- |||||||||| Factors influencing time to viral rebound during analytical treatment interruptions in HIV cure trials (Room 13a/Channel 6) - Jun 18, 2024 - Abstract #AIDS2024AIDS_3973;
The embargo on all abstracts, including oral abstract, poster exhibition, e-poster and late breakers, will lift on Tuesday, 23 July 2024, at 10:00 am Central European Summer Time (CEST). If an abstract is part of an official AIDS 2024 press conference that occurs before that time, the embargo on that abstract lifts at the start of the official press conference.
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, VRC07-523LS / National Institute of Allergy and Infectious Diseases, IAVI, TaiMed Biologics
Post-Intervention HIV Control Linked to Early In Vivo CD8+ T-Cell Proliferative Response to Rebound (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1052;
P=N/A, P1/
To our knowledge, these studies are the first to demonstrate a relationship between the early in vivo CD8+ T cell proliferative response to viral reactivation and HIV control post-ART. The results support continued focus on developing HIV cure strategies that enhance HIV-specific CD8+ T cell proliferative capacity.
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, VRC07-523LS / National Institute of Allergy and Infectious Diseases, IAVI, TaiMed Biologics
Effect of Broadly Neutralizing Antibody Exposure on HIV Rebound Following Combination Immunotherapy (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_950;
P1/2
Our results suggest that post-treatment setpoint was not driven by bNAb susceptibility and that the association of IQ90 and setpoint is driven by higher VRC07-523LS levels at the time of rebound in those who rebounded earlier and had higher setpoints. Overall, bNAb PK-PD is likely not responsible for lower observed post-treatment setpoints during this trial, suggesting the effect is likely attributable to changes in anti-HIV immune function.
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Trial completion date, Trial primary completion date, Metastases: Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - Oct 23, 2023
P1, N=28, Active, not recruiting,
Overall, bNAb PK-PD is likely not responsible for lower observed post-treatment setpoints during this trial, suggesting the effect is likely attributable to changes in anti-HIV immune function. Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2023 --> May 2025
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, 3BNC117 / Rockefeller University, Cornell University, Frontier Biotech, Gilead, lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Trial completion: TITAN: Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV (clinicaltrials.gov) - May 23, 2023
P2a, N=47, Completed,
ClinicalTrials.gov identifier: NCT03837756 . Active, not recruiting --> Completed
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Lefitolimod (TLR agonist) and ipilimumab in patients with advanced solid tumors: A phase I trial. (On Demand | Hall A; Poster Bd # 406) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2332;
The combination of high subcutaneous doses or intra-tumoral administration of lefitolimod in combination with ipilimumab is safe and well tolerated in patients with advanced cancers, with preliminary antitumor activity observed. Clinical trial information: NCT0266877.
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, 3BNC117 / Rockefeller University, Cornell University, Frontier Biotech, Gilead, lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
THE IMPACT OF 3BNC117; 10-1074; AND LEFITOLIMOD ON HIV-1 PERSISTENCE: THE TITAN TRIAL (Ballroom 1 (Level 5)) - Feb 13, 2023 - Abstract #CROI2023CROI_211;
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Biomarker, Journal, IO biomarker: CD169 (Siglec-1) as a Robust Human Cell Biomarker of Toll-Like Receptor 9 Agonist Immunotherapy. (Pubmed Central) - Jul 30, 2022
Finally, in a clinical trial in HIV-infected individuals receiving immunotherapy treatment with MGN1703, we observed a uniform upregulation of CD169 on monocytes after dosing with 97% of classical monocytes positive for CD169 (p=0.002). Hence, in this comprehensive evaluation ex vivo, in an animal model, and in a clinical trial, we find increases in the percentage of CD169 positive monocytes to be a reliable and robust biomarker of immune activation following TLR9 agonist treatment.
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, 3BNC117 / Rockefeller University, Cornell University, Frontier Biotech, Gilead, lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Enrollment closed: TITAN: Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV (clinicaltrials.gov) - Mar 31, 2022
P2a, N=47, Active, not recruiting,
Hence, in this comprehensive evaluation ex vivo, in an animal model, and in a clinical trial, we find increases in the percentage of CD169 positive monocytes to be a reliable and robust biomarker of immune activation following TLR9 agonist treatment. Recruiting --> Active, not recruiting
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Enrollment change, Metastases: Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - Feb 15, 2022
P1, N=28, Active, not recruiting,
Recruiting --> Active, not recruiting N=55 --> 28
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Trial completion date, Trial primary completion date, Metastases: Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - Nov 2, 2021
P1, N=55, Active, not recruiting,
N=55 --> 28 Trial completion date: May 2021 --> May 2024 | Trial primary completion date: May 2021 --> May 2023
- |||||||||| 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.
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, 3BNC117 / Rockefeller University, Cornell University, Frontier Biotech, Gilead, lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Trial completion date, Trial primary completion date: TITAN: Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV (clinicaltrials.gov) - Apr 22, 2021
P2a, N=48, 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. Trial completion date: Feb 2021 --> Feb 2023 | Trial primary completion date: Jul 2020 --> Jul 2022
- |||||||||| TVGV-HB / Thevax Genetics Vaccine, lefitolimod (MGN1703) / Mologen, OncXerna Therap, iPharma
Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker: TLR9 activation cooperates with T cell checkpoint blockade to regress poorly immunogenic melanoma. (Pubmed Central) - Jul 22, 2020
Using both a TLR9 agonist (MGN1703) and a CTLA-4 antibody (9D9-IgG2a) of increased potency cured 50% of bi-lateral B16-F10 melanoma. These findings suggest that intra-tumoral TLR9 agonists can improve sensitivity of poorly immunogenic tumors to T cell checkpoint blockade, and that newer, higher potency TLR agonists and checkpoint antibodies can raise the therapeutic ceiling for this combination therapy.
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Enrollment closed, Metastases: Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - Jul 20, 2020
P1, N=55, Active, not recruiting,
These findings suggest that intra-tumoral TLR9 agonists can improve sensitivity of poorly immunogenic tumors to T cell checkpoint blockade, and that newer, higher potency TLR agonists and checkpoint antibodies can raise the therapeutic ceiling for this combination therapy. Recruiting --> Active, not recruiting
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Trial completion date, Trial primary completion date, Metastases: Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - Nov 14, 2019
P1, N=60, Recruiting,
These properties of potent immune surveillance reactivation render lefitolimod an ideal candidate as therapeutic agent for immuno-oncology, e.g. improving CPI strategies. Trial completion date: May 2020 --> May 2021 | Trial primary completion date: May 2019 --> May 2021
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, 3BNC117 / Rockefeller University, Cornell University, Frontier Biotech, Gilead, lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Enrollment open: TITAN: Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV (clinicaltrials.gov) - May 7, 2019
P2a, N=48, Recruiting,
Hence, and given its mode of action, lefitolimod will be evaluated in combination with other anti-cancer immunotherapies. Not yet recruiting --> Recruiting
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, 3BNC117 / Rockefeller University, Cornell University, Frontier Biotech, Gilead, lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
New P2a trial: TITAN: Combining TLR9 Agonist With bNAbs for Reservoir Reduction and Immunological Control of HIV (clinicaltrials.gov) - Feb 11, 2019
P2a, N=48, Not yet recruiting,
- |||||||||| lefitolimod (MGN1703) / Mologen, OncXerna Therap, iPharma
Journal, IO biomarker: The TLR9 agonist MGN1703 triggers a potent type I interferon response in the sigmoid colon. (Pubmed Central) - Dec 14, 2018
TLR9 expression at baseline was inversely proportional to the change in integrated HIV DNA during MGN1703 treatment (P=0.020). In conclusion, MGN1703 induced a potent type I IFN response, without a concomitant general inflammatory response, in the intestines.Mucosal Immunology advance online publication, 02 August 2017; doi:10.1038/mi.2017.59.
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Trial completion date, Metastases: Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - Oct 5, 2018
P1, N=60, Recruiting,
In conclusion, MGN1703 induced a potent type I IFN response, without a concomitant general inflammatory response, in the intestines.Mucosal Immunology advance online publication, 02 August 2017; doi:10.1038/mi.2017.59. Trial completion date: May 2020 --> May 2019
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Trial completion, Phase classification, Enrollment change, Trial primary completion date, IO biomarker: TEACH: Toll-like Receptor 9 Agonist Treatment in Chronic HIV-1 Infection (clinicaltrials.gov) - Jun 29, 2017
P1b/2a, N=12, Completed,
Active, not recruiting --> Completed Enrolling by invitation --> Completed | Phase classification: P1/2 --> P1b/2a | N=16 --> 12 | Trial primary completion date: Jan 2017 --> Jun 2017
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Enrollment closed, Trial primary completion date, Immunomodulating, Metastases: IMPALA: Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment (clinicaltrials.gov) - Jun 22, 2017
P3, N=540, Active, not recruiting,
Enrolling by invitation --> Completed | Phase classification: P1/2 --> P1b/2a | N=16 --> 12 | Trial primary completion date: Jan 2017 --> Jun 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2017 --> Mar 2019
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Trial primary completion date, Immunomodulating: IMPULSE: Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC (clinicaltrials.gov) - Mar 23, 2017
P2, N=102, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2017 --> Mar 2019 Trial primary completion date: Mar 2017 --> Nov 2016
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Enrollment open, Trial initiation date, Trial primary completion date, Metastases: Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - May 13, 2016
P1, N=60, Recruiting,
Trial primary completion date: Mar 2017 --> Nov 2016 Not yet recruiting --> Recruiting | Initiation date: Aug 2016 --> May 2016 | Trial primary completion date: Aug 2019 --> May 2019
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead, Yervoy (ipilimumab) / Ono Pharma, BMS
Trial initiation date, Trial primary completion date, Metastases: Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - May 4, 2016
P1, N=60, Not yet recruiting,
Not yet recruiting --> Recruiting | Initiation date: Aug 2016 --> May 2016 | Trial primary completion date: Aug 2019 --> May 2019 Initiation date: Mar 2016 --> Aug 2016 | Trial primary completion date: Mar 2019 --> Aug 2019
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Enrollment open, Trial primary completion date, IO biomarker: TEACH: Toll-like Receptor 9 Agonist Treatment in Chronic HIV-1 Infection (clinicaltrials.gov) - Mar 15, 2016
P1/2, N=16, Enrolling by invitation,
Initiation date: Mar 2016 --> Aug 2016 | Trial primary completion date: Mar 2019 --> Aug 2019 Active, not recruiting --> Enrolling by invitation | Trial primary completion date: May 2016 --> Jan 2017
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Enrollment closed, Immunomodulating: IMPULSE: Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC (clinicaltrials.gov) - Nov 8, 2015
P2, N=100, Active, not recruiting,
Active, not recruiting --> Enrolling by invitation | Trial primary completion date: May 2016 --> Jan 2017 Recruiting --> Active, not recruiting
- |||||||||| lefitolimod (MGN1703) / OncXerna Therap, iPharma, Gilead
Enrollment closed, IO biomarker: TEACH: Toll-like Receptor 9 Agonist Treatment in Chronic HIV-1 Infection (clinicaltrials.gov) - Sep 18, 2015
P1/2, N=16, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
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