- Calidi was awarded $3.1 million to support the
development of Supernova-1 (SNV1) program through IND application
- City of Hope, a cancer research and treatment
organization, was awarded $12 million to support a Phase 1
physician-sponsored clinical trial evaluating Calidi’s
licensed oncolytic virotherapy NeuroNova-2 (NNV2) platform in
patients with recurrent high-grade glioma
LA JOLLA, CALIF–(December 13, 2022)–(BUSINESS
WIRE)– Calidi Biotherapeutics, Inc. (Calidi), a
clinical-stage biotechnology company that is pioneering allogeneic stem
cell-based platforms to revolutionize oncolytic virus immunotherapies, today
announced that the California Institute for Regenerative Medicine (CIRM) has
awarded the company a $3.1 million grant to support continued development of
the company’s Supernova-1 (SNV1) pre-clinical program through
Investigational New Drug (IND) application. In addition, CIRM has awarded City of Hope a $12 million grant to
fund a Phase 1 physician-sponsored clinical trial evaluating Calidi’s
licensed oncolytic virotherapy NeuroNova platform in patients with recurrent
high-grade glioma, a form of advanced brain cancer.
The first grant was awarded to Calidi to support IND-enabling
studies, finalize manufacturing, and the completion of Calidi’s IND
application for the SNV1 program. SNV1 is composed of allogeneic,
adipose-derived mesenchymal stem cells (AD-MSC) loaded with the oncolytic
vaccinia virus Cal1, targeting a variety of solid tumors including
metastatic/unresectable melanoma, triple negative breast cancer, and
advanced head and neck squamous cell carcinoma. Calidi’s research has
shown the potential ability of SNV1 to shield the viral payload from the
immune system, supporting efficient delivery to tumor sites and effectively
potentiating oncolytic viruses. A previously conducted physician-sponsored
Phase 1 clinical trial using autologous adipose-derived stromal cells
demonstrated excellent safety and early signs of efficacy in 24 patients
with advanced solid tumors and two patients with acute myeloid leukemia
(AML).
“With limited treatment options and poor survival rates,
there remains a significant unmet need for the development of effective
treatment options for patients suffering from metastatic/unresectable
melanoma, triple negative breast cancer, and advanced head and neck squamous
cell carcinoma,” said Boris Minev, M.D., President, Medical and
Scientific Affairs of Calidi Biotherapeutics and the principal investigator
of this grant. “This generous grant from CIRM will accelerate the
further development of SNV1 through our IND application and beyond.”
“I have been working with an incredible team of scientists
in Calidi’s research laboratories to develop this powerful
off-the-shelf stem cell-based oncolytic therapy with the potential to
revolutionize the treatment of solid tumors,” said Antonio F.
Santidrian, Ph.D., co-inventor of SNV technology and SVP, Global Head of
R&D of Calidi Biotherapeutics. “We are deeply appreciative of the
CIRM funding mechanism and the unanimous vote of CIRM’s independent
reviewers to support the development of SNV1, which will allow us to
validate the platform in a clinical setting.”
The second grant was awarded to City of Hope to study the effects
of multiple dose application of neural stem cells (NSC)-based oncolytic
virotherapy in patients with recurrent high-grade gliomas. The study will
utilize Calidi’s licensed NNV2 oncolytic virotherapy platform, a
cutting-edge therapeutic candidate comprising tumor-tropic neural stem cells
delivering an oncolytic adenovirus selectively to tumor sites in patients
with recurrent high-grade glioma. The grant was awarded to City of Hope to
support the manufacturing of the therapeutic agent, the conducting of the
multi-center Phase 1 trial, and the determination of activity,
biodistribution, immunogenicity, and preliminary clinical efficacy. The
study received FDA authorization to proceed with a Phase 1 clinical trial,
which will be led by principal investigator Jana
Portnow, M.D., Professor in City of Hope’s
Department of Medical Oncology & Therapeutics Research and Co-Director
of the Brain Tumor Program at City of Hope, one of the largest cancer
research and treatment organizations in the United States and a founding
member of the National Comprehensive Cancer Network. Calidi holds an
exclusive worldwide licensing agreement for patents covering the
NSC-CRAd-S-pk7 technology (NeuroNova).
“I am honored that CIRM has recognized the expertise City of
Hope has in early-phase development of leading-edge therapies for brain
tumors,” Portnow said. “Our research portfolio has piloted
multiple innovative strategies to fight brain cancer, including the use of
neural stem cells that act as homing devices to deliver therapies directly
to tumors in the brain.”
“I am delighted by the grant awarded to our collaborators at
City of Hope for the treatment of recurrent brain tumors in adults. We
believe our neural stem cell-mediated virotherapy has the potential to drive
improved clinical outcomes for patients with high grade gliomas. Given
NNV2’s ‘off-the-shelf’ nature, this therapy will be lower
cost than autologous cell-based therapies and could be rapidly made
available, bringing value to the healthcare system, and providing diverse
patient populations access to treatment,” said Calidi Biotherapeutics
CEO and Chairman of the Board Allan J. Camaisa. “We are pleased to
receive the support of CIRM and the further endorsement of our NeuroNova
platform and are excited for the continued advancement of this Phase 1 study
with our partners at City of Hope.”
About Calidi Biotherapeutics
Calidi Biotherapeutics is a clinical-stage immuno-oncology company
with proprietary technology that is revolutionizing the effective delivery
and potentiation of oncolytic viruses for targeted therapy against
difficult-to-treat cancers. Calidi Biotherapeutics is advancing a potent
allogeneic stem cell and oncolytic virus combination for use in multiple
oncology indications. Calidi’s off-the-shelf, universal cell-based
delivery platforms are designed to protect, amplify, and potentiate
oncolytic viruses currently in development leading to enhanced efficacy and
improved patient safety. Calidi Biotherapeutics is headquartered in La
Jolla, California. For more information, please visit www.calidibio.com.
Contacts:
For Investors:
Stephen Jasper
stephen@gilmartinir.com
Forward-Looking Statement
This press release may contain forward-looking statements and
information relating to, among other things, Calidi Therapeutics and its
business plan and strategy, and the highly competitive pharmaceutical
industry. These forward-looking statements are based on the beliefs of,
assumptions made by, and information currently available to the Company.
When used in this press release, the words “estimate,”
“project,” “believe,” “anticipate,”
“intend,” “expect” as well as similar terms, are
forward-looking in nature. These forward-looking statements involve a
number of risks, uncertainties (many of which are beyond Calidi’s
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performance to be materially different from those expressed or implied
by these forward-looking statements. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date on which they are made. Calidi Therapeutics does not
undertake any obligation to revise or update these forward-looking
statements to reflect events or circumstances after such date or to
reflect the occurrence of unanticipated events.