Vaxinia clears Cohort 1 in the combination arm with...

Vaxinia clears Cohort 1 in the combination arm with pembroluzimab - the end is in sight

Good news yesterday that Vaxinia has cleared the first cohort in combination with Pembroluzimab (i.e., Keytruda). Keytruda’s owners Merck shall no doubt be keeping a watchful eye on proceedings from afar, as they approach a patent cliff with respect to their blockbuster MAB. The announcement seems to have been tempered somewhat by Leslie Chong’s failure to refer to potential “positive signals” from trial patients, as she has in the past. That said she did express excitement at being close to finding out the impact Professor Fong’s ingenious virus has had in treating solid tumour cancer patients. Keep in mind Yuman has stated this vaccine is one of the best ever formulated, with all solid tumour types on the radar, in this trial and beyond.

The question becomes how far Professor Fong decides to dial up the therapeutic window in search of Vaxinia’s optimal biological dose rate. He has suggested several more parts of his potent oncolytic virus can be added prior to side effects becoming evident in patients. In other words patient dosage rates can be increased significantly before toxicity becomes apparent. This factor whilst promising from both a commercial and treatment perspective could in fact prolong the trial as supervisors continue to ratchet up dosage rates in search of their products equilibrium.

Perhaps of further note is the company’s directive to identify and then illustrate success in distinctive cancer types, (ie, pancreatic or stomach cancer as an example). If Vaxinia can be shown to have regressed if not eradicated solid tumours in multiple patents within the one cancer indication, e.g., pancreatic, then the door is open for FDA Fast Track Approval, for clearly the drug is in the realms of a “significant breakthrough therapy”.

Either way, even if the clinical trial continues to progress somewhat deeper and further into the new year the results of existing cohorts are set to published at SITC in November this year. Professor Fong has stated that once the virus infects a tumour, it works, and that the goal is now to ascertain the most appropriate mode of delivery, particularly to those “hard to get to” tumours such as tumours in the liver or pancreas, and those behind the abdominal cavity wall within patients. Given his confirmation the virus is working at earlier shareholder conferences, November is set to be present an inflexion point for IMU holders, who have been hanging on by a thread in search of the potential pot of gold at the end of the rainbow this trial represents. For not only does the Vaxinia trial have ramifications for solid tumour patients, the viruses tentacles have the potential to lure in CAR T and allogenic therapies, whose providers (including now Imugene themselves through Azer cel) currently have little or no medical or commercial access to the lucrative solid tumour market.

Is the treatment arm combined with Keytruda showing more positive signs of efficacy than the monotherapy arm in the trial? Was this arm responsible for a higher level of side effects within patients? How are the combination trial patients progressing? The FDA imposes tight restrictions on how and what information Imugene is allowed to publish in relation to patient outcomes during the trial. But once patient biopsies are assessed and peer reviews have been collated, the outcomes shall become clear for all to see. As that day approaches I would be hoping current holders were in a position to stick to their guns and hold onto whatever IMU shares they can at whatever the cost. But then again the world is changing, people are looking shorter and shorter term in their equity investment time frames, whilst cost of living pressures are weighing on those in search of income in their investments.

Whatever your position in the current investment cycle keep a close eye in years to come on the word “Vaxinia” when googling the internet in search of cures for cancer. I’m confident it may just start to rank in google search. And if indeed it does, I’m confident there shall be a price tag attached.

DYOR - Seek investment advice as and when required - Opinions only