Cell Therapy Pipeline Update: Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial

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Cell Therapy pipeline update, Talaris Therapeutics, a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY, announced the initiation of FREEDOM-1 (NCT03995901), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.

What is the objective of the trial:

This pivotal trial will evaluate the safety and efficacy of a single dose of FCR001, the company’s investigational cell therapy designed to durably free LDKT recipients from immunosuppression without rejection of their transplanted organ.

What is FCR001:

FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose in kidney transplant recipients who received a non-myeloablative conditioning regimen. FCR001 contains the donor’s CD34+ cells, facilitating cells, and αβ T cells. This therapy induces or restores patients’ immune tolerance by establishing stable donor chimerism in the transplant recipient without the need for life-long immunosuppression.

With the growing stem cell therapy pipeline, do we have enough manufacturing capacity: 

Given complex manufacturing protocols, and high development costs, stem cell therapy developers are increasingly becoming dependent on contract service providers to leverage long term expertise and optimize operating expenses.

Infographic: why there is a need for Outsourcing in stem cell therapies as per Roots Analysis

Who are the CMOs that can manufacture stem cell therapies: More than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing for various types of stem cell therapies.

Infographic: Stem Cell Contract Manufacturers future evolution of the market as Roots Analysis

With increasing application in regenerative medicine and other neuro-related disorders, stem cell therapies have gained traction in the last few years. In fact, more than 500 interventional stem cell-related clinical studies have been registered in the last five years.

Infographic: Stem Cell Therapy - Demand vs Supply representation

Given that stem cell therapy manufacturing requires highly regulated, state-of-the-art technologies, it is difficult for stakeholders to establish in-house expertise for large-scale manufacturing of stem cell therapies. As a result, stem cell therapy developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs). Specifically, small and mid-sized players in this sector tend to outsource a substantial proportion of clinical and commercial-scale manufacturing processes to contract service providers.

The stem cell manufacturing market for CMO is expected to grow at compounded annual growth rate (CAGR) of 18% during the forecast period 2019 – 2030.