ClinImmune Labs Change Patient Outcomes in Unique Ecosystem

ClinImmune Labs is a network of innovators and dedicated visionaries that specialize in cell therapy and gene therapy. A pioneer in
stem cell therapy, ClinImmune recognizes their team brings a unique ecosystem to the work that pushes successes to the next level,
saving more patients lives across several countries and reaching more advances in scientific discoveries.

CBSA President & CEO, Jennifer Jones Paton, asked Brian M. Freed, Ph.D., DABHI, ClinImmune Lab’s Executive Director, CBSA’s
Key Questions for Life Sciences Innovators.

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Q: Tell us about your company or organization.

A: ClinImmune was founded in 1997 as a transplantation genetics company and has evolved over the past two decades into a cell therapy and gene therapy company.

We have provided immunologic services for over 13,000 solid organ and stem cell transplants at 125 hospitals in 25 countries. ClinImmune was one of the first companies in the United States to obtain FDA licensure for a stem cell therapy.

Q: Describe your team culture. How does your culture shape what your
company or organization produces or offers?

A: ClinImmune has eighty employees and seven faculty who specialize in
immunogenetics, bioinformatics, stem cell biology, transfusion medicine and regulatory medicine.

Together, they form a unique ecosystem by which to advance basic science
discoveries through the technical, medical and regulatory phases of FDA

Q: What are you working on right now?

A: ClinImmune has a Phase I clinical trial at Anschutz Medical Campus using umbilical cord mesenchymal stem cells grown in a bioreactor to treat chronic diabetic foot ulcers, which is the leading cause of amputation in this country.

We also have a patent for gene editing of the HLA molecule to treat patients with rheumatoid arthritis. HLA gene editing is still in the final stages of preclinical development.

Q: How will your work save or change lives?

A: ClinImmune has provided FDAapproved stem cell therapies to over 2,000 patients suffering from hematologic malignancies, stroke, or diabetic foot ulcers.

Diabetic foot ulcers alone affect 3.9 million Americans and lead to 115,000
amputations per year. They have a five-year mortality that is worse than

Q: How has COVID-19 imapcted your company or organization?

A: ClinImmune is preparing to provide mesenchymal stem cells for a clinical trial to treat COVID-associated acute respiratory distress syndrome.

Q: CBSA champions a collaborative life sciences ecosystem because we are #strongertogether. How has being an active participant in our life sciences community supported your success?

A: We are developing a model that combines the technical and regulatory
infrastructure of ClinImmune with the management expertise of CBSA
member, Vida Biomedical to advance promising cell and gene therapies into clinical trials for significantly less than the traditional cost.

We will be working with Vida Biomedical and its subsidiary RheumaGen, which recently agreed to an exclusive license agreement with the University of Colorado, to commercialize our groundbreaking gene editing therapy for rheumatoid arthritis.

We anticipate that our partnership with CBSA will represent a new model by which University of Colorado intellectual property can be ushered through FDA approval and commercialized.

ClinImmune Labs is located within the Fitzsimons Innovation Community.

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