Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 911 |
| INN | Onfekafusp alfa |
| Status | Clinical |
| Drug code(s) | L19-TNF, L19TNF, L19(scFv)2-TNF |
| Brand name | Fibromun |
| mAb sequence source | mAb human |
| General Molecular Category | Immunoconjugate, Immunocytokine |
| Format, general category | Fragment fusion |
| Format details | scFv-TNF |
| Isotype (Fc) | None |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | TNF |
| Discovery method/technology | Phage display-derived |
| Target(s) | Fibronectin EDB, TNF |
| Indications of clinical studies | Glioblastoma, non-melanoma skin cancer, Glioma, soft tissue sarcoma, solid tumors; colorectal cancer; melanoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 01, 2007 |
| 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, Merck Sharp & Dohme |
| Comments about company or candidate | Oct 1 2024: Sun Pharmaceuticals and Philogen S.p.A. announced that they have entered into a global licensing agreement for commercializing Philogen’s specialty product, Fibromun (L19TNF). 16 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). 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. June 2022: Besides the Phase III trial of Nidlegy™ in Stage IIIB,C melanoma in Europe, Philogen is currently running six additional clinical studies with pivotal potential with Nidlegy™ and Fibromun, in Europe and in the United States.” June 26, 2020 I 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. A favorable opinion about the study has now also been obtained by EKOS (Ethics Committee of Eastern Switzerland). Patients enrolled in the clinical study will be treated with intralesional injections of NidlegyTM. NidlegyTM, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional neoadjuvant treatment of patients with resectable Stage III melanoma in two phase III clinical trials.Jan 2019: US Food and Drug Administration (FDA) has granted Orphan Drug Designation status to Fibromun for the treatment of soft tissue sarcoma. NCT03779230 Phase 1/2 study started in May 2019. Philogen lists that a pivotal clinical trial for Fibromun in combination with doxorubicin in metastatic soft tissue sarcoma has started in Europe and is about to start in the USA; NCT03420014 Phase 2 study (A Randomized Study Comparing the Efficacy of the Combination of Doxorubicin and the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF to Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma) started recruiting in Dec 2018. NCT03567889 Phase 3 study started in Sep 2018 (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). NCT02938299 Phase 3 study of darleukin and fibromun Oked in Germany and Italy in December 2015, started in July 2016; EudraCT Number: 2015-002549-72. NCT02938299 Phase 3 study still recruiting as of Sep 2018. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation status to Daromun for the treatment of melanoma stages IIb through IV. Daromun is the combination of darleukin and fibromun. |
| Full address of company | Via Bellaria, 35 53018 Sovicille (SI) – ITALY Europe Italy https://www.philogen.com/contacts/ |
L19TNF component called Fibromun; numerous studies in combination with 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)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |