Gaithersburg, MD – May 2025 — In a breakthrough for patients suffering from Crohn’s disease, L2 Bio has received FDA approval to launch a Phase 2 clinical trial investigating its cutting-edge stem cell therapy — a personalized, regenerative approach that could redefine how inflammatory bowel disease is treated in the United States.

This major regulatory milestone was achieved with comprehensive support from FDAMap, a top-tier regulatory and clinical CRO, and Akan Biosciences, Inc., a Maryland-based company operating one of the nation’s premier GMP facilities for human adult stem cell manufacturing.

“This is more than a trial — it’s a turning point in the future of inflammatory disease treatment,” said Dr. Mukesh Kumar, CEO of FDAMap. “With L2 Bio’s innovation, FDAMap’s regulatory expertise, and Akan Biosciences’ world-class manufacturing capabilities, we are delivering a complete ecosystem to bring this transformative therapy to patients who need it most.”

FDAMap provided full-spectrum support, including protocol development, IND submission, and trial management, while Akan Biosciences will manufacture the clinical-grade stem cell therapy using its state-of-the-art, FDA-compliant production facility. This collaboration ensures that the therapy meets the highest standards of quality, safety, and regulatory readiness.

The trial will evaluate the safety and efficacy of using adult stem cells to reduce inflammation and promote mucosal healing in Crohn’s disease — a chronic, often debilitating condition that affects more than 3 million Americans.

“This FDA approval marks a critical leap forward,” said Vince Liguori, CEO, L2 Bio. “We’re proud to lead the way in developing regenerative therapies with strong scientific foundations and real-world impact. With FDAMap and Akan Biosciences as our partners, we are positioned to bring a revolutionary treatment to patients facing limited options.”

About L2 Bio
L2 Bio is a biotechnology company developing innovative stem cell therapies for inflammatory, autoimmune, and degenerative diseases. The company is focused on delivering regenerative treatments grounded in rigorous science and designed to improve lives.

About FDAMap
FDAMap is a full-service CRO offering regulatory, clinical, and manufacturing guidance for emerging therapeutic technologies. With a track record of success in FDA approvals, FDAMap helps innovators translate science into patient-ready solutions.

About Akan Biosciences, Inc.
Akan Biosciences, Inc. is a Maryland-based biomanufacturing company specializing in the GMP production of adult stem cell therapies. As one of the nation’s premier facilities for regenerative medicine manufacturing, Akan supports clinical trials and commercial therapies with world-class expertise and infrastructure.

Stay connected for updates on new breakthroughs and other projects by following FDAMap on LinkedIn or subscribing to our newsletter at www.fdamap.com. For direct inquiries, contact us today.

Media Contact:
Prashant Kumar
Director of Communications
FDAMap
Phone: +1 877 566 4981 (Extension 102)
Email: pkumar@fdamap.com