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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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2023
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 IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2022
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Medac
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2022
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2021
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 PlatformProduct Type: Large molecule
Recipient: Glycotope
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 27, 2021
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2021
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Syneos Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2020
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 IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2020
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 IProduct 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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