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Celldex Announces Upcoming Late Breaking Oral Presentation of 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Inducible Urticaria at ACAAI 2024

Key Takeaway: Celldex Therapeutics has announced that results from its Phase 2 clinical trial of barzolvolimab for treating chronic inducible urticaria will be presented at the ACAAI Annual Scientific Meeting. The findings will highlight the efficacy and safety of barzolvolimab in addressing two prevalent forms of this condition: cold urticaria and symptomatic dermographism. The presentation is set for October 26, 2024, and may attract significant interest from the medical community given the commonality and impact of these urticaria types.

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful Phase 2 trial results presented at a prominent conference
  • Focus on common forms of chronic inducible urticaria
  • Potential for transformative therapeutics for patients with severe conditions

CONCERNS & RISKS

  • Risks and uncertainties regarding completion of future clinical trials
  • Challenges in gaining regulatory approvals
  • Dependence on sole suppliers for clinical materials

Full Press Release Details

HAMPTON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD)—will be presented in a late breaking oral presentation at the American College of Allergy, Asthma & Immunology's (ACAAI) Annual Scientific Meeting being held in Boston October 24-28, 2024.
Presentation details are as follows:
Abstract Title: Positive Efficacy and Favorable Safety of Barzolvolimab in Chronic Inducible Urticaria: Phase 2 Trial Results
Presenting Author: Jonathan Bernstein, MD, Professor of Clinical Medicine, Department of Internal Medicine, Division of Rheumatology, Allergy and Immunology, University of Cincinnati Medical Center and Partner, Bernstein Allergy Group and Clinical Research Center
Session: LBA003: Distinguished Industry & Late-breaking Oral Abstracts
Date/Time: Saturday, October 26th at 5:43 pm ET
About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Visit www.celldex.com.
Forward Looking Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Senior Vice President, Corporate Affairs & Administration

Frequently Asked Questions

What is the focus of Celldex Therapeutics' recent trial?

The trial focuses on barzolvolimab for chronic inducible urticaria.

When will the trial results be presented?

Results will be presented on October 26, 2024, at 5:43 pm ET.

Who is presenting the trial findings?

Dr. Jonathan Bernstein will present the findings.

What are the forms of CIndU studied in the trial?

The trial studies cold urticaria and symptomatic dermographism.

Where is the presentation taking place?

The presentation is at the ACAAI Annual Scientific Meeting in Boston.

Last updated: Oct 25, 2024