Advancing
Our Pipeline
Our clinical pipeline is powered by end-to-end research and development capabilities. Our Research and Preclinical Development team discovers promising new drug compounds. From there, Global Development brings these investigational candidates through the full clinical development process, from trial design to study execution and lifecycle management. Our product portfolio reflects the true collaborative spirit of Regeneron.
Scientific trailblazers
In 2021, we continued to expand our preclinical and clinical research capabilities through the hard work of our experienced team and application of innovative technologies. While we continue to pursue our industry-leading antibody approach, we are simultaneously bringing new approaches to the clinic. We never stop innovating for patients.
Our growing pipeline has deep
potential for years to come
(as of February 2022)
With more than 30 investigational medicines in the clinical pipeline, including 15 in late-stage development, we are well positioned for future growth and continued patient impact.
Our clinical research is seeking to
address a wide range of disease areas
(as of February 2022)
CARDIOVASCULAR/
METABOLIC DISEASES
Cardiovascular/metabolic:
heart failure, acute pancreatitis prevention, generalized and partial lipodystrophy, heterozygous familial hypercholesterolemia in pediatrics
GENERAL
MEDICINE
General medicine:
COVID-19, heart failure, nonalcoholic steatohepatitis, acute pancreatitis prevention, generalized and partial lipodystrophy, fibrodysplasia ossificans progressive, heterozygous familial hypercholesterolemia in pediatrics, osteoarthritis pain of the knee or hip
HEMATOLOGY
Hematology:
multiple myeloma, aplastic anemia, transthyretin amyloidosis, thrombosis, B-cell non-Hodgkin lymphoma, immunoglobulin A nephropathy, CD55 deficient protein-losing enteropathy, paroxysmal nocturnal hemoglobinuria, myasthenia gravis
IMMUNOLOGY/
INFLAMMATION
Immunology/inflammation:
palmo-plantar pustulosis, nonalcoholic steatohepatitis, polyarticular-course juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, peanut allergy, grass allergy, atopic dermatitis in pediatric patients 6 mo.–5 y.o; eosinophilic esophagitis (EoE) in adults, adolescents, and pediatrics; chronic obstructive pulmonary disease (COPD); bullous pemphigoid; prurigo nodularis; chronic spontaneous urticaria (CSU); allergic bronchopulmonary aspergillosis; chronic inducible urticaria - cold; chronic sinusitis without nasal polyposis; allergic fungal rhinosinusitis, birch allergy, cat allergy
INFECTIOUS
DISEASES
Infectious disease:
COVID-19
ONCOLOGY
Oncology:
solid tumors, certain B-cell malignancies, multiple myeloma, prostate cancer, MET-altered advanced non-small cell lung cancer, MET overexpressing advanced cancer, advanced hematologic malignancies, platinum-resistant ovarian cancer, metastatic or locally advanced cutaneous squamous cell carcinoma, neoadjuvant CSCC, second-line cervical cancer, first-line non-small cell lung cancer chemo combination, adjuvant CSCC
OPHTHALMOLOGY
Ophthalmology:
wet age-related macular degeneration, retinopathy of prematurity, diabetic macular edema
PAIN/NEUROLOGY
Pain/neurology:
osteoarthritis pain of the knee or hip
RARE DISEASES
Rare diseases:
transthyretin amyloidosis, acute pancreatitis prevention, generalized lipodystrophy, fibrodysplasia ossificans progressiva, immunoglobulin A nephropathy, CD55 deficient protein-losing enteropathy, paroxysmal nocturnal hemoglobinuria, myasthenia gravis
Key 2021 clinical research updates by therapeutic area
Infectious diseases
- The robust REGEN-COV development program has reported positive Phase 3 trial results across the spectrum of COVID-19 infection, from prevention, to very early infection, all the way through to hospitalization
- These positive results have been presented at numerous conferences and the New England Journal of Medicine published positive Phase 3 results for REGEN-COV in the treatment of non-hospitalized patients already infected with SARS-CoV-2 as well as to prevent COVID-19 among household contacts of SARS-CoV-2 infected individuals
- We also reported new Phase 3 analyses that showed a single dose of REGEN-COV provides long-term protection against COVID-19
- Laboratory data found that REGEN-COV was not effective against Omicron B.1.1.529; we are progressing several candidates that are active against currently circulating variants of concern, and have already initiated a first-in-human clinical trial of one of these investigational antibodies
Ophthalmology
- The DRCR Retina Network shared initial results from their Protocol W trial in non-proliferative diabetic retinopathy confirming results from our Regeneron-sponsored PANORAMA trial and demonstrating reduced risk of developing vision-threatening complications with every-16-weeks aflibercept dosing regimen
- We completed enrollment in Phase 3 study of aflibercept for retinopathy of prematurity
- For aflibercept 8mg, enrollment was completed in the Phase 3 studies in wet AMD and diabetic macular edema (DME), and we reported initial data that our Phase 2 trial in wet AMD met its primary safety and efficacy endpoints
Cardiovascular and metabolic diseases
- With Alnylam Pharmaceuticals Inc., continued our Phase 1 trial for ALN-HSD in nonalcoholic steatohepatitis
- In 2021, we expanded our hematology clinical pipeline, which now includes 8 product candidates
- For our odronextamab (formerly known as REGN1979) program, we resumed enrolling patients with follicular lymphoma and diffuse large B-cell lymphoma following protocol amendments
- In June 2021, with our collaborator Intellia Therapeutics, Inc., we reported positive interim data from the Phase 1 trial of NTLA-2001 in hereditary transthyretin amyloidosis with polyneuropathy – the first-ever clinical data supporting safety and efficacy of in vivo CRISPR genome editing in humans
- Once again, our dupilumab clinical team had a busy year with research updates across multiple potential indications, starting with atopic dermatitis in pediatrics (6 months-5 years in age) where we reported positive Phase 3 trial results
- For dupilumab, we also initiated a Phase 3 trial in hand and foot atopic dermatitis, and reported separate Phase 3 trial results in three distinct conditions: chronic spontaneous urticaria (Study A), prurigo nodularis and Part B of the trial in eosinophilic esophagitis in adults and adolescents
- For peanut allergy in pediatric patients, we shared positive Phase 2 trial results when combining dupilumab and Aimmune Therapeutics’ AR101, an oral immunotherapy
- For people who are allergic to cats with mild asthma, we also reported positive Phase 2 results for REGN1908-1909
- After a successful Phase 2 trial, we shared initial positive results from our Phase 3 trial for REGN5713-5714-5715 in birch allergic patients with allergic rhinoconjunctivitis
- Currently have 10 solid organ oncology candidates in the clinic, including multiple bispecific antibodies
- For our extensive cemiplimab program, we shared positive data from our Phase 3 chemotherapy combination trial in non-small cell lung cancer (NSCLC), including that it was stopped early based on Independent Data Monitoring Committee (IDMC) recommendation due to statistically significant improvement in overall survival
- At the American Society of Clinical Oncology Annual Meeting, we presented positive data from Phase 1 trial of fianlimab in combination with cemiplimab in advanced melanoma
Pursuing innovative research across many diseases
We invent and research potential new medicines for a broad range of serious conditions. Learn more about our work to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.
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