Amphix Bio lands federal and state grants to manufacture regenerative therapies

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Oct 31, 2024, 11:41 ET

CHICAGO, Oct. 31, 2024 /PRNewswire/ -- Amphix Bio, a company developing a new class of regenerative medicine therapies, announced that it has secured a $1M Small Business Innovation Research (SBIR) Phase II grant from the National Science Foundation (NSF) to scale up manufacturing methods for its platform technology. The platform is based on supramolecular peptide therapeutics that signal the patient's own cells to initiate regenerative processes.

The manufacturing technology developed with the grant funds will be used to produce an off-the-shelf implant for spinal fusion surgeries. This product was recently designated as a Breakthrough Device by the FDA for treating back pain caused by degenerative disc disease. In its Phase I project, Amphix Bio developed new manufacturing methods for its bone regeneration therapy and created a moldable, putty-like formulation that demonstrated efficacy in large animal models. The goals of the Phase II project are to scale up production of the company's therapeutic peptides, develop new manufacturing methods for the putty formulation, and complete biocompatibility testing.

At the end of the project, the company plans to produce final-packaged, end-sterilized spine implants validated in large animal studies, the final step before beginning clinical trials.

"We are grateful to the NSF for this Phase II funding and are excited to advance our manufacturing capabilities to bring the supramolecular therapeutics platform into the clinic," said Amphix Bio co-founder and CEO Nick Sather, PhD. "Our technology can offer a simpler and safer solution for treating debilitating back pain, without the side effects associated with harvesting autograft tissue or using recombinant proteins to induce bone growth."

Amphix Bio recently strengthened its team with new hires in manufacturing and operations, as the company gears up for clinical trials. Iwona Maciagiewicz, PhD, joined the company last year and brings extensive experience in biotech manufacturing, including small molecules, biologics, and diagnostic devices. Hussain Sangji, PhD, joined Amphix Bio in 2024 from the Boston Consulting Group (BCG), where he led strategy and operations projects for major global Biopharma and MedTech companies.

The grant brings the company's total SBIR funding to $1.25M. In addition to the SBIR grant, the company recently received non-dilutive funding from the Illinois Science and Technology Coalition aimed at supporting innovation in the state. These grants will expand Amphix Bio's long-running collaborations at Northwestern University. Wellington Hsu, MD, and Erin Hsu, PhD, professors of orthopedic surgery at Northwestern's Feinberg School of Medicine, will oversee pre-clinical testing and advise clinical development of the product.

About Amphix Bio

Amphix Bio spun out from Northwestern University in 2021. The Chicago-based company is developing a new class of supramolecular therapies that instruct cells to initiate regenerative processes and restore function lost from injury, disease, or aging. These therapies contain tens of thousands of biological signals that trigger targeted signaling pathways while forming scaffolds to support tissue growth. Amphix Bio's goal is to use regenerative medicine to increase human healthspans — the length of time that people can live productive, fulfilling lives.

Learn more at www.amphixbio.com, or contact us at [email protected].

SOURCE Amphix Bio