Diakonos Oncology Receives FDA Fast Track Designation for Pancreatic Cancer Dendritic Cell Vaccine; Names Daniel D. Von Hoff, M.D. to Scientific Advisory Board
2024年7月15日 - 6:30PM
ビジネスワイヤ(英語)
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 (DCV) for pancreatic
ductal adenocarcinoma. In addition, the company has named to its
Scientific Advisory Board, Daniel D. Von Hoff, M.D., Distinguished
Professor at the Translational Genomics Research Institute (TGen)
in Phoenix, AZ, and City of Hope, and an experienced investigator
against pancreatic cancer.
“This second FDA Fast Track designation of our autologous
dendritic cell vaccines for pancreatic cancer is another
acknowledgement of the incredible potential of this innovative
immunotherapy for treating the most deadly cancers,” said Mike
Wicks, Diakonos CEO. “We are thrilled to have Dr. Von Hoff join us
as an advisor as we pursue clinical development of our vaccine in
this deadly disease,” Mr. Wicks added. “The first designation was
for our lead vaccine for glioblastoma multiforme (GBM) which
successfully completed dosing for the Phase 1 trial and has
significantly improved 12 month survival in those patients to well
over what would be expected with the standard of care.” (See the
press release)
Dr. Von Hoff is an internationally recognized physician and
scientist whose research has contributed to the development of many
anticancer agents that are routinely used in clinical practice. His
research at TGEN focuses on development of therapies for patients
with advanced pancreatic cancer. He also was a founder of ILEX
Oncology which was acquired by Genzyme.
In addition to his work with TGEN, Dr. Von Hoff holds the
Virginia G. Piper Distinguished Chair for Innovative Cancer
Research at HonorHealth Clinical Research Institute, and is
Professor of Medicine at the Mayo Clinic, Scottsdale, AZ.
“Diakonos's unique dendritic cell vaccine has shown encouraging
results in treating glioblastoma, a terrible disease with few
effective treatments. Pancreatic cancer patients also need
additional treatment options,” said Dr. Von Hoff. “I look forward
to working with Diakonos to help develop effective treatments for
patients with pancreatic cancer with the same targeted
technology.”
About FDA Fast Track:
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. Pancreatic ductal adenocarcinoma is
the most common pancreatic cancer. It is the third leading cause of
cancer deaths in the U.S. and the number of cases is growing.
According to the National Institutes of Health, the average
five-year survival rate is less than 13%, and in 2024 an estimated
51,750 people will die and 66,440 will be newly diagnosed.
About Diakonos’ DCV Technology:
The company’s DCVs are made with a patient’s dendritic cells and
a sample of their tumor. These highly differentiated double-loaded
dendritic cell vaccines activate robust cytotoxic TH1 cell
signaling pathways that initiate a natural immune response to
target and eliminate cancer cells. This is achieved without any
genetic modification of the patient’s immune cells, which greatly
simplifies the manufacturing process and significantly reduces
costs when compared to leading cell therapy approaches.
About Diakonos Oncology Corp.
Based in Houston, TX, Diakonos Oncology is a clinical-stage
biotechnology company dedicated to revolutionizing cancer
immunotherapy and focusing on difficult-to-treat indications,
including glioblastoma and PDAC. A variant of the DOC1021 treatment
platform are also in early-stage clinical testing in angiosarcoma
(AS). For more information visit: www.diakonosoncology.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240715129278/en/
Jay Hartenbach pr@diakonosoncology.com