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  • ||||||||||  vidutolimod (CMP-001) / Checkmate Pharma
    Journal, PD(L)-1 Biomarker, IO biomarker:  Direct and indirect immune effects of CMP-001, a virus-like particle containing a TLR9 agonist. (Pubmed Central) -  Dec 22, 2021   
    Despite aspects of an immunosuppressive phenotype, these monocytes demonstrated increased ability to augment autologous CD4 T-cell proliferation. These findings shed light on the complexity of the mechanism of action of anti-Qβ-coated CMP-001 and provide insight into pathways that may be targeted to further enhance the efficacy of this novel approach to immunotherapy.
  • ||||||||||  INCAGN1949 / Incyte, vidutolimod (CMP-001) / Regeneron
    Enrollment open, Combination therapy, Metastases:  CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma (clinicaltrials.gov) -  Oct 18, 2021   
    P1/2,  N=42, Recruiting, 
    Clinical studies to confirm the efficacy of vidutolimod + PD-1 blockade in patients with previously untreated unresectable/metastatic melanoma (phase 2/3, NCT04695977 ) or PD-1 blockade–refractory melanoma (phase 2, NCT04698187 ) are ongoing. Not yet recruiting --> Recruiting
  • ||||||||||  vidutolimod (CMP-001) / Checkmate Pharma
    Journal:  In situ immunization of a TLR9 agonist virus-like particle enhances anti-PD1 therapy. (Pubmed Central) -  Oct 7, 2021   
    These results demonstrate that in situ vaccination with CMP-001 can induce both local and abscopal antitumor immune responses. Additionally, the antitumor efficacy of CMP-001 combined with α-PD-1 therapy warrants further study as a novel immunotherapeutic strategy for the treatment of HNSCC.
  • ||||||||||  vidutolimod (CMP-001) / Checkmate Pharma
    Journal:  Monocytes Exposed to Immune Complexes Reduce pDC Type 1 Interferon Response to Vidutolimod. (Pubmed Central) -  Sep 29, 2021   
    Immune complexes, including but not limited to anti-Qβ-coated vidutolimod, indirectly suppressed TLR9-mediated Type 1 Interferon production by pDCs in a monocyte-dependent manner. These findings indicate that anti-Qβ-coated vidutolimod has effects in addition to those mediated by TLR9 that could have important clinical implications for understanding the mechanism of action of this exciting new approach to in situ immunization and cancer immunotherapy.
  • ||||||||||  Opdivo (nivolumab) / BMS, vidutolimod (CMP-001) / Regeneron
    Trial completion:  CMP-001 in Combo With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease (clinicaltrials.gov) -  Sep 16, 2021   
    P2,  N=34, Completed, 
    These findings indicate that anti-Qβ-coated vidutolimod has effects in addition to those mediated by TLR9 that could have important clinical implications for understanding the mechanism of action of this exciting new approach to in situ immunization and cancer immunotherapy. Active, not recruiting --> Completed
  • ||||||||||  ivuxolimab (PF-04518600) / Pfizer, PD 360324 / Pfizer, utomilumab (PF-05082566) / Pfizer
    Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases:  A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) (clinicaltrials.gov) -  Aug 19, 2021   
    P1b/2,  N=398, Active, not recruiting, 
    Active, not recruiting --> Completed Trial completion date: Feb 2024 --> Apr 2022 | Trial primary completion date: Feb 2024 --> Apr 2022
  • ||||||||||  Review, Journal:  Current status of intralesional agents in treatment of malignant melanoma. (Pubmed Central) -  Jul 20, 2021   
    This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.
  • ||||||||||  vidutolimod (CMP-001) / Regeneron
    Enrollment open, Combination therapy:  CMP-001 and Pre-operative Stereotactic Body Radiation Therapy (SBRT) in Early Stage Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov) -  Jul 8, 2021   
    P2,  N=40, Recruiting, 
    Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents. Not yet recruiting --> Recruiting
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), vidutolimod (CMP-001) / Regeneron
    Trial completion date, Trial primary completion date:  CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov) -  May 3, 2021   
    P1/2,  N=39, Recruiting, 
    Trial completion date: May 2021 --> Aug 2021 Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Apr 2021 --> Apr 2022
  • ||||||||||  INCAGN1949 / Incyte, vidutolimod (CMP-001) / Regeneron
    Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Metastases:  CMP-001 and INCAGN01949 for Patients With Stage IV Pancreatic Cancer and Other Cancers Except Melanoma (clinicaltrials.gov) -  Apr 22, 2021   
    P1/2,  N=42, Not yet recruiting, 
    As a novel immunotherapeutic agent, CMP-001 may be effective for treating patients with PC. Trial completion date: Jul 2023 --> Jul 2024 | Initiation date: Jul 2020 --> Jul 2021 | Trial primary completion date: Jul 2022 --> Jul 2023
  • ||||||||||  vidutolimod (CMP-001) / Regeneron
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy (clinicaltrials.gov) -  Jan 31, 2021   
    P1b,  N=199, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
  • ||||||||||  vidutolimod (CMP-001) / Regeneron
    Enrollment open:  CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma (clinicaltrials.gov) -  Jan 27, 2021   
    P2,  N=100, Recruiting, 
    Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Not yet recruiting --> Recruiting