Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 909 |
| INN | Bifikafusp alfa, Onfekafusp alfa |
| Status | Regulatory review |
| Drug code(s) | L19-IL2/L19-TNF, L19IL2/L19TNF, L19(scFv)-IL2/L19(scFv)2-TNF |
| Brand name | Nidlegy, Daromun |
| mAb sequence source | mAb human |
| General Molecular Category | Immunoconjugate, Immunocytokine, Mixture |
| Format, general category | Fragment fusion |
| Format details | scFv-IL2, scFv-TNF |
| Isotype (Fc) | None |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | IL-2, TNF |
| Discovery method/technology | Phage display-derived |
| Target(s) | Fibronectin EDB |
| Indications of clinical studies | Non-melanoma skin cancer, metastatic melanoma, Pancreatic Cancer, Solid Tumours |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Regulatory review EU |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2005 |
| Start of Phase 2 | September 15, 2012 |
| Start of Phase 3 | July 15, 2016 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Philogen S.p.A. |
| Licensee/Partner | Sun Pharma |
| Comments about company or candidate | June 4, 2024 - Philogen S.p.A. and Sun Pharmaceutical Industries Limited are pleased to announce the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy™, an investigational treatment for neoadjuvant (i.e., prior to surgery) locally advanced fully resectable melanoma. October 2023 - Philogen S.p.A. and Sun Pharmaceutical Industries Limited announce positive results from the Phase III PIVOTAL trial in patients with locally advanced fully resectable melanoma (NCT02938299) and intention to submit marketing applications. Phase 3 studies for: Soft tissue sarcoma (NCT04650984) is recruiting as December 23, 2022; melanoma (in combination with L19IL2) (NCT03567889 is recruiting as of April 10, 2023 and NCT02938299 is recruiting as of April 11, 2022) May 2023: Sun Pharma and Philogen enter into an Exclusive Distribution, License, and Supply Agreement for Commercializing specialty product, NIDLEGY™ in Europe, Australia and New Zealand. NCT04362722 combo with L19TNF started in Sep 2020 recruiting as of last update in April 2022. NCT03705403 Phase 2 trial is testing if the combination of stereotactic ablative body radiotherapy (SABR) and L19-IL2 improve the progression-free survival in patients with limited metastatic non-small cell lung cancer (NSCLC); non-commercial sponsors; recruitin as of Jan 2021. NCT02938299 Phase 3 Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients due for completion in Dec 2018 has unknown status as of Jan 2021: It is in a Phase I trial of darleukin + stereotactic body radiation therapy (SBRT) in Netherlands for the treatment of oligometastatic solid tumour. Phase 3 study of darleukin and fibromun Oked in Germany and Italy in December 2015, started in July 2016. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation status to Daromun for the treatment of melanoma stages IIb through IV. |
| Full address of company | Via Bellaria, 35 53018 Sovicille (SI) – ITALY Europe Italy https://www.philogen.com/contacts/ |
L19TNF component called Fibromun; L19IL2 component called Darleukin. Described in Weiss et al. Immunocytokines are a promising immunotherapeutic approach against glioblastoma (https://stm.sciencemag.org/content/12/564/eabb2311) Darleukin (L19-IL2) is an immunostimulatory compound consisting of the human vascular targeting antibody L19 and the human cytokine, interleukin 2 (http://www.philogen.com/en/products/pipeline/darleukin_9.html)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |