Hemogenyx Pharmaceuticals plc develops clinical-stage biopharmaceutical therapies for blood and autoimmune diseases. Company news centers on HG-CT-1, its CAR-T cell therapy program for relapsed or refractory acute myeloid leukemia, including FDA IND reporting, clinical development updates, product stability work and lentiviral-vector manufacturing processes.
Recurring announcements also cover the company's CDX and CBR product candidates, platform technologies used for novel product development, and capital-market actions such as equity issuance, warrant exercises, prospectus publication, total voting rights and admissions of ordinary shares to trading on the London Stock Exchange.
Hemogenyx Pharmaceuticals has successfully raised £4,056,250 through the issuance of 162,250,000 new ordinary shares at 2.5 pence per share. This fundraising effort will support the advancement of their HEMO-CAR-T product candidate into clinical trials and the development of their Chimeric Bait Receptor (CBR) platform. The shares are expected to be admitted for trading on the London Stock Exchange around February 2, 2023, increasing the total issued capital to 1,141,999,321 shares. CEO Dr. Vladislav Sandler highlighted the importance of moving forward with their key products to combat viral infections.
Hemogenyx Pharmaceuticals plc has successfully completed its third Process Qualification run for the manufacturing of HEMO-CAR-T cells in cGMP compliant facilities. This achievement is crucial for the submission of an Investigational New Drug (IND) application to the FDA, required for initiating Phase I clinical trials. The company will conduct analytical release tests to ensure the quality of these cells, which will also be tested by a third party before the data is compiled for the IND submission.
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Hemogenyx Pharmaceuticals has completed its second Process Qualification run for the manufacturing of HEMO-CAR-T cells in compliant clean rooms. This step is crucial for filing an Investigational New Drug application with the FDA, necessary for starting Phase I clinical trials. The company plans to execute a minimum of three identical manufacturing runs to meet regulatory requirements. The progress underscores Hemogenyx's commitment to advancing therapies for severe blood diseases.
Hemogenyx Pharmaceuticals has successfully completed its first Process Qualification (PQ) run for the manufacture of HEMO-CAR-T cells, a crucial step in preparing for the Investigational New Drug (IND) application to the FDA. This PQ run is part of at least three required identical runs to facilitate the IND submission necessary for Phase I clinical trials. The process was executed in a cGMP-compliant environment, followed by quality verification tests on the manufactured cells, indicating readiness for further regulatory steps in the development of new therapies for blood diseases.
Hemogenyx Pharmaceuticals plc has successfully completed its second and final Process Development run for HEMO-CAR-T cell manufacturing in cGMP-compliant facilities. This advancement is a crucial step towards submitting the Investigational New Drug application to the FDA for initiating Phase I clinical trials of HEMO-CAR-T. The company is now preparing for engineering runs as part of its Process Qualification phase. Hemogenyx focuses on developing innovative therapies for serious blood diseases and aims to enhance patient access to life-saving bone marrow transplants.
Hemogenyx Pharmaceuticals has released its interim results for the six months ending June 30, 2022. The company reported a loss of £1,300,653, a decrease from the £3,632,338 loss in 2021, with cash reserves of £5,799,495. Key advancements include the preparation to file an Investigational New Drug (IND) application for HEMO-CAR-T, bolstered scientific teams, and the establishment of a new facility in Manhattanville, New York. The company continues to explore the development of CDX antibodies and Chimeric Bait Receptor platforms.
Hemogenyx Pharmaceuticals will present at the H.C. Wainwright 24th Annual Global Investment Conference in New York City from September 12-14, 2022. CEO Dr. Vladislav Sandler will discuss the company's progress in developing therapies for blood diseases. The conference will feature corporate presentations and investor meetings, accessible through a webcast. This event aims to boost Hemogenyx's visibility and establish its role in treating severe blood and autoimmune diseases, underlining the potential impact of their bone marrow transplantation technologies.
Hemogenyx Pharmaceuticals announces the appointment of Stuart Tinch as Director of Quality, enhancing their commitment to Good Manufacturing Practice (GMP) standards. Tinch, with over seven years of experience, will focus on implementing quality systems for the company’s lead therapy, HEMO-CAR-T, currently being prepared for clinical trials. His previous role at Expression Therapeutics involved establishing GMP facilities, which aligns with Hemogenyx's goals of ensuring high-quality standards for its product candidates.
Hemogenyx Pharmaceuticals announced the grant of a significant patent by the China National Intellectual Property Administration for its bi-specific antibody technology, enhancing its intellectual property portfolio. The granted patent (No. 201780034711.2) pertains to an innovative method to eliminate hematopoietic stem cells for patients undergoing bone marrow transplantation. This breakthrough could potentially reduce reliance on toxic conditioning treatments, significantly impacting blood cancer therapy, including acute myeloid leukemia. The original application dates back to April 2016, with US rights granted in 2021.