Kimera® Labs Responds to FDA Warning Letter

Kimera® Labs Inc., a privately held clinical stage biotechnology company, responded to a Warning Letter (WL) received from the Food and Drug Administration (FDA) on September 5, 2023. That same WL was listed on the FDA website on January 4, 2024. The WL was in response to an inspection conducted in its Miramar, FL facility between July 11, 2022, and July 21, 2022. During that inspection, FDA took the position that three cellular exosome products produced at that facility for research use, XoGlo®, XoGlo Pro®, and Amino2X®, were pharmaceutical drugs required to comply with the most stringent current good manufacturing practices (cGMPs) applicable to commercial manufacturers of pharmaceutical products.

Soon after the inspections in July 2022, Kimera Labs filed detailed responses to the agency Form 483 that listed observations made by the FDA field investigators. The Warning Letter noted that, in FDA's view, those responses did not adequately address issues including: validation of aseptic and sterilization processes; validation of manufacturing processes; documentation of specific cleaning methods; and stability data to support one-year expiration dating. FDA did not find that any products distributed by Kimera Labs were contaminated. No adverse event reports have been received by Kimera Labs and the appropriate sterility testing results, demonstrating that the lot in question was free from pathogens, were provided . "We provided FDA with a full response to these alleged pharmaceutical cGMP deviations and will soon file an update on the actions we have taken to conform to drug manufacturing standards," said Duncan Ross, Ph.D., Founder and CEO of Kimera Labs. Previously, on May 12, 2023, Kimera Labs received approval of an Investigation New Drug application (IND) to manufacture and test XoGlo Pro to treat inflammation associated with COVID-19.

FDA regulation of cell therapies has become much more stringent. "Kimera Labs remains dedicated toward development of cellular-based exosomes by ensuring their manufacturing safety, purity and potency," said Mr. Ross. "It is our highest priority," he added. Kimera Labs also manufactures exosome products intended for cosmetic use while it continues to research and develop potential new drug applications for use to treat human disease.

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 COVID-19. The Company believes that its strict donor screening practices, its 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 has been approved to conduct 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," 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 innovative new uses of cellular exosomes. Kimera® has employed 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. "This significant investment allowed us to gain FDA approval of the most well-described extracellular vesicle IND application at this time," said Jan Torres Ph.D., COO of Kimera Labs. "We hope that these well characterized proofs will allow us to produce multiple IND approved therapeutic treatments for various afflictions within the next two years."

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