Drugs / PBA-0405
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | solid adenocarcinoma with mucin production | 2023-11-21 | “We have applied to the U.S. Food and Drug Administration (FDA) for approval to test molecule PBA-0405 (exploratory Investigational New Drug; eIND)” multiqure.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 0 | NCT06273852 | Apr 2024 → Mar 2025 | head and neck squamous cell carcinoma, soft tissue sarcoma, triple-negative breast carcinoma | Pure Biologics S.A. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-02-26 | Pure Biologics S.A. | Results Pure Biologics achieves key milestone with successful completion of Phase 0 study for PBA-0405 in cancer treatment multiqure.com ↗
Pure Biologics today announced the successful completion of its Phase 0 clinical study for the novel cancer therapy, PBA-0405. |
| 2023-12-22 | Pure Biologics S.A. | Regulatory PB004 project – the FDA approval to proceed with Phase 0 clinical trial multiqure.com ↗
Pure Biologics has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase 0 clinical trial in Project PB004 for the PBA-0405 molecule. |
| 2023-11-21 | Pure Biologics S.A. | Regulatory eIND submission for the PB004 project and further development of PB003G towards Phase 0 multiqure.com ↗
We have applied to the U.S. Food and Drug Administration (FDA) for approval to test molecule PBA-0405 (exploratory Investigational New Drug; eIND), the lead candidate in project PB004 in a Phase 0 clinical trial in patients with solid tumors. |
| 2023-07-31 | Pure Biologics S.A. | Results PB004 project – efficacy and safety confirmed in in vivo models multiqure.com ↗
A preclinical proof-of-concept (PoC) was obtained for candidate PBA-0405 based on its ability to inhibit tumor growth in a human tumor model containing a molecular target (ROR-1). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-02-26 | Pure Biologics S.A. | Pure Biologics achieves key milestone with successful completion of Phase 0 study for PBA-0405 in cancer treatment multiqure.com ↗ |
| 2023-12-22 | Pure Biologics S.A. | PB004 project – the FDA approval to proceed with Phase 0 clinical trial multiqure.com ↗ |
| 2023-11-21 | Pure Biologics S.A. | eIND submission for the PB004 project and further development of PB003G towards Phase 0 multiqure.com ↗ |
| 2023-07-31 | Pure Biologics S.A. | PB004 project – efficacy and safety confirmed in in vivo models multiqure.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PBA-0405 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06273852 ↗ |
| Route | Other | “PBA-0405 when administered intratumorally in microdose quantities via the CIVO device” NCT06273852 ↗ |