Kimera Labs Inc issued the following announcement on August 18.
Kimera® Labs Inc, a privately held clinical stage biotechnology company, announces the filing of an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class XoGlo® isolated placental mesenchymal stem cell-based exosomes. Founded in 2012, Kimera® generated the first publicly available isolated exosome product and has treated over 35,000 thousand patients for a variety of investigational uses. Kimera currently employs 40 PhDs, technicians and staff at its Miramar Florida 27,000 sq. ft. GMP manufacturing facility, the first and only laboratory dedicated solely to exosome R&D and production in the US.
Exosomes have been referenced in scientific and medical publications to exhibit anti-inflammatory properties, including recently published articles on their investigational use for the treatment of Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19 infection. Kimera® believes that its strict donor screening practices, ultra purification methods, and current Good Manufacturing Practices (cGMPs) ensure the quality and purity of its exosome products for the intended IND clinical trial. The Company is proposing a 160 patient clinical trial in a non-hospital ambulatory setting.
"I am very proud to have overseen the development of this company from its creation without outside investment to the delivery of a robust FDA IND application, in advance of the stipulated FDA conformance May 2021 date," stated Kimera® Labs founder and CEO, Duncan Ross PhD. "Our completed IND document was a six year project that involved the input of a team of passionate scientists operating without a guidebook in a novel, constantly evolving field of virus sized particles."
Since 2016, Kimera® has invested in unrivaled in-house research and production capacity to support additional IND applications coming over the next 12 months. Kimera® employs a number of in-house laboratory assays and proprietary exosome characterization methods, including its ONI super-resolution microscope which uses Stochastic Optical Reconstruction Microscopy (STORM), to better characterize and optimize its exosome products. Jan Torres, COO of Kimera®, states that "this significant investment has allowed us to put forth what we hope to be the most well-described extracellular vesicle IND application at this time. Furthermore, we hope that these well characterized proofs will allow us to output multiple IND-approved therapeutic treatments for various afflictions within the next two years."
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