DBV Technologies S.A. operates as a clinical-stage specialty biopharmaceutical company. The company focuses on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT, its proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch).
The company has generated significant data...
DBV Technologies S.A. operates as a clinical-stage specialty biopharmaceutical company. The company focuses on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT, its proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch).
The company has generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated. Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. The company is advancing this unique technology to treat children suffering from food allergies for whom safety is paramount since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock.
The company’s most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. The company also has an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy, as well as two planned Phase 3 supplementary safety studies, one in peanut-allergic children ages four through seven, and one in peanut-allergic toddlers, ages one through three.
The company has earlier-stage food allergy programs including Viaskin Milk, which is in Phase 2 of clinical development for Cow’s Milk Allergy and Eosinophilic Esophagitis, or EoE.
Strategy
The key elements of the company’s strategy are to pursue the continued development of Viaskin Peanut for toddlers and children with peanut allergy; seek regulatory approval for Viaskin Peanut in the United States and the European Union; advance the clinical development of additional Viaskin product candidates in the United States and other major markets; and build a broad immunotherapy product pipeline with its innovative Viaskin technology platform.
Product Candidates
The company’s product development strategy is based on leveraging Viaskin’s clinical potential. The company selects its target product candidates with the aim to address allergies that have high unmet medical needs.
Viaskin Peanut for children ages 4-11
The company’s lead product candidate, Viaskin Peanut, has completed a global Phase 3 development program for the treatment of peanut allergic patients four to 11 years of age.
EPITES (Peanut EPIT Efficacy and Safety Study)
In December 2015, the company initiated a pivotal Phase 3 trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 µg in children four to 11 years of age suffering from peanut allergy. PEPITES was a global, randomized 2:1, double-blind, placebo-controlled Phase 3 trial, in which 356 pediatric peanut-allergic patients were treated with Viaskin Peanut 250 µg or placebo for 12 months.
Results of PEPITES Trial
In October 2017, the company announced topline results from PEPITES, in which it observed a statistically significant response with a favorable tolerability profile, with 35.3% of patients responding to Viaskin Peanut 250 µg after 12 months of treatment as compared to 13.6% of patients in the placebo arm.
With respect to CRD, a key secondary endpoint which measures threshold reactivity during the DBPCFC, the company observed that at month 12, patients treated with Viaskin Peanut 250 µg or placebo reached a mean CRD of 906 mg (median 444 mg) and 361 mg (median 144 mg) of peanut protein, respectively. Patients in the active and placebo arms entered the trial at similar sensitivity levels; mean CRD at baseline was 211.7 mg (median 144 mg) in the Viaskin Peanut arm and 212.5 mg (median 144 mg) in the placebo arm.
REALISE (REAL Life Use and Safety of EPIT)
In November 2016, the company initiated a Phase 3 trial in peanut-allergic children four to 11 years of age designed to assess the use and safety of Viaskin Peanut 250 µg in routine clinical practice.
In March 2017, the company announced the completion of enrollment in REALISE, which randomized 393 subjects in 32 centers across North America.
After the initial blinded six-month period, 97.5% of subjects in both the placebo and active arms opted into an open-label portion of the study, which continued monitoring subjects for a total of 36 months of active treatment.
Viaskin Peanut for Children ages 1-3
The company is also developing Viaskin Peanut for the treatment of peanut allergy in toddlers one to three years of age, given the high unmet need and absence of approved treatments for this population. This program is independent from the Viaskin Peanut Program in 4–7-year-olds and uses the cVP (original patch).
In August 2017, the company initiated Part A of the EPITOPE (EPIT in Toddlers with Peanut Allergy) trial of Viaskin Peanut. EPITOPE is a two-part, pivotal Phase 3 clinical trial assessing the safety and efficacy of Viaskin Peanut for the treatment of peanut-allergic toddlers one to three years of age.
In September 2018, the company announced that the independent data safety and monitoring board, or DSMB, completed its review of Part A of EPITOPE and recommended that the dose of Viaskin Peanut 250 µg be evaluated in Part B. On October 26, 2018, the company announced that the first subject was enrolled in Part B of EPITOPE.
On June 26, 2020, the company announced that in Part A, subjects in both treatment arms showed consistent treatment effect after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results.
In June 2022, the company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms.
Supplemental Safety Study in Toddlers (COMFORT Toddlers)
In April 2023, the company received pre-BLA Type B Meeting Written Responses from the FDA related to the Viaskin Peanut program in toddlers.
In July 2023, the company received Type C Meeting Written Responses from the FDA regarding key study design elements for the COMFORT Toddlers supplemental safety study. In summary, COMFORT Toddlers will be a 6-month Double-Blind, Placebo-Controlled (DBPC) study involving approximately 400 toddlers, aged 1 through 3 years, randomized at a 3:1 ratio (active to placebo) with a 12-month open-label extension. Subsequently, in October 2023, the company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Toddlers.
Viaskin Peanut for Children ages 4-7
The company will evaluate the modified (circular) Viaskin Peanut patch in children ages 4-7 years with peanut allergy in two Phase 3 clinical trials with the intent for the trials to support a future BLA submission in this age group.
VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy)
On September 7, 2022, the company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy. The company defineds initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB) approval and Ethics Committee (EC) opinion.
On September 21, 2022, the company announced it had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission.
On December 23, 2022, the company announced the FDA lifted the partial clinical hold and confirmed it satisfactorily addressed all clinical hold issues.
On March 7, 2023, the company announced screening of the first subject in VITESSE. Screening of the last subject was anticipated in the first half of 2024, and topline results are anticipated in the first half of 2025.
Viaskin Milk
The company’s second product candidate, Viaskin Milk, is in development for the treatment of cow’s milk protein allergy, (IgE-mediated) or CMPA, in children two to 17 years of age, and received fast track designation from the FDA in 2016. In November 2014, the company initiated a multi-center, double-blind, placebo-controlled, randomized Phase 1/2 dose-finding trial to study the safety and efficacy of Viaskin Milk in 198 subjects with Immunoglobulin E, or IgE, mediated CMPA, which it refers to as the Milk Efficacy and Safety, or MILES, trial. The MILES (Milk Efficacy and Safety) clinical trial was designed to determine a safe and effective dose in two age groups: children ages two to 11 and adolescents ages 12 to 17. In February 2018, the company announced topline results from Part B of the MILES study.
Other Applications for the Viaskin Platform
In addition to its development programs in food allergies, the company has explored the use of its Viaskin technology for the treatment of inflammatory and autoimmune diseases with high unmet medical need. Human proof-of-concept trials have been conducted with Viaskin in EoE and as a booster vaccination against Bordetella pertussis, or whooping cough, in healthy adults. The company’s other earlier stage research programs have included vaccination for respiratory syncytial virus (RSV), as well as potential treatments for inflammatory bowel disease (IBD), celiac disease and type I diabetes.
Diagnostic Tool Development
In May 2016, the company entered into a Development Collaboration and License Agreement (the Collaboration Agreement) with Société des Produits Nestlé S.A. (NESTEC).
Potential Biomarker Applications
The company is continuing to explore other cellular mechanisms modulated by EPIT, such as biomarkers, in collaboration with external companies and academic institutions in both the United States and EU.
Manufacturing and Supply
Proprietary Viaskin Technology
The company has engineered a proprietary manufacturing technology for Viaskin patch, which is designed to comply with the most stringent pharmaceutical production standards, including those promulgated by the FDA, in order to enable Viaskin to deliver proteins via intact skin. This novel pharmaceutical process, which was fully developed by it, uses an electrospray to spray homogeneous, thin, dry protein layers onto the Viaskin patch.
Viaskin is a Highly Scalable Manufacturing Technology
The company relies on a single contract manufacturer to manufacture and supply the active pharmaceutical ingredients (API) used in its Viaskin product candidates. On February 1, 2018, the company entered into a Master API Supply Agreement with Sanofi which sets forth the terms and conditions governing the manufacture and supply of peanut, milk and egg API to be used in its Viaskin product candidates.
The company relies on a single contract manufacturer, FAREVA Amboise (FAREVA), to manufacture and supply clinical and commercial batches of Viaskin Peanut patches.
Intellectual Property
The company’s patent portfolio includes pending patent applications and issued patents in the United States and in foreign countries. To date, patents directed to the Viaskin electrostatic patch, as well as allergen desensitization methods, have been issued in the major markets, including in particular the United States, Europe, Canada and Australia. The company also has extensive know-how and trade secrets covering part of the Viaskin patch manufacturing method using electrospray technology.
These patents and applications generally fall into five broad categories:
two U.S. patents, which the company owns, relating to the Viaskin electrostatic patch and its use, which expired in 2022;
patents and patent applications which the company owns relating to its electrospray method of manufacturing the Viaskin electrostatic patch, which may expire as early as 2029;
patents and patent applications the company co-owns with Assistance-Publique-Hôpitaux de Paris, or AP-HP, and the Université Paris Cité relating to the treatment of peanut, milk, egg, and other allergies using its Viaskin patch technology, which may expire as early as 2028;
design patents and patent applications, which the company owns relating to various components of the Viaskin patch, which may expire as early as 2038; and
a variety of other patent applications that the company owns or co-owns relating, for example, to prophylactic uses of the Viaskin patch technology and to treatment of other indications using the Viaskin patch technology.
U.S. Patent Term Extension and Marketing Exclusivity
Depending upon the timing, duration, and specifics of the FDA approval of the company’s product candidates, some of its U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments.
Co-Ownership Agreement
AP-HP and Université Paris Cite
In December 2008, the company entered into an assignment, development and co-ownership agreement with AP-HP and Université Paris-Descartes, which through a merger and a name change became Université Paris Cite, by which it agreed to terms of co-ownership with AP-HP and Universite Paris Cite of certain U.S. and foreign patents and patent applications, referred to herein as the shared patents.
Research and Development
In the year ended December 31, 2023, the company spent $60.2 million in research and development expenses to advance the development of its product candidates.
Government Regulation
The company’s product candidates must be approved by the FDA through the Biologics License Application, or BLA, process before they may be legally marketed in the United States. The company relies and expects to continue to rely, on third parties for the production of clinical and commercial quantities of its products in accordance with current good manufacturing practices (cGMP) regulations.
History
DBV Technologies S.A. was founded in 2002. The company was incorporated as a societe par actions simplifiee (S.A.S.) under the laws of the French Republic in 2002.