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Lead Product(s): 131I-omburtamab
Therapeutic Area: Oncology Product Name: 131I-8H9
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
Y-mAbs has received a Refusal to File letter from the U.S.FDA regarding the Biologics License Application for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, which was submitted in August 2020.
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Lead Product(s): Umbralisib
Therapeutic Area: Oncology Product Name: TGR-1202
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 13, 2020
Details:
U.S. FDA has accepted the Company’s New Drug Application (NDA) for umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL).
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Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
SM-88 has demonstrated encouraging tumor responses in 15 different cancers across four separate studies with minimal serious grade 3 or higher adverse events .
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Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2020
Details:
TYME-88-Panc pivotal trial enrolling patients using oral SM-88 as a potential treatment for third-line pancreatic cancer.
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Lead Product(s): Margetuximab,Retifanlimab,MGD013
Therapeutic Area: Oncology Product Name: MGAH22
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2020
Details:
Lancet Oncology has published results from a Phase 2 study of margetuximab plus pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive gastroesophageal adenocarcinoma (GEA) who have previously been treated with chemotherapy and trastuzumab.
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Lead Product(s): Omburtamab
Therapeutic Area: Oncology Product Name: 131I-8H9
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
Omburtamab is an investigational, mAb that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.
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Lead Product(s): Dianhydrogalactitol
Therapeutic Area: Oncology Product Name: VAL-083
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: National Brain Tumor Society
Deal Size: $0.5 million Upfront Cash: Undisclosed
Deal Type: Funding June 24, 2020
Details:
This loan aims to support VAL-083’s preparation for participation in the Global Coalition for Adaptive Research’s sponsored trial, Glioblastoma Adaptive Global Innovative Learning Environment study.
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Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
Oral SM-88 is designed to selectively disrupt cancer’s metabolic process and cause cancer cell death; SM-88 is currently in a pivotal trial for 3rd-line pancreatic cancer. Preclinical data shows statistically significant tumor reduction in SM-88 treated arms versus controls.
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Lead Product(s): Margetuximab,INCMGA00012,MGD013
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020
Details:
Margetuximab is currently being evaluated in the Phase 2/3 MAHOGANY clinical trial in combination with checkpoint inhibition, with/without chemotherapy, as a first-line treatment for patients with HER2-positive gastric cancer or gastroesophageal junction cancer.
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Lead Product(s): Methyltyrosine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2020
Details:
Lead pipeline investigational compound, SM-88, represents a new approach designed to selectively disrupt cancers metabolic process leading to cancer cell death SM-88 has demonstrated clinical responses in 15 different cancer types across four separate studies.
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