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[{"orgOrder":0,"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group and Radius Health, Inc. Announce Publication of Elacestrant Pivotal Phase 3 EMERALD Clinical Trial Data in The Journal of Clinical Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"orgOrder":0,"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group and Radius Health, Inc. Present a Subgroup Analysis From the Elacestrant Pivotal Phase 3 EMERALD Clinical Trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group\u2019s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+\/HER2- Advanced or Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"orgOrder":0,"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group's Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+\/HER2- Advanced or Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"orgOrder":0,"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant\u2019s PFS Increases with Duration of Prior CDK4\/6i in ER+, HER2- in Metastatic Setting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"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":"Large molecule","graph2":"Philogen"},{"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":"Large molecule","graph2":"Philogen"},{"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":"Large molecule","graph2":"Philogen"},{"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":"Large molecule","graph2":"Philogen"},{"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":"Large molecule","graph2":"Philogen"},{"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":"Large molecule","graph2":"Philogen"},{"orgOrder":0,"company":"MolMed","sponsor":"AGC Biologics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"AGC to Complete the Acquisition of MolMed on July 31, 2020","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"MolMed"}]

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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 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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            RAD1901 (elacestrant) is an investigational selective estrogen receptor degrader (SERD). Preclinical studies indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

            Lead Product(s): Elacestrant

            Therapeutic Area: Oncology Product Name: RAD1901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 30, 2022

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            Elacestrant (RAD1901), if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union.

            Lead Product(s): Elacestrant

            Therapeutic Area: Oncology Product Name: RAD1901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Radius Health

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 19, 2022

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            Submission supported by results from pivotal Phase 3 EMERALD study of RAD1901 (elacestrant) showing statistically significant efficacy over current standard-of-care (SOC) medications for both overall study population and patients whose tumors harbor an ESR1 mutation.

            Lead Product(s): Elacestrant

            Therapeutic Area: Oncology Product Name: RAD1901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2022

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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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            Elacestrant (RAD1901), is an investigational selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer.

            Lead Product(s): Elacestrant

            Therapeutic Area: Oncology Product Name: RAD1901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Radius Health

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 06, 2022

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            Details:

            RAD1901 (elacestrant) is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer.

            Lead Product(s): Elacestrant

            Therapeutic Area: Oncology Product Name: RAD1901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 20, 2022

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            Details:

            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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