Happy to wait29 May 2024 18:26
Thought it may be time to remember what is in progress, article from Proactive Investors 9th April this year
Hemogenyx Pharmaceuticals important raise and CAR-T potential makes it one to watch
Hemogenyx will use the newly raised funds to take HEMO-CAR-T into the clinic to treat AML later this year.
The open-label study will test for any potential side effects from treating people with blood-borne diseases and assess how the therapy interacts with the body.
A secondary goal or 'endpoint' will be whether any of the critically ill AML patients chosen for the trial respond to the CAR-T infusion.
Under the strict guidelines laid down by the US Food & Drug Administration, patients will be dosed individually one month apart, recognising people are being administered with a potentially toxic cells.
Hemogenyx hopes to have the results from “two, or even three patients” in time for the American Society of Hematology conference in early December.
Success at this stage would be a 30% response rate, says Dr Vladislav Sandler, chief executive and co-founder of Hemogenyx.
Investigational work will be carried out by a team from the University of Pennsylvania, led by Professor Nolle Frey, who has headed a number of important CAR-T clinical trials.
The entre was provided by Professor Carl June, the ‘father’ of CAR-T, and his colleague, Dr Saar Gill, who was involved in the preclinical research on HEMO-CAR-T.
On the university’s involvement, Sandler said: “This isn’t a situation where we’ve paid [UPenn] to carry out the work. They don’t work like that. All along it been data driven.”
While no guarantee of success, it provides validation for the science behind the efforts of Hemogenyx.
So expensive is the process of creating individual CAR-T treatments, that cash raised in February may be enough to dose three patients.
Hemogenyx will look to further non-dilutive funding to assess a cohort of around 18 AML sufferers, which will take it to the phase II stage of the clinical evaluation.
This is key, as it is the point that big pharma has weighed into the sector with the deals mentioned above.
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