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MDR-101:

Our lead product candidate is MDR-101, a cellular immunotherapy manufactured from a living kidney donor’s blood and bone marrow cells. MDR-101 is designed to allow certain kidney transplant recipients with a genetically-matched, or HLA-matched, living kidney donor to stop all immunosuppressive drug use, while preserving long-term transplant kidney function and survival. A Phase 2 trial of the Stanford predecessor product candidate in 28 patients demonstrated the ability to achieve persistent mixed chimerism in 86% (24 of 28) of patients and eliminated the need for all immunosuppressive drugs in 82% (23 of 28) of patients. Additionally, as of March 31, 2018, 73% (19 of 26) have been off all immunosuppressive drugs for more than two years, including some with ongoing durable responses lasting five to 10 years from the time of stopping all immunosuppressive drugs. Two patients remain in follow-up, are free of immunosuppressive drugs, and have not yet reached two years off all drugs. We are currently enrolling patients in a pivotal Phase 3 clinical trial. More information on this clinical trial is available at https://clinicaltrials.gov/ct2/show/NCT03363945.

MDR-102:

Our product candidate MDR-102 is a cellular immunotherapy for kidney transplant recipients with a genetically-mismatched, or HLA-mismatched, living donor, and is also manufactured from a kidney donor’s blood and bone marrow cells. While the process is similar, it uses a different proprietary composition than MDR-101. MDR-102 is intended to treat living donor, HLA-mismatched kidney transplant patients in order to reduce the risk of kidney rejection, minimize immunosuppressive therapy and thereby improve long-term transplant kidney function and survival. In a Phase 1 study, of the Stanford predecessor product candidate in 22 patients, Stanford researchers identified a CD34+ cell dose that resulted in the achievement of sustained mixed chimerism, lasting 12 months or longer. Of the 10 patients who achieved sustained mixed chimerism, receiving more than 10 x10^6 CD34/kg, 9 were able to undergo immunosuppressive drug reduction to maintenance on a single drug. As of September of 2018, these same 9 patients did not develop biopsy proven acute rejection, or BPAR, de novo donor specific antibodies (dnDSA), or Grade 2 or greater interstitial fibrosis and/or tubular atrophy, or IF/TA, during follow-up. In contrast, only 18% (2 of 11) of patients who did not achieve sustained mixed chimerism were able to undergo immunosuppressive drug reduction and 64% (7 of 11) of these patients developed at least one episode of BPAR, dnDSA or Grade 2 or greater IF/TA. We expect to open a Phase 2/3 trial of MDR-102 in the fourth quarter of 2018. More information on this clinical trial is available at https://clinicaltrials.gov/ct2/show/NCT03605654.

MDR-103:

Our product candidates intended for delayed therapy in transplant patients are MDR-103 and MDR-103-MM. The first, MDR-103, is designed to treat transplant recipients who already received an HLA-matched, living donor kidney transplant months or years before. MDR-103 is intended to allow these patients to eliminate all immunosuppressive drug use, while preserving transplant kidney function and survival. In the third quarter of 2018, we expect to initiate a Phase 2 proof-of-concept trial of MDR-103 in these patients. The primary efficacy endpoint is the proportion of subjects achieving persistent mixed chimerism, defined as achieving mixed chimerism for at least six months. We also intend to explore delayed therapy in HLA-mismatched kidney transplant recipients. More information on this clinical trial is available at https://clinicaltrials.gov/ct2/show/NCT03606746.