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Via Bellaria, 35, 53018 Sovicille (SI)
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(+39) 0577.1781.6
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L19TNF (onfekafusp alfa) is a homotrimer that forms from engineered peptides for the L19 antibody in scFv format fused to human TNF. It is being evaluated in combination with doxorubicin for the treatment of first-line advanced or metastatic soft tissue sarcoma.


Lead Product(s): Onfekafusp Alfa,Doxorubicin Hydrochloride

Therapeutic Area: Oncology Product Name: L19TNF

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 20, 2024

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Nidlegy (bifikafusp alfa & onfekafusp alfa) is designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF which are manufactured independently, and which are mixed prior to intralesional administration.


Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 16, 2023

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Under the supply agreement, MSD provides their anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), to be evaluated in combination with Philogen's immunocytokines L19IL2, L19TNF, and Nidlegy (bifikafusp alfa) in a randomized Phase II clinical trial in unresectable melanoma patients.


Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa,Pembrolizumab

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: UndisclosedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Merck & Co

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 01, 2023

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Under the agreement, Sun Pharma will have exclusive rights to commercialise Nidlegy (bifikafusp alfa), a new anti-cancer biopharmaceutical, being developed by Philogen for melanoma and non-melanoma skin cancers, in the territories of Europe, Australia and New Zealand.


Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 30, 2023

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L19TNF is a fully-human immunomodulatory product consisting of the L19 antibody and TNF. The L19 antibody is specific to the EDB domain of fibronectin and mediates selective localization of TNF to the site of disease while sparing healthy organs.


Lead Product(s): Fibromun,Lomustine

Therapeutic Area: Oncology Product Name: L19TNF

Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: University Hospital Zürich

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 24, 2023

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Nidlegy (bifikafusp alfa) is combination of the immunocytokines L19IL2 and L19TNF, which is being developed as intralesional treatment for patients with advanced locoregional melanoma and non-melanoma skin cancers.


Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 25, 2022

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Nidlegy™, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional treatment of patients with advanced melanoma and in BCC and cSCC in an ongoing Phase II study.


Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 17, 2022

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Nidlegy, as a neoadjuvant was found to be well-tolerated and 149 out of the anticipated 214 patients have been safely treated in PIVOTAL phase III trial in melanoma patients with locally advanced, fully resectable metastatic cancer.


Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2022

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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.


Lead Product(s): L19TNF

Therapeutic Area: Oncology Product Name: Fibromun

Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 08, 2020

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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. Patients enrolled in the study will be treated with intralesional injections of NidlegyTM.


Lead Product(s): Bifikafusp alfa,Onfekafusp alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 26, 2020

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