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 that the U.S. Food and Drug Administration
(FDA) has granted Orphan Drug Designation to CAN-2409, Candel’s
most advanced multimodal biological immunotherapy candidate, for
the treatment of pancreatic cancer.
“We recently reported data from the phase 2
randomized clinical trial of CAN-2409 in borderline resectable
pancreatic cancer, showing that CAN-2409, when added to standard of
care, more than doubled the median overall survival obtained with
standard of care alone,” said Paul Peter Tak, MD, PhD, FMedSci,
President and Chief Executive Officer of Candel. “We are pleased
that the FDA has now granted Candel with both Orphan Drug and Fast
Track Designation to this program, as we seek to reshape the
treatment paradigm in pancreatic cancer.”
“Obtaining Orphan Drug Designation marks a
significant milestone for Candel, as we continue to develop
CAN-2409 for pancreatic cancer,” said Garrett Nichols. M.D., M.S.,
Chief Medical Officer at Candel. “We are excited by this FDA
designation, which further supports Candel’s efforts in the
development of medicines to cure less prevalent yet challenging to
treat cancers. The evidence base for CAN-2409 is growing, as we
read out clinical trials in patients with difficult-to-treat
cancers, such as our recent results in pancreatic ductal
adenocarcinoma, and non-small cell lung cancer later in the current
quarter.”
Earlier this month, Candel reported updated
overall survival 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). The
observed data from a March 29, 2024 cut-off showed notable
improvement in estimated median overall survival of 28.8 months
after experimental treatment with CAN-2409 versus only 12.5 months
in the control group. At 24 months, survival rate was 71.4% in
CAN-2409 treated patients versus only 16.7% in the control group
after chemoradiation. At 36 months, estimated survival was 47.6% in
the CAN-2409 group versus 16.7% in the control group. No new safety
signals were observed, providing further support that multiple
injections of CAN-2409 were generally well tolerated, with no
dose-limiting toxicities and no cases of pancreatitis. Analysis of
resected tumors showed treatment with CAN-2409 modified the tumor
microenvironment, with the local recruitment and activation of
cytotoxic lymphocytes and increased levels of proinflammatory
cytokines, supporting the activation of a robust systemic
anti-tumor immune response.
About Orphan Drug
Designation
Orphan Drug Designation is granted by the FDA to
drugs or biologics intended to treat a rare disease or condition,
defined as one that affects fewer than 200,000 people in the United
States. Orphan Drug Designation provides certain financial
incentives to support clinical development, and the potential for
up to seven years of marketing exclusivity for the product for the
designated orphan indication in the United States if the product is
ultimately approved for its designated indication.
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 tumor and induce an individualized, systemic anti-tumor
immune response. HSV-tk is an enzyme that locally converts orally
administered valacyclovir into a toxic metabolite that kills nearby
cancer cells, resulting in the release of a wide variety of cancer
antigens. At the same time, the adenoviral serotype 5 capsid
protein has the potential to elicit a pro-inflammatory response in
the tumor microenvironment. 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. As a result, CAN-2409 is an
off-the-shelf drug candidate, designed to result in an
individualized anti-tumor immune response with the potential to
treat a broad range of solid tumors. Encouraging monotherapy
activity as well as combination therapy activity with SoC
radiotherapy, surgery, chemotherapy, and immune checkpoint
inhibitors have previously been shown in several preclinical and
clinical settings. Furthermore, to date, more than 1,000 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 PDAC, and localized, non-metastatic prostate
cancer. CAN-2409 has been granted Fast Track Designation by the FDA
for treatment of PDAC, stage III/IV NSCLC in patients 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, and treatment of localized, primary
prostate cancer in combination with radiotherapy to improve the
local control rate, decrease recurrence and improve disease-free
survival. Candel’s pivotal phase 3 clinical trial in prostate
cancer is being conducted under a Special Protocol Assessment by
FDA.
About Pancreatic Ductal Adenocarcinoma
(PDAC)
Pancreatic cancer is a highly lethal form of
cancer, and it 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. Effective therapeutics
for pancreatic cancer, including PDAC, which accounts for 90% of
all pancreatic carcinomas, are urgently needed.
Surgical resection offers the only chance of
cure; thus, a major therapeutic goal for patients 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 pancreatic cancer. The addition of
adjuvant chemotherapy has been shown to improve survival rates only
slightly. To this end, there has been an increase in use of
neoadjuvant chemotherapy and chemoradiation regimens for patients
with borderline resectable PDAC. Neoadjuvant regimens are intended
to debulk the tumor, thereby increasing the proportion of patients
who may become eligible for surgical resection and potentially
achieve complete resection. Unfortunately, cures often remain
elusive as most patients experience disease recurrence due to
residual micrometastatic disease.
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 PDAC (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 1b clinical
trial in recurrent high-grade glioma (rHGG). 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;
expectations regarding the therapeutic benefit of the Company’s
programs, and the ability of CAN-2409 to improve the median overall
survival of patients with PDAC; and expectations regarding the
potential benefits conferred by Orphan Drug Designation and Fast
Track Designation. 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; the Company’s ability to
continue as a going concern; expectations regarding the therapeutic
benefit of the Company’s programs; that final data from the
Company’s 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, including strategic plans for the
Company’s business and product candidates; and other risks
identified in the Company’s filings with the U.S. Securities and
Exchange Commission (SEC) including the Company’s most recent
Annual Report on Form 10-K 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 of the date
hereof and should not be relied upon as representing its views as
of any subsequent date.
Investor ContactTheodore JenkinsVP
Investor Relations and Business DevelopmentCandel Therapeutics,
Inc.Tjenkins@candeltx.com
Media ContactAljanae
ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
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