolerability and Immune Response of AG-707
AG-707
Genital Herpes
NCT00231049Enrollment35StartMar 2006Primary Completion-Completion- - Phase 1Completed
Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
Aroplatin
Malignancies, B-Cell Lymphoma
NCT00316511Enrollment21StartMar 2006Primary CompletionJun 2008Completion- - Phase 1Terminated
Safety and Tolerability Study of AutoSynVax™ Vaccine in Subjects With Advanced Cancer
AutoSynVax™ vaccine
Advanced Cancer
NCT02992977Enrollment3StartJan 2017Primary CompletionDec 2018CompletionDec 2019 - Phase 1Completed
Phase 1a Study to Evaluate Immunogenicity of ASV®
ASV® AGEN2017 + QS-21 Stimulon® adjuvant
Solid Tumor, Adult
NCT03673020Enrollment3StartMay 2019Primary CompletionFeb 2021CompletionFeb 2021 - Phase 1Active, not recruiting
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Botensilimab, Balstilimab
Advanced Cancer, Angiosarcoma +6
NCT03860272Enrollment499StartMar 2019Primary CompletionJan 2025CompletionDec 2027est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | autologous human tumor-derived HSPPC-96 | NCT00033904 |
| Phase 3 | Completed | HSPPC-96 or Oncophage | NCT00039000 |
| Phase 3 | Terminated | HSPPC-96 | NCT00126178 |
| Phase 3 | Withdrawn | Balstilimab (BAL), Topotecan | NCT04943627 |
| Phase 2 | Terminated | Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™. | NCT00058747 |
| Phase 2 | Completed | autologous human tumor-derived HSPPC-96 | NCT00081809 |
| Phase 2 | Terminated | autologous human tumor-derived HSPPC-96 | NCT00082459 |
| Phase 2 | Completed | HSPPC-96 | NCT00098085 |
| Phase 2 | Terminated | HSPPC-96 | NCT01147536 |
| Phase 2 | Completed | HerpV and QS-21, Placebo | NCT01687595 |
| Phase 2 | Terminated | AGEN1884 in combination with pembrolizumab | NCT03411473 |
| Phase 2 | Terminated | AGEN2034, AGEN1884 | NCT03894215 |
| Phase 2 | Withdrawn | AGEN2034, AGEN1884 | NCT04607200 |
| Phase 2 | Withdrawn | Balstilimab, Balstilimab + Zalifrelimab | NCT05033132 |
| Phase 2 | Terminated | Botensilimab, Balstilimab | NCT05529316 |
| Phase 2 | Active, not recruiting | Botensilimab, Balstilimab | NCT05608044 |
| Phase 2 | Completed | Botensilimab, Gemcitabine | NCT05630183 |
| Phase 1/2 | Completed | Zalifrelimab | NCT02694822 |
| Phase 1/2 | Completed | AGEN2034 | NCT03104699 |
| Phase 1/2 | Completed | Zalifrelimab, Balstilimab | NCT03495882 |
| Phase 1 | Completed | AG-707 | NCT00231049 |
| Phase 1 | Completed | Aroplatin | NCT00316511 |
| Phase 1 | Terminated | AutoSynVax™ vaccine | NCT02992977 |
| Phase 1 | Completed | ASV® AGEN2017 + QS-21 Stimulon® adjuvant | NCT03673020 |
| Phase 1 | Active, not recruiting | Botensilimab, Balstilimab | NCT03860272 |
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