Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a
clinical stage biopharmaceutical company focused on developing and
commercializing viral immunotherapies to help patients fight
cancer, today announced the presentation of updated data from an
ongoing phase 1b clinical trial of its herpes simplex virus-1
(HSV-1) replication-competent viral immunotherapy candidate,
CAN-3110, in patients with rHGG that has recurred after standard of
care (SoC) treatment. The data were presented today during the 5th
Glioblastoma Drug Development Summit in Boston, Massachusetts.
“We have recently reported encouraging clinical and
biomarker activity data observed after a single dose of CAN-3110 in
patients with rHGG. We observed a nearly doubling of the expected
median overall survival in this therapy-resistant patient
population,” said Francesca Barone, MD, PhD, Chief Scientific
Officer of Candel. “The data presented today further supports that
repeated doses of CAN-3110 are feasible and generally
well-tolerated in rHGG, potentially further improving the clinical
activity of this investigational medicine. Safety and tolerability
of both repeated injections and serial biopsies, performed prior to
the administration of CAN-3110, will be monitored to gauge disease
progression and tissue response to treatment. We look forward to
sharing additional biomarker and clinical activity data in the
second half of this year.”
To date, over 50 patients have been treated with a
single dose of CAN-3110 in the phase 1b clinical trial of CAN-3110
in recurrent high-grade glioma (rHGG). 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). Results from the
ongoing phase 1b clinical trial were published in Nature in Q4
2023. CAN-3110 received U.S. Food and Drug Administration (FDA)
Fast Track Designation for treatment of rHGG in Q1 2024, based on
these data.
“Dosing patients with multiple injections
represents the next step forward in the development of CAN-3110 for
rHGG,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of
Candel. “The observed data suggest that repeated injections of
CAN-3110 are well tolerated, supporting the design of a future
phase 2 clinical trial in this indication. We’re excited by our
recent progress -- as illustrated by the publication in Nature,
CAN-3110’s recent FDA Fast Track designation, and the collaboration
with Batavia Biosciences -- to accelerate the development and
production of CAN-3110, along with our update presented today.
Together, we hope this will help to accelerate the development of a
better treatment for patients with high unmet need.”
About the phase 1 clinical trial of
CAN-3110 in rHGG
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, two cohorts of 12 patients with rHGG
will receive up to six injections of CAN-3110 over a four-month
period.
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 rHGG. 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-HSV1 positive patients who
received CAN-3110 was more than 14 months.
Candel expects to initiate Investigational New
Drug-enabling work in a second indication characterized by Nestin
expression.
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 for CAN-3110 in recurrent high-grade
glioma and glioblastoma; the possibility of using early biological
readouts as a predictor of clinical response; and expectations
regarding the therapeutic benefit of its programs, including the
potential for its programs to extend patient survival. 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 current and future development programs; the
Company’s ability to continue as a going concern; 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 filings with the U.S. Securities and
Exchange Commission (SEC), including the Company’s most recent
Annual Report on Form 10-K 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.
Investor ContactTheodore
JenkinsVP Investor Relations and Business DevelopmentCandel
Therapeutics, Inc.tjenkins@candeltx.com
Media ContactAljanae
ReynoldsDirectorWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
Candel Therapeutics (NASDAQ:CADL)
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