Amicrobe, Inc. announces kilogram-scale GMP manufacturing of Amicidins - synthetic proteins to prevent and treat life-threatening infections
Amicrobe has collaborated with contract manufacturer Polypeptide Therapeutic Solutions (PTS, Valencia, Spain) to produce Amicidin-α and Amicidin-β
CARLSBAD, Calif., Sept. 21, 2021 /PRNewswire/ -- Amicrobe, Inc., designs and develops breakthrough biologics at the interface of materials science and biotechnology. Called Amicidins, these synthetic proteins are made for local application to exposed tissues, such as those found in surgical and traumatic wounds. To produce clinical-grade Amicidins, Amicrobe selected contract manufacturer Polypeptide Therapeutic Solutions (PTS), a global leader in amino acid polymer synthesis and characterization. In a successful collaboration, Amicrobe's lead biologics, Amicidin-α and Amicidin-β, were produced at kilogram-scale under Good Manufacturing Practice (GMP) guidelines. The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has funded the development of Amicidin-β since 2017.
Amicidin-α combines physical barrier properties and microbicidal activity to prevent infection in surgical wounds, acting as an intra-operative barrier for exposed, vulnerable tissues. Amicidin-β combines surfactant properties and microbicidal activity to treat contaminated and infected tissues, including those with prosthetic implants and biofilms. GMP drug substances produced by PTS will be used for remaining GLP toxicology studies and first-in-human clinical trials. Amicidin-α and Amicidin-β are expected to be active ingredients in several products for surgery/trauma, and beyond.
Dr. Michael P. Bevilacqua, CEO and CSO of Amicrobe, stated, "Amicidins are produced using robust polymer methods, more frequently found in the field of materials science than biotechnology. As we approach first clinical trials, we are very pleased to work with PTS as they have deep understanding of amino acid polymer synthesis, including application of GMP principles. Their teams have proven astute and responsive in this new approach, and they have been a great partner."
José Vicente Pons Andreu, CEO of PTS Polypeptides, remarks: "We are excited to collaborate with Amicrobe on these programs. The collaboration between Amicrobe and PTS combines the expertise of a leader in biologics with our precision poly amino acid technology, creating superior and more stable engineered local antimicrobials. We look forward to supporting Amicrobe further in all the programs with our precision polymer solutions."
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust, Germany's Federal Ministry of Education and Research (BMBF), and the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF). The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.
About Amicrobe:
Amicrobe, Inc., is developing a new class of locally applied products to prevent and treat life-threatening infections, with early focus on surgery and trauma. Its powerful technology platform creates synthetic proteins, called Amicidins. Amicidins combine beneficial physical properties and safety with broad microbicidal activity for superior local performance. They can be produced in a multitude of formulations and formats including hydrogels, emulsions, dry fibers, dressings, and thin films. Amicrobe is headquartered in Carlsbad, California. For more information, please visit https://www.amicrobe.com/.
About PTS:
PTS Polypeptide Therapeutic Solutions, is the leader in the design and manufacturing of GMP grade polyaminoacid-based drug delivery systems. The Company's proprietary PAA technologies provide precision targeting and safe delivery for nucleic acids, cell and gene therapies, biologics and small molecule pharmaceutical products. The Company is headquartered in Valencia, Spain and supports customers worldwide. For more information on Polypeptide Therapeutic Solutions, visit pts-polypeptides.com.
PTS is a portfolio company of Arcline, a growth-oriented private equity firm that seeks to invest in thriving middle market businesses with structurally recurring revenue streams in high value industries. Arcline's differentiated investment strategy combines deep business model expertise, proactive thematic research, an unrelenting focus on the upside and a collaborative, management-first approach to value creation. Launched in 2019, Arcline currently has $4.3 billion in cumulative capital commitments. The firm's more than 35 professionals are predominantly based in New York and San Francisco. For more information about Arcline's investment philosophy and values, visit www.arcline.com.
Contacts:
Amicrobe, Inc.
Eric Rusaw
Associate Director of Corporate Development
+1-888-490-1180
erusaw@amicrobe.com
Polypeptide Therapeutic Solutions
Amador Garcia
Marketing Director
+34 963-769-080
agarcia@pts-polypeptides.com
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