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    [{"orgOrder":0,"company":"Byondis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Byondis Initiates Phase II Study of Antibody-Drug Conjugate [Vic-]Trastuzumab Duocarmazine in Advanced Endometrial Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Byondis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Byondis Initiates Phase I Study of Antibody-Drug Conjugate SYD1875","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Byondis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Byondis Initiates Phase I Study of ADC [Vic-]Trastuzumab Duocarmazine + Niraparib in HER2-Expressing Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Byondis","sponsor":"Syneos Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Byondis Intends to Bag Commercialisation Partner for Breast Cancer ADC by 2H21","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Byondis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Byondis Announces Positive Topline Results of Pivotal Phase III TULIP\u00ae Study in Patients With HER2-Positive Unresectable Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Byondis","sponsor":"Glycotope","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Byondis , Glycotope Enter Platform Access Agreement Discovery and Development","therapeuticArea":"Oncology","highestDevelopmentStatus":"Discovery Platform","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Discovery Platform"},{"orgOrder":0,"company":"Byondis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Byondis ESMO Late-Breaking Presentation Confirms ADC [Vic-] Trastuzumab Duocarmazine (SYD985) Superior to Physician's Choice in Pre-treated Locally Advanced or Metastatic HER2-Positive Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Byondis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Byondis' Biologics License Application for [Vic-] Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Byondis","sponsor":"Medac","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EMA Validates Marketing Authorization Application for Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Byondis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Byondis Initiates Phase I Study of Next Generation Antibody-Drug Conjugate BYON3521","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Byondis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. Food and Drug Administration Issues Complete Response Letter for Byondis' [Vic-]Trastuzumab Duocarmazine","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]

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              U.S. Food and Drug Administration Issues Complete Response Letter for Byondis' [Vic-]Trastuzumab Duocarmazine

              Details:

              SYD985 ([vic-]trastuzumab duocarmazine) is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).

              Lead Product(s): (vic-) Trastuzumab Duocarmazine

              Therapeutic Area: Oncology Product Name: SYD985

              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 May 15, 2023

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              Byondis Initiates Phase I Study of Next Generation Antibody-Drug Conjugate BYON3521

              Details:

              BYON3521.001 intends to evaluate safety, PK and preliminary efficacy of BYON3521 in up to 150 patients aged 18 or over with histologically confirmed c-MET-expressing, MET-amplified or MET-mutated (except exon 14 mutated) locally advanced or metastatic solid tumors.

              Lead Product(s): BYON3521

              Therapeutic Area: Oncology Product Name: BYON3521

              Highest Development Status: Phase I Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 25, 2022

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              EMA Validates Marketing Authorization Application for Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer

              Details:

              Antibody part of SYD985 (trastuzumab duocarmazine) binds to HER2 on surface of cancer cell and the ADC is internalized by cell. After proteolytic cleavage of linker, the inactive cytotoxin is activated and DNA damage is induced, resulting in tumor cell death.

              Lead Product(s): (vic-) Trastuzumab Duocarmazine

              Therapeutic Area: Oncology Product Name: SYD985

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Medac

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 18, 2022

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              FDA Accepts Byondis' Biologics License Application for [Vic-] Trastuzumab Duocarmazine (SYD985) in HER2-Positive Metastatic Breast Cancer

              Details:

              SYD985 ((vic-) trastuzumab duocarmazine) ,met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement of 2.1 months over PC. TULIP also demonstrated supportive overall survival (OS) results.

              Lead Product(s): (vic-) Trastuzumab Duocarmazine

              Therapeutic Area: Oncology Product Name: SYD985

              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 12, 2022

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              Byondis ESMO Late-Breaking Presentation Confirms ADC [Vic-] Trastuzumab Duocarmazine (SYD985) Superior to Physician's Choice in Pre-treated Locally Advanced or Metastatic H...

              Details:

              Pivotal Phase III TULIP® Study Showed [Vic-] Trastuzumab Duocarmazine (SYD985) Provided 2.1 month increase in progression-free survival compared to standard treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).

              Lead Product(s): Tastuzumab Duocarmazine

              Therapeutic Area: Oncology Product Name: SYD985

              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 September 19, 2021

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              Byondis , Glycotope Enter Platform Access Agreement Discovery and Development

              Details:

              Byondis has gained exclusive rights to evaluate and develop antibodies against selected novel GlycoTargets, with the option to in-license these antibodies for development as antibody-drug conjugates (ADCs). Specific financial terms have not been disclosed.

              Lead Product(s): Antibody-drug Conjugate

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Discovery Platform Product Type: Large molecule

              Recipient: Glycotope

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement July 27, 2021

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              Byondis Announces Positive Topline Results of Pivotal Phase III TULIP® Study in Patients With HER2-Positive Unresectable Breast Cancer

              Details:

              The Phase III TULIP study “SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer” met its primary endpoint of progression-free survival, demonstrating a statistically significant improvement over physician’s choice.

              Lead Product(s): Trastuzumab Duocarmazine

              Therapeutic Area: Oncology Product Name: SYD985

              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 June 08, 2021

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              Byondis Intends to Bag Commercialisation Partner for Breast Cancer ADC by 2H21

              Details:

              Byondis is drafting plans to pursue commercialisation partners for when results from its Phase III breast cancer antibody-drug conjugate study are released in 2Q21.

              Lead Product(s): Trastuzumab duocarmazine

              Therapeutic Area: Oncology Product Name: SYD985

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Syneos Health

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 16, 2020

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              Byondis Initiates Phase I Study of ADC [Vic-]Trastuzumab Duocarmazine + Niraparib in HER2-Expressing Solid Tumors

              Details:

              First patients have started treatment in a Phase I study of its investigational antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) in combination with niraparib in patients with a HER2-expressing locally advanced or metastatic solid tumor.

              Lead Product(s): Trastuzumab duocarmazine,Niraparib Tosylate

              Therapeutic Area: Oncology Product Name: SYD985

              Highest Development Status: Phase I Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 25, 2020

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              Byondis Initiates Phase I Study of Antibody-Drug Conjugate SYD1875

              Details:

              The First-in-Human Dose-Escalation and Expansion Study with the Antibody-Drug Conjugate SYD1875 will evaluate the safety, pharmacokinetics and preliminary efficacy of SYD1875 in patients with 5T4-expressing.

              Lead Product(s): SYD1875

              Therapeutic Area: Oncology Product Name: SYD1875

              Highest Development Status: Phase I Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 11, 2020

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