Hemogenyx Regulatory News (HEMO)

13 October 2021

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

CDX Licence Agreement

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces that it has signed a licence agreement (the "Agreement") with the global biopharmaceutical company Eli Lilly and Company ("Lilly"). Under this Agreement, Lilly grants the Company an exclusive worldwide licence to certain intellectual property developed by Lilly ("IP") related to a CDX bispecific antibody ("CDX" or the "Licensed Product") for all uses, including the treatment of acute myeloid leukemia ("AML") and other blood cancers.

Following an earlier agreement between Lilly and the Company, Lilly carried out work in developing and validating CDX and thus created IP of its own, which the Company needs to further develop and exploit CDX.

Under the Agreement, the Company has agreed to make an up-front payment to Lilly of US$250,000. The Agreement also provides for milestone payments to Lilly of up to US$1 million through to Phase II clinical trials. Lilly is also eligible to receive substantial additional milestone payments based on the achievement of prespecified clinical, regulatory, and commercial milestones upon reaching certain minimum sales, as well as tiered royalties on sales. In addition, the Company will pay Lilly a percentage of any cash payments received in respect of any sub-licence of the licensed IP.

A lead CDX antibody candidate has been successfully created and the Company is initiating investigational new drug ("IND")-enabling studies that include manufacturing of the antibody for animal toxicology studies and subsequent clinical trials. The work done to date fully validates the Company's original expectations and shows wider potential applications for CDX than originally envisaged. It is now being developed for conditioning for bone marrow transplantation and also for the treatment of several blood cancers, as further described below in the section headed 'About CDX' below.

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

"The successful completion of the licence agreement with Lilly represents a real milestone in the development of the Company. It opens an unobstructed low-cost path for the Company toward clinical proof of concept for one of its main product candidates, the CDX bispecific antibody. We are now focused on advancing it to clinical trials. Our collaboration with Lilly has proved highly beneficial and we now look forward to taking the project forward."

About CDX

Hemogenyx Pharmaceuticals' CDX antibody was conceived to render conditioning for bone marrow transplants safer by eliminating the side effects that accompany traditional methods of patient preparation for bone marrow transplantation. Work to date confirms that it may be effective in this function and also confirms that the antibody will have substantially wider applicability. In particular, it targets a majority of forms of relapsed/refractory acute myeloid leukaemia ("R/R AML"), a subset of acute lymphoblastic leukaemia ("ALL"), and myelodysplastic syndrome (myelodysplasia or "MDS").

Effective and non-toxic conditioning via CDX would extend BM/HSC transplantation to older and more frail patients and also grow the market by making the therapy safer and therefore applicable to larger numbers of patients.

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 inside information for the purposes of Article 7 of Regulation No 596/2014 (as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018) until the release of this announcement. The person responsible for arranging for the release of this announcement on behalf of Hemogenyx Pharmaceuticals plc is Dr Vladislav Sandler, Chief Executive Officer & Co-Founder.

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About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals 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.