FDA approves IND for PSC’s stem cell therapy candidate for Covid-19

Calidi Biotherapeutics said that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.

Calidi has partnered with PSC for over two years—most recently contributing the stem cell lines used to manufacture treatment for the upcoming first trial, “CoronaStem 1,” which will be conducted among 20 hospitalized COVID-19 patients in California.

“We are extremely pleased to continue our partnership with PSC, securing and providing stem cells from healthy donors in strict accordance with FDA guidelines,” said Allan J. Camaisa, Chairman and CEO of Calidi Biotherapeutics. “We’ve seen the impressive capabilities of allogeneic mesenchymal stem cells [MSCs] firsthand through Calidi’s years of work, and strongly believe that they can help provide a therapeutic solution for the global pandemic. They’ve demonstrated to be efficient vehicles for oncolytic virus delivery and potentiation upon direct injection into cancerous tumors, an approach which has revealed potent anti-tumor effects not only at the injected tumor site but also at distant metastatic tumor sites.”

At the request of the White House Coronavirus Task Force, PSC applied for expedited review of their IND filing in the PSC-Calidi product through the newly-formed FDA Coronavirus Therapeutic Accelerator Program (CTAP) in April 2020.

“We’re optimistic about the efficacy of these adipose-derived MSCs for therapeutic treatment of COVID-19 patients as well as powerful treatments for cancer. They are truly powerful cells,” said Dr. Bob Harman, Chairman and CEO of Personalized Stem Cells. We’ve also been very pleased with the results of our good manufacturing practices and interactions with the FDA.”

The CoronaStem 1 study will proceed in the coming weeks, managed and conducted by PSC, among a limited number of COVID-19 patients, as outlined in the IND submission. PSC plans to proceed onto a larger phase 2 clinical trial and potentially into FDA compassionate use programs to reach more patients pending the success of the initial trial.