Hemogenyx Pharmaceuticals PLC (LSE:HEMO, OTC:HOPHF), the clinical-stage biopharmaceutical group developing treatments for cancers and viral diseases, said it has expanded its clinical trials for its lead asset, HEMO-CAR-T, adding a prestigious but unnamed US medical centre to its list of study sites.
At the same time, clinical site setup is underway at the University of Pennsylvania and the new medical facility.
This multi-step process involves thorough internal reviews by the science review committee and the internal review board of both clinical sites, along with budget negotiations and logistics planning.
The company is collaborating with Prevail Infoworks, a contract research organisation (CRO), to manage and oversee the planning for these trials.
In addition to its current efforts, Hemogenyx is seeking to expand the HEMO-CAR-T, which uses the company's humanised monoclonal antibody, to include pediatric acute myeloid leukaemia (AML) and a subset of pediatric acute lymphoblastic leukaemia (ALL) patients.
An amendment to the clinical protocol to include pediatric AML is currently under review by third-party experts. If approved, the company plans to implement clinical trials for pediatric AML at the newly established clinical site.
"The addition of a world-renowned medical centre to our HEMO-CAR-T clinical trial sites marks a significant step forward in our mission to develop life-saving therapies," said Dr Vladislav Sandler, the company's CEO.
"Our expansion into pediatric indications for HEMO-CAR-T highlights our commitment to addressing unmet medical needs in both adult and pediatric populations."
In the same update, investors were told scientists at Hemogenyx Pharmaceuticals are developing and testing multiple assets based on its chimeric bait receptor (CBR) platform.
The plan is to identify the best candidates for targeting rare cancers, such as epithelial ovarian carcinoma. Selected candidates will undergo rigorous testing to advance them to investigational new drug (IND)-enabling studies.
CBR is an advanced immunotherapy designed to reprogram or redirect innate immune cells, such as macrophages, to prevent and combat infections from existing and emerging viral threats, as well as to eliminate specific types of cancer.
In parallel, Hemogenyx is developing mRNA-based delivery of CBRs for treating airborne viral infections via intranasal administration.
Recent improvements in the stability of mRNA-based CBRs are expected to enhance the effectiveness of this treatment.
Running alongside this, CEO Sandler said the company was looking for additional, non-dilutive investment.
"We look forward to updating our shareholders and the market as we continue to make strides in our development programmes," he added.