drugset
Drugs / AGI-134
last change Dec 2023 re-read 3 minutes ago

AGI-134

Investigated by
Agalimmune Ltd.

Trials 1

today NCT03593226 · Ph 1/2
20192020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT03593226 Nov 2018 → Dec 2023 — Agalimmune Ltd. Completed Met primary

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2023-03-22 BioLineRx, Ltd. Results BioLineRx Reports 2022 Financial Results and Recent Corporate and Portfolio Updates biolinerx.com ↗
First-in-human, single-agent study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers.
2022-12-20 BioLineRx, Ltd. Results BioLineRx Announces Results from Phase 1/2a Study of Investigational Anti-Tumor Vaccine AGI-134 in Metastatic Solid Tumors biolinerx.com ↗
2019-09-03 BioLineRx, Ltd. Results BioLineRx Successfully Completes Dose-Escalation Part of Phase 1/2a Clinical Study for AGI-134, a Novel Immunotherapy for Treatment of Solid Tumors biolinerx.com ↗
AGI-134 was found to be safe and well tolerated, with no serious drug-related adverse events or dose-limiting toxicities reported.
2019-05-07 BioLineRx, Ltd. Regulatory BioLineRx Announces FDA Approval of IND Application for AGI-134, a Novel Immunotherapy Anti-Cancer Vaccine for Solid Tumors biolinerx.com ↗
2018-11-20 BioLineRx, Ltd. Regulatory BioLineRx Announces Receipt of FDA Biological Product Designation for Novel Cancer Immunotherapy Candidate AGI-134 biolinerx.com ↗
2018-03-26 BioLineRx, Ltd. Regulatory BioLineRx Announces Notice of Allowance From USPTO for Patent Covering AGI-134 - a Novel Immunotherapy for Treating Solid Tumors biolinerx.com ↗
2018-01-23 BioLineRx, Ltd. Results BioLineRx Reports Data at ASCO-SITC Conference Showing Complete Tumor Regression by AGI-134 in Pre-Clinical Studies biolinerx.com ↗
In the two models, there was complete tumor regression in 50% and 67%, respectively, of mice treated with AGI-134.

All press releases naming this drug 11 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as AGI-134 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03593226 ↗
Route Other “25 mg AGI-134 (1 mL) via intratumor injection.” NCT03593226 ↗