Barzolvolimab

« Back Mar 3, 2025 - CDX-622 inhibits SCF and TSLP-dependent inflammatory signatures in human skin - - Phase 1 study in healthy volunteers ongoing - HAMPTON, N.J., March 03, 2025 (GLOBE NEWSWIRE) -- 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: Inhibits TSLP and SCF-dependent activities in vitro with similar potency as its parental mAbs as well as tezepelumab and barzolvolimab Preferentially inhibits the soluble over the membrane form of SCF, which may lead to differential impact on KIT-dependent processes Inhibits both SCF and TSLP-dependent inflammatory signatures in a human skin explant model Exhibits mAb-like PK properties and leads to significant reduction in skin mast cell signatures Was well tolerated in a GLP toxicology study at all dose levels, with no observed adverse effect level, including at the highest dose level tested (75 mg/kg) and led to a profound mast cell depletion in several tissues 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. Forward Looking Statement This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company Contact Sarah Cavanaugh Senior Vice President, Corporate Affairs & Administration (508) 864-8337 scavanaugh@celldex.com Patrick Till Meru Advisors (484) 788-8560 ptill@meruadvisors.com Source: Celldex Therapeutics, Inc.

SAN DIEGO, March 2, 2025 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio"), a leading biotech company dedicated to developing innovative biologic treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the release of interim analysis of CSU (Chronic Spontaneous Urticaria) Phase II data for LP-003, the novel long-acting anti-IgE antibody, at the 2025 American Academy of Allergy, Asthma & Immunology annual meeting (AAAAI 2025). LP-003 demonstrated superior improvement compared to Omalizumab in mean change of UAS7 (urticaria activity score 7) from baseline and percentage% of patients with UAS7=0 at week 4 and week 12. The presentation of the poster titled "An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU" by LongBio marked a significant moment during the conference. Title: An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU ClinicalTrials.gov ID: NCT06228560 Date and Time: March 2nd, 2025, 9:45 am (UTC -5) Location: Convention Center, Ground Level, Hall A. Poster Number: 685 Methods: This is a multi-center, double-blind, placebo-controlled Phase II clinical study, randomized to receive 100 mg Q8W, 200 mg Q8W or 200 mg Q4W of LP-003 or 300mg Omalizumab or placebo (n=40/group). The primary endpoint is the proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 12. Secondary endpoints include mean change of UAS7 from baseline at week 4 and 12, and other efficacy and safety endpoints. Comparing to the first-generation anti-IgE antibody, omalizumab, LP-003 shows: superior improvement in mean change of UAS7 from baseline at week 12 as well as the percentage% of patients with UAS7=0 at week 4 and week 12. rapid and sustained relief in CSU symptoms in a dose-dependent manner. favorable safety profile, no statistically significant difference in adverse events were found between LP-003 and placebo groups. These results suggested that LP-003 might become a best-in-class anti-IgE therapy. In addition, LP-003's efficacy result was also comparable to barzolvolimab without raising any new safety concerns. Barzolvolimab is an anti-C-KIT mAB developed by Celldex, and intended to explore its application in CSU field. Together with its long-acting profile, LP-003 stands as a strong challenger in CSU market, positioning it at the forefront of the CSU treatment. CSU stands as a prevalent skin disorder affecting approximately 1–2% of the global population. Not only that, ~35% patients are not well controlled or refractory to the first-line treatment (anti-histamines). The US market size will reach $2 billion USD in 2026 and increase by 8-10% CAGR in next five years. According to the market research from RAPT, even with efficacy 20% below omalizumab, prescribers still prefer less frequent dosing. LP-003 not only with achieving the longer dosing interval than omalizumab, but also showed superior efficacy. It marks a major step forward, positioning the LP-003 at the forefront of the anti-IgE field. This achievement also marks a significant milestone for LP-003 following its initial success in allergic rhinitis, and LongBio is planning to continue exploring its promising potential in food allergy and asthma. The Phase II trial of asthma has started and the agency (NMPA, China FDA) approved a dosing interval of every 3 months (Q12W). LP-003 also got the IND approval of food allergy last year and planning to initial the clinical trial in the near future. Food allergy is huge market with great potential (>$10 billion USD) but less competitors. Based on the epidemiology research, there are more than 13.5 million adults and 3.5 million children are suffering food allergy in US and anti-IgE therapy is the only approved MOA by FDA. With ongoing studies in allergic rhinitis, CSU, asthma and food allergy, Longbio's innovative approach to biologic therapies continues to show remarkable potential for addressing unmet medical needs across allergic diseases. LP-003 would stand poised to make a significant impact on the global allergy and immunology markets. About LongBio LongBio is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and rare diseases, serving patients and society. LongBio aims to bring our drugs to both domestic and international markets with our partners, especially to bring patients with more affordable and high-quality bio-medicines. Our leading pipeline is a next generation of anti-IgE antibody (LP-003), which is already in Phase III stage, and prepare for pre-BLA in 2025H2. LP-003 has started clinical studies of several indications, like allergic rhinitis, CSU and asthma. Another pipeline is a bifunctional complement inhibitor, LP-005, with fully inhibition of all three pathways in complement system. The Phase II of PNH of LP-005 is on-going at present, intending to explore renal diseases and neuroinflammations in the near future. For more information, please visit: or please contact: [email protected]. SOURCE LongBio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED