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DRUG:

Intron A (interferon α-2b)

i
Other names: SCH 30500, YM 14090
Company:
Biogen, Merck (MSD)
Drug class:
IFNα 2b stimulant
13h
MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera (clinicaltrials.gov)
P3, N=586, Recruiting, University of Birmingham | Trial completion date: Feb 2028 --> Apr 2030 | Trial primary completion date: Aug 2026 --> Oct 2028
Trial completion date • Trial primary completion date
|
Jakafi (ruxolitinib) • hydroxyurea • Intron A (interferon α-2b)
8d
New trial
|
PML (Promyelocytic Leukemia)
|
Venclexta (venetoclax) • Intron A (interferon α-2b)
1m
Commitment Complex Splicing Factors in Cancers of the Gastrointestinal Tract-An In Silico Study. (PubMed, Bioinform Biol Insights)
This study demonstrates the versatility of in silico analysis to determine molecular function of large macromolecular complexes such as the spliceosome CC. Furthermore, our analysis indicates that therapeutic lowering of CC levels in colon cancer patients may enhance patient survival.
Journal
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1)
|
TP53 mutation • KRAS mutation • BRAF mutation • U2AF1 mutation
|
Intron A (interferon α-2b)
4ms
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov)
P2, N=24, Recruiting, Roswell Park Cancer Institute | Trial completion date: Aug 2025 --> Nov 2025 | Trial primary completion date: Aug 2025 --> Nov 2025
Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
|
CD8 (cluster of differentiation 8)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
4ms
Integrated analysis reveals the immunotoxicity mechanism of BPs on human lymphocytes. (PubMed, Chem Biol Interact)
In addition, the results of ingenuity pathway analysis demonstrated the inhibition of T lymphocyte function, including differentiation, movement, and infiltration. Our results, for the first time, delineate the mechanisms underlying the immunotoxicity of BHPF in human lymphocytes.
Journal
|
IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL1B (Interleukin 1, beta) • IL5 (Interleukin 5)
|
Intron A (interferon α-2b)
4ms
NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov)
P2, N=30, Suspended, Roswell Park Cancer Institute | Trial completion date: May 2024 --> May 2026 | Trial primary completion date: May 2024 --> May 2026
Trial completion date • Trial primary completion date • Surgery
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
6ms
Trial completion date • Combination therapy • IO biomarker
|
CD8 (cluster of differentiation 8)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
7ms
Trial completion date • Surgery
|
IFNA1 (Interferon Alpha 1)
|
Yervoy (ipilimumab) • Intron A (interferon α-2b)
8ms
Trial completion date • Combination therapy • Surgery • Metastases
|
Yervoy (ipilimumab) • Intron A (interferon α-2b)
9ms
Trial completion date • Metastases
|
Avastin (bevacizumab) • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Intron A (interferon α-2b) • octreotide acetate
9ms
NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov)
P2, N=30, Suspended, Roswell Park Cancer Institute | Trial completion date: Nov 2024 --> May 2024 | Trial primary completion date: Nov 2023 --> May 2024
Trial completion date • Trial primary completion date • Surgery
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
10ms
Enrollment open
|
CD8 (cluster of differentiation 8)
|
CD8 positive
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
11ms
Engineering a New IFN-ApoA-I Fusion Protein with Low Toxicity and Prolonged Action. (PubMed, Molecules)
In addition, the chimeric form had reduced cytotoxicity towards Vero cells and increased cell viability under viral load conditions compared with commercial IFN-a2b preparations. Analysis of the pharmacokinetic profile of ryIFN-ApoA-I after a single subcutaneous injection in mice showed a 1.8-fold increased half-life of the chimeric protein compared with ryIFN.
Journal
|
APOA1 (Apolipoprotein A-I)
|
Intron A (interferon α-2b)
11ms
Trial completion date • Surgery
|
CD4 (CD4 Molecule)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Yervoy (ipilimumab) • Intron A (interferon α-2b)
1year
Interferon Alpha Therapy for Cervical CINI and HPV Infection (clinicaltrials.gov)
P1, N=90, Recruiting, Mongolian National University of Medical Sciences
New P1 trial
|
Intron A (interferon α-2b)
1year
EFFICACY OF INTRAVESICAL NADOFARAGENE FIRADENOVEC FOR PATIENTS WITH BCG-UNRESPONSIVE CARCINOMA IN SITU OF THE BLADDER: 36-MONTH FOLLOW-UP FROM A PHASE 3 TRIAL (SUO 2023)
Intravesical nadofaragene firadenovec, administered once every three months, demonstrated a sustained durability of response in patients with BCG-unresponsive CIS±Ta/T1 papillary disease. Nadofaragene firadenovec represents a novel treatment option for BCG-unresponsive NMIBC with a favorable benefit-to-risk ratio. *All patients had passed 36 months at data cutoff on 09 September 2021.
Clinical • P3 data
|
Intron A (interferon α-2b) • Adstiladrin (nadofaragene firadenovec-vncg)
over1year
A CASE OF PULMONARY AND CUTANEOUS INVOLVEMENT OF LYMPHOMATOID GRANULOMATOSIS IN IMMUNOCOMPETENT FEMALE (CHEST 2023)
CASE PRESENTATION: An 81-year-old female with a history of unprovoked DVT/PE on rivaroxaban presented to ED with progressive dyspnea on exertion for four months, a recent fever with a nonproductive cough, night sweats, and two subcutaneous nodules on her low back...These findings favored lupus panniculitis with a negative rheumatological workup, and a low dose of hydroxychloroquine was empirically started...The patient was started on R-CHOP... Though rare, lymphomatoid granulomatosis should be suspected for multiple pulmonary and cutaneous nodules, even in immunocompetent patients.
Clinical • IO biomarker
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1) • CD5 (CD5 Molecule) • SOX10 (SRY-Box 10) • CD79A (CD79a Molecule) • IRF4 (Interferon regulatory factor 4) • MME (Membrane Metalloendopeptidase) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
|
CD20 positive
|
Rituxan (rituximab) • hydroxychloroquine • Intron A (interferon α-2b)
over1year
Engineering cytokines for cancer immunotherapy: a systematic review. (PubMed, Front Immunol)
Considering their clinical potential and the early successful use of cytokines in cancer immunotherapy, such as interferon alpha-2b (IFNα-2b; IntronA) and IL-2 (Proleukin), cytokine-based therapeutics have been extensively evaluated in many follow-up clinical trials...In this review, we focus on the recent progress and competitive landscape in cytokine engineering strategies and preclinical/clinical therapeutics for cancer. In addition, aiming to promote engineered cytokine-based cancer immunotherapy, we present a profound discussion about the feasibility of recently developed methods in clinical medicine translation.
Review • Journal
|
IL2 (Interleukin 2) • IFNA1 (Interferon Alpha 1)
|
Intron A (interferon α-2b) • Proleukin (aldesleukin)
over1year
Trial completion • Metastases
|
Keytruda (pembrolizumab) • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over1year
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer (clinicaltrials.gov)
P1/2, N=15, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jul 2023 --> Jul 2025 | Trial primary completion date: Jul 2023 --> Jul 2025
Trial completion date • Trial primary completion date
|
Opdivo (nivolumab) • Intron A (interferon α-2b) • fluorouracil topical • Novaferon (recombinant anti-tumor and anti-virus protein)
over1year
Treatment of basal cell carcinoma with intralesional interferon alfa-2b: an open label clinical trial. (PubMed, Expert Rev Anticancer Ther)
Recurrence was not detected in any of the groups after one year follow up. Intralesional IFN-α 2b injection is an appropriate treatment choice for BCC.
Journal
|
IFNA1 (Interferon Alpha 1)
|
Intron A (interferon α-2b)
over1year
Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=9, Completed, Roswell Park Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Feb 2023
Trial completion • Trial completion date • Surgery
|
PGR (Progesterone receptor) • CD8 (cluster of differentiation 8)
|
ER positive + PGR positive • PGR positive
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over1year
Clinical • P3 data
|
Keytruda (pembrolizumab) • Intron A (interferon α-2b)
over1year
Granulomatous and Sarcoid-like Immune-Related Adverse Events following CTLA4 and PD1 Blockade Adjuvant Therapy of Melanoma: A Combined Analysis of ECOG-ACRIN E1609 and SWOG S1404 Phase III Trials and a Literature Review. (PubMed, Cancers (Basel))
GSLs following anti-CTLA4 and anti-PD1 antibody therapy in patients with melanoma were reported unusually. Reported cases ranged in grade from I to III and appeared manageable. Careful attention to these events and their reporting will be essential to better guide practice and management guidelines.
P3 data • Review • Journal • Adverse events
|
CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Keytruda (pembrolizumab) • Yervoy (ipilimumab) • Intron A (interferon α-2b)
over1year
Interferon alfa-2b in patients with low-grade lymphomatoid granulomatosis and chemotherapy with DA-EPOCH-R in patients with high-grade lymphomatoid granulomatosis: an open-label, single-centre, phase 2 trial. (PubMed, Lancet Haematol)
Interferon alfa-2b is efficacious for treating low-grade lymphomatoid granulomatosis and hence reducing progression to high-grade disease, whereas patients with high-grade lymphomatoid granulomatosis showed expected responses to chemotherapy. Uncontrolled immune regulation of Epstein-Barr virus is hypothesised to result in the emergence of low-grade disease after chemotherapy, for which treatment with interferon alfa-2b is efficacious.
P2 data • Clinical Trial,Phase II • Journal
|
Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • prednisone • Intron A (interferon α-2b)
over1year
Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=9, Active, not recruiting, Roswell Park Cancer Institute | Suspended --> Active, not recruiting | N=24 --> 9 | Trial completion date: May 2023 --> Feb 2024
Enrollment closed • Enrollment change • Trial completion date • Surgery
|
PGR (Progesterone receptor) • CD8 (cluster of differentiation 8)
|
ER positive + PGR positive • PGR positive
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over1year
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov)
P1/2, N=64, Suspended, Roswell Park Cancer Institute | Recruiting --> Suspended
Trial suspension
|
CRP (C-reactive protein)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod)
2years
Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=24, Suspended, Roswell Park Cancer Institute | Trial primary completion date: Aug 2022 --> May 2022
Trial primary completion date • Surgery
|
PGR (Progesterone receptor) • CD8 (cluster of differentiation 8)
|
ER positive + PGR positive • PGR positive
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over2years
Trial suspension
|
PGR (Progesterone receptor) • CD8 (cluster of differentiation 8)
|
ER positive + PGR positive • PGR positive
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over2years
Deglycosylation Does Not Affect the Cytotoxic Action of Adenoviral Interferon α-Induced Bystander Proteins. (PubMed, FASEB J)
The deglycosylated CM (Ad-IFNα TERT-NHUC) produced a same degree of inhibition on the proliferation of KU7 cells (Fig 1). In conclusion, the cytotoxic effects of BSPs is independent of its status of glycosylation.
Journal
|
IFNA1 (Interferon Alpha 1)
|
Intron A (interferon α-2b)
almost3years
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov)
P1/2, N=64, Recruiting, Roswell Park Cancer Institute | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2021 --> Nov 2023
Trial completion date • Trial primary completion date
|
CRP (C-reactive protein)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod)
3years
Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver (clinicaltrials.gov)
P2a, N=15, Completed, Roswell Park Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Nov 2021 --> Aug 2021
Clinical • Trial completion • Trial completion date
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
MSI-H/dMMR • RAS wild-type
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • celecoxib oral
3years
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov)
P1/2, N=64, Recruiting, Roswell Park Cancer Institute | Trial completion date: Apr 2022 --> Nov 2022
Clinical • Trial completion date
|
CRP (C-reactive protein)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod)
over3years
[VIRTUAL] Phase III Trial of Intravesical Nadofaragene Firadenovec in Patients with High-Grade, BCG-Unresponsive, Non-muscle Invasive Bladder Cancer: Two Year Follow-up in the Ta/T1 Cohort (AUA 2021)
Nadofaragene firadenovec was well tolerated and demonstrates durability of response in pts with HG Ta/T1, BCG-unresponsive NMIBC in 24 mos follow-up after first intravesical treatment. Clinical trial information: NCT02773849.
Clinical • P3 data
|
IFNA2 (Interferon Alpha 2)
|
Intron A (interferon α-2b) • Adstiladrin (nadofaragene firadenovec-vncg)
over3years
[VIRTUAL] Efficacy of Intravesical Nadofaragene Firadenovec for Patients with Carcinoma in Situ (CIS), BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC): Longer-Term Follow-up from the Phase III Trial (AUA 2021)
Nadofaragene firadenovec instilled intravesically once every 3 mos demonstrates sustained durability of response with longer follow-up in pts with HG, BCG-unresponsive NMIBC. Clinical trial information: NCT02773849.
Clinical • P3 data
|
IFNA2 (Interferon Alpha 2)
|
Intron A (interferon α-2b) • Adstiladrin (nadofaragene firadenovec-vncg)
over3years
[VIRTUAL] Anti-adenoviral Antibody Levels Predict Nadofaragene Firadenovec Response in BCG-unresponsive NMIBC: Results from a Phase 3 Trial (AUA 2021)
Secondary analysis of the prospective, multicenter phase 3 nadofaragene firadenovec trial in BCG-unresponsive NMIBC indicates a role for assaying baseline and on-treatment Ab titers. A combination of Ab titer and fold-change levels can potentially predict response to this novel therapeutic in a patient population with urgent unmet clinical need.
P3 data
|
IFNA2 (Interferon Alpha 2)
|
Intron A (interferon α-2b) • Adstiladrin (nadofaragene firadenovec-vncg)
over3years
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov)
P1/2, N=64, Recruiting, Roswell Park Cancer Institute | N=44 --> 64 | Trial completion date: Sep 2021 --> Apr 2022
Clinical • Enrollment change • Trial completion date
|
CRP (C-reactive protein)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod)
over3years
[VIRTUAL] Adjuvant anti-PD-1 ab (Toripalimab) versus high-dose IFN-a2b in resected mucosal melanoma: A phase Ⅱ randomized trial. (ASCO 2021)
Both adjuvant toripalimab and HDI therapy improve RFS of mucosal melanoma . Toripalimab shows longer RFS in PDL1 (+) subgroup and better tolerance than HDI.
Clinical
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 negative
|
PD-L1 IHC 22C3 pharmDx
|
Loqtorzi (toripalimab-tpzi) • Intron A (interferon α-2b)
over3years
Neoadjuvant Pembrolizumab and High Dose Interferon Alfa-2b in Resectable Regionally Advanced Melanoma. (PubMed, Clin Cancer Res)
Conclusions Neoadjuvant concurrent HDI and pembrolizumab demonstrated promising clinical activity despite high rates of treatment discontinuation. pCR is a prognostic indicator.
Clinical • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
|
Keytruda (pembrolizumab) • Intron A (interferon α-2b)
over3years
Combination Study of SV-BR-1-GM in Combination With INCMGA00012 and Epacadostat (clinicaltrials.gov)
P1/2, N=60, Recruiting, BriaCell Therapeutics Corporation | Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 positive • HER-2 negative • PGR positive • PGR negative
|
Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • Bria-IMT (SV-BR-1-GM) • Intron A (interferon α-2b) • cyclophosphamide intravenous
almost4years
Dendritic Cell Vaccines Against Her2/Her3, Cytokine Modulation Regimen, and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer (clinicaltrials.gov)
P2a, N=23, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Apr 2023 --> Feb 2024 | Trial primary completion date: Apr 2022 --> Feb 2023
Clinical • Trial completion date • Trial primary completion date
|
ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 positive • HER-2 negative
|
Keytruda (pembrolizumab) • Intron A (interferon α-2b) • Ampligen (rintatolimod)
almost4years
Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver (clinicaltrials.gov)
P2a, N=15, Active, not recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2022 --> Dec 2021 | Trial primary completion date: Apr 2022 --> Dec 2020
Clinical • Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • celecoxib oral