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[{"orgOrder":0,"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Received Clinical Trial Authorisation With Nidlegy in Nonmelanoma Skin Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Announces Publication of Malignant Brain Tumor Study Results in Science Translational Medicine","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Receives Authorisation to Initiate New Study in France to Evaluate Nidlegy\u2122 in Several Nonmelanoma Skin Cancers","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Announces the Completion of A Second Interim Analysis of Its Phase III Clinical Program with Nidlegy for The Treatment of Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Announces Enrolment of 214 Patients in the Nidlegy\u2122 Phase III European Clinical Trial For the Treatment of Locally Advanced Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Philogen","sponsor":"University Hospital Z\u00fcrich","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Publishes New Data on A Fibromun-Based Treatment Combination in Science Translational Medicine in Collaboration with The University Hospital Zurich","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Philogen","sponsor":"Sun Pharmaceutical Industries Limited","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sun Pharma and Philogen Sign Licence Agreement for Anti-Cancer Therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Philogen","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Philogen Announces Clinical Trial Collaboration with MSD","therapeuticArea":"Oncology","highestDevelopmentStatus":"Undisclosed","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nidlegy\u2122 Phase III PIVOTAL Trial Meets the Study\u2019s Primary Objective in Patients with Locally Advanced Fully Resectable Melanoma (Price Sensitive)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"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","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]

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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 III Product 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 III Product 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: Undisclosed Product 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 III Product 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 II Product 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 III Product 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 III Product 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 III Product 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 II Product 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 II Product 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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