Hemogenyx Pharmaceuticals Regulatory News (HEMO)

13 January 2021

Hemogenyx Pharmaceuticals plc 

("Hemogenyx Pharmaceuticals" or the "Company")

Update on CDX Antibody Development

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company ("GlobalCo"). As a result of the Company's successful collaboration with GlobalCo, the Company has chosen a clone of its CDX antibody that is ready for investigational new drug ("IND") application-enabling studies, a significant step toward clinical trials.

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. Under the Agreement, which stipulated that GlobalCo's identity remain anonymous for the time being, Hemogenyx Pharmaceuticals received, free of charge, technical support, access to advanced methods of discovering, developing and engineering antibodies, and certain intellectual property necessary for the successful preclinical development of the Company's lead candidate bi-specific CDX antibody for the treatment of acute myeloid leukemia ("AML"). This work complemented the Company's own development work that was being undertaken.

With the phase of the Agreement relating to the development of the antibody completed, under the Agreement, as of 11 January 2021, GlobalCo has three months to exercise an option to license the Company's intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis ("Option"). In the event GlobalCo and Company are unable to reach an exclusive licensing agreement within six months of GlobalCo's exercise of the Option, if any, or if GlobalCo does not exercise the Option, Hemogenyx Pharmaceuticals will have three months to exercise an option to license the GlobalCo's intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis, followed by six months to reach an exclusive licensing agreement.

In either scenario, the Directors are confident that a successful outcome will be achieved to take the development of the CDX antibody forward toward clinical trials. In the meantime, the Company and GlobalCo will continue developing the CDX antibody asset.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: 

"We are extremely pleased with the outcome of our collaboration with GlobalCo, which has resulted in a CDX antibody that is ready to be developed for clinical trials. I am very proud of the Company's team of scientists who, without a doubt, have proven that Hemogenyx Pharmaceuticals is capable of performing cutting edge research and development of the highest calibre. The completion of the development of the CDX antibody with GlobalCo is a key milestone on our path to creating an effective treatment for patients suffering from AML, and we look forward to entering into the next phase of negotiations with GlobalCo."

About AML

AML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than 30% in adults) and is currently treated using chemotherapy, rather than the potentially more benign and effective form of therapy being developed by Hemogenyx Pharmaceuticals. The successful development of the new therapy for AML would have a major impact on treatment and survival rates for the disease.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation No 596/2014 until the release of this announcement. 

Enquiries:

About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals plc is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.

The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.

For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. The Company's technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation.