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 that, in the second quarter of 2024, it expects to report
topline overall survival data from its ongoing, open-label, phase 2
clinical trial of CAN-2409 plus valacyclovir in combination with
continued immune checkpoint inhibitor treatment (ICI) in patients
with non-resectable, stage III/IV non-small cell lung cancer
(NSCLC) who progressed while on treatment with PD-(L)1 inhibitor
therapy (Cohort 2).
“As we approach full enrollment of a cohort of
approximately 40 patients with documented radiographic progression
on PD-(L)1 inhibitor treatment, we expect that we will be able to
report topline overall survival data for this cohort in the second
quarter of 2024,” said Paul Peter Tak, MD, PhD, FMedSci, President
and Chief Executive Officer of Candel. “In conjunction with this
topline data, we will assess whether the effect on tumor biology
previously reported could translate into improved survival, which
we believe is what matters to patients and regulators. We remain
optimistic that this expected dataset could help initiate
discussions with regulators about a future potentially
registrational clinical trial in this indication of serious unmet
disease.”
Dr. Tak continued, “In the near-term, we continue
to expect to present additional clinical and immunological
biomarker activity data from this clinical trial in the third
quarter of this year. To date, we have reported mechanistic
evidence that CAN-2409 plus valacyclovir can induce a systemic
anti-tumor response in ICI inadequate responders, which had shown
improvement of injected and uninjected tumor size and an overall
beneficial effect on tumor growth over time.”
In 2022, the Company presented preliminary evidence
that CAN-2409 plus valacyclovir, when added to first line PD-(L)1
inhibitor therapy, in late-stage NSCLC patients showing
radiographic progression despite at least 18 weeks of ICI
treatment, is able to 1) induce local and systemic reduction in the
size of tumor lesions, with an abscopal effect in uninjected
lesions (Aggarwal C et al. J Clin Oncol 2022;40(16) Suppl:9037
[ASCO abstract]), and 2) change the tumor growth trajectory after
follow up, and significantly decrease the monthly rate of tumor
growth (Aggarwal C et al. Virtual R&D Day, December 2022).
These data supported the application for Fast Track designation,
granted by the U.S. Food and Drug Administration for this program
in April 2023. The Company remains on target to present additional
clinical and immunological biomarker activity data in the third
quarter of 2023. Based on enrollment rates and duration of
follow-up in Cohort 2, the Company expects to present topline data
for overall survival in this Cohort, a key clinical endpoint of
interest to regulatory bodies in this patient population, in the
second quarter of 2024.
CAN-2409 is an investigational off-the-shelf viral
immunotherapy designed to induce an individualized, systemic immune
response against the patient’s specific tumor. CAN-2409 plus
valacyclovir in combination with continued PD-(L)1 inhibitors is
being evaluated in an ongoing, open-label phase 2 clinical trial
(NCT04495153) in patients with non-resectable, stage III/IV NSCLC
and an inadequate response to ICI treatment.
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical
company focused on developing viral immunotherapies that elicit a
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. 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 CAN-3110 is the lead product
candidate from the HSV platform. 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 CAN-2409
CAN-2409, Candel’s most advanced viral
immunotherapy candidate, is a replication-defective adenovirus that
is designed to deliver the herpes simplex virus thymidine kinase
(HSV-tk) gene to cancer cells. 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 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 non-small
cell lung cancer, 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
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.
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 outcome of interactions with regulatory
authorities with respect to the Company’s product candidates and
programs and expectations regarding the therapeutic benefit of its
programs. 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; 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)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Candel Therapeutics (NASDAQ:CADL)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024