Drugs / TB-403
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02748135 | May 2016 → Oct 2020 | embryonal neoplasm | Oncurious NV | Completed | No outcome recorded |
| Phase 1 | NCT01308684 | May 2011 → Feb 2013 | glioblastoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01308723 | Mar 2011 → Jan 2012 | hepatocellular carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01148758 | May → Sep 2010 | colorectal cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00702494 | Jun 2008 → Sep 2009 | cancer | BioInvent International AB | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT03669393 | Sep 2018 → Nov 2019 | macular telangiectasia type 1, retinal telangiectasia | ThromboGenics | Completed | No outcome recorded |
| Phase 2 | NCT03499223 | Apr 2018 → Jul 2019 | diabetes mellitus, diabetic macular edema | Oxurion | Completed | No outcome recorded |
| Phase 2 | NCT03071068 | Dec 2016 → Apr 2018 | diabetic macular edema | ThromboGenics | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2021-04-12 | BioInvent International AB | Results BioInvent's partner Oncurious NV presents Phase I data on TB-403 in pediatric cancer bioinvent.com ↗
The conclusion from the phase I study is that the results warrant further evaluation of TB-403 in pediatric subjects with relapsed or refractory medulloblastoma (MB). |
| 2019-08-20 | BioInvent International AB | Results BioInvent's partner Oxurion NV has reported topline month 3 results of Phase lla Study Evaluating THR-317 (anti-PLGF), in Combination with Ranibizumab, for DME bioinvent.com ↗
Combination therapy did not show increase in best corrected visual acuity (BCVA) in the overall population at Month 3. |
| 2019-08-20 | ThromboGenics | Results Oxurion NV Reports Topline Month 3 Results of Phase 2a Study Evaluating THR-317 (anti-PLGF), in Combination with Ranibizumab, for DME oxurion.com ↗
At Month 3, no improvement was observed in mean BCVA with the combination therapy when compared to ranibizumab monotherapy in the overall population. |
| 2019-06-06 | ThromboGenics | Results Oxurion NV – Data from Phase 1/2 Clinical Study evaluating THR-317 (anti-PlGF) for DME presented at 2019 FLORetina Meeting oxurion.com ↗ |
| 2018-07-19 | BioInvent International AB | Results BioInvent's partner ThromboGenics reports Day 150 topline data from phase l/ll study of THR-317 in patients with Diabetic Macular Edema bioinvent.com ↗
The study met its primary endpoint of safety for both the 4 mg and 8 mg doses. |
| 2018-07-19 | ThromboGenics | Results ThromboGenics Reports Day 150 Topline Data from its Phase 1/2 Clinical Study evaluating THR-317 (anti-PlGF) for the Treatment of Diabetic Macular Edema (DME) oxurion.com ↗
Study results confirm safety and tolerability of THR-317 for intra-ocular use, and show improvement in visual acuity for up to 90 days after last injection |
| 2018-04-04 | BioInvent International AB | Results BioInvent's partner ThromboGenics presents initial data from a Phase l/ll study of THR-317 in patients with Diabetic Macular Edema bioinvent.com ↗
ThromboGenics also announced that 30 % of the anti-VEGF treatment naive study subjects treated with THR-317 in the 8 mg group showed ≥ 15 letter gain from baseline at Day 90 versus 5.3 % in the 4 mg group. |
| 2018-04-04 | ThromboGenics | Results ThromboGenics Reports Initial Data from its Clinical Study evaluating THR-317 for the Treatment of Diabetic Macular Edema (DME) oxurion.com ↗
THR-317 was safe and well tolerated. |
| 2016-01-07 | BioInvent International AB | Regulatory BioInvent announces FDA acceptance of the Investigational New Drug application for the phase I/IIa study with TB-403 bioinvent.com ↗ |
| 2013-02-28 | BioInvent International AB | Results New Paper in Cell highlights the potential role of TB-403 (anti-PlGF) in the treatment of medulloblastoma, a pediatric brain tumor bioinvent.com ↗
The Cell publication highlights for the first time a new mechanism of action, showing that PlGF plays a vital role in the brain and that its expression is required for the growth and spread of medulloblastoma. |
| 2009-11-16 | BioInvent International AB | Results BioInvent and ThromboGenics Complete Phase I Patient Trial of Anti-PlGF Cancer Therapeutic TB-403 in Patients with Advanced Solid Tumours bioinvent.com ↗
Lund, Sweden and Leuven, Belgium - 16 November 2009 - BioInvent International AB (OMXS: BINV) and ThromboGenics NV (Euronext Brussels: THR) today announced positive results from a Phase I trial of their novel anti-cancer monoclonal antibody TB-403 in patients with advanced solid tumours. |
| 2008-06-03 | BioInvent International AB | Results BioInvent and ThromboGenics report positive Phase I results for anti-PlGF cancer therapeutic TB-403 bioinvent.com ↗
The results of the trial have shown that TB-403 met both primary endpoints regarding safety and tolerability, and secondary endpoints examining pharmacokinetics. |
| 2008-01-18 | BioInvent International AB | Regulatory BioInvent and ThromboGenics Receive Approval to Begin Clinical Trials of TB-403 for the Treatment of Cancer bioinvent.com ↗
BioInvent International AB (Nordic Exchange: BINV) and co-development partner ThromboGenics NV (Euronext Brussels: THR) announce today that they have received approval from the regulatory authorities in Denmark to initiate a Phase I clinical trial of the novel anti-cancer agent TB-403. |
All press releases naming this drug 32 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TB-403 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02748135 ↗ |
| Known as | RG-7334 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2109545 ↗ |
| Known as | RO5323441 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01148758 ↗ |
| Known as | THR-317 | “3 intravitreal injections of THR-317 4mg approximately 1 month apart” NCT03071068 ↗ |
| Action | Inhibit | “The antibody binds to PlGF and inhibits the binding to it's receptor, VEGF-1.” NCT00702494 ↗ |
| Modality | Monoclonal antibody | “TB-403 (humanized monoclonal antibody against placental growth factor (PlGF))” NCT02748135 ↗ |
| Route | Intravenous | “multiple intravenous doses of TB-403” NCT00702494 ↗ |
| Target | PGF | “anti-PlGF recombinant monoclonal antibody, 4mg dose” NCT03071068 ↗ |