Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Immunotherapy
IRX 2 · 3 trials · 4 indications
Number of patients who showed pCR post surgery. pCR rate (ypT0/Tis ypN0) is defined as the proportion of subjects without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy per the current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization.
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization. Assessment of progression/disease recurrence occurred by physical exam and annual imaging for the duration of the follow up portion of the study. Median EFS was estimated using the Kaplan-Meier method.
The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described.
| Arm | Type | Description |
|---|---|---|
| Control | EXPERIMENTAL | Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery. |
| Arm A | EXPERIMENTAL | • Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery. |
| Regimen 1 | EXPERIMENTAL | IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy. |
| Regimen 2 | ACTIVE_COMPARATOR | Regimen 1 but without IRX-2 |
| IRX-2 Regimen | EXPERIMENTAL | The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin, zinc supplementation, and omeprazole. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region. |
| IRX 2 | DRUG | IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells. |
| IRX-2 | BIOLOGICAL | Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. |
| Cyclophosphamide | DRUG | Method of Administration: Cyclophosphamide is administered once by IV |
| Indomethacin | DRUG | Method of Administration: Indomethacin is administered orally for 21 days. |
| Zinc-containing multivitamin | DIETARY_SUPPLEMENT | Method of Administration: Zinc-containing multivitamin is administered orally for 21 days. |
| Omeprazole | DRUG | Method of Administration: Omeprazole is administered orally for 21 days |
| Zinc | DRUG | 21 days of zinc gluconate (65 mg) as part of an oral multivitamin |
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. 2. Be a male or female subje...
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IRX-2 is an investigational biologic therapy being developed for squamous cell carcinoma of the head and neck and squamous cell carcinoma of the oral cavity. It is a monoclonal antibody modality in Phase 2 clinical development. Ernexa Therapeutics Inc. (ticker: ERNA) is the developer. IRX-2 has been studied in newly diagnosed patients with Stage II, III, or IVA oral cavity cancer.
IRX-2 is being studied for squamous cell carcinoma of the head and neck, including squamous cell carcinoma of the oral cavity. Clinical testing has focused on patients with newly diagnosed Stage II, III, or IVA oral cavity disease and on patients with operable head and neck cancer. It remains investigational and is not approved for commercial use.
Ernexa Therapeutics Inc. (ticker: ERNA) is the developer of IRX-2. The company is advancing the asset in oncology, where it has been evaluated in Phase 2 studies of squamous cell carcinoma of the head and neck and squamous cell carcinoma of the oral cavity.
IRX-2 is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. Two Phase 2 trials have been completed, one in newly diagnosed Stage II, III, or IVA squamous cell carcinoma of the oral cavity and one in operable head and neck cancer.
IRX-2 has been studied in two completed Phase 2 trials. NCT02609386 evaluated the IRX-2 regimen in 105 patients with newly diagnosed Stage II, III, or IVA squamous cell carcinoma of the oral cavity across the United States, Brazil, Canada, and the United Kingdom. NCT00210470 studied IRX-2 in 27 patients with operable head and neck cancer.
Yes, IRX-2 and IRX 2 refer to the same investigational therapy developed by Ernexa Therapeutics Inc. (ticker: ERNA). The spelling without a hyphen is an alternative rendering of the same drug name used in searches and references to the Phase 2 oncology program.