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 highlighted recent successes across the Company's
immunotherapy portfolio and provided updates on multiple upcoming
milestones.
“Candel is innovating a new frontier in
immunotherapy, backed by promising clinical and biomarker data in
hard-to-treat indications with six data readouts expected this
year,” said Paul Peter Tak, MD PhD FMedSci, President and CEO of
Candel. “Candel is focused on delivering key value drivers to
maximize the impact of its assets and to create substantial value
to patients and other stakeholders. In 2023, we received Fast Track
Designation from the FDA for CAN-2409, our most advanced product
candidate, for both NSCLC and pancreatic cancer. Clinical data from
the ongoing phase 1 clinical trial of CAN-3110 in patients with
recurrent high-grade glioma have recently been published in Nature,
which further supports the scientific and clinical excellence of
Candel’s programs.”
Dr. Tak continued: “Beyond our promising drug
candidates that are being tested in the clinic, the novel enLIGHTEN
Discovery Platform has already demonstrated the capability to
generate experimental candidates, expanding Candel’s potential to
create value through novel collaborations to develop treatments for
diverse types of cancer. We are excited for our upcoming clinical
and scientific readouts in 2024.”
2024 Anticipated Data Readouts and Key
Catalysts:
Candel plans to announce 6 anticipated readouts
across its 3 platforms in 2024, which include novel clinical and
biomarker data in lung cancer, pancreatic cancer, brain cancer and
a potentially registrational phase 3 clinical trial in prostate
cancer.
- Phase 2 topline overall survival (OS) data for CAN-2409 in
NSCLC expected in Q2 2024
- Phase 2 updated overall survival data for CAN-2409 in
borderline resectable pancreatic cancer expected in Q2 2024
- New preclinical data on the second drug candidate from the
enLIGHTEN™ Discovery Platform expected by Q3 2024
- Phase 1 data for CAN-3110 in recurrent high-grade glioma
expected in 2H 2024 for the multiple injection cohort
- Phase 2 topline data for CAN-2409 in low-to-intermediate-risk,
localized, non-metastatic prostate cancer expected in Q4 2024
- Phase 3 topline data for CAN-2409 in localized
intermediate/high-risk prostate cancer expected in Q4 2024
These milestones present a compelling opportunity
for progress, success and significant differentiation, underscoring
the Company's dedication to advancing its therapeutic pipeline.
2023 Accomplishments:
- Phase 2 clinical trial of CAN-2409 in NSCLC
- In September 2023, the Company announced encouraging initial
activity and biomarker data from the phase 2 clinical trial of
CAN-2409 in NSCLC. Initial data suggests that ongoing survival is
consistent with an increased tail on the maturing survival curve.
Negative or low PD-L1 status appears to be associated with long
survival in CAN-2409 treated patients. Biomarker data suggests an
association between immune cell activation after the second
injection of CAN-2409 and subsequent survival.
- U.S. Food and Drug Administration (FDA) granted Fast Track
Designation for CAN-2409 plus valacyclovir in combination with
pembrolizumab to improve survival or delay progression in patients
with Stage III (not candidates for curative intent) or Stage IV
non-small cell lung cancer, 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.
- Phase 2 clinical trial of CAN-2409 in non-metastatic
pancreatic cancer
- In November 2023, the Company reported initial positive interim
clinical activity and biomarker data from a randomized, controlled
clinical trial where a notable increase in survival was observed in
patients with borderline resectable pancreatic ductal
adenocarcinoma (PDAC) after experimental treatment with CAN-2409.
Estimated OS rate at 36 months was 71.4% in patients treated with
CAN-2409 plus standard of care chemoradiation followed by resection
versus 16.7% in the control arm treated with standard of care
chemoradiation followed by resection. In patients with progressive
disease, there was both a CA19-9 and a survival response to salvage
chemotherapy in the CAN-2409 arm, but not in the control arm.
Safety analysis demonstrated that multiple injections of CAN-2409
were generally well tolerated, with no reported dose-limiting
toxicities and no reported cases of pancreatitis.
- FDA granted Fast Track Designation for CAN-2409 plus prodrug
(valacyclovir) for the treatment of patients with pancreatic ductal
adenocarcinoma to improve overall survival.
- Phase 1 clinical trial of CAN-3110 in high-grade
glioma
- In October 2023, Candel published results in Nature
demonstrating that CAN-3110 was well tolerated with no
dose-limiting toxicity reported. The investigators observed a
nearly doubling of the expected median (mOS) after a single
CAN-3110 injection, achieving a median OS 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). Increased infiltrating
immune cells in the tumor microenvironment and expansion of the T
cell repertoire after treatment were also associated with improved
survival, demonstrating the ability of CAN-3110 to elicit both a
local and systemic antitumoral response.
- enLIGHTEN™ Discovery Platform
- During the Society for Immunotherapy of Cancer (SITC) 2023
Annual Meeting and the International Oncolytic Virus Conference in
November 2023, Candel presented preclinical data from the first
experimental candidate from its discovery pipeline: Alpha
201-macro-1, an investigational, locally delivered biological
oncolytic therapeutic, designed to interfere with the CD47/SIRP1a
pathway, which demonstrated better inhibition of tumor growth when
compared to systemic anti-CD47 antibody therapy in a mouse model of
breast cancer.
Advancing the Immunotherapy Field
The Company is poised to advance the next generation of viral
immunotherapy, leveraging a data-driven approach to create new
assets by design and advance development of existing drug
candidates, creating new value inflection points.
“The data generated with CAN-3110 in recurrent high-grade glioma
represents a significant step forward in the development of
groundbreaking therapeutic candidates for this difficult to treat
disease,” said Francesca Barone, M.D. PhD, CSO, at Candel
Therapeutics. “At the same time, they provide initial proof of
concept for the expansion of CAN-3110 in other Nestin positive
indications. With the enLIGHTEN Discovery Platform, we are
leveraging our internal capabilities in advanced analytics, cancer
biology and vectorology to design a new class of multimodal
therapeutics that are able to overcome mechanisms of resistance
present in the tumor microenvironment. This platform is open for
collaborations with external partners.”
Operational Excellence and
Efficiency:
- The Company's strategic prioritization of programs highlights
Candel Therapeutics' commitment to operational excellence and
efficiency. This focus has translated into an extension of Candel
runaway, while providing the opportunity to generate preclinical
data in support of the expansion of CAN-3110 in novel indications,
to develop enLIGHTEN for external partnerships, and deliver on the
readouts of Candel’s advanced clinical trials.
- This approach positions the Company for sustained success in
the current dynamic market for new cancer therapeutics.
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. The
Company plans to explore the right partnering opportunities for the
future development of this asset.
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. In October 2023, 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 more than 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 the enLIGHTEN™ Discovery
Platform
The 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 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, expectations regarding the therapeutic benefit
of its programs, including the potential for its programs to extend
patient survival; 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
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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