Dupilumab

In November, Sanofi and Regeneron’s Dupixent triumphed in a second phase 3 study in COPD, potentially teeing up Dupixent’s approval as the inaugural biologic to treat the lung disease and the first major advancement in the indication in more than a decade. Even as new Sanofi drugs like Beyfortus and Altuviiio come into their own, the French pharma’s immunology powerhouse Dupixent shows no signs of slowing down. In fact, Sanofi is already gearing up for the antibody’s potential debut in what CEO Paul Hudson dubbed the drug’s “next major growth pillar.” Sanofi is preparing to launch Dupixent in chronic obstructive pulmonary disease (COPD) “as early as late June,” Hudson said on an analyst call Thursday. The FDA is set to rule on Dupixent’s merits in COPD on June 27. The approval would mark Dupixent’s sixth U.S. indication behind those for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis. Dupixent already has a strong reputation with pulmonologists thanks to the drug’s asthma and rhinosinusitis nods, Hudson noted. Still, the CEO caveated that it would take some time to drive awareness and diagnosis of COPD with type 2 inflammation, and, as a result, the “inflection of sales growth [for Dupixent in COPD] is likely to come in 2025.” Should the approval come through, Hudson said he was confident that “COPD will become the next major growth pillar for Dupixent.” Back in November, Sanofi and Regeneron’s Dupixent triumphed in a second phase 3 study in COPD, potentially teeing up Dupixent’s approval as the inaugural biologic to treat the lung disease and the first major advancement in the indication in more than a decade. Results from the NOTUS study showed that patients on Dupixent, compared to those on placebo, experienced a 34% reduction in COPD exacerbations that needed additional treatment. The antibody also produced significant lung function improvement within 12 weeks, which remained intact through 52 weeks. Meanwhile, Sanofi is also developing another antibody against COPD—itepekimab—and together with Dupixent, the two COPD drugs could clinch combined peak sales of roughly 5 billion euros in that indication, Hudson pointed out. Hudson made his remarks on Dupixent’s potential COPD launch as the drug grew sales 25% to 2.8 billion euros (around $3 billion) in 2024’s first quarter. That performance has cemented Sanofi’s thesis that Dupixent could reach roughly 13 billion euros ($13.9 billion) in sales for the entire year, Hudson said. Aside from the potential COPD nod, Dupixent has benefited from label expansions in markets beyond the U.S. as well, the CEO pointed out. In February, for instance, Japan became the first country to sign off on Sanofi’s anti-inflammatory blockbuster in chronic spontaneous urticaria (CSU), which causes sudden hives, deep swelling under the skin and persistent itch. There are approximately 110,000 people in Japan who suffer from uncontrolled moderate-to-severe CSU, Sanofi noted at the time. And in the U.S., Dupixent in late January expanded its label in eosinophilic esophagitis to include kids between the ages of 1 and 11 who weigh at least 33 pounds. The company’s original approval in that indication came in May of 2022 and included patients ages 12 and up. According to Hudson, there are now more than 850,000 patients on Dupixent worldwide, with strong sales contributions coming from the likes of Japan, China and Germany. Beyond Dupixent, Sanofi’s roster of new products, including the AstraZeneca-partnered respiratory syncytial virus (RSV) immunization Beyfortus, generated close to a billion euros in sales for the quarter, comprising 9% of the company’s total biopharma business, Hudson said. Amid “enthusiastic demand” for Beyfortus, Sanofi and AZ are working to expand the manufacturing network for their RSV antibody, the CEO explained. “We’re confident that we will meet anticipated customer demand and look forward to extending all infant protection programs in the upcoming northern hemisphere RSV season,” Hudson said. All told, Sanofi reaped roughly 10.5 billion euros (about $11.2 billion) in total sales for 2024’s first quarter, signaling 6.7% growth at constant exchange rates over the sum the company generated over the same stretch in 2023.

Oral presentation will feature new data for investigational REGN7075, an EGFRxCD28 costimulatory bispecific with the potential to enhance the treatment of certain advanced solid tumors in combination with Libtayo® (cemiplimab-rwlc) 17 presentations to highlight Regeneron's investigational pipeline including checkpoint inhibitors, CD3 bispecifics and CD28 costimulatory bispecifics April 24, 2024 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data from its oncology and hematology pipeline will be shared across 17 presentations at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, taking place from May 31 to June 5 in Chicago, IL. Notably, new safety and efficacy results from a Phase 1/2 trial investigating the costimulatory bispecific antibody REGN7075 (EGFRxCD28) in combination with Libtayo in patients with certain advanced solid tumors will be featured in an oral presentation. “The breadth of our presentations at ASCO showcase our progress in advancing multiple promising and distinct investigational treatment approaches for a diverse array of difficult-to-treat cancers,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron. “These latest clinical results build on our ongoing commitment to cancer research and reflect our focus on advancing a pipeline of internally-developed candidates that have the potential to offer novel and differentiated therapies. Poised to tackle more than 30 types of cancer, our oncology pipeline is a testament to Regeneron’s relentless commitment to transforming cancer care for those who need it most.” Beyond the REGN7075 data, additional presentations will feature results from Regeneron’s diverse pipeline of checkpoint inhibitors and bispecific antibodies. Among them are presentations on updated data and new analyses for linvoseltamab (BCMAxCD3) in multiple myeloma; odronextamab (CD20xCD3) in several lymphoma subtypes; REGN6569 (GITR) in combination with Libtayo across solid tumors; and fianlimab (LAG-3 inhibitor) in combination with Libtayo in non-small cell lung cancer, melanoma and head and neck cancer. Regeneron presentations at ASCO: The potential uses of Libtayo, REGN7075, odronextamab, linvoseltamab, REGN6569, fianlimab and DB-020 as described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. REGN7075, odronextamab, linvoseltamab, REGN6569, fianlimab and DB-020 are not currently approved for use in any indication. We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time. Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in the European Union, Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Outside of the U.S., the generic name of Libtayo in its approved indication is cemiplimab. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. U.S. FDA-approved Indications Libtayo is a prescription medicine used to treat: People with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation. People with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI. Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. It is not known if Libtayo is safe and effective in children. Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo®, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. 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 of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world. The content above comes from the network. if any infringement, please contact us to modify.