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 its lead investigational
adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the
treatment of patients with pancreatic ductal adenocarcinoma (PDAC)
to improve overall survival.
“We are pleased with the FDA's decision to grant
Fast Track Designation for CAN-2409 in pancreatic cancer,” said
Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel.
“This milestone follows our first interim data report from the
randomized phase 2 clinical trial in patients with borderline
resectable PDAC that showed prolonged and sustained survival after
experimental treatment with CAN-2409, especially when compared to
real-world data on patients receiving radiotherapy treatment.
Candel remains on track to release updated overall survival data
from the interim analysis of this clinical trial in the second
quarter of 2024. We are grateful to the patients, caregivers,
investigators and clinical sites that have taken part in this
clinical trial.”
In November 2023, the Company presented encouraging
overall survival and immunological biomarker data based on an
interim analysis of the randomized, phase 2 clinical trial of
CAN-2409 plus prodrug together with standard of care (SoC)
neoadjuvant chemoradiation followed by resection for borderline
resectable non-metastatic PDAC at the Society for Immunotherapy of
Cancer (SITC) Annual Meeting. An estimated survival rate of 71.4%
at both 24 and 36 months in patients who received 2 or 3 injections
of the CAN-2409 plus prodrug regimen, together with SoC
chemoradiation prior to surgery was observed, versus only 16.7%
estimated survival at both 24 and 36 months in patients treated
with SoC chemoradiation prior to surgery alone. In parallel, the
immunological changes observed in the resected pancreatic tissue
after CAN-2409 administration suggested that this investigational
treatment can activate an effective immunologic antitumoral
response in this otherwise “cold” tumor.
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-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). In addition, 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. 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).
For more information about Candel,
visit: www.candeltx.com
About the Phase 2 Clinical Trial of
CAN-2409 in Non-Metastatic Pancreatic Cancer
This randomized, open-label phase 2 clinical trial
is designed to evaluate the safety, preliminary efficacy, and
biologic activity of a 2-3 injection regimen of CAN-2409 plus
prodrug (valacyclovir or acyclovir) in patients with borderline
resectable PDAC who are being treated with neoadjuvant
chemoradiation prior to resection. After a protocol amendment in
2022, when enrollment of patients with locally advanced PDAC was
discontinued, the clinical trial was designed to exclusively
focused on borderline resectable disease. The clinical trial
remains active but is not currently enrolling new patients. In a
previously completed phase 1b clinical trial, a highly significant
increase in the number of CD8+ tumor infiltration lymphocytes was
demonstrated at the site of the tumor after CAN-2409 treatment.
About CAN-2409
CAN-2409, Candel’s most advanced multimodal
biological immunotherapy candidate, is an investigational
off-the-shelf replication-defective adenovirus designed to deliver
the herpes simplex virus thymidine kinase (HSV-tk) gene to a
patient’s specific tumor and induce an individualized, systemic
immune response against the disease. HSV-tk is an enzyme that
locally converts orally administered valacyclovir into a toxic
metabolite that kills nearby cancer cells. Together, this regimen
is designed to induce an individualized and specific CD8+ T cell
mediated response against the injected tumor and uninjected distant
metastases for broad anti-tumor activity, based on in situ
vaccination against a variety of tumor antigens. Because of its
versatility, CAN-2409 has the potential to treat a broad range of
solid tumors. Encouraging monotherapy activity as well as
combination activity with standard of care radiotherapy, surgery,
chemotherapy, and immune checkpoint inhibitors have previously been
shown in several preclinical and clinical settings. Furthermore, to
date, more than 950 patients have been dosed with CAN-2409 with a
favorable tolerability profile to date, supporting the potential
for combination with other therapeutic strategies without
inordinate concern of overlapping adverse events. Currently, Candel
is evaluating the effects of treatment with CAN-2409 in NSCLC,
borderline resectable PDAC, and localized, non-metastatic prostate
cancer in ongoing clinical trials. CAN-2409 has been granted Fast
Track Designation by the FDA for treatment of PDAC or stage III/IV
NSCLC in patients who are resistant to first line PD-(L)1 inhibitor
therapy and who do not have activating molecular driver mutations
or have progressed on directed molecular therapy. The Company’s
pivotal phase 3 clinical trial in prostate cancer is being
conducted under a Special Protocol Assessment by FDA.
About Pancreatic Ductal Adenocarcinoma
(PDAC)
Pancreatic cancer is a highly lethal malignancy,
and is the fourth leading cause of cancer-related death in the
United States among both men and women. Based on the National
Cancer Institute, Surveillance, Epidemiology and End Results (SEER)
database, pancreatic cancer is expected to account for 3.3% of all
new cancer cases, with an estimated 64,050 new cases and estimated
50,550 deaths in 2023.Effective therapeutics for pancreatic cancer,
including PDAC, which accounts for 90% of all pancreatic
carcinomas, are urgently needed.
Surgical resection offers the only chance of cure,
thus a major therapeutic goal for subjects with non-metastatic
disease is to achieve complete tumor resection. Surgical treatment
(pancreaticoduodenectomy, also known as the Whipple procedure) or
total or distal pancreatectomy (depending on tumor location) is
generally the recommended treatment for patients diagnosed with
resectable cancer; the addition of adjuvant chemotherapy has been
shown to only slightly improve survival rates (20 to 23 months). To
this end, there has been increasing use of neoadjuvant chemotherapy
and chemoradiation regimens for subjects with borderline resectable
pancreatic ductal adenocarcinoma. Neoadjuvant regimens are intended
to debulk the tumor, thereby increasing the proportion of patients
who may become eligible for surgical resection and achieve complete
resection (i.e., resection with negative margins, designated ‘R0
resection’). Unfortunately, even when an R0 resection is initially
achieved, cures remain elusive as most patients experience disease
recurrence due to residual micrometastatic disease. In a recent
meta-analysis of 20 studies representing 283 patients with
borderline resectable PDAC, neoadjuvant FOLFIRINOX with or without
radiotherapy, median OS was only 22.2 months (95% CI, 18.8 to 25.6
months).
Immunotherapy with PD-1 antibodies with or without
CTLA-4 antibodies has been uniformly unsuccessful in patients with
PDAC due to the dense stroma that surrounds PDAC tissue and the
absence of tumor infiltrating lymphocytes.
About Fast Track Designation
Fast Track Designation is a 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 accelerated approval and
priority review.
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 key data readout milestones , including CAN-2409 in
pancreatic cancers such as PDAC expectations regarding the
therapeutic benefit of its programs; 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 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.
Media ContactAljanae
ReynoldsDirectorWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
Investor ContactSylvia
WheelerPrincipalWheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
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