Candel Therapeutics Announces Upcoming Presentations at the 2024 ASCO Annual Meeting
25 Avril 2024 - 2:00PM
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 two abstracts were accepted for
presentation at the 2024 American Society of Clinical Oncology
(ASCO) Annual Meeting taking place May 31 to June 4, 2024, in
Chicago, IL. The first presentation will feature data from the
ongoing phase 1 clinical trial of CAN-3110 in patients with
recurrent high-grade glioma. The presentation will focus on
patients recruited in cohort C, treated with multiple injections of
CAN-3110 (up to six), demonstrating that this approach is both
feasible and well tolerated. The second presentation will show
topline overall survival data from the phase 2 clinical trial of
CAN-2409 plus valacyclovir, in combination with continued immune
checkpoint inhibitor (ICI) treatment in patients with
non-resectable, stage III/IV non-small cell lung cancer (NSCLC) who
have an inadequate response to front line anti-PD(L)1 therapy.
Details are as follows:
CAN-3110 – Recurrent High-Grade Glioma
- 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
- Location: Hall A, McCormick Place Convention
Center, Chicago, IL
CAN-2409 – Non-Small Cell Lung
Cancer
- 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, 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
Full abstracts will be released by ASCO on Thursday, May 23,
2024, at 5:00 PM ET. Details from the presentations will be
available following the events on the Candel website
at https://www.candeltx.com/media/.
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 Standard of
Care (SoC) radiotherapy, surgery, chemotherapy, and ICI, 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 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
ductal adenocarcinoma (PDAC), and localized, non-metastatic
prostate cancer. CAN-2409 has been granted Fast Track Designation
by the U.S. Food and Drug Administration (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. The FDA has
also granted Orphan Drug Designation to CAN-2409 for the treatment
of PDAC.
About CAN-3110CAN-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 HGG (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 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 rHGG,
supported by the Break Through Cancer Foundation.
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; and
expectations regarding the therapeutic benefit of the Company’s
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; 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
hereof date 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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