The trial will explore the safety and efficacy of various dosages of MNV-201 in individuals diagnosed with low risk MDS. Credit: Owlie Productions / Shutterstock.

The US Food and Drug Administration (FDA) has granted clearance for Minovia Therapeutics’ investigational new drug (IND) application to commence a Phase Ib trial of MNV-201 for low-risk myelodysplastic syndrome (MDS).

The dose exploration, open-label trial will explore the safety and efficacy of various dosages of MNV-201 in individuals diagnosed with low-risk MDS.

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The primary focus of the study is to determine the optimal dose and evaluate the treatment’s ability to improve anaemia and the durability of the response.

Minovia plans to enrol a minimum of three patients in each of the low, medium, and high-dose groups. The aim is to enrol up to a total of 15 patients.

An innovative therapy, MNV-201 combines autologous haematopoietic stem cells with allogeneic mitochondria.

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This asset aims to enhance the function of mitochondria in the hematopoietic stem cells of low-risk MDS patients. This could potentially lead to enhanced differentiation into the erythroid lineage and, as a result, ameliorate anaemia.

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In preclinical studies, MNV-201 showed the potential to be administered safely with a low risk of immunogenicity and the possibility of scaling up production to meet the needs of a large patient population.

Minovia Therapeutics CEO Natalie Yivgi Ohana said: “The FDA’s clearance of our IND marks an important achievement for Minovia, allowing us to clinically evaluate our allogeneic mitochondrial cell therapy approach and proceed with the Phase Ib clinical programme for this first-in-class allogeneic mitochondrial therapy for low-risk MDS patients.

“We are pleased to have safely dosed two MDS patients enrolled in an ongoing study under the Israeli Ministry of Health. We look forward to treating additional patients under this IND, as well as to learning about the potential of MAT to improve anaemia in this patient population.”