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DRUG:

Unituxin (dinutuximab)

i
Other names: Ch14.18, Ch 14.18UTC, MOAB Ch14.18, OP-08
Company:
Ohara Pharma, United Therapeutics Corp
Drug class:
GD2 ganglioside inhibitor
8d
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (clinicaltrials.gov)
P2, N=62, Recruiting, New Approaches to Neuroblastoma Therapy Consortium | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
10d
NANT 2013-01: Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells (clinicaltrials.gov)
P1, N=13, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date
|
lenalidomide • Unituxin (dinutuximab)
14d
Rapid Administration Pilot for Infusing Dinutuximab (clinicaltrials.gov)
P4, N=11, Suspended, Children's Hospital Los Angeles | Trial completion date: Aug 2024 --> Jun 2025 | Recruiting --> Suspended | Trial primary completion date: Aug 2024 --> Jun 2025
Trial completion date • Trial suspension • Trial primary completion date
|
temozolomide • cyclophosphamide • irinotecan • topotecan • Unituxin (dinutuximab)
24d
Trial completion date • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
28d
NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
|
MYCN amplification • IL6 expression
|
cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
2ms
MIBG With Dinutuximab +/- Vorinostat (clinicaltrials.gov)
P1, N=45, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Jun 2024 --> Jun 2025
Trial completion date
|
CD34 (CD34 molecule)
|
Zolinza (vorinostat) • Unituxin (dinutuximab) • Azedra (iobenguane I 131) • Leukine (sargramostim)
5ms
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma (clinicaltrials.gov)
P1/2, N=117, Active, not recruiting, Eli Lilly and Company | Trial completion date: Oct 2028 --> Apr 2025 | Trial primary completion date: May 2028 --> Mar 2024
Trial completion date • Trial primary completion date • Combination therapy
|
temozolomide • Verzenio (abemaciclib) • irinotecan • Unituxin (dinutuximab)
5ms
Patterns of recurrence after radiotherapy for high-risk neuroblastoma: Implications for radiation dose and field. (PubMed, Radiother Oncol)
Despite EBRT, LRR remains a contributor to treatment failure in HR-NBL with approximately half of LRRs including a component of marginal failure. Future prospective studies are needed to explore whether radiation fields and doses should be defined based on molecular features such as MYCN amplification, and/or response to chemotherapy.
Journal
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
Unituxin (dinutuximab)
5ms
Targeting both GD2 and B7-H3 using bispecific antibody improves tumor selectivity for GD2-positive tumors. (PubMed, bioRxiv)
We assessed the avidity and selectivity of our GD2-B7-H3 targeting bispecific antibodies (INV34-6, INV33-2, and INV36-6) towards GD2 + /hB7-H3 - B78 cells relative to GD2 + /hB7-H3 + B78 cells using flow cytometry and competition binding assays, comparing results an anti-GD2 antibody (dinutuximab, DINU). The bispecific antibodies, DINU, and a non-targeted bispecific control (bsAb CTRL) were conjugated with deferoxamine for radiolabeling with Zr-89 (t 1/2 = 78.4 h)...This approach should address the severe toxicities associated with GD2-targeting therapies by reducing off-tumor GD2 binding in nerves. Continued improvements in bispecific antibody technologies will continue to transform the therapeutic biologics landscape.
Journal
|
CD276 (CD276 Molecule)
|
Unituxin (dinutuximab)
5ms
NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (clinicaltrials.gov)
P2, N=62, Not yet recruiting, New Approaches to Neuroblastoma Therapy Consortium
New P2 trial • Combination therapy
|
temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
6ms
Enhancing IgA-mediated neutrophil cytotoxicity against neuroblastoma by CD47 blockade. (PubMed, J Immunother Cancer)
These promising results highlight the potential to enhance immunotherapy efficacy against high-risk neuroblastoma through improved neutrophil cytotoxicity by combining IgA therapy with CD47 blockade.
Journal
|
CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
|
Unituxin (dinutuximab)
6ms
Enrollment closed • Combination therapy
|
temozolomide • Verzenio (abemaciclib) • irinotecan • Unituxin (dinutuximab)
7ms
Enrollment open • Surgery
|
ALK (Anaplastic lymphoma kinase) • TERT (Telomerase Reverse Transcriptase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • irinotecan • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • dexrazoxane
7ms
Enrollment closed
|
magrolimab (ONO-7913) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
7ms
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • NCR3LG1 (Natural Killer Cell Cytotoxicity Receptor 3 Ligand 1)
|
Proleukin (aldesleukin) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
7ms
Safety Study of Dinutuximab Combined With Immunotherapy to Treat Neuroblastoma (clinicaltrials.gov)
P2, N=24, Completed, Fundació Sant Joan de Déu | Unknown status --> Completed
Trial completion
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
Unituxin (dinutuximab) • Leukine (sargramostim)
7ms
NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Sep 2024
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
|
MYCN amplification • IL6 expression
|
cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
7ms
Choosing T-cell sources determines CAR-T cell activity in neuroblastoma. (PubMed, Front Immunol)
Moreover, ex vivo culture with IL-7+IL-15+IL-21 could favor CAR-T products with a longer persistence in the host. Our strategy may complement the current use of Dinutuximab in treating NB through its combination with a targeted CAR-T cell approach.
Journal • CAR T-Cell Therapy
|
CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IL2 (Interleukin 2) • IL15 (Interleukin 15) • IL21 (Interleukin 21) • IL7 (Interleukin 7)
|
Unituxin (dinutuximab)
8ms
Trial completion date
|
lenalidomide • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
9ms
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (clinicaltrials.gov)
P2, N=95, Active, not recruiting, Children's Oncology Group | Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
Trial completion date • Trial primary completion date
|
IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CD276 (CD276 Molecule) • TNFA (Tumor Necrosis Factor-Alpha)
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
9ms
STING: NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab (clinicaltrials.gov)
P1/2, N=31, Recruiting, Nationwide Children's Hospital | Trial primary completion date: Dec 2023 --> Dec 2024
Trial primary completion date • Combination therapy
|
temozolomide • irinotecan • Unituxin (dinutuximab) • Leukine (sargramostim)
10ms
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma (clinicaltrials.gov)
P1/2, N=117, Recruiting, Eli Lilly and Company | Phase classification: P1b/2 --> P1/2 | Trial primary completion date: Jun 2027 --> May 2028
Phase classification • Trial primary completion date • Combination therapy
|
temozolomide • Verzenio (abemaciclib) • irinotecan • Unituxin (dinutuximab)
10ms
Therapy for Children With Advanced Stage Neuroblastoma (clinicaltrials.gov)
P2, N=153, Active, not recruiting, St. Jude Children's Research Hospital | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date • Metastases
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • mesna • Proleukin (aldesleukin) • busulfan • Unituxin (dinutuximab) • Leukine (sargramostim) • Neupogen (filgrastim) • humanised dinutuximab (Hu14.18K322A)
10ms
Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (clinicaltrials.gov)
P1, N=82, Suspended, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Dec 2032 | Trial primary completion date: Jun 2026 --> Dec 2032
Trial completion date • Trial primary completion date
|
magrolimab (ONO-7913) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
11ms
Trial completion date • Trial primary completion date • Combination therapy
|
temozolomide • irinotecan • zoledronic acid • Unituxin (dinutuximab)
11ms
New P3 trial
|
ALK (Anaplastic lymphoma kinase) • TERT (Telomerase Reverse Transcriptase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • irinotecan • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • dexrazoxane
11ms
IL15 (N-803) and IL21 (oHSV-21) Significantly Enhance ROR1 CAR NK Cells Against Pediatric Neuroblastoma (TCT-ASTCT-CIBMTR 2024)
The N-803 combined with dinutuximab and exPBNK cells significantly extended the survival of NB xenografts (Chu/Cairo, et al, JITC...C021 was generated by modifying C134 to express human IL21 gene... Our data demonstrated IL15 or IL21 based novel cytokine therapy (N-803 or C021) significantly enhanced the anti-tumor efficacy of ROR1 CAR NK targeting NB in vitro and in vivo
Clinical
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IFNG (Interferon, gamma) • ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1) • GZMB (Granzyme B) • GZMA (Granzyme A) • IL15 (Interleukin 15) • IL21 (Interleukin 21)
|
MYCN amplification • ROR1 expression • ROR1 overexpression
|
Anktiva (nogapendekin alfa inbakicept-pmln) • Unituxin (dinutuximab)
1year
Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons. (PubMed, J Clin Oncol)
The externally controlled analyses presented show a relapse risk reduction in patients with HRNB treated with postimmunotherapy DFMO.
Journal
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
Unituxin (dinutuximab)
1year
Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma (clinicaltrials.gov)
P2, N=41, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
Trial completion • Combination therapy
|
Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
1year
NANT 2013-01: Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells (clinicaltrials.gov)
P1, N=13, Active, not recruiting, New Approaches to Neuroblastoma Therapy Consortium | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
Trial completion date • Trial primary completion date
|
lenalidomide • Unituxin (dinutuximab)
1year
Survival and Local Recurrence Risk in Patients with High-Risk Neuroblastoma Treated with Proton Therapy over a 10 Year Interval. (PubMed, Int J Radiat Oncol Biol Phys)
We observed excellent outcomes in 99 pts treated with proton radiotherapy for HR-NBL from 2010 through 2021, with 81% of patients alive and 92% free of LR. Our data suggest that LR is rare after GTR and 21.6 Gy, and uncommon among pts with STR treated with 36 Gy. A small number of pts received 21.6 Gy after STR, however, this experience suggests that a subset of pts with RD may require RT dose > 21.6 Gy. Further work is required to further characterize individual management of PS in pts with HR-NBL with regard to extent of RD and biologic disease features.
Journal
|
Unituxin (dinutuximab)
1year
Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
P2, N=34, Active, not recruiting, Children's Oncology Group | Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Jun 2023
Trial completion date • Trial primary completion date • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)
1year
Treatment of High-Risk Neuroblastoma with Dinutuximab and Chemotherapy Administered in all Cycles of Induction. (PubMed, Cancers (Basel))
The EOI response of PR or better in the evaluable cohort was 96%. Dinutuximab was well tolerated with all Induction cycles, demonstrated an encouraging EOI response rate, and should be evaluated in a randomized study.
Journal
|
Unituxin (dinutuximab)
1year
Cost-effectiveness analysis of dinutuximab β for the treatment of high-risk neuroblastoma in China. (PubMed, Pediatr Blood Cancer)
Results found that dinutuximab β is not a cost-effective treatment option for children with high-risk NB unless its price is significantly reduced.
Journal • HEOR • Cost-effectiveness • Cost effectiveness
|
Unituxin (dinutuximab)
over1year
The yes-associated protein (YAP) is associated with resistance to anti-GD2 immunotherapy in neuroblastoma through downregulation of ST8SIA1. (PubMed, Oncoimmunology)
Patients with relapsed neuroblastoma are often treated with immunotherapy such as the anti-GD2 antibody, dinutuximab, in combination with chemotherapy...The mechanism of ST8SIA1 suppression by YAP is independent of PRRX1 expression, a mesenchymal master transcription factor, suggesting YAP may be the downstream effector of mesenchymal GD2 resistance. These results therefore identify YAP as a therapeutic target to augment GD2 immunotherapy responses in patients with neuroblastoma.
Journal • IO biomarker
|
PRRX1 (Paired Related Homeobox 1)
|
RAS mutation
|
Unituxin (dinutuximab)
over1year
IgA antibody immunotherapy targeting GD2 is effective in preclinical neuroblastoma models. (PubMed, J Immunother Cancer)
IgA3.0 ch14.18 is a promising new therapy for neuroblastoma, showing (1) increased half-life compared to natural IgA antibodies, (2) increased protein stability enabling effortless production and purification, (3) potent CD89-mediated tumor killing in vitro by healthy subjects and patients with neuroblastoma and (4) antitumor efficacy in long-term mouse neuroblastoma models.
Preclinical • Journal • IO biomarker
|
Unituxin (dinutuximab)
over1year
Ketamine as an Adjunct to Opioid Analgesia in Pediatric Patients with High-risk Neuroblastoma Undergoing Treatment with Dinutuximab (ASA 2023)
Daily average of IV morphine milligram equivalents (MME) and ketamine intake was calculated for each cycle of dinutuximab. Preliminary findings suggest an acceptable adverse effect profile with ketamine use as an adjunctive opioid therapy to relieve pain in pediatric patients receiving dinutuximab infusions.
Clinical
|
Unituxin (dinutuximab)
over1year
Translational considerations for immunotherapy clinical trials in pediatric neuro-oncology. (PubMed, Neoplasia)
While immunotherapy for pediatric cancer has made great strides in recent decades, including the FDA approval of agents such as dinutuximab and tisgenlecleucel, these successes have rarely impacted children with pediatric central nervous system (CNS) tumors...Combinatorial strategies and future directions will be addressed. Through internationally collaborative efforts and consortia, we aim to direct this promising field of immuno-oncology to the next frontier of successful application against pediatric CNS tumors.
Journal
|
Unituxin (dinutuximab)
over1year
TARGETING EWING SARCOMA WITH ANTI-IL1RAP CHIMERIC ANTIGEN RECEPTOR MODIFIED EX-VIVO EXPANDED NATURAL KILLER CELLS (IL1RAP-CAR NK) AND TGF-BETA IMPRINTED NK CELLS (CAR TGFBI NK) IN COMBINATION WITH DINUTUXIMAB AND NKTR-25 (ASPHO 2023)
Our data provide a ra onale for a preclinical evalua on of IL1RAP-CAR NK/TGFbi-NK combined with NKTR-255 and dinutuximab in limi ng ES xenogra tumor growth and/or metastasis and prolonging animal survival in-vivo. Count: 400 words (Limit 400 words) This study was funded by NCI Cancer Moonshot U54 grant (CA232561-01A1).
Preclinical • Combination therapy • IO biomarker
|
IFNG (Interferon, gamma) • TGFB1 (Transforming Growth Factor Beta 1) • IL1RAP (Interleukin 1 Receptor Accessory Protein) • TGFBI (Transforming Growth Factor Beta Induced)
|
NKTR-255 • Unituxin (dinutuximab)
over1year
Enrollment closed • Combination therapy
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
MYCN amplification
|
temozolomide • irinotecan • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim)