Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a
clinical stage biopharmaceutical company focused on developing
viral immunotherapies to help patients fight cancer, today
announced initial positive interim survival and immunological
biomarker data from the ongoing randomized phase 2 clinical trial
of CAN-2409 plus valacyclovir (prodrug) together with standard of
care (SoC) chemoradiation followed by resection for borderline
resectable pancreatic ductal adenocarcinoma (PDAC). Data were
presented today in a poster session titled ‘Neoadjuvant
CAN-2409+Prodrug Plus Chemoradiation for Borderline Resectable or
Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma (PDAC) at
the 2023 Society for Immunotherapy (SITC) Annual Meeting.
“Given frequent recurrence and short survival with SoC
chemotherapy for non-metastatic PDAC, effective new treatment
options are urgently needed,” said Garrett Nichols, MD, MS, Chief
Medical Officer of Candel. “We are encouraged by the improved
survival associated with CAN-2409 for the treatment of borderline
resectable PDAC, demonstrated for the first time in a randomized
clinical trial. CAN-2409 was generally well tolerated without
significant additional local or systemic toxicity when added to SoC
chemoradiation.”
Data Highlights as of August 21, 2023 Data Cutoff,
include:
- Prolonged and sustained survival was observed after
experimental treatment with CAN-2409 plus prodrug in patients with
borderline resectable PDAC (n=13)
- An estimated survival rate of 71.4% at both 24 and 36 months,
observed in patients who received CAN-2409 regimen together with
SoC chemoradiation prior to surgery, versus only 16.7% survival at
24 and 36 months in patients with SoC chemoradiation prior to
surgery.
- Importantly, 5 out of 7 patients who received CAN-2409 were
still alive at the time of data cut-off, with two patients
surviving more than 45 months from enrollment. Only one patient
randomized to control SoC chemotherapy remained alive at data
cut-off (alive at 43 months).
- Median overall survival has not yet been reached in patients
who received CAN-2409; median overall survival was 12.5 months in
the control arm.
- Disease course was altered after salvage chemotherapy with
improved CA19-9 levels and ongoing survival in CAN-2409 arm, but
not in control arm.
- Data showed consistent and robust activation of immune response
after dosing with CAN-2409
- In pancreatic tissue of patients treated with CAN-2409 plus
prodrug together with SoC (but not SoC alone), dense aggregates of
CD8+ granzyme B positive cytotoxic T cells, dendritic cells, and B
cells were observed in the tumor microenvironment.
- Increased levels of soluble granzymes B and H as well as
pro-inflammatory cytokines, including IFN-γ, were observed in
peripheral blood after CAN-2409 treatment, but not with control
treatment.
- CAN-2409 was associated with a favorable tolerability profile
- Addition of CAN-2409 regimen to SoC was generally well
tolerated, with no reported dose-limiting toxicities, including no
cases of pancreatitis.
“The failure of immunotherapy to improve outcomes in pancreatic
cancer is attributed to the highly immunosuppressive tumor
microenvironment, which is largely devoid of immune cells,” said
Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive
Officer of Candel. “The immunological changes induced by CAN-2409,
as observed in the pancreatic tissue after dosing, suggest that
CAN-2409 treatment can convert the immune desert microenvironment
and enable the generation of an effective antitumoral response and
improve survival.”
Further details from the poster will be available at time of the
SITC embargo poster presentation lift on the Candel website
at: www.candeltx.com/media
About the Phase 2 Clinical Trial of CAN-2409 in
Non-Metastatic Pancreatic Cancer
In its current design, the 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 pancreatic cancer who are being treated with
neoadjuvant chemoradiation or stereotactic body radiation therapy.
After amendment in 2022, when enrollment of patients with locally
advanced PDAC was discontinued, the clinical trial is exclusively
focused on borderline resectable disease. 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 Pancreatic Ductal Adenocarcinoma
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 2023.1 Effective therapeutics for pancreatic cancer,
including PDAC, which accounts for 90% of all pancreatic
carcinomas2, 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).2
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).3
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 CAN-2409
CAN-2409, Candel’s most advanced viral 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. The intratumoral administration results in the release of
tumor-specific neoantigens in the microenvironment. At the same
time, the adenoviral serotype 5 capsid protein elicits a strong
pro-inflammatory signal in the tumor microenvironment. This is
designed to create the optimal conditions to induce an
individualized and specific CD8+ T cell mediated response against
the injected tumor and uninjected distant metastases for broad
anti-tumor activity. 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 ICI have
previously been shown in several preclinical and clinical settings.
Furthermore, 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 non-small
cell lung cancer (NSCLC), borderline resectable pancreatic cancer,
and localized, non-metastatic prostate cancer in ongoing clinical
trials.
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical company focused on
developing off-the-shelf viral immunotherapies that elicit an
individualized, systemic anti-tumor immune response to help
patients fight cancer. Candel’s engineered viruses are designed to
induce immunogenic cell death through direct viral-mediated
cytotoxicity in cancer cells, thus releasing tumor neo-antigens
while creating a pro-inflammatory microenvironment at the site of
injection. This leads to in situ vaccination against the injected
tumor and uninjected distant metastases.
Candel has established two clinical stage viral 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 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. 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.
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 current and future development programs,
including the timing and availability of additional data, the
possibility to use early biological readouts as predictor of
clinical response and expectations regarding the therapeutic
benefit of its programs, including the potential for CAN-2409 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; that final
data from our pre-clinical studies and completed clinical trials
may differ materially from reported interim data from ongoing
studies and trials; expectations regarding the therapeutic benefit
of the Company’s programs; 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
References
1 SEER (2023). “Cancer Stat Facts: Pancreatic Cancer.” Retrieved
September 18, 2023, from
https://seer.cancer.gov/statfacts/html/pancreas.html
2 McGuigan A., Kelly P., Turkington R.C., Jones C., Coleman
H.C., McCain R.S. (2018). ‘Pancreatic cancer: A review of clinical
diagnosis, epidemiology, treatment and outcomes’. World J
Gastroenterol 23(43): 4846-4861.
3 Janssen QP, Buettner S, Suker M, Beumer BR, Addeo P,
Bachellier P, Bahary N, Bekaii-Saab T, Bali MA, Besselink MG, Boone
BA, Chau I, Clarke S, Dillhoff M, El-Rayes BF, Frakes JM, Grose D,
Hosein PJ, Jamieson NB, Javed AA, Khan K, Kim KP, Kim SC, Kim SS,
Ko AH, Lacy J, Margonis GA, McCarter MD, McKay CJ, Mellon EA,
Moorcraft SY, Okada KI, Paniccia A, Parikh PJ, Peters NA, Rabl H,
Samra J, Tinchon C, van Tienhoven G, van Veldhuisen E, Wang-Gillam
A, Weiss MJ, Wilmink JW, Yamaue H, Homs MYV, van Eijck CHJ, Katz
MHG, Groot Koerkamp B (2019). ‘Neoadjuvant FOLFIRINOX in Patients
With Borderline Resectable Pancreatic Cancer: A Systematic Review
and Patient-Level Meta-Analysis’. J Natl Cancer Inst 111(8):
782-794.
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