Hemogenyx Pharmaceuticals PLC Announces Lentivirus Re-manufacturing Completed

Rhea-AI Summary

Hemogenyx Pharmaceuticals plc (LSE:HEMO) has successfully completed the re-manufacturing of an improved lentivirus devoid of splice variants, essential for the development of their HEMO-CAR-T cells to treat acute myeloid leukaemia. The re-manufacturing resolves the clinical hold imposed by the FDA, allowing the company to move forward with the IND application and subsequent clinical trials. CEO Dr Vladislav Sandler expressed optimism about the clear path to lifting the clinical hold and the company's commitment to expeditiously resubmit the IND.

Positive

• Successful completion of re-manufacturing resolves FDA clinical hold
• Clear path to lifting the clinical hold and resubmitting the IND
• Optimistic outlook from CEO Dr Vladislav Sandler

Negative

• None.

Lentivirus Re-manufacturing Completed

LONDON, UK / ACCESSWIRE / November 15, 2023 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce the successful completion of the re-manufacturing of an improved lentivirus ("LVV") devoid of splice variants. The LVV is used to programme the Company's Chimeric Antigen Receptor ("CAR") T-cells ("HEMO-CAR-T") for the treatment of acute myeloid leukaemia ("AML"). Spontaneous splicing during the manufacturing of LVV was the only reason for the clinical hold imposed by the U.S. Food and Drug Administration ("FDA") on the Investigational New Drug ("IND") application for the Company's HEMO-CAR-T product candidate. As agreed with the FDA, before the resubmission of the IND, the Company will perform an additional process qualification run of the end-to-end process for the manufacture of HEMO-CAR-T cells using the new LVV and we will now put this process into effect.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are pleased that we have a clear path to the lifting of the clinical hold. We are now working hard to complete the schedule of work set out in the plan presented and agreed to by the FDA and to re-submit the IND as expeditiously as possible to move forward with clinical trials of HEMO-CAR-T."

About AML and CAR-T Therapy
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 a new therapy for AML would have a major impact on treatment and survival rates for the disease.

CAR-T therapy is a treatment in which a patient's own T-cells, a type of immune cell, are modified to recognize and kill the patient's cancer cells. The procedure involves: isolating T-cells from the patient; modifying the isolated T-cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient's cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.

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.

Enquiries:

Hemogenyx Pharmaceuticals plc	https://hemogenyx.com
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder	headquarters@hemogenyx.com
Peter Redmond, Director	peter.redmond@hemogenyx.com
SP Angel Corporate Finance LLP	Tel: +44 (0)20 3470 0470
Matthew Johnson, Vadim Alexandre, Adam Cowl
Peterhouse Capital Limited	Tel: +44 (0)20 7469 0930
Lucy Williams, Duncan Vasey, Charles Goodfellow

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.

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SOURCE: Hemogenyx Pharmaceuticals PLC

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FAQ

What is the purpose of the re-manufacturing of the lentivirus?

The re-manufacturing is essential for the development of HEMO-CAR-T cells to treat acute myeloid leukaemia, resolving the clinical hold imposed by the FDA.

Why was the clinical hold imposed by the FDA?

The clinical hold was due to spontaneous splicing during the manufacturing of the lentivirus, which has now been resolved.

What is the CEO's outlook on the completion of the re-manufacturing?

CEO Dr Vladislav Sandler expressed optimism about the clear path to lifting the clinical hold and the company's commitment to expeditiously resubmit the IND.