On May 27, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported significant progress in the development of ERNA-101, the company’s lead therapeutic candidate, achieving multiple critical milestones that position the program for a planned Investigational New Drug (IND) submission in the third quarter of 2026 and the anticipated initiation of its first-in-human clinical study.

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The company has successfully completed process development activities for the ERNA-101 manufacturing process and has now transitioned into Good Manufacturing Practice (GMP) manufacturing in preparation for clinical development. In parallel, technology transfer activities for ERNA-101 are actively underway, representing another major operational milestone supporting the planned IND submission timeline.

"These achievements represent a defining moment for Ernexa Therapeutics," said Sanjeev Luther, CEO of Ernexa Therapeutics. "Completing process development and advancing into GMP manufacturing are critical steps toward IND clearance and the launch of our first-in-human clinical study for ERNA-101. We are executing against our development strategy with urgency and discipline and remain firmly on track for our planned IND filing in the third quarter of 2026, Most importantly, we believe ERNA-101 has the potential to bring new hope to patients and families in need of better therapeutic options."

The advancement of ERNA-101 reflects continued momentum across the company’s development and manufacturing operations and marks an important evolution in Ernexa’s corporate trajectory toward becoming a clinical-stage biotechnology company.

"With technology transfer now in progress and manufacturing activities advancing as planned, we believe Ernexa is entering a transformational phase," added CEO, Sanjeev Luther. "These milestones will significantly strengthen our operational readiness and reinforce our confidence in the path toward clinical evaluation of ERNA-101."

ERNA-101 is being advanced as part of Ernexa Therapeutics’ broader mission to develop innovative therapies designed to address significant unmet medical needs.

Key Highlights

IND submission for ERNA-101 targeted for Q3 2026
Technology transfer activities currently in progress
Process development for ERNA-101 manufacturing successfully completed
Transition to GMP manufacturing underway in preparation for clinical studies
Company advancing toward anticipated transformation into a clinical-stage biotechnology company
Progress supports planned first-in-human clinical study following IND clearance

(Press release, Ernexa Therapeutics, MAY 27, 2026, View Source [SID1234666137])