Oncology | Phase II/ Phase III Developments | UNITED STATES

Tyme Technologies

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TYME Announces Orphan Drug Designation for SM-88 as Potential Treatment for Patients with Pancreatic Cancer

Lead Product(s): Alpha-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 .

Tyme Technologies

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TYME Provides Business Update and Announces Preliminary First Quarter Fiscal 2021 Financial and Operating Results

Lead Product(s): Alpha-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.

MacroGenics

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MacroGenics Announces Lancet Oncology Publication of Margetuximab Data in Gastric Cancer

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.

Y-mAbs Therapeutics

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Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA

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.

DelMar Pharmaceuticals

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DelMar Pharmaceuticals Receives $500,000 Loan from the National Brain Tumor Society and National Foundation

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.

Tyme Technologies

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TYME Presents New Preclinical Data Supporting SM-88 Mechanism of Action at AACR 2020

Lead Product(s): Alpha-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.

MacroGenics

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MacroGenics Announces Margetuximab Granted Orphan Drug Designation in the U.S. for Gastric Cancer

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.

Tyme Technologies

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TYME Announces Abstracts Selected for Publication at the 2020 American Society of Clinical Oncology Annual Meeting

Lead Product(s): Alpha-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.

Tyme Technologies

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TYME Announces Abstracts Selected for Presentation at the American Association for Cancer Research, AACR 2020

Lead Product(s): Alpha-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 15, 2020

Details:

Preclinical data suggests multiple mechanisms of action for SM-88, including an increase in reactive oxygen species, alterations in autophagy and immunomodulation.

TG Therapeutics

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TG Therapeutics Receives Orphan Drug Designation for Umbralisib

Lead Product(s): Umbralisib,Ublituximab,Bendamustine

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 March 05, 2020

Details:

Both the MZL and FL cohorts of the UNITY-NHL trial met their primary endpoints .

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Tyme Technologies

TYME Announces Orphan Drug Designation for SM-88 as Potential Treatment for Patients with Pancreatic Cancer

Tyme Technologies

TYME Provides Business Update and Announces Preliminary First Quarter Fiscal 2021 Financial and Operating Results

MacroGenics

MacroGenics Announces Lancet Oncology Publication of Margetuximab Data in Gastric Cancer

Y-mAbs Therapeutics

Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA

DelMar Pharmaceuticals

DelMar Pharmaceuticals Receives $500,000 Loan from the National Brain Tumor Society and National Foundation

Tyme Technologies

TYME Presents New Preclinical Data Supporting SM-88 Mechanism of Action at AACR 2020

MacroGenics

MacroGenics Announces Margetuximab Granted Orphan Drug Designation in the U.S. for Gastric Cancer

Tyme Technologies

TYME Announces Abstracts Selected for Publication at the 2020 American Society of Clinical Oncology Annual Meeting

Tyme Technologies

TYME Announces Abstracts Selected for Presentation at the American Association for Cancer Research, AACR 2020

TG Therapeutics

TG Therapeutics Receives Orphan Drug Designation for Umbralisib