Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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[{"orgOrder":0,"company":"Senhwa Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Senhwa Biosciences Receives US FDA \u2018Study May Proceed\u2019 Letter to Treat BRCA2+ or PALB2+ Solid Tumors With CX-5461","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"TAIWAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Senhwa Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Senhwa Begins Patient Dosing Phase 1b Expansion Study of Pidnarulex to Treat Solid Tumors with HR Gene Mutations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"TAIWAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Senhwa Biosciences","sponsor":"Peter MacCallum Cancer Centre","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Senhwa\u2019s Pidnarulex to Combined With Pfizer\u2019s Talazoparib in a Clinical Trial for the Treatment of Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"TAIWAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Senhwa Biosciences","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Senhwa's Pindnarulex in Combination Study with Pfizer's Talazoparib for the Treatment of Prostate Cancer Granted Approval to Initiate from Australian HREC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"TAIWAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Senhwa Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Senhwa Announces First Patient Successfully Dosed in Phase I Study of Pindnarulex in Combination with Pfizer's Talazoparib for the Treatment of Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"TAIWAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"}]

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            CX-5461 (pidnarulex) stabilizes the DNA G-quadruplexes of cancer cells which leads to disruption of the cell's replication fork. Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1/2 and PALB2 mutations.

            Lead Product(s): Pidnarulex,Talazoparib

            Therapeutic Area: Oncology Product Name: CX-5461

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 31, 2022

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            CX-5461 (Pidnarulex) demonstrated clinically significant and persist benefits in patients with specific tumor biomarkers, such as BRCA1/2, and PALB2 mutations, and who had been exposed to platinum and other chemotherapeutics.

            Lead Product(s): Pidnarulex,Talazoparib

            Therapeutic Area: Oncology Product Name: CX-5461

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 06, 2022

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            Pidnarulex synthetically derived small molecule in combination with Talazoparib (PARP inhibitor), potential therapy in patients with metastatic castration-resistant prostate cancer.

            Lead Product(s): Pidnarulex,Talazoparib

            Therapeutic Area: Oncology Product Name: CX-5461

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Peter MacCallum Cancer Centre

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2021

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            In a previous phase 1 trial, Pidnarulex demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers, such as BRCA1/2, and PALB2 mutations and that were also resistant to platinum and other chemotherapeutics.

            Lead Product(s): Pidnarulex

            Therapeutic Area: Oncology Product Name: CX-5461

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 10, 2021

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            In the CCTG Trial, CX-5461 demonstrated clinically significant and lasting benefits in patients with specific tumor biomarkers that were resistant to platinum and other chemotherapeutics.

            Lead Product(s): Pidnarulex

            Therapeutic Area: Oncology Product Name: CX-5461

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 24, 2020

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