Associated tags: Glioblastoma, PDAC, Cancer, Pharmaceutical industry, Research, Clinical trial, South Texas Medical Center, MD Anderson Cancer Center, Cooper University Hospital, Viral, Neurosurgery, Immunology, Person, Texas Medical Center, Immune system, Survival, Fast Track, Associate, Assistant, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Injection, Baylor University, University of Arizona College of Medicine – Phoenix, Patient
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Pharmaceutical industry Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today it has completed enrollment for its Phase 1 trial of DOC1021, a unique dendritic cell vaccine, for Glioblastoma Multiforme (GBM).
Key Points:
- Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today it has completed enrollment for its Phase 1 trial of DOC1021, a unique dendritic cell vaccine, for Glioblastoma Multiforme (GBM).
- With the first patient enrolled in October 2021, DOC1021 has been administered to 16 patients across four dose levels.
- To date, DOC1021 appears to be very safe and well tolerated as there have been no attributable serious adverse events observed from DOC1021.
- In addition to the Phase 1 trial of DOC1021 for GBM ( NCT04552886 ), the company has two other vaccines in clinical development for pancreatic cancer ( NCT04157127 ) and angiosarcoma ( NCT05799612 ).
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Monday, November 20, 2023
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Pharmaceutical industry Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today that Ian H. Bellayr, Ph.D., a regulatory expert with the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH), has joined the company as its Chief Regulatory Officer.
Key Points:
- Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today that Ian H. Bellayr, Ph.D., a regulatory expert with the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH), has joined the company as its Chief Regulatory Officer.
- Bellayr's regulatory expertise arrives at a crucial time for Diakonos as we conclude our Phase 1 glioblastoma trial,” said Mike Wicks, Chief Executive Officer of Diakonos.
- “Diakonos has a unique technology that allows for a personalized cell therapy that is unbiased in its potential to effectively treat multiple indications.
- Diakonos’ lead dendritic cell vaccine, DOC 1021, is in Phase 1 trials in the U.S. for glioblastoma ( NCT04552886 ).
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Tuesday, October 17, 2023
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Vaccine Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s unique dendritic cell vaccine, DOC1021.
Key Points:
- Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s unique dendritic cell vaccine, DOC1021.
- The designation was based on positive preliminary safety and efficacy data from a Phase 1 clinical trial enrolling patients with glioblastoma multiforme (GBM).
- FDA Fast Track designation is intended to speed development and review of drugs that show early clinical promise in treating severe or life-threatening conditions.
- This pivotal designation can help propel Diakonos closer to delivering DOC1021 to GBM patients, of which only 7% survive more than five years.
