Celldex Therapeutics, Inc.

The Food and Drug Administration on Friday approved a new use for Sanofi and Regenerons top-selling immune disease drug Dupixent, clearing the medicine to treat a chronic skin condition that causes hives.The agency OKd Dupixent for chronic spontaneous urticaria, an inflammatory skin disease that causes hives to form on the body and leads to severe itching, burning or swelling. Dupixent is specifically available for people 12 years of age or older whose symptoms persist despite antihistamine treatment. In a statement, Regeneron estimated more than 300,000 people in the U.S. fit that description.Urticaria describes a group of hive-forming skin conditions that in recent years have become an active area of drug research. They can crop up either on their own or be induced by environmental factors, such as cold or warm temperatures, and last for weeks or even years at a time.While people can receive antihistamines or the biologic Xolair, many dont respond. And even if they do, relief can take weeks. Several drugmakers, including Sanofi and Regeneron, Celldex Therapeutics, Jasper Therapeutics and Novartis, are advancing therapies they claim can improve upon standard care.Dupixent is the first of this new group to reach market, even after setbacks prolonged its development path. The drug missed the main goal of one of its key studies in 2022. The FDA rejected the companies' initial application a year later and requested more efficacy data.Sanofi and Regeneron provided those results in 2024 via a trial called Liberty-Cupid Study C, which enrolled patients who had uncontrolled symptoms and were taking antihistamines. They reported that patients who added Dupixent to their regimen experienced an almost 50% reduction in itch and urticaria activity scores compared to those given a placebo. Those data were the basis for the FDAs approval Friday.Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease, said Regeneron Chief Scientific Officer, George Yancopoulos, in the companys statement.The clearance gives Dupixent, which generated nearly $14 billion in sales last year, seven approved uses. Yet some analysts are skeptical of Dupixents commercial potential in urticaria. In a research note last year, analysts at Cantor Fitzgerald said they viewed Dupixents results in urticaria as underwhelming compared to the data generated so far by Celldex. In March, the investment bank Jefferies, after speaking with dermatologists, said the drug seems a non factor compared to other emerging agents for the condition.Dupixent is already approved for chronic urticaria in Japan, Brazil and the United Arab Emirates. Its currently under regulatory review elsewhere, including in the EU. '

– CDX-622 inhibits SCF and TSLP-dependent inflammatory signatures in human skin – – Phase 1 study in healthy volunteers ongoing – HAMPTON, NJ, USA I March 03, 2025 I Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive preclinical data from CDX-622, a novel bispecific antibody that targets two non-redundant, complementary pathways implicated in inflammation and fibrosis—thymic stromal lymphopoietin (TSLP) and mast cell depletion via stem cell factor (SCF) starvation. The data demonstrate that CDX-622 neutralizes both SCF and TSLP, reducing tissue mast cells and inhibiting Type 2 inflammatory responses, supporting its potential to improve clinical activity over single target inhibition in inflammatory diseases and fibrotic disorders. The data were presented by Diego Alvarado, PhD, Vice President of Research at Celldex Therapeutics, in a poster presentation ( #708 ) as part of the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2025. “We are pleased to present these data which demonstrate the exciting potential of CDX-622,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “We believe dual neutralization of SCF and TSLP can potentially deliver profound clinical benefit for patients with inflammatory and fibrotic disorders where both mast cells and TSLP play a pathogenic role. Based on these preclinical findings, last November, we initiated a Phase 1 study in healthy volunteers that is actively enrolling and look forward to presenting initial data from this important clinical program later this year.” In the poster presented, preclinical studies demonstrate that CDX-622: About CDX-622 CDX-622 is a bispecific antibody that targets two complementary, clinically validated pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. SCF activation of the KIT receptor is required for mast cell survival and plays a key role in their activation, maturation and tissue recruitment. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. A Phase 1 randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants is actively enrolling. About Celldex Therapeutics, Inc. Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Visit www.celldex.com . SOURCE: Celldex Therapeutics

Novartis is spending $55 million on global rights to Kyorin Pharmaceutical’s preclinical drug for inflammatory diseases in a deal that comes almost two decades after Novartis’ first pact with the Japanese drugmaker. The Swiss company will get an exclusive license to develop, manufacture and sell Kyorin’s MRGPRX2 antagonist, dubbed KRP-M223. The Japanese biotech could receive up to $777.5 million in milestones as well as tiered royalties on sales, according to a company release Monday. The release did not say when the program could be ready to enter the clinic. Novartis will be responsible for global development of KRP-M223 but Kyorin still has the option to manufacture and commercialize the drug in Japan. KRP-M223 has the potential to treat several mast cell-driven conditions, including chronic spontaneous urticaria (CSU). CSU leads to spontaneous hives and swelling that can last for more than six weeks. The disease affects around 40 million people worldwide. Kyorin’s drug works by blocking MRGPRX2, which is involved in activating mast cells that release histamine and tryptase, leading to itching and swelling. Incyte’s INCB000262, which shares the same target, hit a snag in November when preclinical safety concerns forced the company to pause enrollment in a Phase 2 CSU trial. Other candidates in more advanced development for CSU target the c-Kit protein. These include Celldex’s barzolvolimab and Jasper Therapeutics’ briquilimab , both of which are in mid-stage studies. Novartis previously teamed up with Kyorin in 2006, when it licensed the rights to the Japanese biotech’s immunosuppressant drug KRP-203, although that program was later shelved. In 2020, two former Novartis executives launched a company called Priothera Limited to continue advancing KRP-203 with a focus on acute myeloid leukemia patients getting a hematopoietic stem cell transplant.