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-3110, a next
generation oncolytic viral immunotherapy, for the treatment of
recurrent high-grade glioma (rHGG). Glioblastoma (GBM) is the most
common and aggressive form of high-grade glioma.
CAN-3110 was previously granted Fast Track
Designation by the FDA for the treatment of rHGG. Candel is
currently evaluating CAN-3110 in a multi-institutional phase 1b
clinical trial in rHGG. Results from Arm A of the ongoing phase 1b
clinical trial in rHGG exploring the clinical and biomarker
activity of a single dose administration of CAN-3110 were published
in Nature, demonstrating a strong anti-tumoral response associated
with extended survival.1 The Company will present data on the
feasibility and safety of multiple doses of CAN-3110 in patients
with rHGG, supported by the Break Through Cancer Foundation, in a
trials-in-progress poster presentation at the 2024 ASCO Annual
Meeting.
“Building on the momentum of the FDA’s Fast
Track Designation, recently granted to this program, the Orphan
Drug Designation for CAN-3110 further reinforces the potential of
this therapy and underscores the urgent need for novel and
effective treatments for patients with rHGG,” said Paul Peter Tak,
MD, PhD, FMedSci, President and Chief Executive Officer of Candel.
“This designation not only reinforces our commitment to offering
new hope and potential patient treatment options, but it also
enables us to leverage development incentives and accelerate our
efforts to evaluate new indications in the clinic. We are
continuing our work in the phase 1b clinical trial of CAN-3110 and
look forward to sharing further clinical updates in the second half
of 2024.”
E. Antonio Chiocca, M.D., Ph.D., Chair of the
Department of Neurosurgery at Brigham and Women's Hospital,
Professor at Harvard Medical School, and Principal Investigator on
the phase 1b clinical trial, said: “We are grateful to the FDA for
recognizing the urgent need for new treatments in rHGG. Patients,
and their families, affected by this disease, face immense
challenges that the standard of care and conventional therapies
have failed to adequately address. The early clinical data suggests
that CAN-3110's unique dual mechanism of action, combining
oncolysis and immune activation, has the potential to overcome
these challenges for rHGG patients.”
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-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 designed to be
conditional to the expression of Nestin in cancer cells. CAN-3110
is being evaluated in a phase 1b clinical trial in patients with
recurrent high-grade glioma (rHGG). In October 2023, the Company
announced that Nature published results from this ongoing clinical
trial. CAN-3110 was well tolerated with no dose-limiting toxicity
reported. In the clinical trial, the investigators observed median
overall survival after a single CAN-3110 injection of more than 12
months in this therapy-resistant condition.1 The Company and
academic collaborators are currently evaluating the effects of
multiple CAN-3110 injections in rHGG, supported by the Break
Through Cancer Foundation. CAN-3110 has previously received FDA
Fast Track Designation for the treatment of rHGG.
Details on the CAN-3110 ASCO poster are
as follows:
The trials-in-progress poster presentation will
focus on cohort C of the ongoing phase 1b clinical trial of
CAN-3110 in patients with rGBM, the most common form of rHGG.
Previously presented data showed the ability of a single CAN-3110
injection to double median overall survival (mOS) in the rGBM
population, as compared to contemporary control cohorts. Patients
presenting with seropositivity to HSV1, reached mOS of 14 months,
largely exceeding expected survival of 6 to 9 months or less for
this population.
In cohort C, supported by the Break Through
Cancer Foundation, two cohorts of 12 patients will receive up to
six injections of CAN-3110 over a four-month period. Cohort C is
currently exploring the safety and tolerability of CAN-3110 in
patients with rGBM. Patients in cohort C are treated with up to six
doses of CAN-3110 delivered by stereotactic injections on days 0,
15, 30, 60, 90 & 120, along with concomitant biopsies over the
four-month treatment period.
Two sub-cohorts (1&2) of patients who will
receive 1x107 pfu or 1x108 pfu per injection of CAN-3110 have been
planned for six patients per cohort, using a Bayesian optimal
interval (BOIN) design for dose ranging.
- Six patients have accrued, completing cohort 1; no
dose-limiting toxicities or severe adverse events were
observed.
- More than 300 core biopsies were obtained from all six patients
across the planned time points.
- Biopsies were processed for “-omic” analyses, including
single-cell RNA sequencing,
proteomics/phophoproteomic/immunopeptidomics, metabolomics, spatial
transcriptomics, and cell profiling.
ASCO Presentation details
are as follows:
- Trials-in-Progress Poster Presentation
Title: Longitudinal stereotactic injections of
oncolytic immunoactivating rQNestin34.5v.2 (CAN-3110) with
concomitant biopsies for “-omic” analyses in recurrent glioblastoma
(GBM)
- Presenter: David A. Reardon, MD,
Professor of Medicine at Harvard Medical School; Clinical Director,
Center for Neuro-Oncology at Dana Farber Cancer Institute
- Session Title: Poster Session – Central
Nervous System Tumors
- Session Date/Time: Saturday, June 1,
2024; 9:00 AM - 12:00 PM CT
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 phase 1b clinical trial in 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, key data
readout milestones, and expectations regarding the therapeutic
benefit of the Company’s programs, including the potential for
CAN-3110 to extend survival of patients with rHGG; 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 therapeutics 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 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.
Investor Contact:Theodore
JenkinsVP, Investor Relations and Business DevelopmentCandel
Therapeutics, Inctjenkins@candeltx.com
Media Contact:Kyle EvansICR
WestwickeCandelPR@westwicke.com
____________________
[1] Ling AL, et al. Nature.
2023;623(7985):157-166.
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