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 updated activity data from its ongoing, open-label, phase
2 clinical trial of CAN-2409 plus valacyclovir in combination with
continued immune checkpoint inhibitor (ICI) treatment in patients
with non-resectable, stage III/IV non-small cell lung cancer
(NSCLC), who have an inadequate response to front line anti-PD(L)1
therapy. These patients historically have had an expected median
overall survival of 10-13 months (Reckamp K et al. J Clin Onc
2022;40:2295-2306). The aim of the CAN-2409 immunotherapy antitumor
strategy is to raise the tail on the survival curve by increasing
the number of long survivors beyond 10-13 months.
In 2022, the Company presented data from this phase 2 clinical
trial where patients who received two administrations of CAN-2409
plus prodrug demonstrated: 1) increased infiltration of CD8+
cytotoxic T cells in the tumor microenvironment, systemic expansion
of effector T cells and increased soluble granzyme B levels in
peripheral blood, 2) favorable changes in the trajectory of tumor
progression, 3) decreased tumor size of target lesions in most
patients, and 4) reduced size of uninjected tumor lesions (Aggarwal
C et al. Abstract #9037 ASCO June 2022 and Aggarwal C et al. Candel
Virtual R&D Day, December 2022). These data were further
confirmed in the current update.
Highlights as of August 1, 2023 data cutoff,
include:
- As of data cutoff (August 1, 2023),
40 patients across Cohort 1 (stable disease at enrollment; n=5) and
Cohort 2 (progressive disease at enrollment; n=35) were evaluable,
as they received two courses of CAN-2409 + valacyclovir and
completed the 12-week treatment window.
- While overall survival is not yet
mature, Candel has observed an encouraging number of long
survivors, which the Company believes that CAN-2409 may induce a
new state of functional immunosurveillance and durable disease
control in a subset of the patients.
- Of the 40 evaluable
patients, 15 patients have lived ≥ 12 months; of these, 10 patients
have lived > 18 months, of whom 70% (7/10) were alive as of last
follow up. All 4 patients (100%) with OS > 24 months were alive
at last follow up, with the longest reaching 31.7 months (data
cutoff August 1, 2023).
- An additional 18
out of the 40 evaluable patients are also alive but have not yet
reached 12 months of follow up.
- Notably, many
patients treated with CAN-2409 have had long survival (≥ 12 months)
despite having disease features generally associated with advanced
disease and reduced likelihood to benefit from ICI therapy, such as
low or negative PD-L1 expression, including:
- Amongst patients
alive ≥ 12 months with known PD-L1 status (14/15), 93% had negative
or low PD-L1 score (<1 or between 1-49).
- Advanced disease
with stage IV in 73% (11/15), lymph node involvement in 73%
(11/15), pleural effusion in 40% (6/15), bone metastases in 27%
(4/15), adrenal metastases in 20% (3/15), brain metastases in 13%
(2/15), liver metastases in 7% (1/15), involvement of 3 or more
organs in 13% (2/15), and ECOG performance status 1 in 40%
(6/15).
- There was a significant increase
observed in activated central memory, effector-memory, effector T
cells, and NK cells after CAN-2409 treatment. These include
CD8+Ki67+IFNg+ T cells, CD8+ granzyme B+Ki67+ T cells,
CD56+CD16+granzyme B+ NK cells, and gd+ T cells. Candel also
observed an increase in B memory cells after CAN-2409
treatment.
- Candel observed an increase in
effector/cytotoxic T cells and NK cells in peripheral blood after
the second CAN-2409 administration associated with improved
survival (≥ 12 months).
- Candel continued
to observe a favorable safety / tolerability profile after CAN-2409
treatment in NSCLC. There were no dose limiting toxicities or grade
4 or greater treatment related adverse events. Grade 3 treatment
related adverse events were reported in < 10% of patients
receiving at least one dose of CAN-2409 (safety population), which
Candel believes compares favorably to current standard of care
options.
- Candel expects to
share topline overall survival data for Cohort 2 in the second
quarter of 2024, assuming mature data at that time.
“We are very encouraged by the initial survival data,
particularly for Cohort 2 which enrolled patients whose disease
progressed despite receiving anti-PD(L)1 treatment. This patient
population represents a major unmet need, since median survival
following progression is typically less than 12 months with
available treatments,” said Paul Peter Tak, MD, PhD, FMedSci,
President and Chief Executive Officer of Candel. “Importantly, 93%
of patients with long survival were low or negative for PD-L1
expression, which we believe confirms the potential of CAN-2409 to
convert patients with highly immunosuppressive tumor
microenvironments, unresponsive to ICI treatment, into long term
survivors. These early data support the promise and potential of
CAN-2409 to provide a long-term survival tail in some of the most
difficult to treat NSCLC cases.”
Dr. Tak continued, “Our approach is patient-centric. The
proposed treatment regimen for CAN-2409 with prodrug is
approximately 12 weeks, and patients can continue their anti-PD(L)1
therapy at local treatment centers, reducing treatment burden. The
immediate goal is to provide a treatment benefit through disease
stabilization via the addition of CAN-2409. The ultimate goal is to
extend patient survival with improved quality of life. These data
support a survival benefit in individual patients, which continues
to be associated with a favorable safety and tolerability profile,
particularly when compared to standard of care taxane-based
chemotherapy.”
“The latest biomarker research performed by Candel, PACT, CIMAC
and the National Cancer Institute further supports and expands
previous findings,” said Francesca Barone, MD, PhD, Chief
Scientific Officer of Candel. “We demonstrated for the first time
the potential of CAN-2409 to engage the humoral arm of the immune
system, broadening the scope of the antitumoral immune response.
The correlations between early changes in key effector immune
populations after CAN-2409 treatment and survival suggest the
possibility to use early biological readouts as predictors of
clinical response.”
“Although ICIs have transformed initial therapy in NSCLC and
extended life for many patients, there still remains a serious
unmet need, especially in patients with low levels of PD-L1
expression,” said Charu Aggarwal, MD, MPH, Associate Professor for
Lung Cancer Excellence, Perelman School of Medicine, University of
Pennsylvania, and Co-Principal Investigator for the phase 2
clinical trial. “Most patients progress following ICI treatment and
options after progression are often associated with toxicity and
small treatment benefit. The report of today’s initial promising
data on survival gives us an insight into the potential of CAN-2409
to produce a sustained anti-tumor immune response and potentially
extend the lives of patients living with advanced NSCLC. I look
forward to the maturation of these overall survival data and
expected readout in Q2 2024.”
About CAN-2409CAN-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 intra-tumoral 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 NSCLC,
borderline resectable pancreatic cancer, and localized,
non-metastatic prostate cancer in ongoing clinical trials. The U.S.
Food and Drug Administration granted Fast Track designation for
CAN-2409 plus valacyclovir in combination with pembrolizumab in
order to improve survival or delay progression in patients with
stage III/IV NSCLC who are resistant to first line anti-PD(L)1
therapy and who do not have activating molecular driver mutations
or have progressed on directed molecular therapy.
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), 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.
About the Partnership for Accelerating Cancer
Therapies
The biomarker research in the phase 2 clinical trial of CAN-2409
in NSCLC is supported by the Partnership for Accelerating Cancer
Therapies (PACT), a project that supports research to identify,
develop, and validate robust biomarkers ‐ standardized biological
markers of disease and treatment response ‐ to advance new
immunotherapy treatments that harness the immune system to attack
cancer. PACT is overseen by the Foundation for the National
Institutes of Health. The pharmaceutical companies participating
that make funding for this project possible are: AbbVie, Amgen,
Boehringer Ingelheim, Bristol‐Myers Squibb, Celgene Corporation,
Genentech, Gilead, GlaxoSmithKline, Janssen/Johnson &
Johnson, Novartis, and Pfizer.
National Cancer Institute Support
Scientific and financial support for the CIMAC-CIDC Network is
provided through the National Cancer Institute (NCI) Cooperative
Agreements: U24CA224319 (to the Icahn School of Medicine at Mount
Sinai CIMAC), U24CA224331 (to the Dana-Farber Cancer Institute
CIMAC), U24CA224285 (to the MD Anderson Cancer Center CIMAC), and
U24CA224309 (to the Stanford University CIMAC).
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, 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 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
Candel Therapeutics (NASDAQ:CADL)
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Candel Therapeutics (NASDAQ:CADL)
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