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Lead Product(s): N-803,BCG Vaccine
Therapeutic Area: Oncology Product Name: Anktiva
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: NantKwest
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger December 21, 2020
Details:
The combination of NantKwest’s Natural Killer (NK) cell platform and ImmunityBio’s immunotherapy fusion protein, immunomodulator, and adenovirus platforms have already resulted in complete responses in late stage, difficult to treat metastatic cancers.
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Lead Product(s): ARX788
Therapeutic Area: Oncology Product Name: ARX788
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: NovoCodex
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2020
Details:
Patients who failed prior Kadcyla® (T-DM1) or Enhertu® (DS-8201a) achieved clinical responses, as assessed by RECIST v1.1 in the ACE-Pan Tumor-01 (ARX788-1711) tria.
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Lead Product(s): Nivolumab,Oxaliplatin,Tegafur
Therapeutic Area: Oncology Product Name: Opdivo
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 December 10, 2020
Details:
The supplemental application for approval for Opdivo® has been filed based on the data from the following 2 clinical studies: CheckMate -649 study (ONO-4538-44) and ATTRACTION-4 study (ONO-4538-37.
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Lead Product(s): Selinexor
Therapeutic Area: Oncology Product Name: Xpovio
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 November 20, 2020
Details:
Twice-Weekly XPOVIO® (selinexor) Demonstrates a Statistically Significant Improvement in Median PFS in Patients with Advanced Unresectable Dedifferentiated Liposarcoma Following at Least Two Prior Therapies.
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Lead Product(s): Margetuximab,Retifanlimab,Capecitabine
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 October 06, 2020
Details:
MAHOGANY is a Phase 2/3 clinical trial in two modules designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GC/GEJ.
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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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