Minovia Therapeutics Announces FDA Clearance of IND Application for a Phase Ib Clinical Trial of MNV-201 in Low Risk Myelodysplastic Syndrome

MNV-201 is a mitochondrial cell therapy product composed of autologous hematopoietic stem cells enriched with allogeneic mitochondria

In pre-clinical studies, MNV-201 demonstrated improved engraftment and bone marrow reconstitution potential of patient derived hematopoietic stem cells

In vitro data also demonstrated improved ability to differentiate to erythroid cells, supporting potential for improvement in biomarkers of anemia

HAIFA, Israel, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd, a clinical stage biopharmaceutical company advancing mitochondrial cell therapies for primary and secondary mitochondrial diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MNV-201, an autologous hematopoietic stem cell product augmented with allogeneic mitochondria. The IND supports the initiation of a Phase Ib dose exploration clinical trial of MNV-201 in patients with Low Risk Myelodysplastic Syndrome (MDS).

Anemia is a common and serious symptom in patients with low-risk myelodysplastic syndrome (LR-MDS), affecting almost 90% of cases and is often the primary characteristic of the disease. Anemia in MDS can have a negative impact on quality of life and may correlate with decreased progression-free survival and overall survival. 

“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 program for this first-in-class allogeneic mitochondrial therapy for low risk MDS patients,” said Natalie Yivgi Ohana, PhD, CEO of Minovia. “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 anemia in this patient population.”

The Phase Ib clinical trial is an open-label, dose exploration study to evaluate the safety and efficacy of MNV-201 in subjects with low risk MDS. This trial will continue our campaign to evaluate dose exploration and safety of single or repeat dosing of MNV-201. The trial will also enable assessment of efficacy in improving anemia and durability of response. The study is expected to enroll at least three patients each in the low, medium and high dose cohorts, and up to a total of 15 patients in total. For more information visit clinicaltrials.gov.

About MNV-201
MNV-201 is an autologous hematopoietic stem cell product enriched with allogeneic mitochondria. MNV-201 aims to restore mitochondrial function in low risk MDS patient hematopoietic stem cells, resulting in improved differentiation to erythroid lineage with the potential to improve anemia. Preclinical research suggests the potential for safe dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for MNV-201 therapy.

About Minovia Therapeutics
Minovia Therapeutics Ltd. is a clinical stage biotechnology company advancing mitochondrial cell therapies for primary-genetic and age-related mitochondrial diseases. Minovia's clinical stage product candidate, MNV-201, is composed of mobilized peripheral blood, autologous CD34+ cells enriched with allogeneic, cryopreserved placental derived mitochondria, produced by Minovia's proprietary Mitochondrial Augmentation Technology (MAT). The enrichment of hematopoietic stem cells with healthy and functional mitochondria aims to restore stem cells function of patients suffering mitochondrial dysfunction, caused both by mtDNA mutations or deletions in pediatric patients suffering from primary mitochondrial diseases, or in adults with age-related bone marrow failure disorders. MNV-201 is currently in clinical studies for pediatric patients with single-large scale mtDNA deletion syndromes (Pearson Syndrome and Kearn Sayre Syndrome) with four patients successfully dosed; and in Low Risk Myelodysplastic Syndrome. For more information, please visit www.minoviatx.com or follow the Company LinkedIn.

About Low Risk Myelodysplastic Syndrome

Myelodysplastic syndromes (MDS) are a group of bone marrow failures that occur when the blood-forming cells in the bone marrow become abnormal leading to an abnormal differentiation and production of one or more blood cell types. Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenias or progression to acute myeloid leukemia (AML). MDS is generally a disease that develops with aging; the median age at diagnosis of MDS is ~70 years.

Mitochondrial Dysfunction in MDS: Scientific literature shows a correlation between mitochondrial dysfunction and MDS progression. It is known that ineffective hematopoiesis in MDS results from increased susceptibility of clonal myeloid progenitors to apoptosis. This may be triggered by intrinsic factors, such as mitochondrial polarization due to iron retention in ringed sideroblasts. A subset of MDS patients present with sideroblastic anemia, a phenotype common in Pearson Syndrome patients and which implicates mitochondrial dysfunction of HSPCs as part of the pathology of MDS.

Contact Information: Natalie Yivgi Ohana, Co-Founder and CEO

Phone: +972-74-7039954

Email: info@minoviatx.com


Minovia Therapeutics Announces FDA Clearance of IND Application for a Phase Ib Clinical Trial of MNV-201 in Low Risk Myelodysplastic Syndrome

THỦ THUẬT HAY

Cách khắc phục khi Facebook của bạn bị 'dính' Virus

Nếu Facebook bị virus hoặc tài khoản của bạn đã bị hack? Dưới đây là bốn cách mà bạn nên thử: phục hồi tài khoản của bạn, thay đổi mật khẩu của bạn, loại bỏ các ứng dụng nghi ngờ, và thực hiện quét virus.

Đem tính năng bảo mật độc quyền của Galaxy A 2017 lên mọi máy Android

Bộ đôi Samsung A5 2017 và A7 2017 được trang bị tính năng bảo mật SecureFolder, xuất hiện lần đầu tiên trên siêu phẩm Galaxy Note 7. Đây là cách bạn mang tính năng độc đáo này lên tất cả các máy Android khác dễ dàng.

Cách tạo hình ảnh động với hiệu ứng đặc biệt chỉ với iOS 11 và Live Photo

Bản cập nhật iOS 11 mang lại khá nhiều thay đổi trong giao diện cũng như thêm các tính năng hay. Bài viết này sẽ hướng dẫn bạn tạo ra những bức...

Muốn chống theo dõi vị trí điện thoại, tắt định vị GPS là chưa đủ

Sở hữu một chiếc smartphone hiện đại sẽ mang lại nhiều tiện ích hữu dụng cho người dùng tuy nhiên cũng ẩn chứa không ít rủi ro. Một trong số đó là việc bị theo dõi vị trí bí mật. Hôm nay chúng tôi sẽ chia sẻ cho các

Cách sửa lỗi Adobe Flash Player bị chặn trên Cốc Cốc và Firefox

Không hiển thị nội dung Flash, Plugin không hồi đáp hoặc bị treo là những lỗi thường xuyên xảy ra khi duyệt web, chơi game khiến người dùng vô cùng khó chịu. Vậy phải làm sao đây?

ĐÁNH GIÁ NHANH

Đánh giá Toyota Avanza 2018 1.5AT 7 chỗ – chật hẹp và yếu hay không?

Với mức giá 593 triệu đồng, nhưng vẫn cung cấp 7 chỗ ngồi, Toyota Avanza thực hiện nhiệm vụ lấp vào khoảng trống bên dưới mẫu xe đàn anh Fortuner. Cũng giống như chiếc xe Mitsubishi Xpander vừa ra mắt, đây sẽ là lựa

Đánh giá hiệu năng ASUS Zenfone 3 Max: Đủ dùng trong hầu hết trường hợp

ASUS Zenfone 3 Max là chiếc điện thoại tầm trung với thời lượng pin vượt trội. Và đây cũng là sản phẩm đầu tiên của ASUS sử dụng vi xử lý MediaTek.