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Find Oncology Drugs in Phase II/III Clinical Development in UNITED STATES

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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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