DBV Technologies to Present New Data at ACAAI 2023

Rhea-AI Summary

DBV Technologies will present new data on the use of Viaskin Peanut in peanut-allergic toddlers at the ACAAI 2023 Annual Scientific Meeting. The data will include interim 12-month results from the ongoing Phase 3 open-label extension to the EPITOPE trial. Viaskin Peanut is the Company's lead product candidate designed to reduce the risk of allergic reactions to peanuts.

Montrouge, France, November 2, 2023

DBV Technologies to Present New Data at ACAAI 2023

• New data to include late-breaking abstract detailing interim 12-month results from the ongoing Phase 3 open-label extension to the EPITOPE trial (EPOPEX) of Viaskin™ Peanut in peanut-allergic toddlers.
  
  

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that new data on the use of Viaskin™ Peanut (DBV712) 250 μg in peanut-allergic toddlers will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, which is being held Thursday, November 9 – Monday, November 13, 2023, in Anaheim, CA.

A late-breaking oral abstract has been accepted by the ACAAI and will be presented on the interim 12-month results from the ongoing Phase 3 open-label extension to the EPITOPE trial (EPOPEX) trial of Viaskin™ Peanut in peanut-allergic toddlers. The presentation will be available on DBV’s website, www.dbv-technologies.com, following the conclusion of the meeting for those who are unable to attend.

This year’s meeting will also feature a “Product Theater” on Individualizing Peanut Allergy Management: A Case-based Panel Discussion. Drs. Douglas Mack, David Stukus, and Julie Wang will engage in a discussion around the factors influencing peanut allergy management, such as use of food challenges and effects of comorbidities, using various patient scenarios. The Product Theater is scheduled for Saturday, November 11, from 11:35 a.m. to 1:00 p.m. PST.

DBV is sponsoring the 32^nd Annual FIT Bowl, a game show-type competition that tests allergy, asthma, and immunology knowledge of participating teams from training programs around the country. The competition is set to be held on Saturday, November 11, from 5:45 p.m. to 7:45 p.m. PST. In addition, DBV is a 2023 ACAAI Benefactor Level Corporate Council Member. The Company will also host a booth in the ACAAI Exhibit Hall from Saturday, November 11 – Monday, November 13^th.

“We are very pleased to have a significant presence at ACAAI again this year and add to the growing body of data on the potential of Viaskin Peanut as a new treatment option for peanut-allergic toddlers,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “With no FDA approved treatments, toddlers and their families must practice avoidance, which can be stressful and can significantly impact quality of life. Our goal is to complete the remaining regulatory steps in support of a Biologics License Application (BLA) as quickly and efficiently as possible to potentially bring this novel treatment to these patients in need.”

DBV Abstracts:

Late Breaking Abstract Presentation

“EPOPEX, Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-allergic Toddlers: 1-year Open-Label Extension to EPITOPE” will be presented by Matthew Greenhawt, M.D., M.Sc., MBA, FACAAI, Children’s Hospital Colorado, Aurora, CO.

• Abstract ID: LB010
• Presentation Date: Saturday, November 11
• Presentation Time: 9:40 a.m. – 9:50 a.m. PST
• Session/location: Late-breaking Oral Abstracts - Session 1: Food Allergy; Exhibit Hall C – ePoster Area – LIVE Presentation Stage

Viaskin Peanut is the Company’s lead product candidate designed to reduce the risk of allergic reactions due to accidental exposure to peanuts. An investigational, non-invasive, once-daily epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to re-educate the immune system. The safety and efficacy of Viaskin Peanut have not yet been established by the U.S. Food and Drug Administration or the European Medicines Agency.

About DBV Technologies
DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies’ food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

Forward Looking Statements
This press release may contain forward-looking statements and estimates, including, but not limited to, statements regarding the therapeutic potential of Viaskin™ Peanut and EPIT™ and DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or project herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth herein can be found in DBV Technologies’ regulatory filings with the Autorité des Marchés Financiers (“AMF”), DBV Technologies’ filings and reports with the U.S. Securities and Exchange Commission (“SEC”), and future filings and reports made with the AMF and SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

Investor Contact
Katie Matthews
+ 1 (857) 529-2363
katie.matthews@dbv-technologies.com

Media Contact
Angela Marcucci
+1 646-842-2393
angela.marcucci@dbv-technologies.com 

Viaskin and EPIT are trademarks of DBV Technologies.

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FAQ

What data will DBV Technologies present at the ACAAI 2023 Annual Scientific Meeting?

DBV Technologies will present new data on the use of Viaskin Peanut in peanut-allergic toddlers, including interim 12-month results from the ongoing Phase 3 open-label extension to the EPITOPE trial.

What is Viaskin Peanut?

Viaskin Peanut is DBV Technologies' lead product candidate designed to reduce the risk of allergic reactions due to accidental exposure to peanuts. It is an investigational, non-invasive, once-daily epicutaneous patch.

Has the safety and efficacy of Viaskin Peanut been established?

No, the safety and efficacy of Viaskin Peanut have not yet been established by the U.S. Food and Drug Administration or the European Medicines Agency.