Hemogenyx Pharmaceuticals Regulatory News (HEMO)

Hemogenyx Pharmaceuticals Plc 

("Hemogenyx" or the "Company")

LakePharma appointed as Service Provider for lead drug development

Hemogenyx Pharmaceuticals Plc (LSE: HEMO), the biotechnology company developing novel therapies to transform bone marrow, or blood stem cell, transplantation for the treatment of blood diseases, announced today it has chosen LakePharma, Inc. as its service provider for the development and manufacturing of Hemogenyx's lead product, CDX bi-specific antibodies. The company believes that CDX bi-specific antibodies could replace traditional methods of conditioning patients for bone marrow transplants-eliminating the need for pre-transplantation chemotherapy and radiation, which can damage a patient's health-and allow more patients to benefit from the curative power of bone marrow transplants.

The relationship between Hemogenyx Pharmaceuticals and LakePharma is designed to have a seamless product development process, from discovery to biomanufacturing, as Hemogenyx moves its cutting-edge therapies toward clinical trials. Strategically, the formalization of this relationship is particularly significant because it marks a major step in the pre-clinical development of Hemogenyx's CDX antibodies. Undertaken with the expertise and validated technology of LakePharma, the largest US-based biologics contract research organization, this step brings Hemogenyx significantly closer to its goal of taking the CDX antibodies into clinical trials at the earliest opportunity with a faster path through pre-clinical trials.

Dr. Vladislav Sandler, CEO of Hemogenyx, said: "After a thorough evaluation process, we chose to partner with LakePharma for the development and manufacture of CDX antibodies for preclinical tests. The speed, quality and sophistication of LakePharma's services gives us confidence that we will go into clinical trials on time with a reliable product that will eventually save lives."

Dr. Hua Tu, Founder and CEO of LakePharma, commented: "LakePharma has been providing antibody engineering and bioproduction service to Hemogenyx for several years and helped them to create the underlying IP for their CDX technology. We are pleased to see that LakePharma's one-stop-shop capabilities can be applied towards Hemogenyx's breakthrough product development."

Hemogenyx has achieved proof of principle for the use of CDX antibodies to condition patients for bone marrow transplant and anticipates beginning clinical trials of the therapy within 18 months. Already, Hemogenyx has functionally validated CDX bi-specific antibodies in vitro and in vivo in humanized mouse models. It is anticipated that the CDX bi-specific antibodies will be capable of use as an "off-the-shelf" conditioning product available for application for all BM/HSC transplantations that require conditioning.

Blood cancers affect more than 1.1 million people in the United States each year, and it is estimated that 171,500 new blood cancer diagnoses were made in 2016. Hemogenyx seeks to fundamentally change how patients are conditioned before transplantation. Currently, patients receive chemotherapy and radiation treatments before transplant. These preparative regimens are toxic and non-selective, resulting in severe side effects that can be life-threatening or lead to complications including radiation damage, fertility issues, bone damage and bone growth problems.

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About Hemogenyx Pharmaceuticals Plc

Hemogenyx Pharmaceuticals Plc is a publicly traded company (LSE: HEMO) headquartered in London, with its wholly owned U.S. operating subsidiary, HemoGenyx LLC, located in its state-of-the-art research facility in Brooklyn, New York. HemoGenyx is a preclinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapies and treatments for blood diseases such as leukemia and lymphoma. The company's leading technologies aim to change the way in which bone marrow/hematopoietic stem cell (BM/HSC) transplants are performed and improve their efficacy. HemoGenyx's two distinct and complementary products include an immunotherapy product for patient conditioning-the CDX bi-specific antibody-and a cell therapy product for BM/HSC transplantation-the HuPHEC. Each of these products holds the potential to revolutionize the way BM/HSC transplants are being performed, offering solutions that mitigate the dangers and limitations associated with the current standard of care. For more information, visit www.hemogenyx.com.

About LakePharma

LakePharma is the leading US-base biologics company specializing in antibody engineering, antibody discovery, molecular engineering, protein chemistry, bioexpression, biofunction, bioprocessing, and bioanalytics. LakePharma focuses on integrated platforms to support projects throughout the drug discovery process. LakePharma offers dedicated client services and sophisticated software to provide real-time access to project data via a secure cloud-based portal. For more information, visit www.lakepharma.com.