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Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"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":"Preclinical","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"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 II","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"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":"Preclinical","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Philogen","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Philogen Announces Clinical Trial Collaboration with MSD","therapeuticArea":"Oncology","highestDevelopmentStatus":"N\/A","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"N\/A"},{"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":"Preclinical","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"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":"Preclinical","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Philogen","sponsor":"Sun Pharmaceutical Industries Limited","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen and Sun Pharma seek EMA approval for melanoma therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 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Find Clinical Drug Pipeline Developments & Deals by Philogen
Announced the filing of a marketing authorisation application with the European Medicines Agency for Nidlegy, an investigational neoadjuvant therapy, for locally advanced, fully resectable melanoma.
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.
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.
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
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.
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.
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.
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.
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.
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.