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DRUG:

citoplurikin (IRX-2)

i
Other names: IRX-2, IRX 2
Associations
Company:
Eterna Therap
Drug class:
T-cell stimulant
Associations
3ms
Trial completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
nCounter® PanCancer Immune Profiling Panel
|
cyclophosphamide • citoplurikin (IRX-2) • omeprazole
5ms
NeoIRX: Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=12, Active, not recruiting, Providence Health & Services | Trial primary completion date: Jun 2024 --> Jul 2023
Trial primary completion date
|
Keytruda (pembrolizumab) • doxorubicin hydrochloride • cyclophosphamide • citoplurikin (IRX-2)
9ms
Trial completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
PD-L1 expression • HER-2 negative
|
nCounter® PanCancer Immune Profiling Panel
|
cyclophosphamide • citoplurikin (IRX-2) • omeprazole
9ms
IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer (clinicaltrials.gov)
P1, N=8, Active, not recruiting, City of Hope Medical Center | Phase classification: P1b --> P1 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Phase classification • Trial completion date • Trial primary completion date • Metastases
|
Opdivo (nivolumab) • cyclophosphamide • citoplurikin (IRX-2)
11ms
IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma (clinicaltrials.gov)
P1, N=19, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date
|
Imfinzi (durvalumab) • cyclophosphamide • citoplurikin (IRX-2)
12ms
IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma (clinicaltrials.gov)
P1, N=19, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Phase classification: P1b --> P1
Phase classification
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Imfinzi (durvalumab) • cyclophosphamide • citoplurikin (IRX-2)
1year
Association of pathologic complete response with the 27-gene IO score and week 3 IOpath response following neoadjuvant pembrolizumab +/- intralymphatic cytokines in the neoIRX trial (SABCS 2023)
Subjects with stage II-III TNBC were randomized 1:1 (n=12) to receive induction pembrolizumab (200mg IV) +/- peri-areolar IRX-2 (IRX-2 arm: 1 ml SQ x2 daily for 10 days + cyclophosphamide 300 mg/m2 IV x 1) preceding initiation of pembrolizumab + NAC... A subset of TNBCs experience brisk IO response following single-cycle IO (IOpath response), which is associated with 100% pCR in this preliminary dataset, highlighting IOpath as a potential surrogate biomarker to guide NAC de-escalation or omission in early-stage TNBC. Baseline 27-gene IO score predicts pCR and week 3 IOpath response. A future study is planned (neoINBRX) to evaluate the feasibility of combining baseline IO score with week 3 IOpath response to identify and treat IO-sensitive tumors with chemotherapy-sparing IO combination therapy.
Clinical • PD(L)-1 Biomarker • IO biomarker
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IFNG (Interferon, gamma)
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DetermaIO™
|
Keytruda (pembrolizumab) • cyclophosphamide • citoplurikin (IRX-2)
over1year
IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer (clinicaltrials.gov)
P1b, N=8, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023
Trial completion date • Trial primary completion date • Metastases
|
Opdivo (nivolumab) • cyclophosphamide • citoplurikin (IRX-2)
over1year
Trial completion
|
cyclophosphamide • citoplurikin (IRX-2) • omeprazole
over1year
Enrollment change • Trial completion • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • cyclophosphamide • citoplurikin (IRX-2)
almost2years
LATPS, a novel prognostic signature based on tumor microenvironment of lung adenocarcinoma to better predict survival and immunotherapy response. (PubMed, Front Immunol)
Survival analysis in 28 advanced lung cancer patients treated with an anti-PD-1 regimen at Nanfang hospital revealed that the LATPS-low subgroup had better immunotherapy benefit. LATPS is an effective predictor to distinguish survival, immune characteristics, and immunotherapy benefit in LUAD patients.
Journal • PD(L)-1 Biomarker • IO biomarker
|
CD3D (CD3d Molecule) • IRX2 (Iroquois Homeobox 2)
|
citoplurikin (IRX-2)
over2years
IRX-2, Cyclophosphamide, and Pembrolizumab in Treating Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Cancer (clinicaltrials.gov)
P1b/2; Suspended --> Active, not recruiting | Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Feb 2022 --> Feb 2023
Trial completion date • Trial primary completion date • Enrollment closed
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PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • cyclophosphamide • citoplurikin (IRX-2)
almost3years
Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) (clinicaltrials.gov)
P1, N=16, Active, not recruiting, Providence Health & Services | Trial completion date: Dec 2020 --> Jan 2023 | Trial primary completion date: Apr 2018 --> Oct 2022
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
cyclophosphamide • citoplurikin (IRX-2) • omeprazole
3years
The neoIRX trial: locoregional cytokine therapy to promote immunologic priming and enhanced response to neoadjuvant pembrolizumab plus chemotherapy in triple negative breast cancer (TNBC) (SABCS 2021)
Background: In stage II/III TNBC, pembrolizumab when combined with chemotherapy (doxorubicin, cyclophosphamide, paclitaxel [ACT], and carboplatin) improves event free survival and pathologic complete response (pCR) rate (Keynote-522 study)...2 Page, DB. Clin Cancer Res 2020; 26.7:1595-1605.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
VENTANA PD-L1 (SP142) Assay
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • citoplurikin (IRX-2)
3years
neoIRX: a phase II trial of locoregional cytokine therapy to promote immunologic priming and clinical response to neoadjuvant pembrolizumab plus chemotherapy in triple negative breast cancer (TNBC) (SITC 2021)
Background Background: The FDA has approved pembrolizumab in combination with neoadjuvant chemotherapy (doxorubicin, cyclophosphamide, paclitaxel [ACT], and carboplatin) for stage II/III TNBC, on the basis of improved event free survival (EFS) and pathologic complete response (pCR) rate in the Keynote-522 study.1 Novel combination immunotherapy strategies may further improve outcomes and allow the opportunity to de-escalate the chemotherapy backbone, potentially mitigating grade III/IV toxicities which occurred in 81% of recipients...As of 7/28/2021, n=7/30 subjects are enrolled (Providence Cancer Institute, Portland, OR, Providence St. John’s Cancer Institute, Santa Monica, CA, Baylor Medicine, Houston, TX).
P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
VENTANA PD-L1 (SP142) Assay
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • doxorubicin hydrochloride • citoplurikin (IRX-2)
over3years
IRX-2, Cyclophosphamide, and Pembrolizumab in Treating Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Cancer (clinicaltrials.gov)
P1b/2, N=20, Suspended, City of Hope Medical Center | Trial completion date: Feb 2021 --> Feb 2022 | Recruiting --> Suspended | Trial primary completion date: Feb 2021 --> Feb 2022
Clinical • Trial completion date • Trial suspension • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • citoplurikin (IRX-2) • cyclophosphamide intravenous
over3years
[VIRTUAL] QuPath versus InForm: Digital image analysis of multiplex immunofluorescence (mIF) tumor-infiltrating lymphocyte (TIL) outcomes in an immunotherapy clinical trial (AACR 2021)
Exploratory mIF biomarker outcomes in clinical trials may depend on the method of image analysis. Further work is ongoing to evaluate and improve upon discordant results using QuPath v. InForm. These data also highlight the importance of collaborative efforts via the NIH Cancer Immune Monitoring and Analysis Centers to standardize and validate mIF methodologies across institutions.
Clinical • Tumor-Infiltrating Lymphocyte • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • FOXP3 (Forkhead Box P3)
|
PD-L1 expression
|
citoplurikin (IRX-2)
almost4years
Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer. (PubMed, Breast Cancer Res)
P1; mIF is useful for quantifying treatment-related dynamic changes in sTILs/PD-L1 and is concordant with clinical assays, but with greater precision. Hierarchical linear modeling can mitigate the effects of intratumoral heterogeneity on immune cell count estimations, allowing for more efficient detection of treatment-related pharmocodynamic effects in the context of clinical trials.
Journal • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • FOXP3 (Forkhead Box P3)
|
PD-L1 expression
|
VENTANA PD-L1 (SP142) Assay
|
citoplurikin (IRX-2)
almost4years
Clinical • Enrollment open
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • citoplurikin (IRX-2) • cyclophosphamide intravenous
over4years
Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial. (PubMed, Oral Oncol)
The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).
Clinical • Journal • Tumor-Infiltrating Lymphocyte • PD(L)-1 Biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
|
PD-L1 expression • CDKN2A negative • TILs
|
cyclophosphamide • citoplurikin (IRX-2) • omeprazole
over4years
EMP1 promotes the malignant progression of osteosarcoma through the IRX2/MMP9 axis. (PubMed, Panminerva Med)
EMP1 is upregulated in OS tissues and closely linked to lymphatic metastasis and distant metastasis. It stimulates the malignant progression of OS through the IRX2/MMP9 axis.
Journal
|
MMP9 (Matrix metallopeptidase 9)
|
citoplurikin (IRX-2)
over4years
Clinical • Trial suspension
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • citoplurikin (IRX-2) • cyclophosphamide intravenous
over4years
[VIRTUAL] NEXT GENERATION SEQUENCING IDENTIFIES COMMON MUTATIONAL SIGNATURES IN NOVEL GENES REPRESENTING DIFFERENT BIOLOGICAL PATHWAYS ASSOCIATED WITH ACUTE TRANSFORMATION IN CHRONIC MYELOID LEUKEMIA (EHA 2020)
Potential of our newly genes as novel biomarkers of CML progression, particularly, blast crisis transformation should be tested. Furthermore, further functional cellular and molecular biological studies should be carried out to explore their role as novel drug targets for advanced phase CML.
Next-generation sequencing • BRCA Biomarker • IO biomarker
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • BCL2 (B-cell CLL/lymphoma 2) • JAK2 (Janus kinase 2) • FANCD2 (FA Complementation Group D2)
|
citoplurikin (IRX-2)
over4years
[VIRTUAL] Concordance of multispectral immunofluorescence (mIF) with programmed death ligand 1 (PD-L1) and stromal tumor infiltrating lymphocyte (sTILs) clinical assays in early-stage breast cancer (BC). (ASCO 2020)
mIF is concordant with SP142 and sTIL prognostic assays, but with increased precision to quantify treatment related changes. Regression modeling can dramatically improve the utility of mIF as a surrogate immune-based biomarker. Our approach is being utilized in ongoing phase II studies to compare the activity of pembrolizumab +/- locoregional cytokines (IRX-2) in triple negative BC, and paclitaxel/trastuzumab +/- pembrolizumab +/- pertuzumab in HER2-positive BC.
Clinical • Tumor-Infiltrating Lymphocyte • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • FOXP3 (Forkhead Box P3)
|
PD-L1 expression • HER-2 positive
|
Keytruda (pembrolizumab) • Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • citoplurikin (IRX-2) • trastuzumab biosimilar
almost5years
A phase Ib study of pre-operative, locoregional IRX-2 cytokine immunotherapy to prime immune responses in patients with early stage breast cancer. (PubMed, Clin Cancer Res)
IRX-2 is safe in early stage breast cancer. Potentially favorable immunomodulatory changes were observed, supporting further study of IRX-2 in early stage breast cancer and other malignancies.
Clinical • P1 data • Journal
|
PD-L1 (Programmed death ligand 1)
|
cyclophosphamide • citoplurikin (IRX-2)
5years
Multispectral immunofluorescence (mIF) to detect dynamic changes in PD-L1 expression, immune cell (IC) infiltration, and tumor-IC interactions in primary breast cancer (BC) immuno-oncology (I-O) clinical trials (SABCS 2019)
Introduction: Anti-PD-1/L1 (atezolizumab) is effective in first-line, PD-L1-positive triple negative breast cancer, however it is becoming increasingly apparent that the majority of breast cancers will require novel I-O combination strategies... We describe a framework for use of mIF as a high-dimensional biomarker for use with I-O clinical trials to gain mechanistic insight into the biologic effects of I-O therapies in primary BCs. mIF can be used to detect dynamic changes in sTIL score and IC PD-L1 expression, and therefore may serve to complement the H&E sTIL score and SP142 PD-L1 clinical assay in the context of I-O clinical trials. The greater precision of regression-assisted mIF may facilitate discovery of treatment-related I-O effects, potentially with smaller sample size requirements.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • FOXP3 (Forkhead Box P3)
|
Tecentriq (atezolizumab) • citoplurikin (IRX-2) • cyclophosphamide intravenous