Amphix Bio lands federal and state grants to manufacture regenerative therapies
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CHICAGO, Oct. 31, 2024 ~ Amphix Bio, a leading company in the development of regenerative medicine therapies, has announced that it has been awarded a $1 million Small Business Innovation Research (SBIR) Phase II grant from the National Science Foundation (NSF). The grant will be used to scale up manufacturing methods for the company's innovative platform technology, which is based on supramolecular peptide therapeutics that signal the patient's own cells to initiate regenerative processes.

The main focus of this grant is to develop manufacturing technology that will enable Amphix Bio to produce an off-the-shelf implant for spinal fusion surgeries. This product has recently been designated as a Breakthrough Device by the FDA for its potential in treating back pain caused by degenerative disc disease. In its Phase I project, Amphix Bio successfully developed new manufacturing methods for its bone regeneration therapy and created a moldable, putty-like formulation that showed promising results in large animal models. With this Phase II grant, the company aims to further scale up production of their therapeutic peptides, develop new manufacturing methods for the putty formulation, and complete biocompatibility testing.

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According to Amphix Bio co-founder and CEO Nick Sather, PhD, "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." He also added that their technology has the potential to offer a simpler and safer solution for treating debilitating back pain without any side effects associated with traditional methods such as harvesting autograft tissue or using recombinant proteins.

In preparation for clinical trials, Amphix Bio has recently expanded its team with new hires in manufacturing and operations. Dr. Iwona Maciagiewicz joined the company last year and brings extensive experience in biotech manufacturing including small molecules, biologics, and diagnostic devices. Dr. Hussain Sangji also joined Amphix Bio in 2024 from the Boston Consulting Group (BCG) and will be leading strategy and operations projects for major global Biopharma and MedTech companies.

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This grant brings Amphix Bio's total SBIR funding to $1.25 million. In addition to the SBIR grant, the company has also received non-dilutive funding from the Illinois Science and Technology Coalition to support innovation in the state. These grants will further expand Amphix Bio's collaborations with Northwestern University. The company will be working closely with Dr. Wellington Hsu, MD, and Dr. Erin Hsu, PhD, professors of orthopedic surgery at Northwestern's Feinberg School of Medicine, who will oversee pre-clinical testing and advise on the clinical development of the product.

With this new grant funding and strengthened team, Amphix Bio is well-positioned to advance their innovative regenerative medicine therapies towards clinical trials and potentially revolutionize the treatment of back pain caused by degenerative disc disease.
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