cavrotolimod (AST-008)
/ Exicure, Bluejay Therap
- LARVOL DELTA
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November 07, 2024
Phase2b/3 Study of Neoantigen-specific T Cell Immunotherapy in Newly Diagnosed O6 – Methylguanine Methyltransferase Unmethylated (MGMT -) Glioblastoma
(SNO 2024)
- "TVI-AST-008 is a randomized clinical trial of a novel neoantigen-specific T cell immunotherapy regimen proven invariably curative in rodent models and clinically effective in trials of patients with relapsed/resistant GBM...Patients in the control arm undergo standard IMRT-chemotherapy followed by adjuvant chemotherapy with temozolomide...Patients are followed with physical exams and surveillance MRI for evidence of disease progression. The trial is targeted for 15 centers in the US."
P2/3 data • P2b data • Tumor-specific neoantigens • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
November 01, 2024
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection
(ANZCTR)
- P1 | N=40 | Recruiting | Sponsor: Bluejay Therapeutics, Inc | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024
Enrollment open • Trial initiation date • Hepatitis B • Hepatology • Infectious Disease • Inflammation
October 15, 2024
PRE-CLINICAL CHARACTERIZATION OF CAVROTOLIMOD, A TLR9 AGONIST FOR THE TREATMENT OF CHRONIC HEPATITIS B
(AASLD 2024)
- "Cavro has demonstrated the ability to induce a strong cellular and humoral immune response in pre-clinical studies, which may result in sustained control of HBV infection. A Phase 1b study has initiated to evaluate CAVRO in patients with CHB."
Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • IFNG • IL10 • IL6 • TLR3 • TLR7 • TLR8 • TNFA
July 05, 2024
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection
(ANZCTR)
- P1 | N=40 | Not yet recruiting | Sponsor: Bluejay Therapeutics, Inc
New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation
July 05, 2024
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection
(ANZCTR)
- P1 | N=80 | Not yet recruiting | Sponsor: Bluejay Therapeutics, Inc
New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation
October 14, 2020
[VIRTUAL] Safety and preliminary efficacy of intratumoral cavrotolimod (AST-008), a spherical nucleic acid TLR9 agonist, in combination with pembrolizumab in patients with advanced solid tumors
(SITC 2020)
- P1b/2 | "The Phase 2 dose expansion stage is examining cavrotolimod 32 mg IT in combination with IV pembrolizumab for the treatment of advanced Merkel cell carcinoma (MCC) and in combination with IV cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma (CSCC). Conclusions IT administration of cavrotolimod appears to be safe and well tolerated in combination with pembrolizumab. Durable responses have occurred in patients previously experiencing progressive disease on PD-1 blockade."
Clinical • Combination therapy • IO biomarker • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer
February 28, 2023
Classic and new strategies for the treatment of advanced melanoma and non-melanoma skin cancer.
(PubMed, Front Med (Lausanne))
- "In recent years, the combination therapy of nivolumab plus ipilimumab has gained ground in studies for its survival and response rate benefits in patients with advanced melanoma...On the contrary, in advanced and metastatic BCC, successful therapeutic strategies, such as vismodegib and sonidegib, are based on the inhibition of aberrant activation of the Hedgehog signaling pathway...In patients with locally advanced or metastatic SCC, who are not candidates for surgery or radiotherapy, anti-PD1 agents such as cemiplimab, pembrolizumab, and cosibelimab (CK-301) have shown significant results in terms of response rate. PD-1/PD-L1 inhibitors, such as avelumab, have also been used in Merkel carcinoma, achieving responses in half of the patients with advanced disease...Two of the most promising molecules used in combination with immunotherapy are cavrotolimod (a Toll-like receptor 9 agonist) and a Toll-like receptor 7/8 agonist...Neoadjuvant treatment with cemiplimab in CSCCs..."
IO biomarker • Journal • Metastases • Review • Genetic Disorders • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • CD4 • CD8 • IL15
December 31, 2022
A first-in-human phase 1 study of cavrotolimod, a TLR9 agonist spherical nucleic acid, in healthy participants: Evidence of immune activation.
(PubMed, Front Immunol)
- P1 | "The results demonstrated that cavrotolimod is a potent innate immune activator, specifically stimulating Th1-type immune responses, and exhibits PD properties that may result in anti-tumor effects in patients with cancer. This study suggests that cavrotolimod is a promising clinical immunotherapy agent."
Journal • P1 data • Immune Modulation • Immunology • Inflammation • Oncology • TLR9
April 07, 2022
Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors
(clinicaltrials.gov)
- P1b/2 | N=57 | Terminated | Sponsor: Exicure, Inc. | Trial completion date: Dec 2023 ➔ Mar 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2022 ➔ Mar 2022; The study was canceled for administrative reasons.
IO biomarker • Trial completion date • Trial primary completion date • Trial termination • Head and Neck Cancer • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer
December 16, 2021
Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors
(clinicaltrials.gov)
- P1b/2; N=57; Active, not recruiting; Sponsor: Exicure, Inc.; Recruiting ➔ Active, not recruiting; N=130 ➔ 57
Clinical • Enrollment change • Enrollment closed • IO biomarker • Head and Neck Cancer • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer
December 11, 2021
Exicure, Inc. Announces Results of Internal Investigation and Implementation of Strategic Measures to Reduce Cash Burn and Prioritize Pipeline Focus
(Businesswire)
- "After a review of the Audit Committee’s findings from the investigation and in combination with a previously initiated strategic review of the Company’s business plans and objectives and its existing cash resources, the Company’s Board of Directors has implemented the following approved plan:...Discontinuation of further enrollment and the ethical wind down of the Company’s ongoing Phase 1b/2 cavrotolimod (AST-008) clinical trial in patients with solid tumors"
Trial status • Oncology • Solid Tumor
November 19, 2021
Exicure, Inc. Reports Third Quarter 2021 Financial Results and Corporate Progress
(Businesswire)
- "Cavrotolimod (AST-008): As a result of enrollment delays contributed to by COVID-19, the Company now expects to report top-line overall response rates (ORR) results in the second half of 2022 rather than the first half of 2022."
P2 data • Merkel Cell Carcinoma • Oncology • Skin Cancer • Squamous Cell Carcinoma
October 14, 2020
[VIRTUAL] Safety and preliminary efficacy of intratumoral cavrotolimod (AST-008), a spherical nucleic acid TLR9 agonist, in combination with pembrolizumab in patients with advanced solid tumors
(SITC 2020)
- P1b/2 | "The Phase 2 dose expansion stage is examining cavrotolimod 32 mg IT in combination with IV pembrolizumab for the treatment of advanced Merkel cell carcinoma (MCC) and in combination with IV cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma (CSCC). Conclusions IT administration of cavrotolimod appears to be safe and well tolerated in combination with pembrolizumab. Durable responses have occurred in patients previously experiencing progressive disease on PD-1 blockade."
Clinical • Combination therapy • IO biomarker • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer
April 29, 2020
[VIRTUAL] AST-008: A novel approach to TLR9 agonism with PD-1 blockade for anti-PD-1 refractory Merkel cell carcinoma (MCC) and cutaneous squamous cell carcinoma (CSCC).
(ASCO 2020)
- P1b/2 | "The phase II dose expansion is using the recommended regimen (RP2D) of IT AST-008 plus flat dose pembrolizumab or cemiplimab to treat two cohorts of pts with advanced/metastatic MCC or CSCC, respectively. The planned phase II enrollment is 58 pts across about 15 US-based sites. Research Funding: Exicure Inc"
Genetic Disorders • Immune Modulation • Inflammation • Merkel Cell Carcinoma • Neuroendocrine Tumor • Oncology • Solid Tumor • Squamous Cell Carcinoma
May 16, 2020
[VIRTUAL] Phase 1b/2 study of an intratumoral TLR9 agonist spherical nucleic acid (AST-008) and pembrolizumab: Evidence of immune activation
(AACR-II 2020)
- P1b/2 | "IT AST-008 is well tolerated at the doses administered and is associated with dose-proportional systemic immune activation. Gene expression analysis suggests increased lymphocytes in the injected tumor after IT AST-008 and in both injected and witness tumors after combination therapy."
IO Biomarker • Late-breaking abstract • P1/2 data • Oncology • Solid Tumor • CD8 • IL1R1
April 05, 2019
AST-008, a TLR9 agonist spherical nucleic acid, activated NK cells, T cells, and cytokines in healthy subjects in a Phase I clinical trial
(AACR 2019)
- "AST-008 is a potent innate immune activator and exhibits pharmacodynamic properties that are expected to result in anti-tumor effects in patients with cancer. A Phase 1b/2 study of AST-008 in combination with pembrolizumab in cancer patients is ongoing."
Clinical • P1 data
August 18, 2021
Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors
(clinicaltrials.gov)
- P1b/2; N=130; Recruiting; Sponsor: Exicure, Inc.; Trial completion date: Jun 2023 ➔ Dec 2023; Trial primary completion date: Dec 2021 ➔ Jun 2022
Clinical • IO biomarker • Trial completion date • Trial primary completion date • Head and Neck Cancer • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer
August 13, 2021
Exicure Provides Interim Results from Ongoing Phase 1b/2 Clinical Trial of Cavrotolimod (AST-008) [Google translation]
- '"Merkel cell carcinoma is an aggressive skin cancer with a high probability of metastasis. Observing a patient with metastatic MCC who had been previously progressing on pembrolizumab monotherapy and radiation, achieve a complete response, is highly encouraging,' said Dr. Sunandana Chandra, M.D..."
Media quote
August 05, 2021
Exicure Provides Interim Results from Ongoing Phase 1b/2 Clinical Trial of Cavrotolimod (AST-008)
(Businesswire)
- P1b/2, N=130; NCT03684785; Sponsor: Exicure, Inc; “As of the data cut-off date of July 1, 2021, 26 patients, all with documented progression on anti-PD-(L)1 therapy, have been dosed in the Phase 2 stage, of whom 17 patients were evaluable. Nine of the 17 evaluable patients were in the MCC cohort and, per RECIST v1.1, best overall response was a complete response (CR) in one MCC patient and stable disease in one MCC patient. Injected and non-injected tumor lesions completely resolved in the MCC patient with a CR, supporting systemic (abscopal) effects…The confirmed ORR in all evaluable MCC patients enrolled in total in the Phase 1b/2 trial was 21% (three of 14) as of the July 1, 2021 data cutoff date. The three patients were comprised of two CRs and one partial response (PR). Biopsy of individual tumor lesions of the MCC patient assessed as PR by RECIST v1.1 revealed no evidence of residual tumor.”
Media quote • P1/2 data • Merkel Cell Carcinoma • Oncology • Squamous Cell Skin Cancer
July 20, 2021
Current status of intralesional agents in treatment of malignant melanoma.
(PubMed, Ann Transl Med)
- "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..."
Journal • Review • Gene Therapies • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • CD40 • IL12A • MAGEA3 • TYRP1
May 12, 2021
Exicure, Inc. Reports First Quarter 2021 Financial Results and Corporate Progress
(Businesswire)
- "The Phase 1b/2 clinical trial of intra-tumoral cavrotolimod in combination with approved checkpoint inhibitors pembrolizumab or cemiplimab, for the treatment of patients with advanced or metastatic MCC or CSCC, is open and actively enrolling patients:...The Company expects to provide interim results from the Phase 2 portion of the clinical trial in mid-2021, and we expect to report overall response rate (ORR) results in the first half of 2022."
P2 data • Head and Neck Cancer • Melanoma • Merkel Cell Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma
March 11, 2021
Exicure, Inc. Reports Full Year 2020 Financial Results and Corporate Progress
(Businesswire)
- "Announced in December 2020 the issuance of two new U.S. patents and a new patent allowance covering cavrotolimod (AST-008) through 2034. Exicure is conducting a clinical trial in which cavrotolimod (AST-008) is being given in combination with pembrolizumab or cemiplimab for the treatment of locally advanced or metastatic MCC or CSCC...In the Phase 2 portion of this trial, Exicure is planning to enroll two separate cohorts of patients with advanced or metastatic MCC or CSCC...The Company expects to open up to 30 sites for the Phase 2 stage of the clinical trial by the end of 2021."
Enrollment status • Patent • Merkel Cell Carcinoma • Oncology • Squamous Cell Carcinoma
March 03, 2021
Exicure Granted Orphan Drug Designation by the U.S. Food and Drug Administration for Cavrotolimod
(Businesswire)
- “Exicure, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its clinical product candidate, cavrotolimod (AST-008), for the treatment of patients with Merkel cell carcinoma (MCC).”
Orphan drug • Merkel Cell Carcinoma • Oncology
January 12, 2021
Convention vs. Innovation I: Telemedicine/Virtual Visits Should Now Be A Preferred Option For Following Patients With PD After Diagnosis
(Cleveland Clinic)
CME
November 09, 2020
Exicure Presents Positive Clinical Data with Cavrotolimod at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting
(Businesswire)
- P1/2, N=130; NCT03684785; Sponsor: Exicure, Inc; “Highlights from the Phase 1b Dose-Escalation Stage: The RECIST-confirmed ORR was 21% (4/19 patients) overall in the Phase 1b dose-escalation stage, reflecting 1 complete response and 3 partial responses. In the highest cavrotolimod dose cohort (32 mg), which was selected as the Phase 2 dose, the RECIST-confirmed ORR was 33% (2/6 patients). Responses were durable and ongoing at the time of data analysis, with progression-free survival exceeding 6 months in all 4 responders and 16 months in 2 responders. 85% of patients overall (17/20 patients) and 75% of responders (3/4) were progressing on anti-PD-1 therapy at the time of trial enrollment. Systemic (abscopal) effects were observed, with shrinkage of regional or distant noninjected tumors....Authors: Steven J. O’Day...Sunandana Chandra."
P1/2 data • Merkel Cell Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma
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