Celldex Therapeutics Presents Positive Preclinical Data from Inflammatory Bispecific Antibody Program CDX-622 at AAAAI 2025
Celldex Therapeutics (NASDAQ:CLDX) has presented positive preclinical data for CDX-622, their novel bispecific antibody targeting inflammatory and fibrotic disorders, at the AAAAI 2025 Annual Meeting. The antibody works by targeting both thymic stromal lymphopoietin (TSLP) and stem cell factor (SCF) pathways.
The preclinical studies demonstrated that CDX-622 effectively neutralizes both SCF and TSLP, reducing tissue mast cells and inhibiting Type 2 inflammatory responses. Key findings show the antibody inhibits inflammatory activities with similar potency to existing treatments, preferentially targets soluble SCF, and demonstrates favorable pharmacokinetic properties.
A Phase 1 study in healthy volunteers, initiated in November, is currently ongoing with initial data expected later in 2025. The compound showed strong safety profile in toxicology studies, with no adverse effects observed even at the highest dose level of 75 mg/kg.
Celldex Therapeutics (NASDAQ:CLDX) ha presentato dati preclinici positivi per CDX-622, il loro nuovo anticorpo bispecifico mirato a disturbi infiammatori e fibrotici, durante l'Annual Meeting AAAAI 2025. L'anticorpo agisce mirando sia ai percorsi della timina stromale linfopoietina (TSLP) che al fattore delle cellule staminali (SCF).
Gli studi preclinici hanno dimostrato che CDX-622 neutralizza efficacemente sia SCF che TSLP, riducendo i mastociti tissutali e inibendo le risposte infiammatorie di tipo 2. I risultati chiave mostrano che l'anticorpo inibisce le attività infiammatorie con una potenza simile a quella dei trattamenti esistenti, mirando preferenzialmente a SCF solubile e dimostrando favorevoli proprietà farmacocinetiche.
Uno studio di Fase 1 su volontari sani, avviato a novembre, è attualmente in corso con dati iniziali attesi entro la fine del 2025. Il composto ha mostrato un forte profilo di sicurezza negli studi tossicologici, senza effetti avversi osservati anche al livello di dose più elevato di 75 mg/kg.
Celldex Therapeutics (NASDAQ:CLDX) ha presentado datos preclínicos positivos para CDX-622, su nuevo anticuerpo bispecífico dirigido a trastornos inflamatorios y fibróticos, en la Reunión Anual AAAAI 2025. El anticuerpo actúa dirigiéndose tanto a la timina estromal linfopoyetina (TSLP) como a las vías del factor de células madre (SCF).
Los estudios preclínicos demostraron que CDX-622 neutraliza efectivamente tanto SCF como TSLP, reduciendo los mastocitos del tejido e inhibiendo las respuestas inflamatorias de tipo 2. Los hallazgos clave muestran que el anticuerpo inhibe las actividades inflamatorias con una potencia similar a la de los tratamientos existentes, dirigiéndose preferentemente a SCF soluble y demostrando propiedades farmacocinéticas favorables.
Un estudio de Fase 1 en voluntarios sanos, iniciado en noviembre, está en curso con datos iniciales esperados para finales de 2025. El compuesto mostró un fuerte perfil de seguridad en estudios de toxicología, sin efectos adversos observados incluso en el nivel de dosis más alto de 75 mg/kg.
셀덱스 테라퓨틱스 (NASDAQ:CLDX)는 AAAAI 2025 연례 회의에서 염증 및 섬유성 질환을 타겟으로 하는 새로운 이중 특이성 항체인 CDX-622에 대한 긍정적인 전임상 데이터를 발표했습니다. 이 항체는 흉선 기질 림프포이에틴 (TSLP)과 줄기세포 인자 (SCF) 경로를 모두 타겟으로 작용합니다.
전임상 연구에서는 CDX-622가 SCF와 TSLP를 효과적으로 중화시키며, 조직 비만세포를 감소시키고 2형 염증 반응을 억제하는 것을 보여주었습니다. 주요 발견은 이 항체가 기존 치료제와 유사한 효능으로 염증 활동을 억제하며, 용해성 SCF를 선호적으로 타겟하고 유리한 약동학적 특성을 나타낸다는 것입니다.
11월에 시작된 건강한 자원자를 대상으로 한 1상 연구가 현재 진행 중이며, 초기 데이터는 2025년 말에 예상됩니다. 이 화합물은 독성학 연구에서 강력한 안전성 프로필을 보여주었으며, 75 mg/kg의 최고 용량에서도 부작용이 관찰되지 않았습니다.
Celldex Therapeutics (NASDAQ:CLDX) a présenté des données précliniques positives pour CDX-622, leur nouvel anticorps bispécifique ciblant les troubles inflammatoires et fibrosants, lors de la réunion annuelle AAAAI 2025. L'anticorps agit en ciblant à la fois la thymine stromale lymphopoïétine (TSLP) et les voies du facteur de cellules souches (SCF).
Les études précliniques ont démontré que CDX-622 neutralise efficacement à la fois SCF et TSLP, réduisant les mastocytes tissulaires et inhibant les réponses inflammatoires de type 2. Les résultats clés montrent que l'anticorps inhibe les activités inflammatoires avec une puissance similaire à celle des traitements existants, cible préférentiellement le SCF soluble et présente des propriétés pharmacocinétiques favorables.
Une étude de phase 1 sur des volontaires en bonne santé, lancée en novembre, est actuellement en cours avec des données initiales attendues pour fin 2025. Le composé a montré un fort profil de sécurité dans les études toxicologiques, sans effets indésirables observés même au niveau de dose le plus élevé de 75 mg/kg.
Celldex Therapeutics (NASDAQ:CLDX) hat positive präklinische Daten für CDX-622, ihren neuartigen bispezifischen Antikörper zur Behandlung von entzündlichen und fibrotischen Erkrankungen, auf dem AAAAI-Jahrestreffen 2025 präsentiert. Der Antikörper wirkt, indem er sowohl die Thymus-stromale Lymphopoietin (TSLP) als auch die Stammzellfaktor (SCF) Signalwege anvisiert.
Die präklinischen Studien zeigten, dass CDX-622 sowohl SCF als auch TSLP effektiv neutralisiert, Gewebemastzellen reduziert und entzündliche Reaktionen vom Typ 2 hemmt. Wichtige Ergebnisse zeigen, dass der Antikörper entzündliche Aktivitäten mit ähnlicher Potenz wie bestehende Behandlungen hemmt, bevorzugt lösliches SCF anvisiert und günstige pharmakokinetische Eigenschaften aufweist.
Eine Phase-1-Studie bei gesunden Freiwilligen, die im November begonnen wurde, ist derzeit im Gange, und erste Daten werden für Ende 2025 erwartet. Der Wirkstoff zeigte in toxikologischen Studien ein starkes Sicherheitsprofil, wobei selbst bei der höchsten Dosis von 75 mg/kg keine unerwünschten Wirkungen beobachtet wurden.
- Positive preclinical efficacy data showing dual pathway inhibition
- Clean safety profile with no adverse effects at highest dose (75 mg/kg)
- Phase 1 trial actively enrolling
- Similar potency to existing treatments
- Still in early development phase
- Clinical efficacy in humans yet to be demonstrated
Insights
Celldex's CDX-622 represents a scientifically compelling approach to inflammatory disease treatment. The bispecific antibody design targeting both TSLP and SCF pathways is particularly noteworthy as it addresses two critical mechanisms simultaneously - inhibiting Type 2 inflammation via TSLP neutralization while reducing tissue mast cells through SCF blockade.
The preclinical data demonstrates several important strengths: CDX-622 maintains potency comparable to individual antibodies against each target, shows preferential inhibition of soluble SCF (potentially minimizing off-target effects on other KIT-dependent processes), and produces significant mast cell depletion across multiple tissues. The clean toxicology profile with no observed adverse effects even at high doses (75 mg/kg) is encouraging for clinical development.
This dual-mechanism approach could potentially offer advantages over existing single-target therapies like tezepelumab (anti-TSLP) in conditions where both pathways contribute to pathology. The skin explant model results suggest particular relevance for dermatological conditions, though applications could extend to respiratory and other inflammatory disorders where mast cells and Type 2 inflammation play significant roles.
With the Phase 1 study already underway in healthy volunteers, we should watch for initial clinical data expected later this year to confirm target engagement and early safety signals in humans. This will provide important validation of whether the impressive preclinical profile translates to clinical applications.
This preclinical data announcement represents meaningful pipeline progress for Celldex, building on their expertise in mast cell biology while expanding their inflammation portfolio. The company is strategically leveraging their scientific strengths across programs, as CDX-622 builds upon knowledge gained from their barzolvolimab program.
The progression to clinical testing with an ongoing Phase 1 study demonstrates solid execution on development timelines. Expected data readout later this year will provide important early validation of the approach. However, investors should recognize this remains an early-stage program with significant development milestones still ahead.
The dual-targeting mechanism potentially differentiates CDX-622 in the competitive landscape of inflammatory disease therapeutics. By addressing both TSLP (a validated target with approved therapies) and mast cell depletion via SCF inhibition, Celldex is pursuing a scientifically rational combination approach that could potentially offer improved efficacy in conditions where both pathways contribute to disease.
This program diversifies Celldex's pipeline beyond their lead assets while maintaining focus on immunology applications. The preclinical toxicology results showing no adverse effects at doses up to
For Celldex investors, this program represents pipeline progression that could create additional value beyond their more advanced clinical assets, reinforcing the company's capabilities in developing novel immunology therapeutics.
- 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
FAQ
What are the key findings from CDX-622's preclinical trials presented at AAAAI 2025?
When did Celldex (CLDX) begin Phase 1 trials for CDX-622 and when are results expected?
What is the maximum dose tested for CLDX's CDX-622 in toxicology studies?
How does Celldex's CDX-622 bispecific antibody work?
