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 topline overall survival data from its
phase 2 clinical trial of CAN-2409, a multimodal biological
immunotherapy candidate, plus valacyclovir (prodrug), together with
standard of care (SoC) immune checkpoint inhibitor (ICI) therapy in
patients with Stage III/IV non-small cell lung cancer (NSCLC)
inadequately responding to ICI (anti-PD-(L)1) therapy. The
data will be presented at the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting, to be held in Chicago, May 31 to
June 4, 2024, by Charu Aggarwal, MD, MPH, FASCO, Leslye M. Heisler
Associate Professor for Lung Cancer Excellence at the Perelman
School of Medicine, University of Pennsylvania and Co-Principal
Investigator of the clinical trial.
Highlights of the presentation include: 1)
median overall survival (mOS) of 20.6 months achieved in patients
with progressive disease despite ICI treatment after two
administrations of CAN-2409 plus prodrug; for context, in a 2022
publication of a clinical trial in a similar patient population,
mOS in the control arm that received SoC docetaxel-based
chemotherapy was 11.6 months; improved survival was observed across
both PD-(L)1 positive and PD-(L)1 negative tumors; 2) beneficial
effect on both injected and uninjected tumors in more than 70% of
the patients with metastatic disease and at least one uninjected
tumor; and 3) a significant increase in circulating CD8+ cytotoxic
and CD4+ effector and central memory T cells and increased soluble
granzyme B levels in peripheral blood after the second (‘booster’)
injection of CAN-2409, associated with subsequent prolonged
survival (in each case, as of an April 1 data cut-off). Together,
these data continue to support the emerging differentiated profile
of CAN-2409 in this difficult-to-treat condition.
“The results from our phase 2 trial in NSCLC
continue to support the tremendous promise of CAN-2409 across
multiple solid tumors. We are particularly encouraged by the
overall survival observed in the patients whose disease had
progressed despite receiving prior anti-PD-(L)1 treatment. Improved
overall survival is, ultimately, what matters to patients and to
the regulators,” said Paul Peter Tak, MD, PhD, FMedSci, President
and Chief Executive Officer of Candel. “These results, together
with our recently reported overall survival data in a randomized
clinical trial in pancreatic cancer, add to the growing body of
evidence supporting the notion that CAN-2409 treatment may convert
progressive cancer into stable disease associated with survival
benefit in advanced cancers with high unmet medical
needs.”
Previously, the Company received FDA Fast Track
Designation for CAN-2409 in NSCLC and pancreatic cancer as well as
orphan drug designation in pancreatic cancer.
“Current therapeutic options for advanced NSCLC
patients whose disease progresses despite ICI treatment are
limited; they are characterized by poor tolerability and limited
clinical benefit,” said Charu Aggarwal, MD, MPH, FASCO. “The data
reported today suggest that CAN-2409 can reactivate these patients’
exhausted immune systems, including those with low PD-(L)1
expression. This systemic anti-tumor immune response translated to
a durable response; increased numbers of circulating cytotoxic and
memory T cells were associated with subsequent prolonged survival.
I look forward to the continued development of CAN-2409 in NSCLC as
a promising approach in an area of unmet therapeutic need.”
ASCO presentation highlights:
- The open
label phase 2 clinical trial evaluated the efficacy and safety of
the combination of CAN-2409 plus prodrug (valacyclovir) and
continued, unaltered ICI therapy in patients with an inadequate
response to ICI after at least 18 weeks of treatment. The objective
of the analysis presented at ASCO was to explore whether
experimental treatment with CAN-2409 plus prodrug could improve mOS
in patients treated with two injections.
- 46
patients received two administrations of CAN-2409 plus prodrug and
were evaluable per protocol.
Cohort 1 |
Stable Disease at Study Entry |
n=5 |
Cohort 2 |
Progressive Disease at Study Entry |
n=41 |
|
|
|
- Demographic characteristics of the safety population:
Age |
Years |
Median (Range) |
67 (43-88) |
Sex |
n (%) |
Female |
32 (44) |
Male |
41 (56) |
PD-(L)1 Expression |
n (%) |
<1% |
35 (48) |
1-49% |
15 (21) |
> 50% |
19 (26) |
Unknown |
4 (5) |
Histology |
n (%) |
Squamous |
16 (22) |
Non-Squamous |
57 (78) |
Treatment regimen at enrollment |
n (%) |
Single ICI |
50 (68) |
ICI plus pemetrexed |
23 (32) |
|
|
- We confirmed previously released data on the ability of
CAN-2409 to control disease, with a disease control rate of 100% in
cohort 1 and 70% in cohort 2 patients.
- As of April 1, 2024, mOS of 22.0 months was observed across all
46 patients who had an inadequate response to ICI (both cohorts 1
and 2).In patients with progressive disease despite ICI treatment
(cohort 2), a mOS of 20.6 months was observed. A 2022 publication
of a clinical trial in a similar patient population reported mOS of
11.6 months for SoC docetaxel-based chemotherapy.1
- Improved
mOS was observed in both PD-(L)1 negative and PD-(L)1 positive
tumors in patients with progressive disease (n=37 patients in
cohort 2 for which PD-(L)1 status at baseline was available).
PD-(L)1 Subgroup |
Number of Patients |
mOS (months) |
Negative (<1%) |
16 |
24.5 (7.0, NA) |
Positive (>=1%) |
21 |
20.6 (5.5, NA) |
|
|
|
- 71.4% of patients with metastatic disease and at least one
uninjected tumor (n=35) experienced a beneficial effect on both
injected and uninjected tumors, indicating a systemic anti-tumor
immune response. When using a threshold of >5% decrease, more
than 60.0% of patients showed an abscopal response.
- Increased numbers of circulating CD8+ cytotoxic and CD4+
effector and central memory T cells as well as elevated levels of
soluble granzymes B and H after the second CAN-2409 injection were
associated with subsequent prolonged survival, underpinning the
systemic immune response elicited by CAN-2409 treatment.
- Treatment with CAN-2409 in NSCLC continued to exhibit a
favorable safety and tolerability profile. Bronchoscopic delivery
of CAN-2409 is an extension of existing care for patients with
NSCLC. As of April 1, 2024, there were no dose-limiting toxicities
or grade 4 or higher treatment-related adverse events (TRAEs); the
majority of TRAEs were grade 1 or 2, and there were three grade 3
TRAEs (one pyrexia, two pneumonitis).
Details on the CAN-2409 ASCO abstract are as
follows:
- Poster Presentation Title: Overall survival
after treatment with CAN-2409 plus valacyclovir in combination with
continued ICI in patients with stage III/IV NSCLC with inadequate
response to ICI
- Presenter: Charu Aggarwal, MD, MPH, FASCO,
Leslye M. Heisler Associate Professor for Lung Cancer Excellence,
Perelman School of Medicine, University of Pennsylvania
- Session Title: Poster Session – Lung Cancer –
Non-Small Cell Metastatic
- Session Date/Time: Monday, June 3, 2024; 1:30
PM – 4:30 PM CT
- Location: Hall A, McCormick Place Convention
Center, Chicago, IL
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 tumor. 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. 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 CAN-2409 in
NSCLC, borderline resectable PDAC, and localized, non-metastatic
prostate cancer in ongoing clinical trials. CAN-2409 plus prodrug
(valacyclovir) has been granted Fast Track Designation by the U.S.
Food and Drug Administration (FDA) for the 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
localized primary prostate cancer. Candel’s pivotal phase 3
clinical trial in prostate cancer is being conducted under a
Special Protocol Assessment with the FDA. The FDA has also granted
Orphan Drug Designation to CAN-2409 for the treatment of PDAC.
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 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 expectations regarding the therapeutic benefit of the
Company’s programs, including the potential to use CAN-2409 across
multiple solid tumors and the potential for CAN-2409 to extend
patient survival in pancreatic cancer. 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,
Inc.tjenkins@candeltx.com
Media Contact: Kyle EvansICR
WestwickeCandelPR@westwicke.com
_______________1 Reckamp KL, et al. J Clin Oncol.
2022;40(21):2295-2306.
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