Caladrius Bio (CLBS) Working on Promising Type 1 Diabetes Therapy

Stephen L Kanaval  |

Caladrius Biosciences (CLBS) has potential as a player in the fight against Type 1 Diabetes through autologous CAR-T. This technology is in the hands of few competitors – it is the engineering of CAR (Chimeric Antigen Receptors) and TCR (T Cell Receptors) into a patient’s lymphocytes.

The Phase 2 candidate is CLBS03 for fighting Type 1 Diabetes and it involves drawing the patient’s blood and infusing TREG (T-regulatory cell-based therapy) back into the patient’s blood stream improving their quality of life and saving them from intravenous insulin injections. Type 1 Diabetes is where the autoimmune system attack insulin-producing cells in the pancreas and can affect a patient chronically from childhood onward. The TREG does this by restoring beta cells in the pancreas. The company has teamed up with Sanford Research to begin a Phase 2 trial. The current timeline for those results are not known. That said, the results from the Phase 1 trial were very promising.

Caladrius’ subsidiary, PCT (Progenitor Cell Therapeutics), is a contract service operator that provides research, engineering and development services to clients in the cell therapy field. The subsidiary had a great 2015 with revenues up 27%. Many analysts consider this the bread and butter of the company and Caladrius itself has said they are going to focus on its growth. Here is what the company said in a press release at the beginning of the year:

Following a comprehensive review of the Company’s existing operations and development pipeline, as well as an updated assessment of current market dynamics, current and expected future competitive therapies and the Company’s financial resources, Caladrius has decided to shift greater focus and resources to its growing cell therapy process development, optimization and manufacturing services business at its PCT subsidiary. The rapidly developing cell therapy industry, with several cell-based therapies approaching market approvals which are expected to generate additional demand for commercial manufacturing infrastructure, along with PCT’s continued trend of strong revenue growth, supports the Company’s commitment to focus on growth opportunities for PCT.

And here is the quote from David J. Mazzo, Ph.D., CEO:

Moving forward, we strongly believe PCT represents a compelling opportunity for near- and long-term shareholder value creation and we intend to continue to invest resources in expanding that business, where we are already experiencing noteworthy year-over-year revenue growth…

The company clearly sees potential in this vibrant cell therapy company and seem to now know what they have in mind for growth.

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