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Details:
Xevinapant (formerly known as Debio 1143) is an investigational first-in-class potent oral small-molecule IAP (inhibitor of apoptosis protein) inhibitor for the treatment of LA SCCHN.
Lead Product(s): Xevinapant
Therapeutic Area: Oncology Product Name: Debio 1143
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
Xevinapant is the first Inhibitor of Apoptosis Proteins antagonist with FDA Breakthrough Therapy Designation for previously untreated locally advanced squamous cell carcinoma of the head and neck, in combination with current standard of care.
Lead Product(s): Xevinapant,Cisplatin
Therapeutic Area: Oncology Product Name: Debio 1143
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck Group
Deal Size: $1,070.0 million Upfront Cash: $224.4 million
Deal Type: Collaboration March 01, 2021
Details:
The clinical trial is being conducted to demonstrate the superior efficacy of xevinapant vs. placebo when added to CRT in high risk head and neck patients including those affected in the throat and vocal chords (oropharynx -HPV-negative, hypopharynx and larynx).
Lead Product(s): Xevinapant,Cisplatin,Radiotherapy
Therapeutic Area: Oncology Product Name: Debio 1143
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2020
Details:
The virtual late breaking abstract presentation of the 3-year update for the xevinapant phase II study in high-risk previously untreated locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) patients, will be Presented at ESMO Virtual Congress 2020.
Lead Product(s): Xevinapant,Cisplatin,Radiotherapy
Therapeutic Area: Oncology Product Name: Debio 1143
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
Debio 1143 with CRT showed a statistically and clinically significant improvement in Overall Survival (OS) vs. the control group, suggesting a halving of the risk of mortality.
Lead Product(s): Xevinapant,Cisplatin,Radiotherapy
Therapeutic Area: Oncology Product Name: Debio 1143
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 13, 2020
Details:
The FDA decision was based on the compelling magnitude of the clinically phase II findings in combination with chemo-radiotherapy presented in September 2019 at the ESMO congress.
Lead Product(s): Xevinapant,Cisplatin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2020
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