Drugs / Onfekafusp alfa
Onfekafusp alfa
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05304663 | Jun 2022 → Dec 2024 | glioblastoma | Philogen S.p.A. | Withdrawn | No outcome recorded |
| Phase 1 | NCT04032964 | Sep 2019 → Dec 2024 | soft tissue sarcoma | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04573192 | Feb 2021 → Mar 2025 | glioblastoma | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04443010 | Jan 2021 → Oct 2026 expected | glioblastoma | Philogen S.p.A. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03779230 | May 2019 → Jun 2023 | brain glioma | Philogen S.p.A. | Completed | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT07227350 | Jun 2026 → Feb 2031 expected | skin basal cell carcinoma | Philogen S.p.A. | Recruiting | No outcome recorded |
| Phase 2 | NCT07228442 | Feb 2026 → Feb 2031 expected | skin squamous cell carcinoma | Philogen S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07227870 | Feb 2026 → Feb 2031 expected | skin basal cell carcinoma | Philogen S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07120984 | Jan 2026 → Jan 2029 expected | glioma | Philogen S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06284590 | Jul 2024 → Jul 2028 expected | melanoma | Philogen S.p.A. | Recruiting | No outcome recorded |
| Phase 2 | NCT06336291 | May 2024 → Jun 2026 overdue | glioblastoma | Philogen S.p.A. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05329792 | Mar 2023 → Jun 2024 | Kaposi's sarcoma, cutaneous neuroendocrine carcinoma, keratoacanthoma, primary cutaneous T-cell lymphoma +3 | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 2 | NCT04362722 | Sep 2020 → Sep 2024 | basal cell carcinoma, skin squamous cell carcinoma | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 2 | NCT04733183 | Aug 2020 → Dec 2025 overdue | soft tissue sarcoma | Philogen S.p.A. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03420014 | Dec 2018 → Dec 2024 | leiomyosarcoma | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 2 | NCT02076633 | Dec 2012 → May 2015 | cutaneous melanoma | Philogen S.p.A. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT04650984 | Nov 2017 → Dec 2025 | soft tissue sarcoma | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 3 | NCT02938299 | Jul 2016 → Oct 2024 overdue | melanoma | Philogen S.p.A. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-06-24 | Philogen S.p.A. | Regulatory Philogen Provides Update on Marketing Authorization Application for Nidlegy™ in the European Union philogen.com ↗
After careful consideration of the feedback and ongoing dialogue with EMA, we have decided to withdraw the MAA for Nidlegy™ and resubmit an updated application, in view of the potential of the product in melanoma and beyond. |
| 2025-06-24 | Sun Pharmaceutical Industries, Inc. | Regulatory Philogen Provides Update on Marketing Authorization Application for Nidlegy™ in the European Union sunpharma.com ↗ |
| 2024-07-04 | Philogen S.p.A. | Regulatory Submission of NidlegyTM Marketing Authorization Application Validated by EMA philogen.com ↗
The first marketing authorization application of Nidlegy™ for the treatment of locally advanced fully resectable melanoma was submitted on June 3rd and validated by EMA on June 20 |
| 2024-06-04 | Philogen S.p.A. | Regulatory Richiesta di autorizzazione all’immissione in commercio per il prodotto Nidlegy™ sottomessa all’EMA philogen.com ↗
sono liete di annunciare la sottomissione di una richiesta di autorizzazione all'immissione in commercio (AIC) all'Agenzia Europea per i Medicinali (EMA) per l'approvazione del prodotto Nidlegy™ |
| 2024-06-04 | Philogen S.p.A. | Regulatory Nidlegy™ Marketing Authorization Application Submitted to EMA philogen.com ↗
Nidlegy™ Marketing Authorization Application Submitted to EMA |
| 2024-06-04 | Sun Pharmaceutical Industries, Inc. | Regulatory Press Release Nidlegy™ Marketing Authorization Application Submitted to EMA sunpharma.com ↗
Nidlegy™ Marketing Authorization Application Submitted to EMA |
| 2024-02-20 | Philogen S.p.A. | Results Philogen provides update on pre-planned interim analysis of the Phase III FIBROSARC trial investigating Onfekafusp alfa (L19TNF) in patients with first-line advanced or metastatic Soft Tissue Sarcoma philogen.com ↗
An Independent Data and Safety Monitoring Board reviewed safety and efficacy data of the pre-planned interim analysis and recommended continuing the study as planned by the protocol. |
| 2024-02-20 | Philogen S.p.A. | Results Philogen fornisce un aggiornamento sull’analisi ad interim prevista dallo studio di Fase III FIBROSARC che valuta Onfekafusp alfa (L19TNF) in pazienti con Sarcoma dei tessuti molli, in stato avanzato o metastatico, in prima linea. philogen.com ↗
Un comitato indipendente di monitoraggio dei dati e della sicurezza ha esaminato i dati di sicurezza e di efficacia dell’analisi “ad interim” prevista dal Protocollo e ha raccomandato di continuare la sperimentazione come da Protocollo. |
| 2023-10-16 | Philogen S.p.A. | Results Nidlegy™ Phase III PIVOTAL trial meets the study’s primary objective in patients with locally advanced fully resectable melanoma (Price Sensitive) philogen.com ↗
Intratumoral Nidlegy™ followed by surgery significantly improved the Recurrence-Free Survival compared to surgery alone |
| 2023-10-16 | Sun Pharmaceutical Industries, Inc. | Results Nidlegy™ Phase III PIVOTAL trial meets the study’s primary objective demonstrating statistically significant and clinically meaningful improvement in Recurrence-Free Survival for patients with locally advanced fully resectable melanoma sunpharma.com ↗
Nidlegy™ Phase III PIVOTAL trial meets the study’s primary objective demonstrating statistically significant and clinically meaningful improvement in Recurrence-Free Survival for patients with locally advanced fully resectable melanoma |
| 2023-05-26 | Philogen S.p.A. | Results Philogen Publishes New Data on a Fibromun-based treatment combination in Science Translational Medicine in collaboration with the University Hospital Zürich philogen.com ↗
The study demonstrated that the combination Fibromun and lomustine was highly synergistic and relied on an intact immune system. |
| 2022-02-17 | Philogen S.p.A. | Regulatory Philogen receives authorisation to initiate new study in France to evaluate Nidlegy™ in several non-melanoma skin cancers philogen.com ↗
France’s National Agency for the Safety of Medicines and Health Products (ANSM) has authorized the Company to run a Phase II study of Nidlegy™ in patients affected by different non - melanoma skin cancer indications. |
| 2021-07-02 | Philogen S.p.A. | Results Philogen Announces R&D Program Update philogen.com ↗ |
| 2020-10-08 | Philogen S.p.A. | Results Philogen announces publication of malignant brain tumor study results in Science Translational Medicine philogen.com ↗
The findings of the study show how Philogen’s proprietary antibody-cytokine fusions , called immunocytokines, demonstrated striking single-agent anti -cancer activity in immunocompetent preclinical models bearing orthotopic glioblastoma. |
| 2020-06-26 | Philogen S.p.A. | Regulatory Philogen received clinical trial authorisation with NIDLEGYTM in nonmelanoma skin cancer philogen.com ↗
Philogen S.p.A., a privately -owned biotechnology company, is pleased to announce that the Swiss national competent authority Swissmedic issued the authorization to run a clinical phase II study in patients with locally-advanced, not metastatic nonmelanoma skin cancer. |
| 2020-06-24 | Philogen S.p.A. | Regulatory Philogen received combination pack approval for NidlegyTM philogen.com ↗
NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an appli cation for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004. |
| 2017-10-12 | Philogen S.p.A. | Regulatory Philogen announces authorization from FDA of a pivotal registration trial in USA for the treatment of resectable melanoma philogen.com ↗
Philogen S.p.A. (www.philogen.com), a privately owned biotechnology company, today announced approval by Food and Drugs Administration (FDA) of an IND for a Phase 3 registration trial with investigational melanoma drug DAROMUN (L19IL2 + L19TNF). |
| 2016-10-28 | Philogen S.p.A. | Regulatory The European Commission (EC) has granted Orphan Drug Designation to L19TNF philogen.com ↗
Philogen S.p.A. announced that the European Commission (EC) has granted Orphan Drug Designation to L19TNF for the treatment of soft-tissue sarcoma. |
All press releases naming this drug 21 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Onfekafusp alfa | “Drug: onfekafusp alfa” NCT04733183 ↗ |
| Known as | Fibromun | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298007 ↗ |
| Known as | L19TNF | “L19TNF is a fully human fusion protein consisting of human tumor necrosis factor (TNF)-α fused to the L19 antibody in scFv format, specific to the extra-domain B of fibronectin.” NCT04573192 ↗ |
| Known as | Onfekafusp alfa component of daromun l19tnf | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298007 ↗ |
| Modality | Protein / enzyme biologic | “L19TNF is a recombinant fusion protein” NCT02076633 ↗ |
| Route | Other | “intratumoral injections” NCT02076633 ↗ |