Pacira BioSciences to Present New Data on Clinical Immunogenicity of Intra-Articular PCRX-201 and Its Implications for Dosing Strategy in Knee Osteoarthritis
Pacira BioSciences (NASDAQ: PCRX) announced it will present findings from its Phase 1 study of PCRX-201, a gene therapy candidate for knee osteoarthritis, at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) on May 15, 2025. The presentation will focus on how neutralizing antibodies (NAbs) affect the therapy's efficacy, safety, and potential for redosing.
Dr. MiJeong Kim, Senior Director of Translational Sciences, will deliver the presentation titled "Understanding the Clinical Immunogenicity of Locally Injected HCAd Vector Provides Insight into Optimizing Dosing Strategy." Additionally, Pacira will host a symposium on High-Capacity Adenoviral Vectors (HCAd) for common diseases, featuring speakers from Baylor College of Medicine and Pacira's development team.
Pacira BioSciences (NASDAQ: PCRX) ha annunciato che presenterà i risultati dello studio di Fase 1 su PCRX-201, un candidato alla terapia genica per l'osteoartrite del ginocchio, durante il 28° Congresso Annuale della American Society of Gene and Cell Therapy (ASGCT) il 15 maggio 2025. La presentazione si concentrerà sull'impatto degli anticorpi neutralizzanti (NAbs) sull'efficacia, la sicurezza e il potenziale di somministrazioni ripetute della terapia.
La Dott.ssa MiJeong Kim, Direttrice Senior delle Scienze Traslazionali, terrà la presentazione intitolata "Comprendere l'immunogenicità clinica del vettore HCAd iniettato localmente per ottimizzare la strategia di dosaggio." Inoltre, Pacira ospiterà un simposio sui vettori adenovirali ad alta capacità (HCAd) per le malattie comuni, con interventi di relatori provenienti dal Baylor College of Medicine e dal team di sviluppo di Pacira.
Pacira BioSciences (NASDAQ: PCRX) anunció que presentará los resultados de su estudio de Fase 1 sobre PCRX-201, un candidato a terapia génica para la osteoartritis de rodilla, en la 28ª Reunión Anual de la American Society of Gene and Cell Therapy (ASGCT) el 15 de mayo de 2025. La presentación se centrará en cómo los anticuerpos neutralizantes (NAbs) afectan la eficacia, seguridad y potencial para dosis repetidas de la terapia.
La Dra. MiJeong Kim, Directora Senior de Ciencias Traslacionales, realizará la presentación titulada "Comprendiendo la inmunogenicidad clínica del vector HCAd inyectado localmente para optimizar la estrategia de dosificación." Además, Pacira organizará un simposio sobre vectores adenovirales de alta capacidad (HCAd) para enfermedades comunes, con ponentes del Baylor College of Medicine y del equipo de desarrollo de Pacira.
Pacira BioSciences (NASDAQ: PCRX)는 2025년 5월 15일 제28회 미국 유전자 및 세포 치료 학회(ASGCT) 연례회의에서 무릎 골관절염을 위한 유전자 치료 후보물질인 PCRX-201의 1상 연구 결과를 발표할 예정입니다. 발표는 중화항체(NAbs)가 치료제의 효능, 안전성 및 재투여 가능성에 미치는 영향에 초점을 맞출 것입니다.
전환과학 수석이사인 김미정 박사가 "국소 주입된 HCAd 벡터의 임상 면역원성 이해를 통한 투여 전략 최적화"라는 제목으로 발표를 진행합니다. 또한, Pacira는 Baylor 의과대학 및 Pacira 개발팀 연사들과 함께 흔한 질병을 위한 고용량 아데노바이러스 벡터(HCAd) 심포지엄을 개최할 예정입니다.
Pacira BioSciences (NASDAQ : PCRX) a annoncé qu'elle présentera les résultats de son étude de phase 1 sur PCRX-201, un candidat en thérapie génique pour l'arthrose du genou, lors de la 28e réunion annuelle de l'American Society of Gene and Cell Therapy (ASGCT) le 15 mai 2025. La présentation portera sur l'impact des anticorps neutralisants (NAbs) sur l'efficacité, la sécurité et le potentiel de réadministration de la thérapie.
La Dre MiJeong Kim, directrice principale des sciences translationnelles, donnera une présentation intitulée « Comprendre l'immunogénicité clinique du vecteur HCAd injecté localement pour optimiser la stratégie de dosage ». De plus, Pacira organisera un symposium sur les vecteurs adénoviraux à haute capacité (HCAd) pour les maladies courantes, avec des intervenants du Baylor College of Medicine et de l'équipe de développement de Pacira.
Pacira BioSciences (NASDAQ: PCRX) gab bekannt, dass es die Ergebnisse seiner Phase-1-Studie zu PCRX-201, einem Gentherapie-Kandidaten für Kniearthrose, auf der 28. Jahrestagung der American Society of Gene and Cell Therapy (ASGCT) am 15. Mai 2025 vorstellen wird. Die Präsentation wird sich darauf konzentrieren, wie neutralisierende Antikörper (NAbs) die Wirksamkeit, Sicherheit und das Potenzial für Wiederholungsdosen der Therapie beeinflussen.
Dr. MiJeong Kim, Senior Director für Translationale Wissenschaften, wird die Präsentation mit dem Titel "Verständnis der klinischen Immunogenität lokal injizierter HCAd-Vektoren zur Optimierung der Dosierungsstrategie" halten. Zudem veranstaltet Pacira ein Symposium zu Hochkapazitäts-Adenovirusvektoren (HCAd) für häufige Erkrankungen mit Referenten vom Baylor College of Medicine und dem Entwicklungsteam von Pacira.
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Data will be featured at the ASGCT 28th Annual Meeting
BRISBANE, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced an upcoming podium presentation of findings from its Phase 1 study of PCRX-201 (enekinragene inzadenovec), a locally administered gene therapy candidate for osteoarthritis of the knee. The data will be presented at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in New Orleans on May 15. The presentation will highlight how preexisting and treatment-induced neutralizing antibodies (NAbs) impact the therapy’s efficacy, safety, and redosing potential.
Presentation Title: Understanding the Clinical Immunogenicity of Locally Injected HCAd Vector Provides Insight into Optimizing Dosing Strategy
Presented By: MiJeong Kim, PhD, Senior Director of Translational Sciences at Pacira BioSciences
Date and Time: Thursday, May 15 from 2:15–2:30 PM CT, during the “Immunogenicity/NAb Titers” oral session at ASGCT 2025
Pacira will also host a symposium on HCAd for common diseases, like osteoarthritis.
Symposium Title: High-Capacity Adenoviral Vectors: Advancing Gene Therapy Beyond AAV to Deliver Cost-Effective Therapies for Common Diseases
Speakers:
- Brendan Lee, Professor of Molecular and Human Genetics, Baylor College of Medicine
- Derek Jackson, Vice President, Cell & Gene Therapy Product Development at Pacira BioSciences
- Kilian Guse, Development of Gene Therapy for Musculoskeletal Disorders at Pacira BioSciences
Date and Time: Friday, May 16 from 12:15–1:15 PM CT
About PCRX-201 (enekinragene inzadenovec)
PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today.
In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee – a testament to its promise and potential.
Given the promising Phase 1 results, dosing is underway in a Phase 2 study of PCRX-201 (the ASCEND study) for the treatment of knee osteoarthritis. To learn more about PCRX-201 and the company’s clinical development program, please visit the investor events section of the company’s investor website.
About Pacira
Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The Company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel, locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com.
Investor Contact: Susan Mesco, (973) 451-4030 susan.mesco@pacira.com Media Contact: Sara Marino, (973) 370-5430 sara.marino@pacira.com
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