REGN1908-1909 / Regeneron, Sanofi - LARVOL DELTA

Innovative Strategies to Reduce Exposure and Expression of the Major Cat Allergen Fel d 1. (PubMed, Clin Transl Allergy) - "This review summarizes innovative methods for reducing Fel d 1 production in cats, including genetic, immunological and dietary approaches, with potential implications for allergy prevention in humans."

IO biomarker • Journal • Review • Allergy • Immunology

A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy (clinicaltrials.gov) - P3 | N=64 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Allergy • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Immunological evaluation of cat allergic individuals living with or without a cat (EAACI 2025) - "Blockade of cat- and Fel d 1-induced basophil degranulation with REGN1908-1909 was observed in both populations, achieving significance and numerically greater in WoC as compared to WC. Conclusion This study provides insight into potential immunological differences present in cat allergic individuals WC and WoC that may inform future therapeutic interventions."

Clinical • Immunology

A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy (clinicaltrials.gov) - P3 | N=64 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergy • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy (clinicaltrials.gov) - P3 | N=70 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Allergy • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat Allergy (clinicaltrials.gov) - P3 | N=70 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Allergy • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat (clinicaltrials.gov) - P3 | N=446 | Terminated | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Terminated; Lack of efficacy

Trial termination • Allergic Rhinitis • Allergy • Immunology • Inflammation

A Single Dose Of Fel d 1 Monoclonal Antibodies Regulates Molecular Signatures of Asthma In Nasal Mucosa Upon Cat Allergen Challenge In A Phase 2 Study (AAAAI 2023) - P2 | "Suppression of asthma signatures by Fel d 1 monoclonal antibodies was a sensitive molecular assessment as it occurred in REGN1908/1909-treated subjects regardless of whether they experienced an EAR."

P2 data • Allergy • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat (clinicaltrials.gov) - P3 | N=446 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Mar 2023 | Trial primary completion date: Jan 2024 ➔ Mar 2023

Enrollment closed • Trial completion date • Trial primary completion date • Allergic Rhinitis • Allergy • Immunology • Inflammation

REGN1908/1909 prevented cat allergen-induced early asthmatic responses in an environmental exposure unit. (PubMed, J Allergy Clin Immunol) - "Single-dose REGN1908/1909 significantly prevented reductions in FEV1 in cat-allergic patients with mild asthma upon cat-allergen EEU exposure at 8 days and up to 85 days post-dose."

Journal • Allergic Rhinitis • Allergy • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Efficacy of Anti-Allergen Therapeutics in a Preclinical Model of Allergic Anaphylaxis Correlates with Symptomatic Relief in Allergic Patients (EAACI 2022) - "Blockade of individual mAbs versus mAb cocktails confirms optimal blocking efficacy of Fel d 1 mAb cocktail (REGN1908-1909) compared with either single mAb; Bet v 1 triple mAb cocktail (REGN5713-5714-5715) compared with single mAb (REGN5715) or dual mAb cocktail (REGN5713-5715). Conclusion Blockade of mast cell degranulation in the PCA mouse model correlates to efficacy in clinical settings, validating the model as a useful tool for selection of efficacious anti-allergen therapeutics."

Preclinical • Allergy • Immunology

Efficacy and Safety of the Anti-Fel d 1 Antibodies REGN1908/1909 in CatAllergic Patients with Allergic Rhinitis During Natural Cat Exposure in the Home: Design of a Phase 3, Randomized, Placebo-Controlled Study (EAC 2022) - P3 | "This is the first large phase 3 trial evaluating a novel passive immunotherapy, REGN1908/1909, in cat allergic patients living with cats."

Clinical • P3 data • Allergic Rhinitis • Allergy • Asthma • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat (clinicaltrials.gov) - P3 | N=630 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Aug 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2022 ➔ Jan 2024

Trial completion date • Trial primary completion date • Allergic Rhinitis • Allergy • Immunology • Inflammation

Efficacy of Anti-Allergen Therapeutics in Preclinical Allergy Model Systems Correlate with Symptomatic Relief in a Clinical Setting (AAAAI 2022) - P1 | "Blockade of mast cell degranulation in the PCA mouse model translates to efficacy in clinical settings, thus, validating the model as a useful tool for predicting efficacy of anti-allergen therapeutics. Correlation analyses, in which blockade of mast cell degranulation compared to control for each sample (n=7) was plotted against the corresponding percent reduction in TNSS and SPT, demonstrate that blockade of mast cell degranulation in the PCA mouse model significantly correlates with percent reduction in TNSS after NAC (r2=0.625, p=0.034) and percent reduction in allergen-specific SPT (r2=0.915, p=0.0007). Since human IgE cannot bind mouse FceR, we utilized mice where endogenous mouse FceR1a was replaced with the corresponding human sequence. Mice were administered anti-allergen cocktails or a control and sensitized intradermally with IgE containing baseline plasma from cat-allergic individuals enrolled in a clinical study evaluating Fel d 1 mAbs, REGN1908-1909..."

Preclinical • Allergy • Immunology

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat (clinicaltrials.gov) - P3; N=630; Recruiting; Sponsor: Regeneron Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Allergic Rhinitis • Allergy • Immunology

REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics. (PubMed, Clin Transl Sci) - "A single 600 mg dose maintains total mAb mean concentrations in serum above the target (mean of ~ 10 mg/L) for 8-12 weeks. Maintaining this mean target concentration resulted in translational pharmacodynamic effects: maximal mast cell degranulation in a passive cutaneous anaphylaxis mouse model, and maintenance of clinical efficacy measured by Total Nasal Symptom Score in a previous proof-of-mechanism study."

Clinical • Journal • PK/PD data • Allergy • Immunology

A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat (clinicaltrials.gov) - P3; N=630; Not yet recruiting; Sponsor: Regeneron Pharmaceuticals

New P3 trial • Allergic Rhinitis • Allergy • Immunology

A single dose of REGN1908-1909 reduced the rate of early asthma responses, chest symptoms and rescue medication use in cat-allergic subjects with mild asthma for up to 3 months following a controlled cat allergen challenge: A phase 2, randomized, double-blind, placebo-controlled study (EAACI 2021) - P2 | "More placebo-treated patients received rescue medication upon EEU exit than REGN1908-1909-treated patients, on days 8, 29, 57 and 85, corresponding to a significant decrease in EAR incidence in the REGN1908-1909-treated patients. Conclusion Single-dose REGN1908-1909 significantly reduced the incidence of EARs, chest symptoms and rescue medication use in cat-allergic mild asthmatic subjects upon EEU exposure to cat allergen up to 3 months post dose."

Clinical • Late-breaking abstract • P2 data • Immunology

Regeneron Reports First Quarter 2021 Financial and Operating Results (PRNewswire) - "First quarter 2021 Dupixent® global net sales, which are recorded by Sanofi, increased 48% to $1.26 billion...A regulatory application for Dupixent for children aged 6 to 11 years with severe asthma was also submitted in the European Union (EU)....REGN1908-1909...The Company plans to initiate a Phase 3 study in cat allergic asthmatics later this year....Total revenues also include collaboration revenues of $754 million in the first quarter of 2021...The change in the Company's share of profits from commercialization of antibodies was primarily driven by higher Dupixent profits. In the first quarter of 2021, the Company also recorded Roche collaboration revenue of $67 million in connection with the Company's share of gross profits from sales of the casirivimab with imdevimab antibody cocktail...The higher GAAP and non-GAAP R&D expenses in the first quarter of 2021 were primarily due to costs incurred in connection with development activities related to REGEN-COV."

Commercial • European regulatory • Sales • Asthma • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] A Single-Dose of REGN1908-1909 Reduced Bronchoconstriction in Cat-Allergic Subjects with Mild Asthma for up to 3 months following a controlled cat allergen challenge: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study (AAAAI 2021) - P2 | "As compared to baseline, REGN1908-1909 improved FEV1 AUC(0–2 hours) at day 8 (+15.2%) versus placebo (+1.6%, P<0.001) . A 3-fold higher allergen quantity was tolerated on day 8, relative to baseline, after single-dose REGN1908-1909 (versus placebo P=0.003).  Conclusions Single-dose REGN1908-1909 significantly reduced acute bronchoconstriction and increased the time to EAR in cat-allergic mild asthmatic subjects upon EEU exposure to cat allergen at 8 days and up to 3-months post dose."

Clinical • P2 data • Asthma • Immunology • Respiratory Diseases

Passive Prophylactic Administration with a Single Dose of Anti-Fel d 1 Monoclonal Antibodies REGN1908-1909 in Cat Allergen-Induced Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Trial. (PubMed, Am J Respir Crit Care Med) - P1 | "Single passive dose administration of Fel d 1-neutralizing IgG antibodies improved nasal symptoms in cat-allergic patients, and was underscored by suppression of FcεRI-, FcεRII- and Th2-mediated allergic responses. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02127801."

Clinical • Journal • Allergic Rhinitis • Allergy • Asthma • Immunology • Respiratory Diseases • FCER2 • IL13 • IL4 • IL5

Regeneron Announces Positive Phase 2 Data Evaluating Fel d 1 Antibody Cocktail in Cat-allergic Patients with Mild Asthma (PRNewswire) - P2, N=56; NCT03838731; Sponsor: Regeneron Pharmaceuticals; "The trial met the primary endpoint of preventing early asthma reactions...The trial also met key secondary endpoints, including improved lung function and an increased amount of cat allergen that patients could tolerate following a single dose of treatment, from as early as the first assessment conducted at week 1....REGN1908-1909 significantly extended the median time before patients experienced an early asthma reaction compared to placebo at all time points assessed, including at week 1...Patients taking REGN1908-1909 were able to tolerate a three-fold higher allergen quantity from baseline without experiencing an early asthma reaction..."

P2 data • Allergy • Asthma • Respiratory Diseases

Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants (clinicaltrials.gov) - P1; N=74; Completed; Sponsor: Regeneron Pharmaceuticals; Phase classification: P1/2 ➔ P1

Clinical • Phase classification • Allergic Rhinitis • Allergy • Immunology

Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge (clinicaltrials.gov) - P2; N=56; Completed; Sponsor: Regeneron Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Trial completion

Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge (clinicaltrials.gov) - P2; N=56; Active, not recruiting; Sponsor: Regeneron Pharmaceuticals; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed