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 a strategic restructuring to focus on
continuation and expansion of development of CAN-3110 as well as
the enLIGHTEN™ Discovery Platform, while reducing the
Company’s workforce and expenses associated with enabling
commercial readiness of CAN-2409. The Company expects to present
initial activity and biomarker data for repeated injections of
CAN-3110 in recurrent high-grade glioma in the second half of 2024
and new data for the second drug candidate based on the
enLIGHTEN™ Discovery Platform in Q3 2024. The Company plans to
continue to collect clinical data for key readouts for CAN-2409 in
non-small cell lung cancer (NSCLC), with topline overall survival
data of the open label phase 2 clinical trial expected in Q2 2024;
pancreatic cancer, with an update on overall survival based on an
interim analysis of the randomized, open label clinical trial in Q2
2024; and prostate cancer, with topline data for both fully
enrolled randomized, blinded, placebo-controlled phase 2 and phase
3 clinical trials in Q4 2024.
Based on the encouraging clinical activity data for CAN-2409,
the large number of patients that might benefit from this
treatment, and the investments needed for commercialization, the
Company plans to explore the right partnering opportunities for the
future development of this asset.
To focus on delivering on the value-creating catalysts in 2024,
on November 28, 2023, Candel implemented a reduction in its
workforce of approximately 50%. The Company estimates that it will
incur a one-time restructuring charge of approximately $0.7 million
in the fourth quarter of 2023 related to severance and healthcare
and related benefits for terminated employees. Candel expects that
the reduction in workforce, coupled with the reduced operating
costs, will enable the Company’s existing cash resources to fund
its revised operating plan into the fourth quarter of 2024,
enabling the achievement of key catalysts next year.
“This decision, unfortunately, impacts our workforce,” said Paul
Peter Tak, MD PhD FMedSci, President and CEO of Candel. “I want to
express my sincere gratitude for the very important work and
valuable contributions of our departing employees. They have done
amazing work advancing the pipeline and developing our
investigational medicines. In the current market, we need to remain
laser focused on delivering on our value-creating inflections
points, while managing our expenditures. We have proof of mechanism
and proof of concept in each indication that we are currently
pursuing, and the value created in the past years will be leveraged
in the multiple data readouts planned for 2024.”
About the enLIGHTEN™ Discovery Platform
Candel’s enLIGHTEN™ Discovery Platform is a systematic,
iterative herpes simplex virus (HSV)-based discovery platform
leveraging human biology and advanced analytics to create new
multimodal biological immunotherapies for solid tumors. In October
2022, the Company announced a discovery collaboration with the
University of Pennsylvania Center for Cellular Immunotherapies to
identify how viral immunotherapy could enhance the efficacy of
CAR-T cell therapy in solid tumors. The enLIGHTEN™ Discovery
Platform is designed to deconvolute the complexity of the tumor
microenvironment to identify druggable properties that correlate
with clinical outcomes. These discoveries are rapidly translated
into optimized multi-gene payloads of tumor modulators that are
tailored for specific indications, disease stage, and rationally
designed therapeutic combinations. During the Society for
Immunotherapy of Cancer (SITC) 2023 Annual Meeting and the
International Oncolytic Virus Conference in November 2023, Candel
presented encouraging data on the discovery pipeline, demonstrating
the effects of Alpha 201-macro-1, an investigational locally
delivered biological oncolytic therapeutic designed to interfere
with the CD47/SIRP1a pathway, in a mouse model of breast
cancer.
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 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. Earlier this month, the Company announced that Nature
published results from this 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 treated with CAN-3110 was over 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 H2 2024.
Candel will also initiate IND-enabling work in a second
indication characterized by Nestin expression.
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,
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.
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 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 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 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
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, the estimated charges and costs expected
to be incurred in connection with the Company’s strategic
restructuring efforts, the anticipated cost savings resulting from
the Company’s strategic restructuring efforts, the Company’s
potential pursuit of a strategic partnership for the development of
CAN-2409, and the Company’s cash runway. 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, results and costs related to
the Company’s strategic restructuring efforts; 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
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