Duncan Ross, PH.D., Founder and CEOFrom humble beginnings to becoming a leader in the field of MSC exosome production and isolation, Kimera Labs’ growth is largely attributed to its role in advancing exosome-based diagnostics and therapeutics, supported by two state-of-the-art facilities. These facilities are equipped with ISO 5 hoods and class 7 clean rooms, ensuring the highest cleanliness and safety standards. This infrastructure is critical for the company's R&D efforts, enabling the creation of innovative solutions that seek to expand beyond the aesthetic world it now lives in and continue to push the boundaries of what's possible in the therapeutic and regenerative medicine realm.
Achieving Heights
The road toward excellence has not been easy for Kimera Labs. There have been many challenges as well as many successes. In May of 2023, Kimera received Phase I/IIA approval of their investigational New Drug (IND) Application utilizing their XoGlo® MSC exosome product and is now working diligently on preparations for entering into human clinical trials for the treatment of Long COVID-19.
Kimera Labs has invested in unrivaled in-house research and production capacity to support the innovative use of cellular exosomes. It 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 for the most well-described extracellular vesicle IND application,” says Jan Torres, COO of Kimera Labs. “We hope these well-characterized proofs will allow us to produce multiple IND-approved therapeutic treatments for various afflictions within the next two years.”
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 Ross discovered XoGlo’s proprietary purification process in 2014, Kimera Labs has been at the top of its game with its optimal-purity, isolated stem cell exosomes.
Other biologic tissue laboratories typically manufacture exosome products through direct processing of donor tissues like adult bone marrow or placenta. Kimera produces MSC exosomes from isolated mesenchymal stem cell cultures using chemically defined media that doesn’t contain animal or human serum, following regulations laid out by the FDA. The company believes that its strict donor screening practices, ultra-purification methods, and cGMP manufacturing processes ensure the quality and purity of exosome products for the intended IND clinical trial. It has been approved to conduct a 160-patient trial in a nonhospital, ambulatory setting.
“I am proud to have overseen the development of this company from its creation, without outside investment, to the delivery of a robust FDA IND application,” says Ross. “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.”
In an effort to increase its production capacity, develop new exosome products, and enhance its proprietary exosome purification and characterization process, Kimera Labs expanded into a new state-of-the-art biochemistry laboratory, education hub, and production facility. The new facility supplements its original 6,000-square-foot facility in Miramar. The expansion also enables the development of new exosome-based technologies, including an exosome-based diagnostics division.
A large portion of Kimera’s investment in managing quality is dedicated to the optimal characterization of exosomes to ensure their purity and consistency for potential use in clinical applications.
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We Hope That Developing Academic Partnerships By Leveraging Our Technical Capabilities Can Help Bridge The Gap Between Bench And Bedside And Allow Us To Use Our Industry-Leading Expertise To Produce New Exosome Technologies
Confirming the quality of these MSC exosomes requires advanced multi-modality characterization using technologies such as ELISA protein analysis, high-pressure liquid chromatography (HPLC), RNA sequencing, and NanoSight Nano Tracking Analysis. Kimera Labs is the first private company to include dSTORM super resolution fluorescence microscopy in its batch-verification process. This suite of characterization devices, housed in the new facility, fuels the development of novel exosome-based diagnostic modalities for cancer and other diseases.
The new facility also serves as an educational resource for the exosome scientific community. Its meeting space can accommodate 50 to 100 people for educational events focused on exosomes and their future clinical and scientific development.
Advancement of the nascent exosome industry depends on pioneering new technologies and sharing new developments with the scientific and medical community. Kimera Labs leads the way in this effort.
Four dedicated post-doctoral scientists in its biochemical research and development department enable the development of engineered exosomes that may have applications for specific clinical indications, including autoimmune, inflammatory, degenerative, and malignant conditions. By genetically modifying future cell lines, Kimera Labs opened up a myriad of possibilities directed toward patient-specific therapeutic development.
"Existing at the bleeding edge of exosome science has been a lonely road. We hope that developing academic partnerships by leveraging our technical capabilities can help bridge the gap between bench and bedside and allow us to use our industry-leading expertise to produce new exosome technologies at scale," says Ross.
Kimera Labs’ rich history in exosome research and product development is underpinned by a dedicated team of 50, including many with PhDs, across its R&D characterization, quality control and production departments.
Kimera has successfully obtained FDA Phase I/IIa IND approval for a groundbreaking human study involving MSC Exosomes. The study will evaluate the safety and effectiveness of a single intravenous dose of isolated, proprietary exosomes derived from a placental cell line. These mesenchymal stem cell extracellular vesicles have the potential to treat symptoms of COVID-19 in adults experiencing mild to moderate illness.
Looking ahead, Kimera Labs will incorporate mass spectrometry into its operations to enhance its capabilities and ensure better accuracy and reliability in its assessments. The establishment of a diagnostics division is aimed at broadening its offerings, enabling the provision of characterization services for external entities seeking to delve into exosome analysis.
The lab envisions partnerships to help develop diverse medical indications. It is currently developing a scratch test to enhance wound-healing models and reduce scar formation and is in the process of pursuing additional INDs in domains like aesthetics, wound healing, anti-aging and disease diagnostics.
Not just a laboratory but a catalyst for change, Kimera Labs is rewriting the narrative of regenerative medicine through the potency of exosomes. With a track record in innovation, it continues to be a pioneer and a driving force in advancing the potential of exosomes for better patient outcomes.
