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Special Reports > Exclusives


FDA WARNS EXOSOME MAKER FOR MARKETING OUTSIDE ITS IND


— AGENCY ALSO RAISES CONCERN ABOUT A POTENTIALLY CONTAMINATED PRODUCT BATCH

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage
Today January 22, 2024


MedpageToday

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The FDA has warned Kimera Labs that it can't sell its exosome product for uses
outside of its recently secured investigational new drug (IND) application.

In a warning letteropens in a new tab or window that was posted to the FDA's
website last September, then removed, and then posted again this month, the
agency also told the Miramar, Florida-based company that none of its products
are the subject of a biologics license application (BLA) -- which it would need
to market a biological product like exosomes to treat various conditions.



FDA also pointed out that Kimera "failed to document an investigation into the
positive sterility result" for one of its products, XoGloPro, found during a
July 2022 inspection, adding that all of the vials had been distributed.

While Kimera was issued an IND for its XoGloPro product in May 2023, FDA
acknowledged, the indication was for a phase I/IIa clinical trial evaluating the
safety and efficacy of a single intravenous dose of the drug to treat COVID-19
in adults with mild-to-moderate illness, according to a company press
releaseopens in a new tab or window.

But just because the IND is in effect doesn't mean a company can "commercially
distribute or test market an investigational new drug," the FDA warned.

"Just because you have one IND doesn't mean you can do all that other stuff,"
Paul Knoepfler, PhD, of the University of California Davis, who has long tracked
stem cell products in the U.S., told MedPage Today. "Their exosomes are
[marketed] for so many different things."



In its letter, FDA said Kimera makes two exosome products -- XoGlo and XoGloPro
-- as well as an amniotic fluid product called Amnio2X.

The July 2022 inspection found "significant deviations" from current good
manufacturing practice (CGMP) requirements, according to the FDA, including
failure to establish written procedures to prevent microbiological contamination
of its sterile products; failure to establish adequate cleaning procedures; and
issues with its purity testing methodology.

That inspection also found the issue with the positive sterility result for a
lot of XoGloPro.

"You would have thought those [issues] would have been ironed out before they
got an IND," given that the inspection was in July 2022 and the IND was issued
in May 2023, Knoepfler added.


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The warning letter also noted that because investigators "had some difficulty
obtaining unredacted records, including batch records, from you during the
inspection," FDA "encouraged" the company to review the agency's policy on
circumstances that constitute delaying, denying, limiting, or refusing a drug
inspection.



In its October 2022 response, Kimera said it planned to continue to distribute
existing inventory through a certain time, according to the warning letter. FDA
responded in December 2022 saying it did not agree with that decision "to
continue to distribute these products without a BLA or IND in effect."

Kimera said in its February 2023 response to the FDA that it would "cease all
distribution of existing batches of XoGlo and XoGloPro by Friday, February 10,
2023" for use outside of its IND. FDA told Kimera that its "continued
distribution of your products violates the [Food, Drug, and Cosmetic] FD&C Act
and the [Public Health Service] PHS Act."

Kimera said in a press release emailed to MedPage Today that it conducted
sterility tests of the XoGloPro lot in question, and that it was free from
pathogens. It also shared those data with FDA, the release said.

"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," Duncan Ross, PhD, founder and CEO of Kimera
Labs, said in the release.



To date, Kimera has not received any reports of adverse events tied to its
products, and has recently been approved to conduct a 160-patient clinical trial
in a non-hospital ambulatory setting, according to the press release.

This isn't the first letter FDA has sent to Kimera Labs. In April 2020, FDA sent
an untitled letteropens in a new tab or window to Ross and to Douglas Spiel, MD,
a "clinical consultant" to Kimera, stating that based on the company's claims on
YouTube videos, its products would be regulated as drugs and biological
products.

In its warning letter, the FDA also referenced its December 2019 warningopens in
a new tab or window on exosome products, which it issued after "multiple reports
of serious adverse events experienced by patients who were treated with exosome
products."

Notably, an outbreak in Nebraskaopens in a new tab or window involved around
five patients who became seriously ill, including some who developed sepsis. All
were given an exosome product derived from C-sectioned placentas, according to a
health alert sent by the state to clinicians. Ultimately, the culprit was found
to be a product made by Las Vegas-based EUCYT Laboratoriesopens in a new tab or
window.



Exosomes are tiny packets secreted by stem cells, thought to carry proteins as
well as RNA to build other proteins. On his stem cell blog, Knoepfler
reportedopens in a new tab or window that Kimera makes exosomes from various
kinds of cells, including mesenchymal stem cells from birth tissues.

Currently, no exosome products are approved by the FDA. The agency did not
return a request for comment from MedPage Today.

 * Kristina Fiore leads MedPage’s enterprise & investigative reporting team.
   She’s been a medical journalist for more than a decade and her work has been
   recognized by Barlett & Steele, AHCJ, SABEW, and others. Send story tips to
   k.fiore@medpagetoday.com. Follow

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Comment Please enable JavaScript to view the comments powered by Disqus.


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opens in a new tab or window
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3
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opens in a new tab or window






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opens in a new tab or window
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