RE: A recap of my journey with Hemo - for newbies ahead of the RNS we are all excited about1 Feb 2024 08:02
Continued from last page
It’s now 1st February , 2024;
Share price is currently @ 3.35 pence – valuing the company at £39mThe company released news on 23rd March confirming it had completed the final step required to submit an IND into the FDA for it’s lead clinical candidate CAR-T; with the formality of a final refinement of the paperwork the only thing left to complete.
Hemogenyx are now on the brink of achieving a momentous Biotech milestone; taking their lead clincial candidate, Hemo CAR-T, into Clinical Trials
They entered the final straight in the July 2022 when moving into new premises - a bigger, better 'state of the art' Lab providing the facilities to manufacture CAR-T themselves (and save £millions in doing so vs using third party)
Seven RNSs later, 5 of which charted the manufacturing progress and 2 communicated the critical new appoinments of "director of quality' and 'medical director' the company filed its IND with the FDA in May 2023
Sadly, it was announced in June that the FDA had put the IND on hold due to a single issue that turned out to be 'splicing caused in the manufacturing of the lentivirus.
Vlad and the team have been using AI successfully in their pre-clinical studies. This allowed Hemogenyx to identify the issue before it was formally communciated by the FDA
Since then, (1) the FDA Approved the plan presented by Hemogenyx to address the splicing issue, (2) The lentivirus has been remanufactured with a change in the process that successfully resolved the splicing issue and (3) A full and final'end to end' manufacturing run was completed successfuly having been tested by Hemo and a third party
Hemogenyx submitted a "Complete Response" to the FDA on 15th January 2024; the FDA will communicate their decision within 30 days
Therefore we all remain on tenderhooks for the pivotal RNS that we hope to confirm the FDA has lifted the clincial hold - it genuinely could land any time now between 7am and 6:30pm on trading days - and no later than 13th February (so a maxium of 8 sessions)
It's taken 12 month longer than we all hoped to get to this stage - but in that time Hemo have made significant progress.
The company also released news this year on another of it’s clinical candidates; Here’s the headline update given by the company:
“made significant progress towards the practical use of its Chimeric Bait Receptor ("CBR") platform technology, designed to program immune cells to eliminate viral infections by destroying the viruses that cause them. The Company's scientists have identified a target protein that can be incorporated into a single multipurpose CBR-based therapeutic capable of treating multiple viruses that belong to different viral families, instead of having to make a separate CBR construct for every virus. Among them are Dengue, Ebola, Marburg, Zika and Chikungunya. These viruses are among the most dangerous to humans, causing serious and often fatal diseases, and for which few effect