- City of Hope is first in world to test oncolytic virus,
CF33-hNIS, in people with metastatic solid tumors.
Imugene Limited (ASX:IMU), a clinical stage immuno-oncology
company, and City of Hope, one of the largest cancer research and
treatment organizations in the United States, today announced that
the first patient was dosed in a Phase 1 clinical trial evaluating
the safety of novel cancer-killing virus CF33-hNIS VAXINIA when
used in people with advanced solid tumors. The City of
Hope-developed oncolytic virus has been shown to shrink colon,
lung, breast, ovarian and pancreatic cancer tumors in preclinical
laboratory and animal models.
“Our previous research demonstrated that oncolytic viruses can
stimulate the immune system to respond to and kill cancer, as well
as stimulate the immune system to be more responsive to other
immunotherapies, including checkpoint inhibitors,” said Daneng Li,
M.D., principal investigator and assistant professor of City of
Hope’s Department of Medical Oncology & Therapeutics Research.
“Now is the time to further enhance the power of immunotherapy, and
we believe CF33-hNIS has the potential to improve outcomes for our
patients in their battle with cancer.”
Oncolytic virus therapy is made possible once viruses found in
nature are genetically modified to infect, replicate in and kill
cancer cells, while sparing healthy cells. While immune checkpoint
inhibitors have been effective in certain cancers, patients often
relapse and eventually stop responding to or develop resistance to
this type of treatment. Early research shows oncolytic viruses can
prime a person’s immune system and increase the level of PD-L1 in
tumors, making immunotherapy more effective against cancer.
The multicenter Phase 1 trial will start by delivering a low
dose of CF33-hNIS to cancer patients with metastatic or advanced
solid tumors who have had at least two prior lines of standard of
care treatment. The investigational treatment will be delivered
either as an injection directly into tumors or intravenously.
Once patients in the single therapy group have been treated with
the lowest doses of CF33-hNIS and acceptable safety has been
demonstrated, certain new study participants will receive the
experimental oncolytic virus in combination with the immunotherapy
pembrolizumab, an engineered antibody that improves the immune
system’s ability to fight cancer-causing cells. The study aims to
recruit 100 patients across approximately 10 trial sites in the
United States and Australia.
City of Hope exclusively licensed patent rights covering CF33 to
Imugene Limited, a company developing novel therapies that activate
the immune system against cancer. Imugene has given CF33-hNIS the
name Vaxinia.
“Interestingly, the same characteristics that eventually make
cancer cells resistant to chemotherapy or radiation treatment
actually enhance the success of oncolytic viruses, such as
CF33-hNIS,” said Yuman Fong, M.D., the Sangiacomo Family Chair in
Surgical Oncology at City of Hope and the key developer of the
genetically modified virus. “We are hoping to harness the promise
of viralogy and immunotherapy for the treatment of a wide variety
of deadly cancers.”
The clinical trial is titled “A Phase I, Dose Escalation Safety
and Tolerability Study of VAXINIA (CF33-hNIS), Administered
Intratumorally or Intravenously as a Monotherapy or in Combination
with Pembrolizumab in Adult Patients with Metastatic or Advanced
Solid Tumours (MAST).” The trial is anticipated to run for
approximately 24 months and is funded from existing budgets and
resources.
The U.S. component of the Phase 1 trial is conducted under the
U.S. Food and Drug Administration (FDA) investigational new drug
(IND) process following FDA IND clearance in December 2021. Site
activation and patient recruitment is proceeding.
The first clinical institution in the U.S. to receive ethics
approval is City of Hope, a world-renowned cancer research and
treatment organization in Los Angeles. Additional clinical sites
will be opened across the U.S. in 2022.
Imugene M.D. and CEO Leslie Chong said, “The dosing of the first
patient in our VAXINIA study is a significant milestone for Imugene
and clinicians faced with the challenge of treatment for metastatic
advanced solid tumours. Professor Yuman Fong and the City of Hope
team have provided outstanding research. In addition to the
positive preclinical results, we’re incredibly eager to unlock the
potential of VAXINIA and the oncolytic virotherapy platform.”
About Daneng Li, M.D.
Daneng Li, M.D., is an assistant professor in the Department of
Medical Oncology & Therapeutics Research at City of Hope who
specializes in treating neuroendocrine tumors, liver tumors and
gastrointestinal cancers. Li currently leads City of Hope’s liver
tumors program and is also the co-director of the Neuroendocrine
Tumour Program at City of Hope.
Li earned his undergraduate degree from The Ohio State
University in Columbus, Ohio, where he graduated summa cum laude.
He then went on to receive his medical doctorate from Weill Cornell
Medical College in New York before pursuing an internship and
residency in internal medicine at New York-Presbyterian
Hospital/Weill Cornell Medical Center. He completed a
hematology/oncology fellowship at Memorial Sloan-Kettering Cancer
Center in New York City.
Board certified in internal medicine and medical oncology, Li
serves on several national committees focused on his specialty
tumor types. He has authored many publications in peer-reviewed
literature and has presented his work nationally.
About Imugene (ASX:IMU)
Imugene is a clinical stage immuno-oncology company developing a
range of new and novel immunotherapies that seek to activate the
immune system of cancer patients to treat and eradicate tumours.
Our unique platform technologies seek to harness the body’s immune
system against tumours, potentially achieving a similar or greater
effect than synthetically manufactured monoclonal antibody and
other immunotherapies. Our product pipeline includes multiple
immunotherapy B-cell vaccine candidates and an oncolytic
virotherapy (CF33) aimed at treating a variety of cancers in
combination with standard of care drugs and emerging
immunotherapies such as CAR T’s for solid tumours. We are supported
by a leading team of international cancer experts with extensive
experience in developing new cancer therapies with many approved
for sale and marketing for global markets.
Our vision is to help transform and improve the treatment of
cancer and the lives of the millions of patients who need effective
treatments. This vision is backed by a growing body of clinical
evidence and peer-reviewed research. Imugene is well funded and
resourced, to deliver on its commercial and clinical milestones.
Together with leading specialists and medical professionals, we
believe Imugene’s immuno-oncology therapies will become foundation
treatments for cancer. Our goal is to ensure that Imugene and its
shareholders are at the forefront of this rapidly growing global
market.
About City of Hope
City of Hope's mission is to deliver the cures of tomorrow to
the people who need them today. Founded in 1913, City of Hope has
grown into one of the largest cancer research and treatment
organizations in the U.S. and one of the leading research centers
for diabetes and other life-threatening illnesses. As an
independent, National Cancer Institute-designated comprehensive
cancer center, City of Hope brings a uniquely integrated model to
patients, spanning cancer care, research and development, academics
and training, and innovation initiatives. Research and technology
developed at City of Hope has been the basis for numerous
breakthrough cancer medicines, as well as human synthetic insulin
and monoclonal antibodies. A leader in bone marrow transplantation
and immunotherapy, such as CAR T cell therapy, City of Hope’s
personalized treatment protocols help advance cancer care
throughout the world.
With a goal of expanding access to the latest discoveries and
leading-edge care to more patients, families and communities, City
of Hope’s growing national system includes its main Los Angeles
campus, a network of clinical care locations across Southern
California, a new cancer center in Orange County, California,
scheduled to open in 2022, and Cancer Treatment Centers of America.
City of Hope’s affiliated family of organizations includes
Translational Genomics Research Institute and AccessHope™. For more
information about City of Hope, follow us on Facebook, Twitter,
YouTube, Instagram and LinkedIn.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220517006267/en/
Media Enquiries Matt Wright
matt@nwrcommunications.com.au
Zen Vuong zvuong@coh.org 626-409-9367
Immunogen Inc Dl 01 (TG:IMU)
Historical Stock Chart
From Feb 2025 to Mar 2025
Immunogen Inc Dl 01 (TG:IMU)
Historical Stock Chart
From Mar 2024 to Mar 2025
