Hemogenyx Pharmaceuticals PLC (LSE: HEMO, OTC: HOPHF) announced that it is in the final stages of establishing a clinical site for a Phase I trial of its lead asset, HEMO-CAR-T, aimed at treating acute myeloid leukaemia (AML).
Key Highlights
· The U.S. Food and Drug Administration (“FDA”) lifted the clinical hold on the Investigational New Drug (“IND”) application for HEMO-CAR-T.
· Raised £3.325 million to advance HEMO-CAR-T towards Phase I clinical trials.
· Phase I clinical trials expected to begin shortly at M.D. Anderson Cancer Center (“MD Anderson”) in Texas.
· Continuing to make advancements with the Company’s Chimeric Bait Receptor (“CBR”) and bispecific antibody (“CDX”) programmes.
In an update accompanying its interim results, the company revealed that the prestigious MD Anderson Center in Texas will administer treatment to the first patient. Additionally, the University of Pennsylvania has expressed strong interest in participating, though this will likely occur after the end of the year.
HEMO-CAR-T is an innovative next-generation CAR-T (chimeric antigen receptor T-cell therapy) that transforms the fight against cancer by reprogramming the body’s natural defenses, specifically T-cells, to identify and eliminate cancer cells.
This CAR-T therapy provides a rare offering in the healthcare industry: a potentially curative treatment.
In addition to HEMO-CAR-T, Hemogenyx is advancing two other promising drug candidates targeting different health challenges.
The company’s CBR (Chimeric Bait Receptor) platform represents an advanced immunotherapy designed to reprogram immune cells, such as macrophages, to combat viral infections and target specific cancers. Initially aimed at treating viruses like COVID-19, CBR has demonstrated potential against various cancers, including rare types like epithelial ovarian carcinoma.
The platform’s versatility allows for intranasal delivery of treatments, which could be particularly advantageous for addressing airborne infections. Ongoing research is focused on enhancing the stability of mRNA-based CBRs to improve their efficacy.
Additionally, Hemogenyx is advancing its CDX program, designed to assist AML patients in preparing for bone marrow transplants. CDX targets AML cells directly while also conditioning patients for transplantation.
The company has developed an enhanced version of CDX using bispecific pairing technology, which has shown improved effectiveness in laboratory tests. This new version is currently undergoing animal studies in preparation for clinical trials.
For the six months ending June 30, the company reported a loss of £2.8 million as it invested in its R&D efforts and ended the period with £1.6 million on its balance sheet.
