Cellipont Bioservices and Ernexa Therapeutics Enter Cell Therapy Manufacturing Partnership to Advance ERNA-101 Toward Clinical Trials in Ovarian Cancer

Rhea-AI Summary

Cellipont Bioservices and Ernexa Therapeutics (Nasdaq: ERNA) announced a collaboration on Oct 29, 2025 to advance ERNA-101, Ernexa's lead allogeneic iMSC cell therapy for ovarian cancer, into clinical manufacturing and trials. The agreement covers Engineering, Differentiation, and Production (EDP) activities and cGMP development and scale-up of the ERNA-101 manufacturing process.

ERNA-101 is an off-the-shelf iMSC therapy designed to reprogram immunologically "cold" tumors to "hot" ones; preclinical data were presented at AACR and ASCO. The partnership targets translating preclinical promise into a clinically viable therapy.

Insights

Cell therapy manufacturing strategist

Partnership accelerates ERNA-101 toward clinical manufacturing with a CDMO experienced in iMSC process scale-up.

Cellipont Bioservices will perform Engineering, Differentiation, and Production work to advance ERNA-101 into cGMP clinical manufacturing following the announcement on Oct 29, 2025. This directly links laboratory-stage preclinical progress to a manufacturing pathway required for initiating human trials.

The arrangement reduces a key execution gap: process development and scale-up. Risks remain around successful transfer to cGMP and reproducible scale-up, but those operational risks are scope-limited to manufacturing rather than clinical efficacy.

Watch near-term milestones tied to process qualification, release criteria, and an initial clinical manufacturing batch as indicators of progress; expect updates over the next several quarters ahead of the planned clinical trials.

THE WOODLANDS, Texas, and CAMBRIDGE, Mass., Oct. 29, 2025 /PRNewswire/ -- Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), today announced it has entered into a collaboration with Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease. The partnership agreement will focus on Engineering, Differentiation, and Production (EDP) activities to advance ERNA-101, Ernexa's lead cell therapy for the treatment of ovarian cancer, into clinical manufacturing and clinical trials.

"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 Ernexa (ERNA) announce on October 29, 2025 about ERNA-101?

Ernexa announced a collaboration with Cellipont to advance ERNA-101 into cGMP clinical manufacturing and prepare for clinical trials.

How will the Cellipont partnership affect ERNA-101's manufacturing for ERNA (Nasdaq: ERNA)?

The partnership will support EDP activities and scale-up under cGMP to enable clinical manufacturing of ERNA-101.

What is ERNA-101 and what indication is Ernexa targeting with ERNA (ERNA)?

ERNA-101 is an allogeneic iMSC cell therapy designed to activate immune responses against ovarian cancer.

Did Ernexa present ERNA-101 data before the Cellipont collaboration?

Yes; preclinical ERNA-101 data were presented at AACR and ASCO annual meetings.

Will ERNA-101 be an off-the-shelf therapy for ERNA shareholders?

Yes; ERNA-101 is described as an allogeneic, synthetic iMSC intended to be a scalable, off-the-shelf treatment.

Does the October 29, 2025 announcement provide a clinical trial start date or financial terms for ERNA (ERNA)?

No; the announcement describes the collaboration and cGMP scale-up but does not disclose trial start dates or financial terms.