Celldex Announces First Patient Dosed in Phase 1 Healthy Volunteer Study of CDX-622, a Bispecific Antibody, for the Treatment of Inflammatory Diseases
Celldex Therapeutics (NASDAQ:CLDX) has initiated dosing in its Phase 1a study of CDX-622, a bispecific antibody targeting inflammatory diseases. The study will evaluate safety, pharmacokinetics, and pharmacodynamics in up to 56 healthy volunteers. CDX-622 targets two inflammatory pathways by neutralizing TSLP and depleting mast cells via SCF starvation. The trial consists of two parts: single ascending doses and multiple ascending doses administered intravenously every 3 weeks. A subcutaneous formulation will be added to the study in 2025. The company aims to expand into asthma studies following successful completion of this trial.
Celldex Therapeutics (NASDAQ:CLDX) ha avviato la somministrazione nel suo studio di Fase 1a di CDX-622, un anticorpo bispecifico che mira a trattare le malattie infiammatorie. Lo studio valuterà la sicurezza, la farmacocinetica e la farmacodinamica su un massimo di 56 volontari sani. CDX-622 colpisce due vie infiammatorie neutralizzando il TSLP e deplezionando i mastociti attraverso la privazione di SCF. Il trial si compone di due parti: dosi ascendenti singole e dosi ascendenti multiple somministrate per via endovenosa ogni 3 settimane. Una formulazione sottocutanea verrà aggiunta allo studio nel 2025. L'azienda punta a espandere gli studi sull'asma dopo il completamento con successo di questo trial.
Celldex Therapeutics (NASDAQ:CLDX) ha iniciado la dosificación en su estudio de Fase 1a de CDX-622, un anticuerpo bispecífico dirigido a enfermedades inflamatorias. El estudio evaluará la seguridad, la farmacocinética y la farmacodinámica en hasta 56 voluntarios sanos. CDX-622 apunta a dos vías inflamatorias neutralizando TSLP y depletando mastocitos a través de la privación de SCF. El ensayo consta de dos partes: dosis ascendentes únicas y dosis ascendentes múltiples administradas por vía intravenosa cada 3 semanas. Se añadirá una formulación subcutánea al estudio en 2025. La empresa tiene como objetivo expandirse a estudios de asma tras la finalización exitosa de este ensayo.
셀덱스 테라퓨틱스(NASDAQ:CLDX)는 CDX-622의 1a상 연구에서 투약을 시작했습니다. 이 이중 특이성 항체는 염증성 질환을 표적으로 합니다. 이 연구는 최대 56명의 건강한 자원자에 대한 안전성, 약동학 및 약력학을 평가할 예정입니다. CDX-622는 TSLP를 중화하고 SCF 고갈을 통해 비만세포를 감소시켜 두 가지 염증 경로를 겨냥합니다. 시험은 단일 용량 상승과 3주마다 정맥 주사를 통해 투여되는 다중 용량 상승의 두 부분으로 구성됩니다. 피하 제형은 2025년에 연구에 추가될 예정입니다. 이 회사는 이 시험의 성공적인 완료 후 천식 연구로 확장할 계획입니다.
Celldex Therapeutics (NASDAQ:CLDX) a lancé l'administration dans son étude de Phase 1a de CDX-622, un anticorps bispécifique ciblant les maladies inflammatoires. L'étude évaluera la sécurité, la pharmacocinétique et la pharmacodynamique sur jusqu'à 56 volontaires sains. CDX-622 cible deux voies inflammatoires en neutralisant le TSLP et en réduisant les mastocytes par le biais de la privation en SCF. L'essai se compose de deux parties : des doses uniques ascendantes et des doses multiples ascendantes administrées par voie intraveineuse toutes les 3 semaines. Une formulation sous-cutanée sera ajoutée à l'étude en 2025. L'entreprise vise à s'étendre aux études sur l'asthme après l'achèvement réussi de cet essai.
Celldex Therapeutics (NASDAQ:CLDX) hat die Dossierung in seiner Phase-1a-Studie zu CDX-622 initiiert, einem bispezifischen Antikörper, der auf entzündliche Erkrankungen abzielt. Die Studie wird Sicherheit, Pharmakokinetik und Pharmakodynamik bei bis zu 56 gesunden Probanden bewerten. CDX-622 zielt auf zwei entzündliche Signalwege ab, indem es TSLP neutralisiert und Mastzellen durch SCF-Verarmung abbaut. Die Studie besteht aus zwei Teilen: einmalige steigende Dosen und mehrmalige steigende Dosen, die alle 3 Wochen intravenös verabreicht werden. Eine subkutane Formulierung wird 2025 in die Studie aufgenommen. Das Unternehmen plant, nach erfolgreichem Abschluss dieser Studie in die Asthmaforschung einzusteigen.
- Development of first bispecific antibody candidate for inflammatory diseases
- Potential broad application across respiratory and dermatological disorders
- Complements existing barzolvolimab program, expanding pipeline across five diseases
- Planned expansion into subcutaneous formulation in 2025
- Early-stage Phase 1 trial with results pending
- Multiple doses and lengthy follow-up periods may extend development timeline
Insights
This Phase 1 trial initiation for CDX-622 represents a significant milestone in Celldex's inflammatory disease pipeline. The bispecific antibody's dual mechanism targeting both TSLP and SCF pathways is scientifically innovative, potentially offering enhanced therapeutic benefits compared to single-target approaches. The study's comprehensive design, including both single and multiple ascending doses with a 12-week follow-up period, will provide important safety and biomarker data.
The planned development of a subcutaneous formulation for 2025 could improve patient convenience and market competitiveness. However, investors should note that this is an early-stage trial and meaningful efficacy data won't be available until future studies in specific disease populations. The broad potential application across multiple inflammatory conditions presents significant market opportunity, though development timelines will be lengthy.
HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation.
“The introduction of our first bispecific candidate for inflammatory diseases, CDX-622, builds on our leadership in mast cell biology,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “CDX-622 combines mast cell depletion with inhibition of Type 2 inflammatory responses and could be broadly applicable across a wide range of respiratory and dermatological disorders. Upon successful completion of this study in healthy volunteers, we look forward to building a robust pipeline beginning initially with a study in asthma. Importantly, we believe CDX-622 complements our barzolvolimab program, further strengthening our existing pipeline which is now advancing across five diseases.”
TSLP has been directly implicated in several respiratory and dermatological disorders, such as asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, atopic dermatitis and chronic spontaneous urticaria, and in fibrotic diseases such as systemic sclerosis and idiopathic pulmonary fibrosis. In these disorders, TSLP is often upregulated and associated with disease severity. Similarly, mast cells drive or contribute to the pathophysiology of allergic, inflammatory, autoimmune and fibrotic disorders and CDX-622 contains a unique SCF neutralizing function that is expected to inhibit and deplete mast cells. 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.
The Phase 1a clinical trial is a two-part, randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of
of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants. A single dose of CDX-622 or placebo will be administered intravenously once during Part 1. In Part 2, CDX-622 or placebo will be administered every 3 weeks (Q3W) for up to 6 weeks following the first dose, for a total of 3 doses. Participants will be followed for 12 weeks in both Parts 1 and 2 following the last dose of study drug. Celldex will also assess blood and skin biomarkers associated with and related to SCF and TSLP signaling and other immune inflammatory pathways in healthy participants as exploratory endpoints. A subcutaneous formulation is currently being manufactured and will be added to this study in 2025.
For additional information on this trial (NCT06650761), please visit www.clinicaltrials.gov.
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
FAQ
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