Hemogenyx Pharmaceuticals PLC

A very bright future for Hemogenyx

“…It’s a very exciting time in the company. For our size and for the amount of investment, we have achieved much more than multiple times bigger and better funded companies that are listed or not listed on NASDAQ or elsewhere…”

Twelve months ago, the message from biopharmaceutical group Hemogenyx Pharmaceuticals was the most important catalyst was clinical trials.

There’s been a slight interruptus to that ambition courtesy of the U.S. regulatory body the Food and Drug Administration which has placed a clinical hold on the company’s investigational new drug ‘IND’ application for the treatment of acute myeloid leukaemia.

Founder and chief executive Dr Vladislav ‘Vlad’ Sandler is disappointed but reminds investors “What we’re experiencing right now is not the worst time in the history of the company, and we always survive and will always move forward and that’s precisely what’s going to happen now.”

Obviously, there are several hurdles to overcome including satisfying the FDA’s questions before clinical trials of the HEMO-CAR-T cell therapy can commence, but once the go ahead is given, Hemogenyx is ready.  Waiting is the service provider that will project manage and supervise the running of the phase one trials, and there is cash remaining from the fund raise in January.

“It’s a very exciting time in the company,” says Sandler. “And we are optimistic as ever and unlike the market we don’t recoil when faced with the hiccup. Basically, we double down our efforts and power through. That’s what we have been doing since we went into operations over eight years ago and it’s the keystone of our company’s values and culture. And I have to also emphasize that for our size and for the amount of investment, we have achieved much more than multiple times bigger and better funded companies that are listed or not listed on NASDAQ or elsewhere.”

Those companies referenced might well become potential partners as Sandler tells Sarah Lowther in a video interview (below) that discussions with partners are ongoing but is too diplomatic to expand on how well established and well known these partners are and for what purpose.

It’s worth reminding investors that while the current focus is on the progression of HEMO-CAR-T, the company has a broad pipeline including the Chimeric Bait Receptor ‘CBR’ platform technology, designed to programme immune cells to eliminate viral infections by destroying the viruses that cause them.  Sandler says this is “is poised to change the way we fight viral infections.”

He also lists the ‘horrible viruses’ the company is addressing including Ebola, Zika, SARS Covid 2, Marburg, Dengue and Chikungunya.  The focus now though is addressing the FDA’s concerns and returning to the important catalyst of clinical trials.