/C O R R E C T I O N -- Cellipont Bioservices/
Cellipont Bioservices and Ernexa Therapeutics (ERNA) announced a manufacturing collaboration on Oct. 29, 2025 to advance ERNA-101, Ernexa's lead allogeneic iMSC cell therapy for ovarian cancer, toward clinical manufacturing and trials. The agreement covers engineering, differentiation, and production (EDP) activities and cGMP development and scale-up of the ERNA-101 process. ERNA-101 has shown preclinical potential to convert immunologically "cold" tumors into "hot" tumors, with data presented at AACR and ASCO. No financial terms or clinical timelines were disclosed.
Cellipont Bioservices e Ernexa Therapeutics (ERNA) hanno annunciato una collaborazione di produzione il 29 ottobre 2025 per avanzare ERNA-101, la principale terapia cellulare allogenica iMSC di Ernexa per il cancro ovarico, verso la produzione clinica e i trial. L'accordo riguarda attività di progettazione, differenziazione e produzione (EDP) e lo sviluppo cGMP e la scalatura del processo ERNA-101. ERNA-101 ha mostrato potenziale preclinico per convertire tumori immunologicamente 'freddi' in tumori 'caldi', con dati presentati all'AACR e all'ASCO. Non sono stati resi noti termini finanziari o tempi clinici.
Cellipont Bioservices y Ernexa Therapeutics (ERNA) anunciaron una colaboración de fabricación el 29 de octubre de 2025 para avanzar ERNA-101, la principal terapia celular allogénica iMSC de Ernexa para el cáncer de ovario, hacia la fabricación clínica y los ensayos. El acuerdo cubre actividades de ingeniería, diferenciación y producción (EDP) y desarrollo cGMP y escalado del proceso ERNA-101. ERNA-101 ha mostrado potencial preclínico para convertir tumores inmunológicamente "fríos" en tumores "calientes", con datos presentados en AACR y ASCO. No se divulgaron términos financieros ni calendarios clínicos.
Cellipont Bioservices 와 Ernexa Therapeutics (ERNA) 는 2025년 10월 29일에 ERNA-101, Ernexa의 이식형 iMSC 세포 치료제의 난소암 치료제를 임상 제조 및 시험으로 전환하기 위한 제조 협력을 발표했습니다. 이 계약은 공정 엔지니어링, 분화 및 생산(EDP) 활동과 ERNA-101 프로세스의 cGMP 개발 및 규모 확장을 다룹니다. ERNA-101은 면역학적으로 '냉성' 종양을 '열성' 종양으로 전환할 잠재력을 전임상에서 보여주었고, 데이터가 AACR 및 ASCO에서 발표되었습니다. 재정 조건이나 임상 일정은 공개되지 않았습니다.
Cellipont Bioservices et Ernexa Therapeutics (ERNA) ont annoncé une collaboration de fabrication le 29 octobre 2025 pour faire progresser ERNA-101, la thérapie cellulaire iMSC allogénique phare d'Ernexa pour le cancer de l'ovaire, vers la fabrication clinique et les essais. L'accord couvre les activités ingénierie, différenciation et production (EDP) et le développement cGMP et l'agrandissement du procédé ERNA-101. ERNA-101 a démontré un potentiel préclinique pour convertir des tumeurs immunologiquement "froides" en tumeurs "chaudes", avec des données présentées lors de l'AACR et de l'ASCO. Aucune condition financière ni calendrier clinique n'a été divulguée.
Cellipont Bioservices und Ernexa Therapeutics (ERNA) kündigten am 29. Oktober 2025 eine Fertigungskooperation an, um ERNA-101, Ernexas führende allogene iMSC-Therapie gegen Eierstockkrebs, in die klinische Herstellung und Studien zu überführen. Die Vereinbarung deckt Engineering, Differenzierung und Produktion (EDP)-Aktivitäten sowie die cGMP-Entwicklung und Skalierung des ERNA-101-Prozesses ab. ERNA-101 hat präklinisch das Potenzial gezeigt, immunologisch „kalte“ Tumore in „heiße“ Tumore umzuwandeln, wie auf der AACR- und ASCO-Konferenz vorgestellt. Finanzbedingungen oder klinische Zeitpläne wurden nicht offengelegt.
Cellipont Bioservices وErnexa Therapeutics (ERNA) أعلنا عن تعاون تصنيع في 29 أكتوبر 2025 لدفع ERNA-101، العلاج الخلوي المتوافق allogeneic iMSC الرائد من Ernexa لسرطان المبيض، نحو التصنيع السريري والتجارب. تغطي الاتفاقية أنشطة الهندسة، التمايز، والإنتاج (EDP) وتطوير وتوسيع عملية ERNA-101 وفقًا لمعايير GMP. أظهر ERNA-101 إمكانات ما قبل السريرية لتحويل الأورام المناعية «الباردة» إلى أورام «الحارة»، مع بيانات مقدمة في AACR وASCO. لم يتم الكشف عن أي شروط مالية أو جداول زمنية سريرية.
Cellipont Bioservices 与 Ernexa Therapeutics (ERNA) 于 2025 年 10 月 29 日宣布了一项制造合作，以推动 ERNA-101，Ernexa 的首要同种异体 iMSC 细胞治疗用于卵巢癌，朝临床制造与试验方向发展。该协议涵盖 工程、分化与生产（EDP） 活动，以及 ERNA-101 工艺的 cGMP 开发与放大。ERNA-101 在前临床显示了将免疫性“冷”肿瘤转变为“热”肿瘤的潜力，相关数据在 AACR 与 ASCO 上公布。未披露财政条款或临床时间表。
- cGMP development and scale-up for ERNA-101 manufacturing
- Partnership targets clinical manufacturing to enable trials
- Allogeneic iMSC approach offers off-the-shelf scalability
- No financial terms, timelines, or binding trial start dates disclosed
- ERNA-101 efficacy limited to preclinical data so far
In the news release, Cellipont Bioservices and Ernexa Therapeutics Enter Cell Therapy Manufacturing Partnership to Advance ERNA-101 Toward Clinical Trials in Ovarian Cancer, issued Oct. 29, 2025 by Cellipont Bioservices over PR Newswire, we are advised by the company that the logo has been updated. The complete press release that includes the updated logo follows:
Cellipont Bioservices and Ernexa Therapeutics Enter Cell Therapy Manufacturing Partnership to Advance ERNA-101 Toward Clinical Trials in Ovarian Cancer
"We are pleased to collaborate with Ernexa Therapeutics as they advance a bold and highly differentiated approach to treating cancer," said Darren Head, CEO of Cellipont Bioservices. "Supporting the development of synthetic, allogeneic iMSC therapies like ERNA-101 aligns with our commitment to enabling scientific innovation through collaborative, high-quality cell therapy manufacturing."
"Cellipont brings deep technical capabilities and a shared sense of urgency to help us translate the promise of ERNA-101 into a clinically viable therapy," said Sanjeev Luther, President and CEO of Ernexa Therapeutics. "This collaboration marks an important milestone in advancing our iMSC platform, which we believe has the potential to reshape the treatment landscape for patients with advanced solid tumors."
Ernexa's core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). iMSC is a more specialized type of stem cell that has a unique ability to migrate toward tumors. Ernexa's allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment, without needing patient-specific cell harvesting. ERNA-101 is Ernexa's lead cell therapy product, designed to activate and regulate the immune system's response to recognize and attack cancer cells.
In preclinical studies, presented at this year's AACR and ASCO annual meetings, ERNA-101 has shown the potential to reprogram immunologically "cold" tumors into "hot" ones, increasing immune cell infiltration and suppressing tumor growth. The Cellipont partnership will support the current Good Manufacturing Practice (cGMP) development and scale-up of the ERNA-101 manufacturing process in preparation for upcoming clinical trials.
About Cellipont
Cellipont Bioservices is a premier Contract Development and Manufacturing Organization (CDMO) specializing in the advancement of cell therapies. With a team of industry-leading experts, Cellipont is at the forefront of cell therapy development and manufacturing, offering comprehensive solutions from process development, analytical services, to large-scale commercial manufacturing. Our purpose-built facility, combined with our cutting-edge technology and commitment to quality enable us to support our clients in delivering life-changing cell therapies to patients worldwide. Cellipont Bioservices is dedicated to excellence in all aspects of our operations, ensuring that we not only meet but exceed the expectations of our clients and the communities we serve. To learn more, visit www.cellipont.com and follow us on LinkedIn.
About Ernexa Therapeutics
Ernexa Therapeutics (NASDAQ: ERNA) is developing innovative cell therapies for the treatment of advanced cancer and autoimmune diseases. Ernexa's core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). Ernexa's allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment solution, without needing patient-specific cell harvesting.
ERNA-101 is the company's lead cell therapy product, designed to activate and regulate the immune system's response to recognize and attack cancer cells. ERNA-201 is a cell therapy product designed to target inflammation and treat autoimmune disease. The company's initial focus is to develop ERNA-101 for the treatment of ovarian cancer. For more information, visit www.ernexatx.com.
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SOURCE Cellipont Bioservices
FAQ
What did Cellipont and Ernexa announce on Oct. 29, 2025 regarding ERNA-101 (ERNA)?
How will the Cellipont partnership affect ERNA-101 clinical readiness for ERNA?
Has ERNA-101 shown clinical results for ERNA Therapeutics (ERNA)?
Did Cellipont and Ernexa disclose financial terms or trial timelines for ERNA-101 (ERNA)?
What is the therapeutic approach of ERNA-101 by ERNA Therapeutics (ERNA)?
Why is an allogeneic iMSC approach important for ERNA's ERNA-101 program?
