Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a
clinical stage biopharmaceutical company focused on developing
multimodal biological immunotherapies to help patients fight
cancer, today announced that the U.S. Food and Drug Administration
(FDA) granted Fast Track Designation for CAN-3110 -- a
first-in-class, replication-competent herpes simplex virus-1
(HSV-1) oncolytic viral immunotherapy candidate – for the treatment
of patients with recurrent high-grade glioma (HGG) to improve
overall survival.
“Receiving FDA Fast Track Designation for CAN-3110
reinforces the critical need to find effective treatment options
for patients with recurrent HGG and further supports the potential
of CAN-3110 to address the challenges that the standard of care and
conventional therapies have failed to meet,” said Paul Peter Tak,
MD, PhD, FMedSci, President and CEO of Candel. “As recently
published in Nature, a strong local and systemic anti-tumoral
response and improved survival in patients with recurrent HGG was
observed following a single injection of CAN-3110. We look forward
to reporting additional data, including the potential benefits from
multiple injections of CAN-3110, from the ongoing phase 1b clinical
trial in the second half of 2024.”
In October 2023, Candel and academic collaborators
at the Brigham and Women’s Hospital published results from the
ongoing phase 1b clinical trial in Nature, demonstrating that
CAN-3110 was well tolerated with no dose-limiting toxicity
reported. The investigators observed a nearly doubling of the
expected median overall survival (mOS) after a single CAN-3110
injection, achieving a mOS of ~12 months, compared to historical
reports of less than 6 to 9 months in this therapy-resistant
condition. Positive HSV-1 serology was a predictor of response and
was associated with improved survival (mOS in this population
reached 14 months). Increased infiltrating immune cells in the
tumor microenvironment and expansion of the T cell repertoire after
administration were also associated with improved survival,
suggesting that CAN-3110 can elicit both a local and systemic
antitumoral response.
“Recurrent HGG is one of the most aggressive
malignancies for which there is no cure, representing a significant
and urgent unmet need,” said Antonio Chiocca, MD, PhD, Head of
Department of Neurosurgery at Brigham and Women’s Hospital,
Professor at Harvard Medical School, and Principal Investigator.
“With Fast Track Designation, I look forward to the potential of
accelerating the development of CAN-3110 and the possibility of
bringing this differentiated therapy to patients with recurrent
high-grade glioma as we strive to improve outcomes and provide hope
for patients and their families.”
About CAN-3110
CAN-3110 is a first-in-class, replication-competent
herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy
candidate designed with dual activity for oncolysis and immune
activation in a single therapeutic. Its activity is designed to be
conditional to the expression of Nestin in cancer cells. CAN-3110
is being evaluated in a phase 1 investigator-sponsored clinical
trial in patients with recurrent HGG. In October 2023, the Company
announced that Nature published results from this ongoing clinical
trial. CAN-3110 was well tolerated with no dose-limiting toxicity
reported and CAN-3110 plus prodrug was associated with improved
survival. Positive HSV-1 serology was a predictor of response and
was associated with improved survival. Increased infiltrating
immune cells in the tumor microenvironment and expansion of the T
cell repertoire after treatment were also associated with improved
survival. In the clinical trial, the investigators observed a
nearly doubling of the expected median overall survival after a
single CAN-3110 injection, compared to historical reports of less
than 6 to 9 months in this therapy-resistant condition. By
comparison, survival in the anti-HSV-1 positive patients who
received CAN-3110 was more than 14 months. The Company and academic
collaborators are currently evaluating the effects of multiple
CAN-3110 injections in recurrent HGG, supported by the Break
Through Cancer Foundation, and expect initial results in the second
half of 2024.
Candel expects to initiate IND-enabling work in
a second indication characterized by Nestin expression.
About the phase 1 clinical trial of
CAN-3110 in recurrent HGG
This investigator-sponsored study is led by E.
Antonio Chiocca, MD, PhD, Head of the Department of Neurosurgery at
Brigham & Women’s Hospital and Professor at Harvard Medical
School. The clinical trial comprises three arms. In arm A, 41
patients with recurrent HGG received a single intratumoral
injection of CAN-3110 (dose ranging from 1x106 plaque forming
units (pfu) to 1x1010 pfu), including nine patients with
multifocal/multicentric, deep or bilateral tumors associated with
poor survival. After observing this regimen was generally well
tolerated without dose-limiting toxicity, patients in arm B (n=9)
received a single dose of cyclophosphamide (24 mg/kg), two days
before CAN-3110 injection at doses of 1 x 108 pfu (n=3) and 1
x 109 pfu (n=6). The rationale is based on findings in mouse
models, where cyclophosphamide improved viral persistence in
injected tumors. In arm C, supported by the Break Through Cancer
foundation, two cohorts of 12 patients with recurrent HGG will
receive up to six injections of CAN-3110 over a four-month
period.
About Fast Track Designation
Fast Track Designation is an FDA program designed
to facilitate the development and expedite the review of medicines
with the potential to treat serious conditions and fulfill an unmet
medical need. An investigational medicine that receives Fast Track
Designation may be eligible for more frequent interactions with the
FDA to discuss the candidate’s development plan and, if relevant
criteria are met, may be eligible for priority review.
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical
company focused on developing off-the-shelf multimodal biological
immunotherapies that elicit an individualized, systemic anti-tumor
immune response to help patients fight cancer. Candel has
established two clinical stage multimodal biological immunotherapy
platforms based on novel, genetically modified adenovirus and
herpes simplex virus (HSV) gene constructs, respectively. CAN-2409
is the lead product candidate from the adenovirus platform and is
currently in ongoing clinical trials in non-small cell lung cancer
(NSCLC) (phase 2), borderline resectable pancreatic cancer (phase
2), and localized, non-metastatic prostate cancer (phase 2 and
phase 3). CAN-3110 is the lead product candidate from the HSV
platform and is currently in an ongoing investigator-sponsored
phase 1 clinical trial in recurrent high-grade glioma (HGG).
Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic,
iterative HSV-based discovery platform leveraging human biology and
advanced analytics to create new viral immunotherapies for solid
tumors.
For more information about Candel,
visit: www.candeltx.com
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, express or implied statements
regarding the timing and advancement of development programs,
including the timing and availability of additional data, key data
readout milestones, including CAN-3110 in HGG; expectations
regarding the potential benefits conferred by Fast Track
Designation; expectations regarding the therapeutic benefit of its
programs, including the potential for its programs to extend
patient survival; and expectations regarding cash runway and
expenditures. The words “may,” “will,” “could,” “would,” “should,”
“expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,”
“predict,” “project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, those risks and uncertainties related to the timing and
advancement of development programs; expectations regarding the
therapeutic benefit of the Company’s programs; that final data from
our pre-clinical studies and completed clinical trials may differ
materially from reported interim data from ongoing studies and
trials; the Company’s ability to efficiently discover and develop
product candidates; the Company’s ability to obtain and maintain
regulatory approval of product candidates; the Company’s ability to
maintain its intellectual property; the implementation of the
Company’s business model, and strategic plans for the Company’s
business and product candidates, and other risks identified in the
Company’s SEC filings, including the Company’s most recent
Quarterly Report on Form 10-Q filed with the SEC, and subsequent
filings with the SEC. The Company cautions you not to place undue
reliance on any forward-looking statements, which speak only as of
the date they are made. The Company disclaims any obligation to
publicly update or revise any such statements to reflect any change
in expectations or in events, conditions or circumstances on which
any such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent the Company’s views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date.
Media ContactAljanae
ReynoldsDirectorWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
Investor ContactSylvia
WheelerPrincipalWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
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