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Talaris Therapeutics Presents Data on COVID-19 Outcomes Among Kidney Transplant Patients Treated with FCR001

Low rate of COVID-19 infection observed in vaccinated, durably chimeric patients off immunosuppression

No evidence of acute kidney injury or impaired renal function in FCR001-treated patients with COVID-19 infection

No patients lost chimerism as a result of COVID-19 vaccination or infection

Excerpt from the Press Release:

BOSTON and LOUISVILLE, Ky., April 06, 2022 (GLOBE NEWSWIRE) — Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today shared new data on COVID-19 outcomes among living donor kidney transplant (LDKT) patients treated in the Company’s Phase 2 trial of investigational cell therapy product FCR001 (NCT00497926). The data were presented in a poster at the 2022 Cutting Edge of Transplantation (CEoT) meeting organized by the American Society of Transplantation.

As previously reported, 26 of 37 LDKT recipients of FCR001 from the Company’s Phase 2 study achieved durable chimerism and were able to discontinue and remain off all IS for the duration of follow-up, with a median follow-up of over six years. A retrospective chart review of patients in the Phase 2 study was conducted by researchers at Northwestern University, who examined COVID-19 infection rates, effects of COVID-19 infection, and evidence of antibody response to vaccination. Of the 28 patients for whom data were available, 23 were durably chimeric and all of these patients were able to discontinue chronic immunosuppression (IS). The remaining 5 patients were not durably chimeric and remained on chronic IS.

Of the 23 durably chimeric patients off chronic IS, 18 were vaccinated, of whom 2 (11%) tested positive for COVID-19. None of these 18 patients lost chimerism or had renal dysfunction as a result of their COVID-19 vaccination. Among the remaining 5 patients who were off all chronic IS but were unvaccinated, 3 (60%) tested positive for COVID-19. Among the 5 patients who remained on chronic IS, 4 of whom were vaccinated, 2 (40%) tested positive for COVID-19. COVID-19 infection did not lead to reduction in renal function for the FCR-treated patients. None of the COVID-19-infected patients were hospitalized or developed severe disease.

Additionally, post-vaccination antibody testing had been performed on 4 patients (3 durably chimeric, 1 nonchimeric). These data showed that all 4 patients produced measurable antibody responses to COVID-19 vaccination.

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