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...
IRX 2 is an investigational therapy being studied in oncology for breast cancer and squamous cell carcinomas of the head and neck and oral cavity. It is not approved for any indication and remains in clinical development. Its trials include triple negative breast cancer and newly diagnosed stage II, III, or IVA oral cavity cancer.
IRX 2 is being developed by Ernexa Therapeutics Inc., which trades under the ticker ERNA. The company is the sponsor of the clinical program evaluating IRX 2 in breast cancer and head and neck cancers.
IRX 2 is in Phase 2 clinical development. It has not received FDA approval and is considered investigational. The Phase 2 program includes studies in triple negative breast cancer and squamous cell carcinoma of the oral cavity and head and neck.
IRX 2 has been evaluated in three Phase 2 trials. NCT04373031 is an active, not recruiting study of pembrolizumab, IRX 2, and chemotherapy in triple negative breast cancer. NCT02609386 was a completed trial in newly diagnosed stage II, III, or IVA oral cavity cancer, and NCT00210470 was a completed trial in operable head and neck cancer.
Yes, IRX 2 and IRX-2 refer to the same investigational drug. The hyphenated spelling IRX-2 is an alternative name used for the same Ernexa Therapeutics development program in oncology.