FDA warns exosome makers against marketing outside the IND

The FDA has warned Kimera Labs that it cannot sell its exosome products for any use other than the recently secured Investigational New Drug (IND) application.

In a warning posted on the FDA's website last September, later removed, and reposted this month, the FDA also warned the Miramar, Fla.-based company that none of its products contain biological (BLA) — Biological products like exosomes will need to be marketed to treat a variety of conditions.

The FDA also found that Chimera “failed to document an investigation into a positive sterility result” for one of its products, XoGloPro, which was discovered during a July 2022 inspection, and all vials were distributed. He added that it had been done.

Kimera was issued an IND for its XoGloPro product in May 2023 for a Phase I/IIa indication evaluating the safety and efficacy of a single intravenous dose for COVID-19 in adults with mild illness. The FDA acknowledged that this is a phase clinical trial. Moderate illness, according to a company press release.

However, the FDA warned that just because an IND is in effect does not mean a company can “commercially distribute or market an investigational new drug.”

“Just because you have one IND doesn't mean you can do everything else,” said Dr. Paul Knopfler of the University of California, Davis, who has tracked stem cell products in the United States for years. today's med page. “Their exosomes [marketed] In so many different things. ”

The FDA said in the letter that Kimera makes two exosome products, XoGlo and XoGloPro, and an amniotic fluid product called Amnio2X.

The FDA said a July 2022 inspection found “significant deviations” from current Good Manufacturing Practice (CGMP) requirements. Failure to establish proper cleaning procedures. And then there is the issue of its purity testing method.

The test also found issues with many XoGloPro positive sterility results.

“You thought so. [issues] It would have been resolved before the IND was obtained,” Knopfler added, considering that the inspection took place in July 2022 and the IND was issued in May 2023.

The warning letter also states that because investigators “had some difficulty obtaining unredacted records from you, including batch records, during the inspection,” the FDA will not allow the company to delay, deny, limit, or deny It also said it had “encouraged” authorities to review their policies regarding situations where this applies. drug test.

According to the warning letter, Chimera said in its October 2022 response that it plans to continue distributing existing inventory for a certain period of time. In December 2022, the FDA responded by saying it disagreed with the decision to “continue to distribute these products without an effective BLA or IND.”

In its February 2023 response to the FDA, Kimera said it would “cease distribution of all existing batches of XoGlo and XoGloPro by Friday, February 10, 2023” for use outside the IND. The FDA told Chimera, “The continued distribution of your product… [Food, Drug, and Cosmetic] FD&C Act and [Public Health Service] PHS Law”

Chimera said in an emailed press release. today's med page The XoGloPro lot in question was tested for sterility and confirmed to be free of pathogens. That data was also shared with the FDA, according to the release.

Dr. Duncan Ross, founder and CEO of Kimera Labs, said: “We are providing the FDA with a full response to these alleged drug CGMP deviations and are committed to ensuring compliance with drug manufacturing standards. We will provide an update on the actions we have taken in the coming days,'' the release said. .

To date, Chimera has received no reports of adverse events related to its product and was recently approved to conduct a 160-patient clinical trial in a non-hospital outpatient setting, according to a press release. That's what it means.

This is not the first letter the FDA has sent to Kimera Labs. In April 2020, the FDA sent an untitled letter to Mr. Ross and Mr. Chimera's “clinical consultant” Douglas Spiel, M.D., stating that, based on the company's claims in the YouTube video, the company's products are safe from pharmaceutical and biological drugs. It is regulated as a scientific product.

In its warning letter, the FDA also referenced a December 2019 warning about exosome products that it issued in response to “multiple reports of serious adverse events experienced by patients treated with exosome products.”

Of note, approximately five patients in the Nebraska outbreak became critically ill, including some who developed sepsis. All were given an exosome product derived from a C-section placenta, according to a health alert sent by the state to clinicians. Ultimately, the culprit was determined to be a product manufactured by his Las Vegas-based EUCYT Laboratories.

Exosomes are small packets secreted by stem cells that are thought to carry not only proteins but also RNA for building other proteins. Knoepfler reported on his stem cell blog that chimeras create exosomes from different cell types, including mesenchymal stem cells from birth tissue.

There are currently no exosome products approved by the FDA. The agency did not respond to requests for comment. today's med page.