Regeneron COVID-19 Monoclonal Antibody 2023
Regeneron Pharmaceuticals, Inc. disclosed its intentions to expand its SARS-CoV-2 monoclonal antibody (mAb) offerings in 2023 at the J.P. Morgan Healthcare Conference on January 9, 2023. The Company stated that in the U.S. alone, millions of immunocompromised people will not adequately respond to vaccination, and antibody therapy can be dosed prophylactically to help prevent infection and severe COVID-19 disease. On December 16, 2021, Regeneron issued a statement saying 'Regeneron has confirmed that multiple next generation' mAb from its extensive collection of fully human monoclonal antibodies targeting the SARS-CoV-2 betacoronavirus are active against the Omicron variant.
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. Regeneron technologies enable the rapid and efficient generation of these protective antiviral mAbs outside the body, derived from genetically humanized mice or convalescent humans. The concept that mAb cocktails can prevent viral escape has been demonstrated for traditional antiviral drugs treating HIV and other viruses.
Regeneron announced on August 22, 2023, that the U.S. Biomedical Advanced Research and Development Authority (BARDA) had entered into an agreement to support clinical development, clinical manufacturing, and the regulatory licensure process of a next-generation COVID-19 mAb therapy for the prevention of SARS-CoV-2 infection. The agreement is part of ‘Project NextGen,’ an initiative by the U.S. Department of Health and Human Services (HHS). For the new COVID-19 program, HHS will fund up to 70 percent of Regeneron’s costs for certain clinical development activities for a next-generation mAb therapy with broad neutralizing activity against the SARS-CoV-2 betacoronavirus. The new BARDA contract has an estimated value of up to $326 million of government funding.
Tarrytown, New York-based Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) was founded and led for 35 years by physician-scientists. Regeneron’s unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all homegrown in Regeneron's laboratories. REGN collaborates with Roche to increase the global supply of REGEN-COV. Regeneron is responsible for developing and distributing the treatment in the U.S. Roche is primarily responsible for developing and distributing Ronapreve outside the U.S.
Regeneron REGN14287
On January 9, 2023, Regeneron's presentation at a San Francisco CA conference included slide #27, which stated that the Next-gen COVID antibody binds outside variable RBD and has demonstrated high neutralization activity against all known variants and lineages. And disclosed: Anticipate initiating REGN14287 clinical trial in 2023, pending regulatory discussions. The phase 3 study clinical trial NCT04425629 was last updated on July 29, 2022.
Regeneron's REGEN-COV
Regeneron's REGEN-COV SARS-CoV-2 Monoclonal Antibody (Ronapreve) combines two mAbs, casirivimab and imdevimab, explicitly designed to block the infectivity of SARS-CoV-2, the coronavirus that causes COVID-19. REGEN-COV was the first mAbs therapy to demonstrate an antiviral effect in patients hospitalized with COVID-19. Regeneron does not use human tissue in any of our manufacturing processes. Instead, the manufacture of mAbs starts with a mammalian cell line called the Chinese Hamster Ovary (CHO) cells. These CHO cells are then modified with a synthetic DNA sequence to direct them to make mAbs indistinguishable from human antibodies.
REGEN-COV can be delivered via injection or IV, providing 'passive immunity and immediately protecting people from COVID-19. However, it must be re-administered to remain effective over time. These mAbs can also treat an existing infection, unlike vaccines used preventatively.
The Company announced on October 14, 2021, that the FDA had accepted for priority review a Biologics License Application (BLA) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in specific individuals. A second BLA submission focusing on treating patients hospitalized due to COVID-19 is expected to be submitted later in 2021. The U.S. issued emergency authorization on February 25, 2021. The FDA issued an updated Health Care Provider Fact Sheet for REGEN-COV on December 20, 2021, with specific information regarding expected activity against the Omicron variant (B.1.1.529/BA.1). On January 19, 2022, the UU.S.NIH published an updated version of the statement that the COVID-19 Treatment Guidelines Panel addressed the dominance of the B.1.1.529 (Omicron) variant in the U.S The U.S. revised the authorizations for REGEN-COV on January 24, 2022, to limit their use to only when the patient is likely infected with or exposed to a variant susceptible to these treatments.
DrugBank: DB15691; KEGG D11938, D11939 Dosage, and Administration (Section 2.4) and How Supplied/Storage and Handling (Section 19): updated storage temperature range and duration updated as of November 1, 2021.
REGEN-COV was used as a COVID-19 treatment and preventative for millions of people around the globe, with nearly 3 million doses delivered to the U.S. Government between 2020 and 2022. In the U.S., REGEN-COV can be administered intravenously (as short as 20 minutes) or subcutaneously. The authorized dosage is 600 mg of casirivimab with 600 mg of imdevimab administered together as a single intravenous (IV) infusion or by subcutaneous injection as soon as possible after a positive viral test for SARS-CoV-2 and within ten days of symptom onset. A phase 3 study supported by Regeneron Pharmaceuticals found a 1200 mg subcutaneous dose of REGEN-COV also prevented COVID-19 in household contacts of SARS-CoV-2-infected individuals. As of June 27, 2022, REGEN-COV was unavailable in the U.S.
Regeneron mAb News
August 22, 2023 - "We're pleased to expand our longstanding BARDA relationship, which is predicated on Regeneron's decades of investment in deep scientific research and enabling technologies," said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron.
August 3, 2023 - Regeneron Pharmaceuticals, Inc. announced financial results for the second quarter of 2023 and provided a business update. Second quarter 2023 revenues increased 11% to $3.16 billion versus second quarter 2022. "Regeneron delivered strong financial results in the second quarter of 2023 through increasingly diversified revenue streams, and we remain well-positioned for long-term growth," said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron.
Monoclonal Antibody Clinical Trials
Phase 3 study - NCT04425629 - Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19.
Phase 3 study - NCT04452318 - Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2 - published results in the NEJM on September 23, 2021. And on January 14, 2022, the JAMA Network - Conclusions and Relevance: Among asymptomatic SARS-CoV-2 RT-qPCR–positive individuals living with an infected household contact, treatment with subcutaneous casirivimab and imdevimab antibody combination vs placebo significantly reduced the incidence of symptomatic COVID-19 over 28 days.
